LEVOTUSS*SYRUP 200ML 30MG/5ML

Levotuss 30 mg/5 ml syrup
levodropropizine

What it is and what it is used for
Levotuss contains the active substance levodropropizine, which belongs to a group of medicines called cough suppressants.

This medicine is used to treat the symptoms of cough.

Consult your doctor if you do not feel better or if you feel worse after 2 weeks of treatment.

What you need to know before taking the medicine
Do not take Levotuss:
- 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 excessive mucus production (bronchial hypersecretion);
- if you suffer from birth from certain respiratory mucous membrane disorders characterised by reduced ability to expel mucus (Kartagener's syndrome, ciliary dyskinesia);
- if you are pregnant or breastfeeding (see sub-paragraph "Pregnancy and breastfeeding").

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

Warnings and precautions
Consult your doctor or pharmacist before taking Levotuss:
- 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 sub-paragraph "Other medicines and Levotuss").

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

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

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

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

The adverse reactions found 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 the mucous membranes), urticaria;
- nervousness, drowsiness, personality alteration, 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 attack, 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), exanthema (skin rash), pruritus, 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 undesirable effects in breastfed infants whose mothers took levodropropizine
A case of drowsiness, hypotonia (reduced muscle tone) and vomiting has been reported in an infant after the nursing mother took levodropropizine. Symptoms appeared after feeding and resolved spontaneously after suspending breastfeeding for a few feeds.

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, 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: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.