Azalia - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Desogestrel

Azalia 75 micrograms film-coated tablets

Why is Azalia used? What is it for?

This medicine is for the prevention of pregnancy.

How does it work?

Azalia contains a small amount of a type of female sex hormone, the progestin desogestrel. For this reason, Azalia is referred to as a progestogen-only pill or "minipill". Unlike the combined pills, the minipill does not contain estrogen hormones, only progestin. Most minipills act mainly by preventing sperm from reaching the uterus but are not always able to inhibit the maturation of the egg cell which is the main action of the combined pills.

Azalia differs from other minipills because its dosage is high enough to prevent the maturation of the egg cell in most cases and consequently ensures a high contraceptive efficacy.

Unlike combined pills, Azalia can be used by women who cannot tolerate estrogen and women who are breastfeeding. One downside is the irregular vaginal bleeding that can occur while using Azalia. It is also possible that the bleeding will not occur at all.

Contraindications When Azalia should not be used

Azalia does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Do not take Azalia

Do not use Azalia if you are in any of the conditions listed below. If any of these apply to you, tell your doctor before you start taking Azalia. Your doctor may advise you to use other non-hormonal methods of birth control.

  • If you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
  • If you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, which can lead to blockage of the blood vessel (e.g. in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), in the heart (heart attack) or to the brain (stroke)}.
  • If you have or have suffered from severe liver disease and your liver function values ​​(based on blood tests) have not returned to normal.
  • If you have a tumor that grows under the influence of certain hormones (progestins), such as some types of breast cancer.
  • If you have any vaginal bleeding of an undetermined nature.

If any of these conditions appear for the first time while taking Azalia, you should consult your doctor immediately.

Precautions for use What you need to know before taking Azalia

Talk to your doctor or pharmacist before taking Azalia

If you use Azalia in the presence of any of the following conditions, you may need to be monitored closely.

Your doctor will tell you what to do. Therefore, if any of these conditions occur, tell your doctor before you start taking Azalia:

  • if you have or have ever had breast cancer;
  • if you have liver cancer;
  • if you have or have ever had a venous thromboembolism (blood clot);
  • if you have diabetes;
  • if you have epilepsy (see "Other medicines and Azalia");
  • if you have tuberculosis (see "Other medicines and Azalia");
  • if you have high blood pressure;
  • if you have or have ever had chloasma (yellowish-brown patchy pigmentation of the skin, especially on the face); in this case avoid excessive exposure to the sun or ultraviolet radiation.

Interactions Which drugs or foods can change the effect of Azalia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can stop the pill from working properly. These include medicines to treat:

  • epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and phenobarbital),
  • tuberculosis (e.g. rifampicin, rifabutin),
  • HIV infection (e.g. ritonavir, nelfinavir),
  • fungal infections (e.g. griseofulvin,),
  • activated charcoal used for stomach ailments,
  • preparations based on St. John's wort (Hypericum perforatum).

Your doctor will tell you if you need to take additional contraceptive measures, and for how long. Azalia can also interfere with the action of some medicines, causing them to increase (eg for medicines containing cyclosporine) or reduce their effect.

Warnings It is important to know that:

Breast cancer

Get regular breast checks and contact your doctor promptly as soon as you feel any lumps in your breast.

Breast cancer has been diagnosed slightly more often in women who take the pill than in women of the same age who do not. If the woman stops taking the pill, the risk gradually decreases until, 10 years after stopping treatment, the risk returns to the same as for women who have never used the pill. In women under 40 breast cancer is rare, but the risk increases with increasing age. Consequently, the number of more cases of breast cancer diagnosed is greater the greater the age to which the woman continues to take the pill. The duration of taking the pill is less relevant.

