GOLASEPT CHESTY COUGH*SYR 200

GOLASEPT TOSSE GRASSA 3 mg/ml syrup
Ambroxol hydrochloride

What it is and what it is used for
GOLASEPT TOSSE GRASSA contains the active ingredient ambroxol hydrochloride, belonging to a group of medicines called mucolytics, used to facilitate the elimination of mucus from the respiratory tract. It is indicated in adults and children over 2 years of age for the treatment of secretions in acute and chronic bronchial and pulmonary diseases (i.e., in the presence of cough and in case of difficulty expelling phlegm from the bronchi due to increased or thickened phlegm).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use GOLASEPT TOSSE GRASSA
- if you/your child are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- if you/your child suffer from severe liver and kidney diseases;
- in children under 2 years of age;
- in case of rare hereditary conditions of incompatibility with one of the excipients (see section 2. GOLASEPT TOSSE GRASSA syrup contains sorbitol, propylene glycol, and benzoic acid).

Warnings and precautions
Talk to your doctor or pharmacist before using GOLASEPT TOSSE GRASSA:
- if you/your child have/have had a lesion on the internal surface of the stomach and/or intestine (peptic ulcer).

Severe skin reactions associated with the administration of ambroxol hydrochloride have been reported. If you develop a rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking GOLASEPT TOSSE GRASSA and contact your doctor immediately. Such reactions could be symptoms of serious skin diseases characterized by skin peeling and severe toxic skin reaction (Stevens-Johnson syndrome and Toxic Epidermal Necrolysis). Furthermore, in the initial phase of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN), you/your child might experience non-specific symptoms similar to those of influenza, such as fever, chills, runny nose (rhinitis), cough, and sore throat. Due to these misleading symptoms, it is possible that symptomatic treatment with a cough and cold therapy may be started again.
If you suffer from kidney problems (mild or moderate kidney failure), GOLASEPT TOSSE GRASSA should only be used after consulting your doctor.

Children
Mucolytics can cause a reduction in respiratory capacity (bronchial obstruction) in children under 2 years of age. In fact, the ability to eliminate mucus in the bronchi is limited in this age group, due to the physiological characteristics of the respiratory tract.

These medicines should not be used in children under 2 years of age (see section Do not use GOLASEPT TOSSE GRASSA).

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

The following side effects may occur:
Common (may affect up to 1 in 10 people)
- altered sense of taste (dysgeusia);
- loss of sensation (hypoesthesia) of the mouth and tongue;
- nausea;
- numbness of the throat (pharyngeal hypoesthesia).

Uncommon (may affect up to 1 in 100 people)
- vomiting;
- diarrhoea;
- difficulty digesting (dyspepsia);
- abdominal pain;
- dry mouth.

Rare (may affect up to 1 in 1,000 people)
- headache;
- runny nose (rhinorrhea);
- heartburn (pyrosis);
- constipation;
- skin rashes (rash), appearance of red spots on the skin accompanied by itching (urticaria), contact dermatitis;
- hypersensitivity reactions;
- dry throat;
- difficulty urinating (dysuria);
- fatigue.

Not known (frequency cannot be estimated from the available data)
- anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues) and itching;
- severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis);
- bronchial obstruction.

These side effects are generally temporary. If they occur, consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to 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.