Zerinol sore throat menthol

Package leaflet: Information for the user

Zerinol Gola menta

20 mg tablets
ambroxol hydrochloride
Please 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 instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms 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 taking 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 Zerinol Gola menta is and what it is used for

Zerinol Gola menta contains ambroxol hydrochloride as the active substance. The active substance is
the component of the tablet that produces the desired therapeutic effect.
Zerinol Gola menta has a local anaesthetic effect that relieves pain associated with acute sore throat.
Zerinol Gola menta is used for the symptomatic treatment of acute pain in sore throat.

2. What you should know before taking Zerinol Gola menta

Do not take Zerinol Gola menta

• if you are allergic to ambroxol hydrochloride or to 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 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 fructose intolerance.
• If you have liver or kidney problems, consult your doctor before using Zerinol Gola menta.
• Zerinol Gola menta is not suitable for the treatment of painful oral lesions (e.g., ulcers or sores). If you have mouth ulcers, consult your doctor.
• Episodes of shortness of breath (dyspnea) may occur due to a concomitant illness (e.g., swelling of the throat). Another possible cause is a sensation of tightness in the throat due to the local anaesthetic effect of Zerinol Gola menta. An additional cause may be an allergic reaction, which could also lead to swelling of the mouth and throat.
• The throat and mouth may become less sensitive than usual (numbness).
• Serious skin reactions have been reported with ambroxol hydrochloride administration. If you develop a skin rash (including mucosal lesions such as in the mouth, throat, nose, eyes, genitals), stop taking Zerinol Gola menta and contact your doctor immediately.

Children
Zerinol Gola menta must not be used in children under 12 years of age.
Other medicines and Zerinol Gola menta
Inform 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ambroxol passes into the body of the unborn child. Therefore, Zerinol Gola menta must not be taken during pregnancy, particularly during the first trimester.
Ambroxol is excreted in breast milk. Therefore, Zerinol Gola menta must not be taken during breastfeeding.
Driving and using machines
No effects of Zerinol Gola menta on the ability to drive or operate machinery are known.
Zerinol Gola menta contains sorbitol and lactose
One tablet contains 1.37 g of sorbitol (8.2 g of sorbitol per maximum recommended daily dose), which is a source of fructose (a type of sugar).
If you suffer from fructose intolerance, you must not take this medicine.
One tablet contains less than 1 mg of monohydrate lactose (a type of sugar). This amount normally does not cause problems in people with lactose intolerance.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Zerinol Gola menta is suitable for diabetics.

3. How to take Zerinol Gola menta

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
For adults and children over 12 years of age, 1 tablet to be dissolved in the mouth when needed to relieve pain. Do not take more than 6 tablets per day.
Do not use Zerinol Gola menta for longer than 3 days. If symptoms persist beyond 3 days or you have high fever, consult your doctor.
As shown by clinical studies, the local anaesthetic effect of Zerinol Gola menta is achieved within 20 minutes and lasts for at least 3 hours.
If you take more Zerinol Gola menta than you should
Specific symptoms of overdose in humans have not been reported so far. If you take too many tablets (more than 6 per day), consult your doctor or pharmacist if any symptoms occur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, stop taking Zerinol Gola menta and contact your doctor immediately:

• Allergic reaction with localized swelling of the face, lips, mouth, tongue and/or throat (angioedema). This may cause a sensation of tightness in the throat, difficulty swallowing or breathing;
• Rapid onset of allergic reactions affecting the whole body (anaphylactic reactions, including anaphylactic shock).

The severity of allergic reactions may increase if you take this medicine again, or if you take another medicine containing the same active substance (see section 2, "What you need to know before taking Zerinol Gola menta").

Other possible side effects:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Diarrhoea.
• Indigestion (dyspepsia).
• Stomach ache (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 the available data
(A precise estimate of frequency is not possible, as these side effects did not occur in a series of clinical studies involving 1,226 patients. The frequency category is likely no more than uncommon, but could be lower.)

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

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and on the blister.
The expiry date (EXP.) refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zerinol Gola menta contains
The active substance is ambroxol hydrochloride. One tablet contains 20 mg of ambroxol hydrochloride.
The other ingredients are:

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

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa, 7 – 20121 Milano, Italy
Manufacturer
Delpharm Reims S.A.S
10, rue Colonel Charbonneaux - 51100 Reims - France

This medicinal product is authorised in the European Economic Area countries under the following names:

• 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