For every 10,000 women who take the pill for up to 5 years but stop taking it by the age of 20, less than 1 extra case of breast cancer is likely to occur in the 10 years following stopping. , in addition to the 4 cases normally diagnosed in this age group. Likewise, out of 10,000 women who take the pill for up to 5 years but stop taking it by the age of 30, they are likely to 5 more cases occur in addition to the 44 cases normally diagnosed. Out of 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, 20 more cases are likely to occur in addition to the 160 cases normally diagnosed.

The risk of breast cancer for women using progestogen-only pills such as Azalia is believed to be similar to those taking the pill, but the evidence has provided less conclusive results.

Breast cancer diagnosed in women who take the pill seems less likely to spread than breast cancer diagnosed in women who do not take the pill. It is not known whether the difference in breast cancer risk is caused by the pill. It may be that women who take the Pill undergo more frequent checks and therefore the diagnosis of breast cancer is earlier.

Thrombosis

Contact your doctor immediately if you notice the appearance of possible signs of thrombosis (see also the 'When to contact your doctor' section).

Thrombosis is the formation of a blood clot that can cause a blockage of a blood vessel. Sometimes thrombosis occurs in the deep veins of the legs (deep vein thrombosis). If the clot breaks away from the veins in which it has formed, it can reach and clog the pulmonary arteries, causing what is called "pulmonary embolism." As a result, fatal cases can occur. Deep vein thrombosis occurs rarely and can develop whether you take the pill or not. It can also occur if you become pregnant .

The risk is higher in women who take the pill than in women who do not. The risk of thrombosis with progestogen-only pills such as Azalia is believed to be lower than in those who also take pills that also contain estrogen (combination pills).

Children and adolescents

The safety and efficacy of desogestrel in adolescents below 18 years have not been established. No data are available.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Azalia if you are pregnant or if you think you are pregnant.

Azalia can be used during breastfeeding. Azalia does not affect the production or quality of breast milk. However, small amounts of the active substance in Azalia passes into the milk.

The health of babies breastfed for 7 months by mothers who were taking desogestrel has been studied up to 2.5 years of age. There was no effect on the growth and development of the children observed.

If you are breast-feeding and want to take Azalia, please contact your doctor.

Driving and using machines

Azalia does not affect the ability to drive and use machines.

Azalia contains lactose

Patients with lactose intolerance should be advised that Azalia tablets contain 64.08 mg of lactose (as lactose monohydrate).

If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.

Regular periodic checks

While you are taking Azalia, your doctor will tell you to come back for regular periodic checkups. In general, the frequency and nature of these checks will depend on your personal condition.

Contact your doctor as soon as possible if:

  • you experience severe pain or swelling in either leg, unexplained chest pain, shortness of breath, unusual cough, especially with blood (which indicates a probable thrombosis);
  • you have sudden and severe stomach pains or have a yellowish color (which indicates probable liver problems);
  • you feel a lump in your breast (which indicates probable breast cancer);
  • you experience sudden and severe pain in your lower abdomen or stomach (which indicates a probable ectopic, ie extra-uterine pregnancy);
  • you must be immobilized or undergo surgery (see your doctor at least four weeks in advance);
  • you have unusual and profuse vaginal bleeding;
  • suspected pregnancy.

Dose, Method and Time of Administration How to use Azalia: Posology

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Each blister of Azalia contains 28 tablets. Arrows and days of the week are printed on the front of the blister to help you take the pill correctly. Take the tablet daily at about the same time every day. Swallow the tablet whole with water.

Each time you start a new strip of Azalia, take the tablet from the top row. For example, if you start on Wednesday, you must take the tablet from the top row marked WED.

You must continue to take one tablet a day, until the blister is empty, always following the direction indicated by the arrows. If you start on a Monday, the blister will be empty at the end of the arrows, but in any other case before starting a new blister you must use the tablets left in the top corner of this strip. This way you can easily check if you have taken the tablet. Vaginal bleeding is possible with the use of Azalia (see section "Possible side effects"), however you should continue taking the tablet as usual.

Once the pack is finished, you should start a new pack of Azalia the next day - without interruption and without waiting for bleeding to start.

