Zerinol throat - Package Leaflet

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

Active ingredients: Ambroxol (Ambroxol hydrochloride)

ZERINOL THROAT 20 mg tablets

Zerinol throat package inserts are available for pack sizes:
  • ZERINOL THROAT 20 mg tablets
  • Zerinol Gola 2.5 mg / actuation of oral mucosal spray, solution

Why is Zerinol throat used? What is it for?

Zerinol Gola contains the active substance ambroxol hydrochloride. The active ingredient is the component of the tablet which gives the required therapeutic effect.

Zerinol Throat has a local anesthetic effect that relieves the pain of acute sore throat.

Zerinol Gola is used for the symptomatic treatment of acute pain in sore throat.

Contraindications When Zerinol throat should not be used

Do not take Zerinol Throat

  • if you are allergic (hypersensitive) to the active substance (ambroxol hydrochloride) or to any of the other ingredients of this medicine
  • if you have rare hereditary conditions of fructose intolerance.

Precautions for use What you need to know before taking Zerinol throat

Take special care with Zerinol Gola

  • children under the age of 12 should not take Zerinol Gola should not take Zerinol Gola for more than 3 days. If you still have symptoms after 3 days or if you have a high fever, consult your doctor.
  • if you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicine. See also" Important information about some of the ingredients of Zerinol Gola ".
  • if you have liver or kidney problems, talk to your doctor before using Zerinol Gola.
  • Zerinol Throat is not suitable for the treatment of painful lesions in the mouth (for example, ulcers or sores). If you have mouth ulcers, please see your doctor. - episodes of shortness of breath (dyspnoea) may be observed due to a concomitant illness (eg swelling in the throat). Another reason may be a feeling of constriction in the throat due to the local anesthetic effect of Zerinol Throat. An additional cause may be an allergic reaction, which can also cause swelling of the mouth and throat.
  • your throat and mouth may feel less sensitive than usual (numbness).
  • if widespread lesions occur on the skin or mucosa, treatment with Zerinol Throat should be stopped as a precaution, and a doctor should be consulted immediately. In very few cases, severe skin lesions (such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (NET)) have been observed simultaneously with the administration of expectorant substances, such as ambroxol, which is also the active ingredient of Zerinol Throat. Most of these skin lesions can be explained by the severity of the underlying disease (various infections) or by the use of medicines indicated to treat such conditions or other concomitant diseases, or by a pre-existing severe skin lesion, which may initially manifest itself with unexplained symptoms. specific, typical of the flu.

Interactions What drugs or foods can change the effect of Zerinol throat

Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Warnings It is important to know that:

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breastfeeding.

Ambroxol passes into the body of the unborn child. Zerinol Gola should not be taken during pregnancy, particularly in the first trimester.

Ambroxol is excreted in breast milk. Zerinol Gola should not be taken while breastfeeding.

Driving and using machines

There are no known effects of Zerinol Gola on the ability to drive or use machines.

Important information about some of the ingredients of Zerinol Gola

One lozenge contains 1.37 g of sorbitol (8.2 g of sorbitol per maximum recommended daily dose) and 6.3 mg of sucrose (37.8 mg per maximum recommended daily dose), which are a source of fructose (a type of sugar). If you suffer from fructose intolerance you should not take this medicine.

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

Dosage and method of use How to use Zerinol throat: Dosage

Always take Zerinol Gola exactly according to the instructions given on the package leaflet.

Adults and children over 12 years: 1 tablet to dissolve in the mouth when it needs to relieve pain. Do not take more than 6 tablets per day.

Do not use Zerinol Gola for more than 3 days. If symptoms persist for more than three days or a high fever, consult your doctor.

Clinical data have shown a rapid onset of the effect (which occurs within 20 minutes at the latest). The effect lasts at least 3 hours.

Overdose What to do if you have taken an overdose of Zerinol throat

If you have taken too many tablets (more than 6 per day) consult your doctor or pharmacist if symptoms appear.

