Package leaflet: Information for the user

Levotuss 60mg/10ml syrup in sachet

levodropropizine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 2 weeks of treatment.

Contents of this leaflet:

What Levotuss is and what it is used for
What you need to know before taking Levotuss
How to take Levotuss
Possible side effects
How to store Levotuss
Contents of the pack and other information

1. What Levotuss is and what it is used for

Levotuss contains the active substance levodropropizine, a substance belonging to a group of
medicines called antitussives.
This medicine is used for the treatment of cough symptoms.
Consult your doctor if you do not feel better or feel worse after 2 weeks of treatment.

2. What you should know before taking Levotuss

Do not take Levotuss

if you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”);
if you suffer from a bronchial disease characterized by excessive mucus production (bronchial hypersecretion);
if you have been born with certain respiratory mucosa disorders characterized by reduced ability to expel mucus (Kartagener syndrome, ciliary dyskinesia);
if you are pregnant or breastfeeding (see subsection “Pregnancy and breastfeeding”);

Do not administer 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 have severe reduction in kidney function (severe renal insufficiency with creatinine clearance below 35 ml/min);
if you are elderly, as sensitivity to various medicines may be altered in older people;
if you are taking sedative medicines for the treatment of anxiety and are particularly sensitive (see subsection “Other medicines and Levotuss”).

Cough suppressant medicines treat only symptoms and should only be used while awaiting diagnosis of the underlying cause and/or the effect of treatment for the underlying disease.
Therefore, do not use for prolonged treatments. If after a short period of treatment (2 weeks) there is no noticeable improvement, consult your doctor.
Children
Do not give this medicine to children under 2 years of age (see subsection “Do not take Levotuss”).
Other medicines and Levotuss
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking sedative medicines used for the treatment of anxiety.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Levotuss if you are pregnant (suspected or confirmed) or breastfeeding (see section “Do not take Levotuss”).
Avoid using this medicine if you are planning to become pregnant.
Driving and using machines
This medicine may cause drowsiness (see section 4 “Possible side effects”). If you experience this symptom, avoid driving or operating machinery.
Levotuss contains sucrose
This medicine contains 4 g of sucrose per dose (10 ml): if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This should be taken into consideration in patients with diabetes mellitus.
Levotuss contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate
This medicine contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate. These may cause allergic reactions (including delayed reactions).
Levotuss contains propylene glycol
This medicine contains 22.5 mg of propylene glycol per dose (10 ml).
Levotuss contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per single 10 ml dose (1 sachet), i.e. essentially sodium-free.
This medicine contains 41 mg of sodium per daily dose of 20 ml (2 sachets taken throughout the day), equivalent to 2% of the maximum daily intake recommended by the WHO, corresponding to 2 g of sodium for an adult.
This medicine contains 62 mg of sodium per maximum daily dose of 30 ml (3 sachets taken throughout the day), equivalent to 3% of the maximum daily intake recommended by the WHO, corresponding to 2 g of sodium for an adult.

3. How to take Levotuss

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
Adults and children over 30 kg:
one sachet containing 10 ml of syrup, up to 3 times daily, at intervals of at least 6 hours.
Open the sachet along the dotted line and swallow the contents.
Warning: Do not exceed the recommended doses.
Method of administration
It is recommended to take and administer the medicine away from meals, on an empty stomach.
Continue treatment until coughing stops.
However, if coughing persists after 2 weeks of treatment, stop taking the medicine and consult your doctor. Cough is a symptom, and the underlying disease causing it must be investigated and treated.
Consult your doctor if the condition recurs frequently or if you notice any recent changes in its characteristics.
If you take more Levotuss than you should
In case of accidental ingestion or overdose of Levotuss, contact your doctor immediately or go to the nearest hospital.
In most cases, patients have experienced abdominal pain and vomiting.
If you forget to take Levotuss
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
Most of the adverse reactions observed following administration of levodropropizine were not severe, and symptoms resolved upon discontinuation of therapy and, in some cases, with specific pharmacological treatment.

The adverse reactions reported have an unknown frequency (the frequency cannot be estimated from the available data):

mydriasis (dilation of the eye pupil), bilateral blindness (affecting both eyes);
allergic and anaphylactoid reactions, eyelid edema (swelling of the eyelid), angioneurotic edema (swelling of deep dermis and subcutaneous tissue, which may also involve mucous membranes), urticaria;
nervousness, somnolence, personality alteration, personality disorder;
syncope (transient loss of consciousness), dizziness, vertigo, tremors, paresthesia (abnormal sensation on the skin, tingling), tonic-clonic seizure (grand mal) and petit mal attack, hypoglycemic coma (loss of consciousness caused by a severe reduction in blood glucose levels);
palpitations, tachycardia (accelerated heart rate), 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 (liver inflammation due to impaired biliary 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 ulcers in the mouth);
epidermolysis (rare and potentially serious skin disorders);
weakness of the lower limbs;
general malaise, generalized edema (swelling), asthenia (physical weakness).

Additional adverse effects in breastfed neonates whose mothers have taken levodropropizine
A case of somnolence, hypotonia (reduced muscle tone), and vomiting has been reported in a neonate following maternal intake of levodropropizine. Symptoms appeared after breastfeeding and resolved spontaneously after temporarily discontinuing breastfeeding for a few feeds.

Following the instructions provided in this leaflet can reduce the risk of adverse effects.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Levotuss

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp." The expiry date refers to the last day of that month. The stated expiry date refers to the product in its original packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levotuss contains

The active substance is levodropropizine: 1 ml of solution contains 6 mg of levodropropizine.
The other components are: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavour (containing propylene glycol), purified water.

Description of the appearance of Levotuss and contents of the pack
Levotuss is an oral syrup available in a pack containing 10 sachets, each containing 10 ml.
Marketing Authorization Holder
Dompé farmaceutici S.p.A. - Via San Martino, 12 - 20122 Milan, Italy
Manufacturer
Unither Liquid Manufacturing 1-3 allée de la Neste – B.P. 70319 31773 - Colomiers Cedex (France)