Beginning of the first pack of Azalia

If you are not currently using a hormonal contraceptive (or have not used it in the previous month)

Wait for your period to start. On the first day of your period, take the first tablet of Azalia. No additional contraceptive measures are necessary. It can also start between the second and fifth day of your period but, in this case, make sure you also use additional contraceptive measures (barrier method) in the first seven days of taking the tablets.

Changing from a combination pill, vaginal ring, or transdermal patch.

You can start taking Azalia the day after taking the last tablet of the previous pill, or the day you remove the vaginal ring or transdermal patch (this means no break without a pill, ring or patch). previous contraceptive also contains inactive tablets, you can start Azalia the day after taking the last active tablet (if you are not sure which tablet it is, ask your doctor or pharmacist). If you follow these instructions, you will not need any further contraceptive measures.

You can also start, at the latest, the day after the break interval from the pill, ring or patch, or the day after taking the last placebo tablet of your previous contraceptive. If you follow these instructions, make sure to use additional contraceptive measures (barrier method) for the first 7 days of taking the tablets.

Switching from "another progestogen-only pill (mini-pill).

You can stop taking your previous contraceptive on any day and start taking Azalia right away. No additional contraceptive measures are necessary.

Changing from an injectable contraceptive, implant or progestogen-releasing intrauterine device (IUD).

Start taking Azalia on the day the next injection should be given or the day the implant or IUD is removed. No additional contraceptive measures are necessary.

After giving birth.

You can start taking Azalia between day 21 and day 28 after your baby is born. If you start later, be sure to use additional contraceptive measures (barrier method) during the first course of treatment during the first 7 days of taking the tablets. However, if intercourse has already occurred, pregnancy should be ruled out before starting Azalia.

For women who are breastfeeding, further information is provided in section 2, "Pregnancy and breastfeeding". Your doctor can also advise you on this.

After a "termination of pregnancy or a miscarriage.

Your doctor will advise you on this.

If you forget to take Azalia

If the delay is less than 12 hours

Take the tablet as soon as you remember and the next at the usual time. The contraceptive protection of Azalia is not reduced.

If the delay is more than 12 hours

Take the tablet as soon as you remember to do so and the next at the usual time. This may mean taking two tablets on the same day. It is not harmful. (If you have forgotten more than one tablet, you do not need to take the previously forgotten tablets). You cannot consider yourself fully protected from pregnancy. Continue to take your tablets at the usual time but you must use additional contraceptive measures, such as using a condom for the next 7 days.

The higher the number of consecutive missed tablets, the greater the risk that contraceptive efficacy will decrease.

If you have forgotten one or more tablets in the first week of taking and had sex in the week before you missed the tablets, there is a possibility that you may have become pregnant. Ask your doctor for advice.

If you experience vomiting, diarrhea or if you have taken activated charcoal

If vomiting, severe diarrhea or activated charcoal occurs within 3-4 hours of taking the tablet, the absorption of the active substance may not be complete. In this case, the advice described above should be taken into consideration in case of forgotten tablet-taking.

If you stop taking Azalia

You can stop taking Azalia whenever you want. You are no longer protected against pregnancy since the day of interruption. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken too much Azalia

There is no evidence of serious harmful effects from taking too many Azalia tablets at the same time. In this case, symptoms such as nausea, vomiting and slight vaginal bleeding may occur in young women. For more information, ask your doctor for advice.

Side Effects What are the side effects of Azalia

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects associated with the use of Azalia are described in section 2 "What you need to know before you take Azalia". Read this section for further information and, if necessary, consult your doctor immediately.

While taking Azalia, vaginal bleeding may occur at irregular intervals. It may be small leaks without the need for the use of hygienic protection, or more abundant bleeding, comparable to a light menstruation, which requires the use of sanitary pads. Hygienic bleeding may not occur at all. Irregular bleeding does not indicate a decrease in the contraceptive protection of Azalia. In general, no measures need to be taken, you should just continue to take Azalia. If, however, the bleeding is heavy or heavy. persists, tell your doctor.

