ZERINOL GOLA LIMO*18LOZ 20MG

Zerinol Gola 20 mg lozenges
Ambroxol hydrochloride

What it is and what it is used for
Zerinol Gola contains the active ingredient ambroxol hydrochloride. The active ingredient is the component of the lozenge that provides the required therapeutic effect.

Zerinol Gola has a local anaesthetic effect that relieves the pain of acute sore throat.

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

What you need to know before taking the medicine
Do not take Zerinol Gola:
- if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (see paragraph 6);

Warnings and precautions
Consult your doctor or pharmacist before taking Zerinol Gola.
- You 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 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 mouth lesions (e.g., ulcers or sores). If you have mouth ulcers, consult your doctor.
- Episodes of shortness of breath (dyspnoea) may be observed due to a concomitant illness (e.g. swelling of the throat). Another reason may be a feeling of tightness in the throat due to the local anaesthetic effect of Zerinol Gola. A further cause may be an allergic reaction, which can also cause swelling in the mouth and throat.
- The throat and mouth may feel 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 and contact your doctor immediately.

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

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 and inform your doctor immediately:
- allergic reaction with localized swelling of the face, lips, mouth, tongue and/or throat (angioedema). This may cause a feeling of tightness 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 the medicine is taken again, or if another medicine with the same active ingredient is taken (see paragraph 2 What you need to know before taking Zerinol Gola).

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).
- Alteration of taste (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.
- Skin rash, urticaria.
- Dry throat.

Not known: frequency cannot be estimated from the available data (a precise estimate cannot be made, as side effects did not occur in a clinical study group of 1226 patients. The frequency category is probably not greater than uncommon, but could be lower).
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapid development of swelling of the skin, subcutaneous tissues, mucous membranes and submucous tissues) and pruritus.
- Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
- Vomiting.

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.