Tretinoin Same - Package Leaflet

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

Active ingredients: Tretinoin

Tretinoin same 0.05% cream

Why is Tretinoin Same used? What is it for?

Tretinoin Same is a cream to be applied to the skin containing the active ingredient tretinoin, which belongs to the category of retinoids. Tretinoin Same is indicated in the local treatment of acne (acne vulgaris).

Contraindications When Tretinoin Same should not be used

Do not use Tretinoin Same

  • if you are allergic to tretinoin or any of the other ingredients of this medicine
  • if you are pregnant (see "Pregnancy and breastfeeding").

Precautions for use What you need to know before taking Tretinoin Same

Talk to your doctor or pharmacist before using Tretinoin Same.

  • Absolutely avoid exposure to direct sunlight and ultraviolet lamps as they cause skin irritation. If you cannot avoid such exposure, keep covered the areas where you apply the medicine or use preparations containing high protection sunscreens.
  • If you have skin irritation following sun exposure (sunburn) you must wait for it to disappear before starting or continuing treatment with this medicine. Keep this in mind if you are particularly exposed to the sun for work reasons or if, due to hereditary predisposition, it is very sensitive to sunlight and because of this it tends to develop damage to the skin.
  • X-ray irradiation, atmospheric agents such as wind and cold, can cause an increase in irritation and redness of the skin in people treated with Tretinoin Same.
  • If you suffer from an inflammatory skin reaction called eczema, you may experience severe irritation (see section 4 "Possible side effects").
  • Do not overuse this medicine, as this will cause excessive skin irritation without improving the therapeutic response to treatment.
  • During treatment with Tretinoin Same you can make use of cosmetics as long as the affected skin areas are thoroughly cleaned before applying the medicine.
  • Avoid having hair products, such as perm solutions or medicated shampoos, come into contact with the skin areas treated with this medicine, as they can cause irritation.
  • Avoid making hair removal just before applying the medicine.
  • Avoid contact of Tretinoin Same with the eyes, mouth, nostrils and mucous membranes as it may be irritating. If this happens, practice a thorough washing with water.
  • The use, especially if prolonged, of the products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components) (see paragraph 4 "Possible side effects").

Children

Use in children under 12 years of age is not recommended as the efficacy and safety of using the medicine in this age group has not been established.

Interactions Which drugs or foods can modify the effect of Tretinoin Same

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

  • If you are simultaneously using other preparations that promote skin peeling, such as resorcinol and salicylic acid, take particular care as serious irritation can occur. If you have used these preparations, ask your doctor or pharmacist for advice, as it is advisable to wait for an appropriate amount of time before starting treatment with Tretinoin Same.
  • You must exercise the same caution if you use medicated or abrasive soaps (scrubs), cosmetics with a strong dehydrating effect, products with a high concentration of alcohol, astringents, etc.
  • Unless otherwise indicated by the doctor, a simultaneous prolonged therapy with corticosteroids (medicines used for inflammation) is not recommended as it can favor the appearance of comedones (blackheads).
  • Avoid concomitant use of photosensitizing drugs (which increase sensitivity to light) such as thiazides (medicines used to lower blood pressure), tetracyclines, fluoroquinolones, sulfonamides (medicines used to treat bacterial infections) and phenothiazines (medicines used to treat of psychosis and depression).

Warnings It is important to know that:

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 using this medicine.

Pregnancy

Do not use Tretinoin Same if you are pregnant or if you suspect that you are pregnant, as it may be harmful to an unborn baby.

If you are of childbearing age, take appropriate fertility control measures.

It is advisable to stop treatment for at least one menstrual cycle before planning a pregnancy.

Feeding time

If you are breastfeeding, use Tretinoin Same only when clearly needed and under strict medical supervision

Driving and using machines

Tretinoin Same does not affect the ability to drive or use machines

Tretinoin Same contains cetyl alcohol

It can cause local skin reactions (e.g. contact dermatitis).

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

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

Apply this medicine once a day, preferably in the evening, on dry skin, after cleaning the affected areas. Lightly smear the cream on the lesions with a cotton ball or your fingers. After each application, wash your hands thoroughly.

The therapeutic effect is noticeable after 2-3 weeks of treatment, but it may take up to 6 weeks to obtain significant results.

During the first weeks of treatment you may experience redness at the application points and an "apparent intensification of" inflammation, due to the action of this medicine against deep skin lesions which were previously not visible.

If the skin irritation is too intense, the time interval between one application and the next will have to be increased.

However, a modest irritation is necessary if meaningful results are to be obtained within a reasonable period of time.

After a few weeks of treatment you will get some improvements that remain by applying Tretinoin Same at longer intervals (every 2-3 days).