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 Zerinol throat

Like all medicines, Zerinol Gola can cause side effects, although not everybody gets them.

If any of the following side effects occur, stop taking Zerinol Throat and tell your doctor immediately:

  • allergic reaction with localized swelling of the face, lips, mouth, tongue and / or throat (angioedema). This can cause a feeling of constriction in the throat, difficulty swallowing or breathing.
  • the rapid occurrence of allergic reactions affecting the whole body (anaphylactic reactions, including anaphylactic shock).

The severity of allergic reactions may increase if you take the medicine again, or if you take another medicine with the same substance

Other side effects that may occur:

Common frequency (less than 1 in 10, but more than 1 in 100 treated patients):

  • Feeling sick (nausea)
  • Numbness of the mouth, tongue and throat (oral and pharyngeal hypoesthesia)
  • Change in taste (dysgeusia)

Frequency uncommon (in less than 1 in 100, but more than 1 in 1,000 patients treated):

  • Diarrhea - Indigestion (dyspepsia)
  • Stomach pain (pain in the upper abdomen)
  • Dry mouth

The frequency of the following side effects cannot be estimated from the available data:

  • Urge to scratch (hives, itching)
  • Rash (redness of the skin)
  • Allergic reactions (other hypersensitivity reactions)
  • He retched
  • Dry throat

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Keep this medicine out of the reach and sight of children.

Do not use Zerinol Gola after the expiry date indicated on the carton and blister. The expiry date (EXP) refers to the last day of the month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

OTHER INFORMATION

What Zerinol Throat contains The active substance is ambroxol hydrochloride. One tablet contains 20 mg of ambroxol hydrochloride.

The excipients are:

  • lemon flavoring (containing sucrose)
  • fresh aroma
  • sorbitol (E420)
  • sucralose
  • macrogol 6000
  • talc

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 Zerinol throat 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 ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 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 MARKETING AUTHORIZATION HOLDER08 .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 RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

ZERINOL THROAT LEMON 20 MG

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains 20 mg of ambroxol hydrochloride.

Excipients:

One tablet contains 1.37 g of sorbitol (E 420) and 6.3 mg of sucrose.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Tablet.

White, round tablets with flat surfaces and beveled edges.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Symptomatic treatment of acute pain in sore throat.

04.2 Posology and method of administration

Adults and children over 12 years: up to 6 tablets per day, to be dissolved in the mouth, with a maximum of 1 tablet per dose.

Zerinol Throat lemon 20 mg lozenges can be used for up to 3 days. If symptoms or a high fever persist, the patient should consult a doctor.

04.3 Contraindications

Zerinol Throat lemon 20 mg lozenges are contraindicated in patients with known hypersensitivity to ambroxol or to any of the excipients.

Patients with fructose intolerance should not take Zerinol Lemon Throat 20 mg lozenges, as these contain significant amounts of sorbitol.

04.4 Special warnings and appropriate precautions for use

Zerinol Throat lemon 20 mg lozenges should not be used in children under 12 years of age.

Zerinol Throat lemon 20 mg lozenges can be used for up to 3 days. If symptoms worsen or persist after 3 days or if the patient has a high fever, a doctor should be consulted.

In very few cases, severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (NET) have been observed simultaneously with the administration of expectorants such as ambroxol hydrochloride. Most of these injuries can be explained by the severity of the patient's underlying disease and / or other concomitant medications.

Furthermore, in the initial phase of Stevens-Johnson syndrome or toxic epidermal necrolysis (NET), the patient may initially experience non-specific prodrome symptoms similar to those of influenza, such as fever, body aches, rhinitis, cough and sore throat.

Because of these misleading, nonspecific, flu-like prodrome symptoms, symptomatic treatment with cough and cold medications may be undertaken. Therefore, if new skin or mucosal lesions occur, consult your doctor immediately and discontinue treatment with ambroxol hydrochloride as a precaution.

Episodes of dyspnea can occur in the context of latent disease such as a swollen throat. Local allergic reactions (see section 4.8: angioneurotic edema) can also cause dyspnoea.