The following side effects have been reported in women taking desogestrel:

Common (may affect up to 1 in 10 people):

  • mood changes,
  • decreased libido,
  • depression,
  • headache,
  • nausea,
  • acne,
  • breast pain,
  • irregular or absent menstrual cycle,
  • weight gain

Uncommon (may affect up to 1 in 100 people):

  • vaginal infections,
  • difficulty wearing contact lenses,
  • He retched,
  • hair loss,
  • painful menstrual cycle,
  • ovarian cysts,
  • tiredness

Rare (may affect up to 1 in 1,000 people)

  • rash,
  • urticaria,
  • blue-red skin nodules (erythema nodosum) (skin disorders)

Ectopic pregnancy (where the baby develops outside the uterus) has been reported on rare occasions. If you have severe or sudden pain in the lower abdomen or stomach area (which may indicate an ectopic pregnancy) you should contact your doctor. as soon as possible.

Apart from the side effects listed, breast discharge or loss may occur.

You should see your doctor immediately if you experience symptoms of angioedema, such as (i) swelling of the face, tongue or pharynx; (ii) difficulty swallowing; or (iii) hives and difficulty breathing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Store in the original package to protect from light and moisture.

This medicinal product does not require any special storage temperatures. Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Azalia contains

  • The active ingredient is desogestrel. One film-coated tablet contains 75 micrograms of desogestrel.
  • The other ingredients are:
    • Tablet core: Lactose monohydrate Potato starch Povidone K-30 Silica, colloidal anhydrous Stearic acid α-Tocopherol all racemic
    • Coating: Polyvinyl alcohol Titanium dioxide E171 Macrogol 3000 Talc

What Azalia looks like and contents of the pack

Azalia is a white to off-white, round, biconvex film-coated tablet, approximately 5.5 mm in diameter, with "D" mark on one side and "75" on the other side.

Azalia film-coated tablets are packed in a blister consisting of clear, rigid PVC / PVDC - aluminum foil. Each blister is placed in a laminated aluminum pouch. The blisters in the pouches are packed in a folded cardboard box together with the leaflet. illustrative and a small case to store the blister.

Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets.

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Azalia can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

AZALIA 75 MCG TABLETS COATED WITH FILM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

One film-coated tablet contains 75 mcg of desogestrel.

Excipient with known effect: 52.34 mg of lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Film-coated tablet.

White to off-white, round, biconvex film-coated tablets of approximately 5.5 mm in diameter, with a "D" mark on one side and "75" on the other.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Contraception.

04.2 Posology and method of administration -

Dosage

The tablets should be taken every day at approximately the same time so that the interval between taking two tablets is always 24 hours. The first tablet should be taken on the first day of the menstrual cycle and then it should be taken one tablet a day continuously without taking into account possible vaginal bleeding. After taking the first pack, start a new pack the next day.

How to start treatment with Azalia

No hormonal contraceptive treatment [in the previous month]

Taking the tablets should start on the first day of the woman's natural cycle (ie the first day of menstruation). It is also possible to start between the second and fifth day of the cycle but, in this case, during the first treatment cycle also recommends using a barrier method during the first seven days of tablet-taking.

After a first trimester abortion

After a first trimester abortion, it is recommended to start immediately. This way there is no need for additional contraceptive measures.

After a birth or second-trimester abortion

Contraceptive treatment with Azalia after childbirth can be started before the arrival of the menstrual cycle. However, if more than 21 days have elapsed, pregnancy must be ruled out and an additional method of contraception must be used during the first seven days of taking the tablets.

For more information on breastfeeding women, see section 4.6.

How to start treatment with Azalia when substituting another method of contraception

Changing from another combined hormonal contraceptive (combined oral contraceptives (COCs), vaginal ring or transdermal patch)

The woman should start treatment with Azalia preferably the day after taking the last active tablet (the last tablet containing the active substance) of the previous COC or the day she removes the vaginal ring or transdermal patch. In this case, no additional contraceptive measures are necessary.

