KOFITUSS DRY COUGH SYRUP 200ML

KOFITUSS SEDATIVO TOSSE 30 mg/5 ml syrup
Levodropropizine

Equivalent medicine

What it is and what it is used for
Consult your doctor if you do not feel better or if you feel worse after 2 weeks of treatment.

KOFITUSS SEDATIVO TOSSE contains the active ingredient levodropropizine which belongs to a group of medicines called cough suppressants that calm coughs (antitussive activity), prevent bronchial contraction (antibronchospastic activity) and relieve allergies (anti-allergic activity).

This medicine is indicated for the treatment of cough.

What you need to know before taking the medicine
Do not take KOFITUSS SEDATIVO TOSSE
- if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in paragraph 6);
- if you suffer from a bronchial disease, characterised by high mucus production (bronchial hypersecretion);
- if you suffer from birth from certain respiratory mucosal disorders characterised by reduced ability to expel mucus (Kartagener's syndrome, ciliary dyskinesia);
- if you are pregnant or breastfeeding (See section "Pregnancy and breastfeeding").

Do not administer this medicine to children under two years of age (see sub-paragraph Children).

Warnings and precautions
Talk to your doctor or pharmacist before taking KOFITUSS SEDATIVO TOSSE.

Take this medicine with caution and inform your doctor:
- if you suffer from severe kidney function reduction (severe renal insufficiency with creatinine clearance below 35 ml/min);
- if you are elderly, as sensitivity to various medicines is altered in the elderly;
- if you are taking sedative medicines (for the treatment of anxiety) and are a particularly sensitive individual (See section "Other medicines and KOFITUSS SEDATIVO TOSSE").

Cough medicines only treat symptoms and should only be used while awaiting diagnosis of the underlying cause and/or the effect of the therapy for the underlying disease. Do not use for prolonged treatments. After a short period of treatment (2 weeks) without appreciable results, consult your doctor.

KOFITUSS SEDATIVO TOSSE does not contain gluten, therefore it is not contraindicated if you suffer from coeliac disease.

Children
Do not give this medicine to children under 2 years of age (see sub-paragraph Do not take KOFITUSS SEDATIVO TOSSE).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Most of the adverse reactions that occurred after taking levodropropizine are not serious and the symptoms resolved with the discontinuation of therapy and, in some cases, with specific pharmacological treatment.

Adverse reactions observed have an unknown frequency (frequency cannot be estimated from the available data):
- mydriasis (dilation of the pupil of the eye), bilateral blindness (affects both eyes);
- allergic and anaphylactoid reactions, palpebral oedema (swelling of the eyelid), angioneurotic oedema (swelling of the deep dermis and subcutaneous tissue that can also affect mucous membranes), urticaria;
- nervousness, drowsiness, personality changes, personality disorder; syncope (transient loss of consciousness), dizziness, vertigo, tremors;
- paraesthesia (abnormal sensation on the skin, tingling), tonic-clonic seizure (grand mal) and petit mal seizure, hypoglycaemic coma (loss of consciousness caused by a severe reduction in blood sugar levels);
- palpitations, tachycardia (accelerated heartbeat), atrial bigeminy (irregular heartbeat);
- hypotension (low blood pressure);
- dyspnoea (difficulty breathing), cough, oedema (swelling) of the respiratory tract;
- stomach pain, abdominal pain, nausea, vomiting, diarrhoea;
- cholestatic hepatitis (inflammation of the liver due to blocked bile excretion);
- urticaria, erythema (skin redness), exanthem (skin rash), itching, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue) and aphthous stomatitis (painful ulcers in the mouth);
- epidermolysis (rare and potentially serious skin diseases);
- weakness of the lower limbs;
- general malaise, generalised oedema (swelling), asthenia (physical weakness).

Additional side effects in breastfed infants of mothers who have taken levodropropizine
A case of drowsiness, hypotonia (reduced muscle tone) and vomiting was reported in an infant after the nursing mother took levodropropizine. The symptoms appeared after feeding and resolved spontaneously by suspending breastfeeding for a few feeds.

Adhering to the instructions contained in the package leaflet reduces the risk of side effects.

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.