For a satisfactory response it is important to apply the medicine regularly.

Do not swallow this medicine.

Do not exceed the recommended dose

Overdose What to do if you have taken too much Tretinoin Same

If you use more Tretinoin Same than you should The use of excessive doses of the product does not improve the therapeutic results but causes an unpleasant irritation of the skin (with redness, peeling, etc.); this irritation disappears by stopping the applications.

Accidental ingestion of Tretinoin Same causes effects similar to those seen with high oral doses of vitamin A (itching, dry skin, joint pain, lack of appetite, etc.).

In case of accidental ingestion / intake of Tretinoin Same, notify your doctor immediately or go to the nearest hospital.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Tretinoin Same

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

Following the use of this medicine, the following side effects may appear:

  • Irritation, even severe, of the application area (erythema). If this occurs, despite having followed the instructions for use and the recommended dosage, you must temporarily stop the treatment, consult your doctor and then use a lower concentration than that previously used. Irritation, even severe, can also occur if applied to skin affected by eczema (inflammatory skin reaction). If you suffer from eczema in the application area you should use this medicine with great caution (see section "Warnings and precautions").
  • Skin lightening (decreased skin pigmentation)
  • Allergic skin reaction, very rarely

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

This medicinal product does not require any special storage conditions.

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 package after EXP. The expiry date refers to the last day of that month.

The expiry date refers to the product in intact packaging, correctly stored

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.

What Tretinoin Same contains

The active ingredient is tretinoin. 100 g of cream contains 0.05 g of tretinoin.

The other ingredients are: cetyl alcohol, stearic acid, isopropyl myristate, polysorbate 60, sorbitan stearate, 70% non crystallizable sorbitol, sorbic acid, sodium edetate, butylhydroxytoluene, purified water.

What Tretinoin Same looks like and contents of the pack

Tretinoin Same is a cream contained in a 20 gram tube.

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 Tretinoin Same 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 interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TRETINOIN SAME 0.05% CREAM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g of cream contain:

Active principle: tretinoin 0.05 g.

Excipients: cetyl alcohol.

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Cream.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Vulgar acne.


04.2 Posology and method of administration

Apply once a day, preferably in the evening, on dry skin, after cleaning the affected areas.

Lightly smear the lesions with a cotton swab or your fingers.

Wash your hands thoroughly after each application. The therapeutic effect is noticeable after 2-3 weeks of treatment, but it may take up to 6 weeks to obtain significant results.

In any case, during the first weeks of treatment there may be redness phenomena at the application site. If the skin irritation is too intense, the intervals between one application and the other must be spaced more apart.

However, a modest skin irritation is necessary if significant results are to be obtained within a reasonable period of time.

During the first weeks an apparent intensification of inflammation can be observed. This is due to the action of the preparation against skin lesions located in depth and previously not visible.

After a few weeks of treatment, favorable therapeutic results will be found which persist by applying TRETINOIN SAME at longer intervals (every 2-3 days).

Therapeutic success is linked to the regularity of the treatments.

Do not exceed the recommended dose.


04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

The use of tretinoin during pregnancy should be avoided.


04.4 Special warnings and appropriate precautions for use

Women of childbearing potential should be made aware of the potential risk and take appropriate fertility control measures.

Exposure to direct sunlight and ultraviolet lamps causes skin irritation, so exposure must be absolutely avoided.

Those who cannot avoid such exposure must keep the affected skin areas covered or use preparations containing sun filters of safe efficacy.

Patients with sunburn should wait for this to disappear before starting or continuing treatment with TRETINOIN SAME.

Those who are particularly exposed to the sun for work reasons must be warned of this.

The recommendation should be extended to patients highly sensitive to sunlight due to hereditary predisposition, with a tendency to manifest skin damage induced by sunlight itself.

In case of X-ray irradiation, TRETINOIN SAME can cause an increase in skin irritation and redness.

Atmospheric agents such as wind and cold can also cause skin irritation in patients under treatment with TRETINOIN SAME.

The preparation must not be brought into contact with the eyes, mouth, nostrils and mucous membranes.

If this happens, it is advisable to carry out a thorough washing with water.

Do not overuse the product: this would cause an excessive skin irritation reaction without improving the therapeutic response to the treatment.

Eczema patients may have severe irritation.

Particular caution should be taken in case of concomitant skin treatment with other preparations, especially with drugs that favor skin peeling.

Patients under treatment with TRETINOIN SAME can make use of cosmetics as long as the affected skin areas are thoroughly cleansed before applying the drug. Hair products, such as perm solutions or medicated shampoos, can cause irritation even to normal skin. Avoid that these products come into contact with the skin areas treated with the product. Avoid any hair removal immediately before applying the drug.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena.