The woman can also start treatment at the latest on the day after the usual pill or patch break interval or the day after the last placebo tablet of the previous combined hormonal contraceptive but, in all cases, it is also recommended to use a barrier method in the first 7 days of taking the tablets.

Changing from a progestogen-only method of contraception (mini-pill, injection, implant) or from a progestogen-releasing intrauterine device (IUS)

The woman can switch from a mini-pill on any day (from an implant or an IUS start treatment on the day of removal, from an injectable contraceptive start treatment on the day the next injection should be given) .

Behavior in case of forgetting a tablet

If the time elapsed between taking two tablets is more than 36 hours, contraceptive protection may be reduced. If the time elapsed from the usual time of taking any tablet is less than 12 hours, the missed tablet should be taken. as soon as you remember and the next tablet should be taken at the usual time. If you are more than 12 hours late, you should use additional contraception for the next 7 days. If you forget to take the tablets in the first sexual intercourse took place during the week and during the previous week, the possibility of pregnancy should be considered.

Advice in case of gastrointestinal disorders

In case of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures must be taken. If vomiting occurs within 3-4 hours of taking the tablet, absorption may not be complete. In this case, take Consider the recommendations in case of forgotten tablet-taking in the sub-section "Behavior in case of forgotten tablet".

Therapy monitoring

Before prescribing, a thorough medical history of the patient should be taken and a thorough gynecological examination is recommended to rule out pregnancy. Any bleeding disorders, such as oligomenorrhea and amenorrhea, should be evaluated prior to prescribing. individual circumstances of each case. If the prescribed product can plausibly influence latent or manifest disease (see section 4.4), follow-up visits should be scheduled accordingly.

Despite regular intake of Azalia, disturbances in menstrual bleeding may occur. If bleeding is frequent and irregular, another method of contraception should be considered. If symptoms persist, an organic cause must be ruled out.

The management of amenorrhea during treatment depends on whether or not you take the tablets as directed and may include a pregnancy test.

If pregnancy occurs, treatment should be stopped.

Women should be advised that Azalia does not protect against HIV (AIDS) and other sexually transmitted diseases.

Pediatric population

The safety and efficacy of desogestrel in adolescents aged less than 18 years have not yet been established. There are no data available.

Method of administration

For oral administration.

04.3 Contraindications -

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

- Active venous thromboembolic disorder.

- Severe liver disease, either current or past, until liver function values ​​have returned to normal.

- Known or suspected malignant diseases sensitive to sex steroids.

- Vaginal bleeding of an unknown nature.

04.4 Special warnings and appropriate precautions for use -

If any of the following risk factors / conditions are present, the benefits of using progestogens should be weighed against the possible risks of each individual case and discussed with the woman before deciding to start treatment with Azalia. of aggravation, exacerbation or first appearance of any of these conditions, the woman should contact her doctor. The doctor should decide whether taking Azalia should be discontinued.

The risk of breast cancer generally increases with increasing age. There is a slightly increased risk of being diagnosed with breast cancer during combined oral contraceptive (COC) use. This increased risk gradually disappears over 10 years after COC use is discontinued and is unrelated to duration. of the treatment, but at the age of the woman in the period in which she was using COC. We calculated the expected number of cases diagnosed with breast cancer in 10,000 women taking CHCs (up to 10 years after "stopping treatment) compared to women who have never used an oral contraceptive in the same period and for the same group of patients. age, and is presented in the following table.