The local anesthetic properties of ambroxol can alter sensory perception in the pharyngeal space (see section 4.8: oral and pharyngeal hypoesthesia).

Zerinol Throat lemon 20 mg lozenges are not suitable for the treatment of oral ulcers. In such cases, contact your doctor.

In case of impaired kidney function or severe liver disease, Zerinol Throat lemon 20 mg tablets can only be used after consulting your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of metabolites of ambroxol in the liver may occur in severe renal insufficiency.

This medicinal product contains 8.2 g of sorbitol per maximum recommended daily dose (1.37 g per tablet) and 37.8 mg of sucrose per maximum recommended daily dose (6.3 mg per tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine.

04.5 Interactions with other medicinal products and other forms of interaction

No clinically relevant adverse interactions were observed with other drugs.

04.6 Pregnancy and breastfeeding

Fertility:

Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Pregnancy:

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal growth.

Extensive clinical experience after the 28th week of pregnancy has not shown the appearance of harmful effects on the fetus. Despite this, normal precautions should be taken when taking medicines during pregnancy. Especially during the first trimester, the use of Zerinol Throat lemon 20 mg lozenges is not recommended.

Feeding time:

Ambroxol hydrochloride is excreted in breast milk. Although no adverse effects on infants are expected, the use of Zerinol Throat Lemon 20 mg lozenges is not recommended while breastfeeding.

04.7 Effects on ability to drive and use machines

There is no evidence of effects on the ability to drive and use machines.

No studies have been performed to evaluate the effects on the ability to drive and use machines.

04.8 Undesirable effects

Frequency estimated based on available clinical data:

very common: ≥ 10%,

common: ≥ 1% e

uncommon: ≥ 0.1% e

rare: ≥ 0.01% e

very rare:

not known: frequency cannot be estimated from the available data as adverse reactions were not observed in clinical trials with Zerinol Lemon Throat 20 mg tablets, but only identified as cases reported during post-observation marketing.

Immune system disorders, skin and subcutaneous tissue disorders:

Not known: anaphylactic reactions including anaphylactic shock, angioedema, rash, urticaria, pruritus and other hypersensitivity reactions.

As is generally observed for allergies, the severity of allergic reactions may increase if the patient takes the same substance again (see section 4.3).

Nervous system disorders:

Common: dysgeusia (altered taste).

Gastrointestinal and respiratory, thoracic and mediastinal disorders:

Common: hypoesthesia of the oral cavity and pharynx (see section 4.4), nausea.

Uncommon: diarrhea, upper abdominal pain, dyspepsia, dry mouth.

Not known: vomiting, dry throat.

04.9 Overdose

So far, no specific symptoms of overdose have been reported in humans. The symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the known side effects of Zerinol Lemon Throat 20 mg lozenges at recommended doses. and may need symptomatic treatment.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: preparations for the pharyngeal cavity (local anesthetics).

ATC code: R02AD (the specific code of the active substance has not yet been assigned).

The local anesthetic effect of ambroxol hydrochloride was studied in the rabbit eye model and probably derives from sodium channel blocking properties: ambroxol hydrochloride blocks in vitro the hyperpolarized voltage-gated sodium channels of cloned neuronal cells; the binding was reversible and concentration dependent.

This property is in agreement with further observations relating to pain relief following inhalation of ambroxol hydrochloride in other upper respiratory tract conditions.

Zerinol Throat lemon 20 mg tablets acts locally on the oral and pharyngeal mucosa.

Clinical studies have confirmed the pain relieving effects of Ambroxol lozenges (containing 20 mg ambroxol hydrochloride / lozenge) in patients with sore throat due to acute viral pharyngitis.

With the exception of one, clinical studies have shown an "onset of effect" that occurs within 20 minutes at the latest. The effect lasts at least three hours.

In vitro, ambroxol hydrochloride appears to exert an anti-inflammatory effect. In vitro, cytokine release from blood mononuclear and polymorphonuclear cells but also tissue-bound mononuclear and polymorphonuclear cells was significantly reduced by ambroxol hydrochloride.