Do not swallow.

Keep TRETINOIN SAME, like all medicines in general, out of the reach of children.

The efficacy and safety of use in children under 12 years of age have not been established.

This medicinal product contains cetyl alcohol as an excipients and therefore may cause local skin reactions (e.g. contact dermatitis).


04.5 Interactions with other medicinal products and other forms of interaction

The concomitant treatment of the skin with other preparations that favor skin peeling, such as resorcinol and salicylic acid, can induce serious irritative phenomena, therefore particular caution must be taken.

If the patient has previously been treated with these preparations, it is recommended to wait for an appropriate interval before starting treatment with TRETINOIN SAME.

Unless otherwise prescribed by a doctor, a simultaneous prolonged therapy with corticosteroids is not advisable as it can favor the appearance of comedones.

The concomitant use of photosensitizing drugs such as thiazides, tetracyclines, fluoroquinolones, phenothiazines and sulfonamides should be avoided.

Similar caution must be taken by subjects who use particular soaps (medicated, abrasive), cosmetics with a strong dehydrating effect, products with a high concentration of alcohol, astringents, etc.


04.6 Pregnancy and breastfeeding

Use in pregnancy

Retinoids, if taken by mouth during pregnancy, can cause serious fetal changes.

It is not sufficiently known whether even local application can be harmful to the development of the fetus. In men, despite some reassuring studies, rare cases of malformations have been reported following topical application of retinoids during pregnancy.

In laboratory animal models, with very high dosages, ossification defects have been observed. The significance of these observations is doubtful, a cause-effect relationship is not demonstrated but not even a reasonable safety. Therefore, they suggest behaviors. of prudence and caution.

Therefore the product should not be used during confirmed or presumed pregnancy and women of childbearing age should be informed of the potential risk in order to adopt suitable fertility control measures and to interrupt the product for at least one menstrual cycle before planning a pregnancy. .

Use while breastfeeding

In breastfeeding women, TRETINOIN SAME should only be used when clearly needed and under strict medical supervision.


04.7 Effects on ability to drive and use machines

TRETINOIN SAME does not affect the ability to drive or use machines.


04.8 Undesirable effects

TRETINOIN SAME can cause severe local erythema. If this occurs, despite having followed the instructions for use and the recommended dosage, it is necessary to temporarily interrupt the treatment and subsequently use the concentration lower than that previously adopted.

The product can cause local irritation, even severe, if applied to skin affected by eczema: in these patients TRETINOIN SAME must be used with great caution.

Contact allergy phenomena after topical applications of TRETINOIN SAME have occurred very rarely.

A decrease in skin pigmentation may be observed during treatment with TRETINOIN SAME.


04.9 Overdose

The use of excessive doses of the product does not improve the therapeutic results but causes an unpleasant skin irritation (with redness, desquamation, etc.), which can be reversed with the suspension of applications.

Accidental ingestion of TRETINOIN SAME causes effects similar to those observed with high oral doses of vitamin A (itching, dry skin, joint pain, loss of appetite, etc.). If this occurs, it is necessary to consult a doctor immediately to adopt the most suitable therapies. suitable.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

TRETINOIN SAME is a preparation for external use based on Tretinoin (trans-retinoic acid) intended for the topical treatment of acne.

Tretinoin accelerates the replacement of epidermal cells and, by reducing the thickness of the stratum corneum, counteracts the obstruction of the sebaceous follicle and the formation of blackheads.


05.2 "Pharmacokinetic properties

Tretinoin essentially exerts a local effect at the level of the treated area and, under normal conditions of use, its absorption is limited at the level of the epidermis.


05.3 Preclinical safety data

Acute toxicity

LD 50 (rat per os) 2000 mg / kg; LD 50 (mouse per os) 2200 mg / kg.

Chronic toxicity

Following topical administration, Tretinoin has shown good tolerability both locally and systemically.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Cetyl alcohol, stearic acid, isopropyl myristate, polysorbate 60, sorbitan stearate, 70% non crystallizable sorbitol, sorbic acid, sodium edetate, butylhydroxytoluene, purified water.


06.2 Incompatibility

Nothing to report.


06.3 Period of validity

2 years.


06.4 Special precautions for storage

This medicinal product does not require any special storage conditions.


06.5 Nature of the immediate packaging and contents of the package

Aluminum tube internally coated with protective paint.

20 g tube.


06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

SAVOMA MEDICINALI S.p.A. - Via Baganza N. 2 / A - 43125 PARMA

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 027707037

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Last renewal: January 2013

10.0 DATE OF REVISION OF THE TEXT

AIFA determination of January 2013

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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