Age range Cases expected in COC users Cases expected in non-users 16-19 years 4,5 4 20-24 years 17,5 16 25-29 years 48,7 44 30-34 years 110 100 35-39 years 180 160 40-44 years 260 230

The risk in women using progestogen-only contraceptives (POCs), such as Azalia, is likely to be similar to that associated with taking COCs. However, for POCs, the evidence is less clear. With respect to the risk of getting cancer. over a lifetime, the risk increase associated with CHCs is low. Breast cancer diagnosed in women who take COCs tends to be less clinically advanced than that diagnosed in women who have never used a COC. The increased risk seen in women taking COCs may be due to an earlier diagnosis, the biological effects of the pill, or a combination of both.

Since the biological effects of progestogens on liver cancer cannot be excluded, an individual benefit / risk assessment in women with liver cancer is required.

In case of acute or chronic disturbances of liver function, the woman must consult a specialist in order to perform the appropriate tests and receive appropriate assistance.

Epidemiological studies have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep vein thrombosis and pulmonary embolism). Although the clinical relevance of these data in relation to desogestrel, used as a contraceptive in the absence of an estrogen component, is not known, in the event of thrombosis, treatment with Azalia should be discontinued.Discontinuation of Azalia should also be considered in the event of prolonged immobilization due to surgery or illness. Women with a history of thromboembolic disorders should be aware of the possibility of a recurrence.

Although progestogens may affect peripheral insulin resistance and glucose tolerance, there is no evidence for the need for regimen adjustment in diabetic patients using progestogen-only contraceptives. However during the first months of contraceptive use. , diabetic patients must be carefully followed.

If hypertension is experienced for a prolonged period during use of Azalia or if a significant rise in blood pressure does not respond adequately to antihypertensive therapy, discontinuation of Azalia should be considered.

Treatment with Azalia leads to a decrease in serum estradiol levels to a value which corresponds to the early follicular phase. However, it is not known whether this decrease has a clinically significant effect on bone mineral density.

The protection provided by traditional progestogen-only contraceptives against possible ectopic pregnancy is not as optimal as the protection afforded by COCs, and this has been associated with the frequent recurrence of ovulation during the use of progestogen-only contraceptives. the fact that Azalia significantly inhibits ovulation, a possible ectopic pregnancy must be taken into account in the differential diagnosis in those women who suffer from amenorrhea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Patients with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Azalia.

The onset or worsening of the conditions listed below has been reported both during pregnancy and while taking sex steroids, however a correlation between these conditions and the use of progestins has not been established: jaundice and / or itching due to cholestasis; formation of gallstones; porphyria, systemic lupus erythematosus; uraemic-hemolytic syndrome; Sydenham's chorea; herpes gestationis; hearing loss from otosclerosis; angioedema (hereditary).

Azalia film-coated tablets contain 64.08 mg of lactose (as lactose monohydrate) and therefore cannot be taken by patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption.

04.5 Interactions with other medicinal products and other forms of interaction -

Laboratory tests

The data obtained with COCs have shown that the use of contraceptive steroids can influence the results of some laboratory tests including biochemical parameters of hepatic, thyroid, adrenal and renal function, serum levels of transport proteins, for example of globulin binding of corticosteroids and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis. Changes are generally within the range of normal laboratory values. It is not known to what extent this applies to basic contraceptives. progestogen only.

04.6 Pregnancy and breastfeeding -

Pregnancy

Azalia is not indicated for use during pregnancy. If you become pregnant while taking Azalia, treatment with Azalia should be stopped immediately.

Animal studies have shown that very high doses of progestins can cause the masculinization of the female fetus.

Many epidemiological studies have revealed no increased risk of birth defects in babies born to mothers who used COCs prior to pregnancy, nor did they reveal any teratogenic effects when a COC was inadvertently taken early in pregnancy. Neither did it. Pharmacovigilance data on various desogestrel-containing COCs indicate an increased risk.

Feeding time

Desogestrel does not affect the production or quality (protein, lactose or fat concentrations) of breast milk. However, small amounts of etonogestrel, (the metabolite of desogestrel) are excreted in milk. As a result, the infant could ingest 0.01 - 0.05 mcg of etonogestrel per kg of body weight per day (estimate based on a "milk intake of 150 ml / kg / day).

