Patient Information Leaflet

LEVOPRONT
60 mg/10 ml, syrup
Levodropropizine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if you feel worse, contact your doctor.

Leaflet Contents

What Levopront is and what it is used for
Important information before taking Levopront
How to take Levopront
Possible side effects
How to store Levopront
Contents of the pack and other information

1. What Levopront is and what it is used for

Levopront contains the active substance levodropropizine, which has antitussive and bronchodilator effects.
Levopront is indicated for the symptomatic treatment of non-productive (dry) cough.
Numerous data indicate that this medicine effectively suppresses cough of various origins, such as cough associated with lung cancer, cough related to upper and lower respiratory tract infections, or whooping cough.
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Levopront

When not to use Levopront

if the patient is allergic to the active substance or to any of the other ingredients of this medicine listed in section 6;
in patients with abundant bronchial secretion and impaired function of bronchial ciliary epithelium (Kartagener syndrome, ciliary dyskinesia);
in pregnant and breastfeeding women.

Warnings and precautions
Before starting treatment with Levopront, consult your doctor or pharmacist.
Levopront is a medicine used in the symptomatic treatment of non-productive (dry) cough
and may be used only pending diagnosis of the underlying cause of cough and/or response to treatment
of the disease causing the cough.
Elderly patients
Particular caution is required when administering levodropropizine to elderly patients,
as there is evidence of altered sensitivity to many drugs in this patient group.
Patients with renal impairment
Caution is recommended when administering this medicine to patients with severe renal impairment (creatinine clearance < 35 ml/min).
Levopront with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
In human studies, no changes in EEG curve recordings were observed during administration of
levodropropizine in combination with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.
Levopront with food and drink
Due to lack of information on the effect of food on drug absorption, administration between meals is recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine is contraindicated in women who are pregnant or planning to become pregnant, as well as during breastfeeding.
Driving and operating machinery
Studies evaluating the ability to drive and/or operate machinery have not been conducted.
However, since the medicine may rarely cause drowsiness (see also section 4 Possible side effects), caution should be exercised in patients intending to drive or operate mechanical devices, and they should be informed of this possibility.
Levopront contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 4 g of sucrose in 10 ml of syrup. This should be taken into account in patients with diabetes.
Levopront contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).
Levopront contains propylene glycol
The medicine contains 22.5 mg of propylene glycol in 10 ml of syrup, equivalent to 2.25 mg/ml.
Levopront contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Levopront

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use Levopront for longer than 7 days without consulting a doctor.

Use in children aged 2 years and older
10-20 kg: 3 ml of syrup three times daily;
20-30 kg: 5 ml of syrup three times daily.

Use in adults
10 ml of syrup up to three times daily.

Instructions for use
Levopront should be taken orally, three times daily at intervals of at least 6 hours. The bottle of syrup comes with a measuring device allowing accurate measurement of, among others, 3, 5 and 10 ml.
The bottle is equipped with an additional safety feature – a child-resistant cap. To open the bottle, press down on the cap and turn it in the direction indicated by the arrow.

Treatment should be continued until cough subsides or as directed by a physician.
In all cases where cough persists after 7 days of treatment, use of the medicine should be discontinued and medical advice should be sought. Remember that cough is a symptom of disease and the underlying condition causing it should be diagnosed and treated accordingly.

If more Levopront has been taken than recommended
In case of overdose, inform your doctor or pharmacist immediately. In the event of clinically apparent overdose, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g. gastric lavage, activated charcoal, parenteral fluid administration, etc.).

If a dose of Levopront is missed
Do not take a double dose to make up for a missed dose.
If a patient forgets to take Levopront, they should take the next dose at the usual time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody experiences them.
Adverse reactions during treatment with Levopront are very rare. In most cases, they are not severe complications, and symptoms resolve after discontinuation of treatment, sometimes requiring only specific pharmacological treatment.

Treatment with Levopront should be discontinued and immediate medical help should be sought if the patient experiences any of the following symptoms:

severe skin reactions (e.g. urticaria, itching) or skin disorders, such as those involving blister formation (e.g. epidermolysis);
irregular heartbeat (risk of atrial bigeminy);
allergic and anaphylactic reactions, presenting as swelling, shortness of breath, vomiting, and diarrhea;
hypoglycemic coma.

Immediate medical advice should be sought if any of the listed adverse reactions occur, as they may lead to life-threatening consequences.

Very rare (less than 1 in 10,000 patients):

urticaria, erythema, exanthema, pruritus, angioedema (swelling typically affecting the face or throat, potentially life-threatening), skin reactions;
stomach pain, abdominal pain, nausea, vomiting, diarrhea;
allergic reactions, including immediate reactions, general malaise;
dizziness, balance disturbances, tremors, tingling, numbness;
palpitations, tachycardia, hypotension;
irritability, drowsiness, depersonalization (disturbance in perception of self and surroundings);
dyspnea, cough, edema of the respiratory mucosa;
lack of strength or weakness (asthenia) and lower limb weakness.

In addition, the following adverse reactions have been reported:

glossitis and aphthous stomatitis with fever;
inflammatory condition caused by impaired bile drainage from the liver (cholestatic hepatitis);
cases of generalized edema, fainting, and weakness;
epileptic seizures – grand mal seizures (clonic-tonic convulsions) and petit mal seizures (non-convulsive, so-called petit mal seizures);
pupillary dilation and loss of vision; in both cases, symptoms resolved after discontinuation of the drug;
cases of eyelid edema, which in most cases can be considered angioedema, considering the concurrent occurrence of urticaria;
drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the transfer of levodropropizine to the infant via breast milk from a nursing mother. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feeds.

Using Levopront according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaf combust, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Levopront

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Information on the shelf-life after first opening
Levopront syrup should be used within 2 years after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Levopront contains

The active substance is levodropropizine. 10 ml of syrup contains 60 mg of levodropropizine.
Other ingredients: sucrose, monohydrate citric acid, sodium hydroxide, cherry flavouring (containing, among others, propylene glycol, coumarin, eugenol, cinnamaldehyde), methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

What Levopront looks like and contents of the pack
Levopront is a syrup.
The packaging consists of an amber glass bottle with a polyethylene screw cap with a child-resistant closure and a polypropylene measuring cup, in a cardboard box.
Available pack sizes:
1 bottle - 120 ml
1 bottle - 200 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dompé farmaceutici S.p.A.
Via San Martino 12
20122 Milan, Italy

Manufacturer:
Dompé farmaceutici S.p.A.
Via Campo di Pile
67100 L’Aquila, Italy

Representative of the Marketing Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
representative of the marketing authorisation holder.