Levopront

Package Leaflet: Information for the Patient

LEVOPRONT

60 mg/10 ml, syrup

Levodropropizine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Levopront and what is it used for
• 2. Important information before taking Levopront
• 3. How to take Levopront
• 4. Possible side effects
• 5. How to store Levopront
• 6. Contents of the pack and other information

1. What is Levopront and what is it 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.
Many data indicate that this medicine effectively inhibits cough of various origins, such as cough in lung cancer, cough associated with upper and lower respiratory tract infections, or whooping cough.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before taking Levopront

When not to take Levopront

• in patients with abundant bronchial secretion and disorders of ciliary function of the bronchial epithelium (Kartagener's syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Levopront, you should discuss it with your doctor or pharmacist.
Levopront is a medicine used for the symptomatic treatment of non-productive (dry) cough and can only be used while waiting for the diagnosis of the cause of the cough and/or the effect of the treatment of the underlying disease.

Elderly patients

Particular caution should be exercised when using levodropropizine in elderly patients, as there is evidence of changed sensitivity to many drugs in this group of patients.

Patients with renal impairment

Cautious use is recommended in patients with severe renal impairment (creatinine clearance <35 ml min).< p>

Levopront and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In human studies, no changes in EEG recording were found during administration of levodropropizine in combination with benzodiazepines.
In sensitive individuals, caution should be exercised when taking sedatives.

Levopront with food and drink

Due to the lack of information on the effect of meals on the absorption of the medicine, it is recommended to take it between meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
The medicine is contraindicated in pregnant or breastfeeding women, as well as in women planning to become pregnant.

Driving and using machines

No studies have been conducted to assess the ability to drive and/or operate machinery.
However, since the medicine may rarely cause drowsiness (see also section 4 Possible side effects), caution should be exercised in patients who intend to drive vehicles or operate machinery and inform them of this possibility.

Levopront contains sucrose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the 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 (possible late reactions).

Levopront contains propylene glycol

The medicine contains 22.5 mg of propylene glycol in 10 ml of syrup, which corresponds to 2.25 mg/ml.

Levopront contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Levopront

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Do not take Levopront for more than 7 days without consulting your doctor.

Use in children from 2 years of age

10-20 kg: 3 ml of syrup 3 times a day;
20-30 kg: 5 ml of syrup 3 times a day.

Use in adults

10 ml of syrup up to 3 times a day.

Method of administration

Levopront should be taken orally, 3 times a day, at intervals of at least 6 hours. The bottle with the syrup comes with a measuring cup that allows you to measure, among others, 3, 5, and 10 ml.
The bottle is equipped with an additional safety feature, a child-resistant closure. To open the bottle, press the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until the cough disappears or as directed by your doctor.
In any case, if the cough does not disappear after 7 days of treatment, you should stop taking the medicine and consult your doctor. Remember that cough is a symptom of a disease and the underlying disease should be diagnosed and treated.

Taking a higher dose of Levopront than recommended

If you have taken more than the recommended dose of the medicine, tell your doctor or pharmacist immediately. In case of overdose with clinical symptoms, the doctor will immediately start symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missing a dose of Levopront

Do not take a double dose to make up for a missed dose.
If you forget to take a dose of Levopront, take the next dose at the usual time.
If you have any further doubts about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Levopront can cause side effects, although not everybody gets them.
During treatment with Levopront, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after stopping treatment, sometimes only requiring specific pharmacological treatment.
You should stop taking Levopront and seek medical attention immediately if you experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those involving blistering (epidermolysis);
• irregular heartbeat (risk of atrial bigeminia);
• allergic reaction and anaphylaxis, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma.

Tell your doctor immediately if you experience any of the following side effects, as they may be life-threatening.
Very rare (less than 1 in 10,000 patients):

• hives, rash, erythema, itching, angioedema (angioedema usually occurring in the face or throat, potentially life-threatening), skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate, general malaise;
• dizziness, balance disorders, tremors, tingling, numbness;
• palpitations, tachycardia, decreased blood pressure;
• irritability, drowsiness, depersonalization (disorder of perception of oneself and the environment);
• shortness of breath, cough, swelling of the mucous membrane of the respiratory tract;
• asthenia and weakness of the lower limbs.

The following side effects have also been reported:

• glossitis and aphthous stomatitis with fever;
• inflammatory condition caused by bile flow obstruction from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures - grand mal seizures (clonic-tonic seizures) and petit mal seizures (non-convulsive, so-called petit mal seizures);
• pupil dilation and loss of vision. In both cases, the symptoms disappeared after discontinuation of the medicine.
• cases of eyelid edema, which can be considered as angioedema, taking into account the concurrent occurrence of hives.
• drowsiness, decreased muscle tone, and vomiting in newborns, which were attributed to the transfer of levodropropizine to the infant through breast milk. The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

Taking Levopront according to the instructions in this package leaflet reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Levopront

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.

Information on shelf life after first opening

Levopront syrup should be used within 2 years after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Levopront contains

• The active substance of the medicine is levodropropizine. 10 ml of syrup contains 60 mg of levodropropizine.
• The other ingredients are: sucrose, citric acid monohydrate, sodium hydroxide, flavor and aroma enhancer (cherry flavor, 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 orange glass bottle with a polyethylene child-resistant closure and a polypropylene measuring cup, in a cardboard box.
Available packs:
1 bottle - 120 ml
1 bottle - 200 ml

Marketing authorization holder and manufacturer

Marketing authorization 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 authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
The patient package leaflet in a format suitable for the blind and partially sighted is available at the representative of the marketing authorization holder.

Date of last revision of the package leaflet: