Package leaflet: Information for the patient

LEVOPRONT
60 mg, tablets
Levodropropizine
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of 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 bronchodilatory 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.
Levopront is indicated for use in adults and children with body weight above 30 kg.
If there is no improvement after 7 days, 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 components of this medicine (listed in section 6);
in patients with abundant bronchial secretion and impaired bronchial epithelial ciliary function (Kartagener syndrome, ciliary dyskinesia);
in pregnant or breastfeeding women.

Warnings and precautions
Before starting treatment with Levopront, consult a doctor or pharmacist.
Levopront is a medicine used for symptomatic treatment of non-productive (dry) cough
and should only be used while awaiting diagnosis of the underlying cause of cough and/or response to treatment of the disease causing the cough.
Children
Levopront should not be used in children with body weight below 30 kg and should not be used in children who are unable to swallow tablets.
Elderly patients
Particular caution should be exercised 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 the medicine to patients with severe renal impairment (creatinine clearance < 35 ml/min).
Levopront and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In human studies, no changes in EEG trace 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, it is recommended to take the medicine between meals, on an empty stomach.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated in pregnant women or women 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 lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Levopront contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Levopront

This medicine should always be used 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 adults and children with body weight above 30 kg
1 tablet (corresponding to a 60 mg dose) 3 times daily.
Method of administration
Levopront should be taken orally, 3 times daily at intervals of at least 6 hours.
The tablet should be swallowed whole, with water if necessary.
It is recommended to take the tablet between meals, on an empty stomach.
Do not use in children who cannot swallow tablets.
Treatment should be continued until cough subsides or as directed by the physician.
In any case, if cough persists after 7 days of treatment, discontinue use and seek medical advice. Remember that cough is a symptom of disease and the underlying condition causing it should be diagnosed and treated accordingly.
Overdose of Levopront
In case of taking more than the recommended dose, inform your doctor or pharmacist immediately.
In most cases of overdose, patients have experienced abdominal pain and vomiting. In case of overdose with clinical symptoms, the physician will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).
Missed dose of Levopront
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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone will experience them.
Adverse effects during treatment with Levopront occur very rarely. 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 diseases, for example those involving blister formation (epidermolysis);
irregular heartbeat (risk of atrial bigeminy);
allergic and anaphylactic reactions, manifesting as swelling, shortness of breath, vomiting, and diarrhea;
hypoglycemic coma (loss of consciousness due to significantly reduced blood sugar levels).

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

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

allergic reactions, including immediate-type reactions;
irritability, drowsiness, depersonalization (a disorder involving perception of oneself and surroundings);
dizziness, loss of balance, tremors, tingling, numbness;
palpitations, tachycardia, hypotension;
dyspnea, cough, mucosal edema of the respiratory tract;
stomach pain, abdominal pain, nausea, vomiting, diarrhea;
urticaria, erythema, exanthema, pruritus, angioedema (swelling usually affecting the face or throat, potentially life-threatening), skin reactions;
weakness of the lower limbs, general malaise, lack of energy or weakness (asthenia).

Frequency unknown (frequency cannot be estimated from available data):

cases of eyelid edema, most of which can be considered angioedema, taking into account concurrent occurrence of urticaria;
fainting, seizures – including generalized tonic-clonic seizures and absence seizures (non-convulsive, so-called petit mal seizures);
pupillary dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the drug;
inflammation due to impaired bile outflow from the liver (cholestatic hepatitis);
glossitis and aphthous stomatitis with fever;
cases of generalized edema;
somnolence, decreased muscle tone, and vomiting in newborns, attributed to transfer of levodropropizine to the infant via breast milk from nursing mothers. 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 effects occurring.

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

5. How to store Levopront

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the specified month.
The batch number is indicated after: Lot.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levopront contains

The active substance is levodropropizine. Each tablet contains 60 mg of levodropropizine.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate.

What Levopront looks like and contents of the pack
Levopront is a round, convex, white tablet, 9 mm in diameter, for oral administration.
The packaging consists of a PVC/Aluminum blister in a cardboard box.
The pack contains 10 or 20 tablets.

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

Manufacturer:
Abiogen Pharma S.p.A.
Via Meucci 36
Loc. Ospedaletto
56121 Pisa (PI), 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]