Zerinol for sore throat

Package leaflet: Information for the user

Zerinol Gola 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 told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your doctor or pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

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

Zerinol Gola contains the active substance ambroxol hydrochloride. The active substance is the component
of the tablet that provides the desired therapeutic effect.
Zerinol Gola has a local anaesthetic effect that relieves pain associated with acute sore throat.
Zerinol Gola is used for the symptomatic treatment of acute throat pain in adults and children over 12 years of age.
Consult your 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

Do not take Zerinol Gola

• 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.

• Do not take Zerinol Gola for longer 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 contains sorbitol and sucrose”.
• If you have liver or kidney problems, consult your doctor before using Zerinol Gola.
• Zerinol Gola 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 reason may be a sensation of tightness in the throat due to the local anaesthetic effect of Zerinol Gola. A further possible cause may be an allergic reaction, which could also cause swelling of the mouth and throat.
• The throat and mouth may feel less sensitive than usual (numbness).
• Serious skin reactions have been reported with ambroxol hydrochloride administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Zerinol Gola and contact your doctor immediately.

Children
Do not use Zerinol Gola if you are under 12 years of age.
Other medicines and Zerinol Gola
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 may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Ambroxol passes into the body of the unborn child. Therefore, Zerinol Gola should not be taken during pregnancy, especially during the first trimester.
Ambroxol is excreted in breast milk. Therefore, Zerinol Gola should not be taken during breastfeeding.
Driving and using machines
No effects of Zerinol Gola on the ability to drive or use machines are known.
Zerinol Gola contains sorbitol and sucrose
This medicine contains 1.37 g of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine.
Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
This medicine contains 6.3 mg of sucrose per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Zerinol Gola

Take this medicine exactly as stated in this leaflet or according to the instructions given by 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 tablet to be dissolved in the mouth when you need pain relief. 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 3 days or if you have a high fever, consult your doctor.
Clinical data have shown a rapid onset of action (occurring within a maximum of 20 minutes). The effect lasts for at least 3 hours.
If you take more Zerinol Gola than you should
No specific symptoms of overdose have been reported. In case of taking 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 gets them.
If you experience any of the following side effects, stop taking Zerinol Gola and
inform 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 the medicine again, or if you take another medicine containing the same active substance (see section 2 What you should know before taking Zerinol Gola).
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 disturbance (dysgeusia).

Uncommon: may affect up to 1 in 100 people

• Diarrhea.
• Indigestion (dyspepsia).
• Stomach ache (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 the available data (no precise estimation is possible, as these side effects did not occur in a clinical trial population of 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 generalized exanthematous pustulosis).
• Vomiting.

If any of the side effects worsens, or if you notice any side effects 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, consult your doctor or pharmacist. 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.

5. How to store Zerinol Gola

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 blister. The expiry date (Exp.) refers to the last day of that month.
Do not store Zerinol Gola above 30°C.
Do not dispose of medicines 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 contains
The active substance is ambroxol hydrochloride. Each tablet contains 20 mg of ambroxol hydrochloride.
The excipients are:

• lemon flavour (containing sucrose)
• frescofort flavour
• sorbitol (E420)
• sucralose
• macrogol 6000
• talc.

Description of the appearance of Zerinol Gola 20 mg tablets and package contents
Zerinol Gola 20 mg tablets are white, round tablets with bevelled edges. Both sides are flat.
Zerinol Gola 20 mg tablets are available in aluminium/aluminium blisters.
Pack sizes: 12, 18, 24, 30, 36, 42 and 48 tablets.
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, 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® Zitrone
• Belgium, Luxembourg: Mucoangin® Citron
• Cyprus, Greece: Lysopadol®
• Denmark, Sweden: Mucoangin® Citron
• France: LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
• Germany: Mucoangin® gegen Halsschmerzen Zitrone
• Ireland: Lysopadol® Lemon
• Italy: Zerinol Gola
• Netherlands: Mucoangin® Citroen
• Spain: Lizipadol®