SOBRETUSS*SYR 30MG/5ML

SOBRETUSS 30mg/5ml SYRUP
Levodropropizine

What it is and what it is used for
SOBRETUSS contains the active ingredient levodropropizine, which belongs to a group of medicines called cough suppressants.
This medicine is indicated for the treatment of cough symptoms.
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 SOBRETUSS
- if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from a bronchial disease characterized by high mucus production (bronchial hypersecretion);
- if you suffer from birth from certain disorders of the respiratory mucosa characterized by a reduced ability to expel mucus (Kartagener's syndrome, ciliary dyskinesia);
- if you are pregnant or breastfeeding (see the Pregnancy and breastfeeding section).

Do not administer this medicine to children under two years of age (see the Children section).

Warnings and precautions
Talk to your doctor or pharmacist before taking SOBRETUSS.
Take this medicine with caution and inform your doctor:
- if you suffer from severe kidney problems (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 the section Other medicines and SOBRETUSS).

SOBRETUSS does not contain gluten, therefore it is not contraindicated if you suffer from celiac disease.

Children
Do not give this medicine to children under 2 years of age (see the Do not take SOBRETUSS section).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most adverse reactions that occurred after taking levodropropizine are not serious and symptoms resolved with discontinuation of therapy and, in some cases, with specific pharmacological treatment.

The adverse reactions reported have an unknown frequency (frequency cannot be estimated from the available data):
- mydriasis (dilation of the eye pupil), bilateral blindness (affects both eyes);
- allergic and anaphylactoid reactions, eyelid edema (swelling of the eyelid), angioneurotic edema (swelling of the deep dermis and subcutaneous tissue that can also affect the mucous membranes), urticaria;
- nervousness, drowsiness, personality change, personality disorder;
- syncope (transient loss of consciousness), dizziness, vertigo, tremors, paresthesia (abnormal sensation on the skin, tingling), tonic-clonic convulsion (grand mal) and petit mal attack, hypoglycemic 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);
- dyspnea (difficulty breathing), cough, edema (swelling) of the respiratory tract;
- stomach pain, abdominal pain, nausea, vomiting, diarrhea;
- cholestatic hepatitis (inflammation of the liver due to blockage of biliary excretion);
- urticaria, erythema (skin redness), rash (skin eruption), 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, generalized edema (swelling), asthenia (physical weakness).

Additional side effects in breastfed infants whose mothers have taken levodropropizine
A case of somnolence, hypotonia (reduced muscle tone) and vomiting has been reported in an infant after the nursing mother took levodropropizine. The symptoms appeared after feeding and resolved spontaneously by stopping breastfeeding for a few feedings.
Following the instructions in the package leaflet reduces the risk of side effects.

Reporting 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.