ZERINOL 20 mg Леденцы

Содержание инструкции

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

Zerinol Gola menta

20 mg lozenges
ambroxol hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What is Zerinol Gola menta and what is it used for

Zerinol Gola menta contains ambroxol hydrochlorideas its active ingredient. The active ingredient is the
component of the lozenge that provides the desired therapeutic effect.
Zerinol Gola menta has a local anesthetic effect that relieves the pain of a sore throat.
Zerinol Gola menta is used for the symptomatic treatment of acute pain in a sore throat.

2. What you need to know before you take Zerinol Gola menta

Do not take Zerinol Gola menta

• 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 menta.

• Do not take Zerinol Gola menta for more than 3 days. If your symptoms persist 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 menta contains sorbitol and lactose".
• 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 menta.
• Zerinol Gola menta is not suitable for the treatment of painful mouth sores (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 menta. 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 mucosal lesions such as mouth, throat, nose, eyes, genitals), stop taking Zerinol Gola menta and contact your doctor immediately.

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

Other medicines and Zerinol Gola menta
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, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Ambroxol passes into the body of the unborn child. Zerinol Gola menta therefore, should not be taken
during pregnancy, especially in the first trimester.
Ambroxol is excreted in breast milk. Zerinol Gola menta therefore, should not be taken
during breastfeeding.

Driving and operating machinery
No effects of Zerinol Gola menta on the ability to drive or operate
machinery are known.

Zerinol Gola menta contains sorbitol and lactose
One lozenge contains 1.37 g of sorbitol (8.2 g of sorbitol per maximum daily
recommended dose), which is a source of fructose (a type of sugar).
If you suffer from fructose intolerance, do not take this medicine.
One lozenge contains less than 1 mg of lactose monohydrate (a type of sugar). This dose does not
normally cause problems in people with lactose intolerance.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
Zerinol Gola menta is suitable for diabetics.

3. How to take Zerinol Gola menta

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

If you take more Zerinol Gola menta than you should
So far, no specific symptoms of overdose have been reported in humans. 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 or pharmacist.

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 menta and inform your doctor immediately:

• allergic reaction with localised 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 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 you take Zerinol Gola menta).

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

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

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

• Hypersensitivity reactions.
• Rash, urticaria.
• Dry throat.

Not known: frequency cannot be estimated from available data
(a precise estimate of the frequency is not possible, as side effects have not occurred in a series of clinical studies on 1226 patients. The frequency category is probably 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 reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).
• Vomiting.

If any of the side effects gets worse, or if you notice any side effects not

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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zerinol Gola menta

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 menta contains
The active ingredient is ambroxol hydrochloride. One lozenge contains 20 mg of ambroxol hydrochloride.
The excipients are:

• mint flavour (containing gum arabic, Chinese mint oil, maltodextrins, lactose monohydrate);
• sorbitol (E420);
• sodium saccharin;
• macrogol 6000;
• talc.

Description of the appearance of Zerinol Gola menta 20 mg lozenges and contents of the pack
This medicine is presented as round, white tablets with bevelled edges.
Both sides are flat.
The lozenges are available in plastic/aluminium blisters and alternatively in aluminium/aluminium blisters.
Pack sizes of 8, 10, 12, 16, 18, 20, 24, 30, 32, 36, 40, 42, 48, 50 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l. Via P. Paleocapa, 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 with the
following denominations:

• Austria: Mucoangin® Mint
• Belgium/Luxembourg: Mucoangin® menthe
• France: LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
• Germany: Mucoangin® gegen Halsschmerzen Minze
• Italy: Zerinol® Gola menta