Limited long-term follow-up data are available for infants whose mothers started using Azalia during the fourth to eighth week after delivery. These infants were nursed for 7 months and followed for 1.5 years (n = 32), or up to 2.5 years of age (n = 14). From the assessment of growth and psychomotor development no differences emerged with respect to the infants of mothers who used a copper intrauterine device.

Based on the available data, Azalia can be used during breastfeeding. However, the development and growth of the nursing child whose mother uses Azalia should be carefully monitored.

04.7 Effects on ability to drive and use machines -

Desogestrel has no or negligible influence on the ability to drive or use machines.

04.8 Undesirable effects -

Clinical studies report irregular vaginal bleeding among the most common side effects. In women taking desogestrel, irregular bleeding has been reported in up to 50% of cases. Because desogestrel inhibits ovulation almost 100%, unlike other progestogen-only contraceptives, irregular bleeding is more common than other progestogen-only contraceptives. In 20 to 30% of women, bleeding can become more frequent, while in another 20% bleeding may become less frequent or completely absent. Vaginal bleeding may also have a longer duration. After about two months from the start of treatment, bleeding tends to become less frequent. More information, medical advice and the writing of a bleeding diary can improve the acceptance of this bleeding profile for the woman.

The other most commonly reported undesirable effects in clinical trials with desogestrel (> 2.5%) were: acne, mood changes, breast pain, nausea and weight gain. The undesirable effects are listed in the table below. following.

All undesirable effects are listed by system organ class and frequency; common (≥1 / 100,

MedDRA System Organ Class * Frequency of adverse reactions Common ≥ 1/100, Uncommon> 1 / 1,000, Rare> 1 / 10,000, Infections and Infestations Vaginal infections Psychiatric disorders Mood altered, Libido decreased, Depressed mood Nervous system disorders Headache Eye disorders Contact lens intolerance Gastrointestinal disorders Nausea He retched Skin and subcutaneous tissue disorders Acne Alopecia Skin rashes, Urticaria, Erythema nodosum Diseases of the reproductive system and breast Breast pain, irregular menstruation, Amenorrhea Dysmenorrhea, Ovarian cysts General disorders and administration site conditions Tiredness Diagnostic tests Body weight gain

* MedDRA version 16.1

Breast discharge is possible with the use of Azalia. Ectopic pregnancies have been reported rarely (see section 4.4). In addition, (aggravation of) angioedema and / or aggravation of hereditary angioedema may occur (see section 4.4).

A number of (serious) side effects have been reported in women taking (combined) oral contraceptives. These include venous or arterial thromboembolism, hormone-dependent tumors (eg liver and breast tumors) and chloasma. Some have been covered in detail in section 4.4.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the Website: www. Agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose -

No serious adverse effects from overdose have been reported.

Symptoms such as nausea, vomiting and, in young women, mild vaginal bleeding may occur in this circumstance. There are no antidotes and any further treatment should be symptomatic.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: hormonal contraceptives for systemic use, progestogens.

ATC code: G03AC09.

Azalia film-coated tablets are a progestogen-only pill that contains the progestogen desogestrel.

Mechanism of action

Like other progestogen-only pills, Azalia is best suited during breastfeeding and in women who cannot or do not want to take estrogen. Unlike traditional progestogen-only pills, the contraceptive effect of Azalia is mainly achieved by lactation. "inhibition of" ovulation. Other effects include an increase in the viscosity of the cervical mucus.

In a 2-cycle study, using a definition of ovulation as a progesterone level above 16 nmol / l for 5 consecutive days, the incidence of ovulation was 1% (1/103) with an interval of 95% confidence of 0.02% - 5.29% in the intention to treat group (errors of use and failures of the method). Ovulation inhibition was achieved already in the first treatment cycle. study, with desogestrel discontinued after 2 cycles (56 consecutive days), ovulation occurred on average after 17 days (range 7 - 30 days).

