LEVOTUSS 30 MG/5 ML SYRUP 1 BOTTLE 200 ML

Name
Levotuss 30 mg/5 ml syrup
levodropropizine


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

This medicine is used to treat cough symptoms.

Talk to 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 section 6);
- if you suffer from a bronchial disease characterised by excessive mucus production (bronchial hypersecretion);
- if you have suffered from certain respiratory mucosal disorders since birth, characterised by a reduced ability to expel mucus (Kartagener's syndrome, ciliary dyskinesia);
- if you are pregnant or breastfeeding (see subsection “Pregnancy and breastfeeding”).

Do not give this medicine to children under two years of age (see subsection “Children”).


Warnings and precautions
Talk to your doctor or pharmacist before taking Levotuss:
- if you suffer from severely reduced kidney function (severe renal insufficiency with creatinine clearance below 35 ml/min);
- if you are an elderly person, since sensitivity to various medicines is altered in elderly people;
- if you are taking sedative medicines to treat anxiety and are a particularly sensitive individual (see subsection “Other medicines and Levotuss”).

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

Children
Do not give this medicine to children under 2 years of age (see subsection “Do not take Levotuss”).


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

Most adverse reactions that occurred following the intake of levodropropizine were non-serious and the symptoms resolved with the suspension 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 pupil of the eye), 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 which may also affect the mucous membranes), urticaria;
- nervousness, drowsiness, personality change, personality disorder;
- syncope (transient loss of consciousness), dizziness, vertigo, tremors, paraesthesia (abnormal sensation on the skin, tingling), tonic-clonic convulsions (grand mal) and petit mal seizures, hypoglycemic coma (loss of consciousness caused by a severe drop in blood sugar levels);
- palpitations, tachycardia (rapid 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 bile excretion);
- urticaria, erythema (redness of the skin), exanthema (skin rash), pruritus, angioedema (swelling of the face and mucous membranes), skin reactions, glossitis (inflammation of the tongue) and aphthous stomatitis (painful mouth ulcers);
- epidermolysis (rare and potentially serious skin diseases);
- weakness of the lower limbs;
- general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional side effects in infants breastfed by mothers who have taken levodropropizine
A case of drowsiness, hypotonia (decreased muscle tone), and vomiting has been reported in a newborn after the nursing mother took levodropropizine. The symptoms appeared after feeding and resolved spontaneously after stopping breastfeeding for a few feedings.

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

Reporting of side effects
If you experience 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.