In clinical studies, Ambroxol lozenges (containing 20 mg ambroxylohydrochloride / lozenge) have been shown to significantly reduce redness in sore throats.

05.2 Pharmacokinetic properties

Absorption:

Absorption of all oral forms of non-delayed release ambroxol hydrochloride is rapid and complete, it is also linearly proportional to dose, within the therapeutic range. Maximum plasma levels are reached 1 to 2.5 hours after oral administration of the immediate release formulation and after an average of 6.5 hours for the slow release formulation.

The absolute bioavailability of a 30 mg tablet is 79%.

The slow-release capsules showed a relative bioavailability of 95% (normalized dose) compared to a 60 mg daily dose (30 mg twice daily) administered as an immediate-release tablet.

Due to the increased absorption through the oral mucosa, administration of the lozenges shows an increase of approximately 25% (90% confidence interval = 116 - 134%) in total drug exposure compared to the syrup formulation.

The increased exposure does not adversely affect the pharmacodynamics of ambroxol hydrochloride in the proposed indication.

Distribution:

The distribution of ambroxol hydrochloride from plasma to tissues is rapid and consistent, with the highest concentration of the active substance in the lungs. The volume of distribution following oral administration was estimated to be 552 L. Within the therapeutic range, plasma protein binding was reported to be approximately 90%.

Metabolism and Elimination:

Approximately 30% of the orally administered dose is eliminated via the first pass effect.

Ambroxol hydrochloride is metabolised primarily in the liver by glucuronidation and is partly broken down to dibromoantranilic acid (approximately 10% of the dose) in addition to other minor metabolites. Studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromantranilic acid.

Within 3 days of oral administration, approximately 6% of the dose was found in the free form, while approximately 26% of the dose was recovered in a conjugated form in the urine.

Ambroxol hydrochloride is eliminated with a terminal elimination half-life of approximately 10 hours. Total clearance is in the range of 660 mL / min, and renal clearance is approximately 8% of total clearance.

Pharmacokinetics in special populations:

In patients with hepatic dysfunction the elimination of ambroxol hydrochloride is reduced, resulting in approximately 1.3 - 2 fold higher plasma levels.

Due to the wide therapeutic range of ambroxol hydrochloride, no dose adjustments are required.

Other:

Age and gender do not have a clinically relevant influence on the pharmacokinetics of ambroxol hydrochloride, and therefore require no dose adjustment.

Foods do not affect the bioavailability of ambroxol hydrochloride.

05.3 Preclinical safety data

Non-clinical data derived from conventional pharmacological studies of safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity revealed no special hazard for humans.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Lemon flavor (containing sucrose)

Fresh aroma

Sorbitol (E420)

Sucralose

Macrogol 6000

Talc

06.2 Incompatibility

Not relevant.

06.3 Period of validity

3 years.

06.4 Special precautions for storage

Do not store above 30 ° C.

06.5 Nature of the immediate packaging and contents of the package

Aluminum / aluminum blister.

Packs of 12, 18, 24, 30, 36, 42, 48, tablets.

Not all pack sizes may be marketed.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

BOEHRINGER INGELHEIM ITALIA S.p.A.

Via Lorenzini n. 8 - 20139 Milan (MI)

08.0 MARKETING AUTHORIZATION NUMBER

Pack of 12 tablets - Alu / Alu blister - 041239171

Pack of 18 tablets - Alu / Alu blister - 041239195

Pack of 24 tablets - Alu / Alu blister - 041239219

Pack of 30 tablets - Alu / Alu blister - 041239221

Pack of 36 tablets - Alu / Alu blister - 041239245

Pack of 42 tablets - Alu / Alu blister - 041239260

Pack of 48 tablets - Alu / Alu blister - 041239272

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

15/04/2013

10.0 DATE OF REVISION OF THE TEXT

AIFA determination of 15 April 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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