In a comparative drug efficacy study (which allowed a maximum 3 hour delay in tablet intake) the overall Pearl index in the intention to treat group for desogestrel was 0.4 (95% CI 0.09 - 1.20), compared with 1.6 (95% CI 0.42 - 3.96) for 30 mcg of levonorgestrel.

The Pearl Index for desogestrel is comparable to the historically calculated index for COCs in the general oral contraceptive population.

Treatment with desogestrel leads to a reduction in estradiol levels, reaching a level corresponding to the early follicular phase. No clinically significant effects on glucose, lipid metabolism and haemostasis were observed.

Pediatric population

There are no clinical data available on efficacy and safety in adolescents below 18 years of age.

05.2 "Pharmacokinetic properties -

Absorption

After oral administration, desogestrel is rapidly absorbed and converted to etonogestrel. At steady state, peak plasma levels are reached approximately 1.8 hours after tablet intake and the absolute bioavailability of etonogestrel is approximately 70%.

Distribution

Etonogestrel is bound to 95.5 - 99% serum proteins, in particular to serum albumin and to a lesser extent to sex hormone binding globulin (SHGB).

Biotransformation

Desogestrel is completely metabolised via hydroxylation and dehydrogenation to the active metabolite etonogestrel. Etonogestrel is metabolised by sulfation and glucuronidation.

Elimination

The elimination of etonogestrel is characterized by a mean half-life of approximately 30 hours with no difference between single or multiple dosing. A steady state level is reached in plasma after 4-5 days. Serum clearance after i.v. of etonogestrel is about 10 l / h. Etonogestrel and its metabolites are excreted as free or conjugated steroids in urine and faeces (ratio 1.5: 1). In breastfeeding women, etonogestrel is excreted in breast milk at a milk / serum ratio of 0.37 -0.55. Based on these data and an estimated milk intake of 150ml / kg / day, an infant can ingest 0.01 - 0.05mcg of etonogestrel.

05.3 Preclinical safety data -

Toxicological studies did not reveal any effects other than those resulting from the hormonal properties of desogestrel.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Core of the tablets:

Lactose monohydrate,

Potato starch,

Povidone K-30,

Anhydrous colloidal silica,

Stearic acid,

- All racemic tocopherol

Coating:

Polyvinyl alcohol;

Titanium dioxide E171;

Macrogol 3000;

Talc.

06.2 Incompatibility "-

Not relevant.

06.3 Period of validity "-

2 years.

06.4 Special precautions for storage -

Store in the original package in order to protect from light and moisture. This medicine does not require any special storage temperatures.

06.5 Nature of the immediate packaging and contents of the package -

Azalia film-coated tablets are packed in a blister consisting of rigid clear PVC / PVDC - aluminum foil. Each blister is placed in a laminated aluminum pouch. The blisters in the pouches are packed in a folded cardboard box together with the package insert and a small pouch for storing the blister.

Pack sizes: 1x28, 3x28, 6x28, 13x28 film-coated tablets.

Not all pack sizes may be marketed.

06.6 Instructions for use and handling -

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Gedeon Richter Plc. Gyömroi út 19-21

1103, Budapest - Hungary

08.0 MARKETING AUTHORIZATION NUMBER -

AIC n .:

041762016 - "75 mcg TABLETS COATED WITH FILM" 1X28 TABLETS IN PVC / PVDC / AL BLISTER

041762028 - "75 mcg TABLETS COATED WITH FILM" 3X28 TABLETS IN PVC / PVDC / AL BLISTER

041762030 - "75 mcg TABLETS COATED WITH FILM" 6X28 TABLETS

IN PVC / PVDC / AL BLISTER

041762042 - "75 mcg TABLETS COATED WITH FILM" 13X28 TABLETS IN PVC / PVDC / AL BLISTER

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Date of first authorization: October 2012

10.0 DATE OF REVISION OF THE TEXT -

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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