ZERINOL 20 mg Леденцы

Содержание инструкции

1. Zerinol Gola ribes nero
   1. What is Zerinol Gola ribes nero and what is it for
   2. What you need to know before taking Zerinol Gola ribes nero
   3. How to take Zerinol Gola ribes nero
   4. Possible side effects
   5. How to store Zerinol Gola ribes nero
   6. Contents of the pack and other information

Zerinol Gola ribes nero

20 mg lozenges
ambroxol hydrochloride

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor, pharmacist or
nurse has told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after 3 days.

Contents of this leaflet:

• 1. What Zerinol Gola ribes nero is and what it is used for
• 2. What you need to know before you take Zerinol Gola ribes nero
• 3. How to take Zerinol Gola ribes nero
• 4. Possible side effects
• 5. How to store Zerinol Gola ribes nero
• 6. Contents of the pack and other information

1. What is Zerinol Gola ribes nero and what is it for

Zerinol Gola ribes nero contains the active ingredient ambroxol hydrochloride .The active ingredient is the
component of the lozenge that provides the desired therapeutic effect.
Zerinol Gola ribes nero has a local anesthetic effect that relieves the pain of acute sore throat.
Zerinol Gola ribes nero is used for the symptomatic treatment of acute pain in sore throat in
adults and children over 12 years of age.
See a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Zerinol Gola ribes nero

Do not take Zerinol Gola ribes nero

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Zerinol Gola ribes nero.

• Do not take Zerinol Gola ribes nero for more than 3 days. If you still have symptoms after

3 days or if you have a high fever, consult your doctor.

• If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine. See also "Zerinol Gola ribes nero contains sorbitol”.
• If you suffer from rare hereditary conditions of fructose intolerance.
• If you have liver or kidney problems, talk to your doctor before using Zerinol Gola ribes nero.
• Zerinol Gola ribes nero is not suitable for the treatment of painful lesions of the mouth (e.g., ulcers or sores). If you have mouth ulcers, consult your doctor.
• Episodes of shortness of breath (dyspnea) may be observed due to a concomitant disease (e.g., swelling of the throat). Another reason may be a feeling of constriction in the throat due to the local anesthetic effect of Zerinol Gola ribes nero. A further cause may be an allergic reaction, which can also cause swelling of the mouth and throat.
• The throat and mouth may be less sensitive than usual (numbness).
• Cases of severe skin reactions associated with the administration of ambroxol hydrochloride have been reported. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Zerinol Gola ribes nero and contact your doctor immediately.

Children
If you are under 12 years of age, do not use Zerinol Gola ribes nero.

Other medicines and Zerinol Gola ribes nero
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Ambroxol passes into the body of the unborn child. Zerinol Gola ribes nero should therefore not be taken
during pregnancy, especially in the first trimester.
Ambroxol is excreted in breast milk. Zerinol Gola ribes nero should therefore not be taken
during breastfeeding.

Driving and operating machinery
There are no known effects of Zerinol Gola ribes nero on the ability to drive or operate
machinery.

Zerinol Gola ribes nero contains sorbitol
This medicine contains 1.381 g of sorbitol per lozenge. Sorbitol is a source of fructose. If
your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of
hereditary fructose intolerance, a rare genetic disease in which patients are unable to
metabolize fructose, talk to your doctor before you (or your child) take this medicine. Sorbitol
may cause gastrointestinal problems and have a mild laxative effect.
Zerinol Gola ribes nero is suitable for diabetics.

3. How to take Zerinol Gola ribes nero

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
The recommended dose is:
For adults and children over 12 years of age, 1 lozenge to dissolve in the mouth when you need to
relieve pain. Do not take more than 6 lozenges per day.
Do not use Zerinol Gola ribes nero for more than 3 days. If symptoms persist for more than 3 days or
you have a high fever, consult your doctor.
As shown by clinical studies, the local anesthetic effect of Zerinol Gola ribes nero is
achieved in 20 minutes and its effect lasts for at least 3 hours.

If you take more Zerinol Gola ribes nero than you should
No specific overdose symptoms have been reported. In case of taking too many lozenges
(more than 6 per day) consult your doctor or pharmacist if any symptoms appear.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

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

If any of the following side effects occur, stop taking Zerinol Gola ribes nero 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 tightness in the throat, difficulty swallowing or breathing;
• the rapid onset 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 active ingredient (see section 2: What you need to know before taking Zerinol Gola ribes nero).
Other side effects that may occur:

Common: may affect up to 1 in 10 people

• Feeling unwell (nausea).
• Numbness of the mouth, tongue and throat (oral and pharyngeal hypoesthesia).
• Taste alteration (dysgeusia).

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people

• Hypersensitivity reactions.
• Skin rash, urticaria.
• Dry throat.

Not known: frequency cannot be estimated from available data(a precise estimate cannot be made, as side effects have not occurred in a clinical study group of 1226 patients. The frequency category is likely no greater than uncommon, but may be lower).

• Anaphylactic reactions, including anaphylactic shock, angioedema (rapid development of swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues) and itching.
• Severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
• Vomiting.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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.

5. How to store Zerinol Gola ribes nero

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 and on the blister.
The expiry date (Exp.) refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zerinol Gola ribes nero contains
The active ingredient is ambroxol hydrochloride. One lozenge contains 20 mg of ambroxol hydrochloride.
The excipients are:

• blackcurrant flavour
• menthol flavour
• sorbitol (E 420)
• sucralose
• macrogol 6000
• talc

Description of the appearance of Zerinol Gola ribes nero 20 mg lozenges and content of the
pack
Zerinol Gola ribes nero 20 mg lozenges are round, white tablets with bevelled edges.
Both sides are flat.
Zerinol Gola ribes nero 20 mg lozenges are available in aluminium/aluminium blisters.
Packs of 6, 12, 18, 24, 30, 36, 42, 48 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l.,
Via P. Paleocapa, n.7
20121 Milano

Manufacturer
Delpharm Reims S.A.S.
10, rue Colonel Charbonneaux - 51100 Reims - France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

• Austria: Mucoangin® Johannisbeere
• Belgium/Luxembourg: Mucoangin® Cassis
• France: LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE pastille édulcorée au sorbitol et au sucralose
• Germany: Mucoangin® gegen Halsschmerzen Waldbeere
• Italy: Zerinol® Gola ribes nero