Levopront

Package Leaflet: Information for the Patient

LEVOPRONT

60 mg, tablets

Levodropropizine

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

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any 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.
Levopront is indicated for use in adults and children with a body weight of over 30 kg.
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 syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women.

Warnings and precautions

Before taking Levopront, 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 disease causing the cough.

Children

Levopront should not be used in children with a body weight of less than 30 kg and should not be used in children who are unable to swallow tablets.

Elderly patients

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

Patients with renal impairment

Caution is recommended when using the medicine 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 the EEG recording were found during the 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, on an empty stomach.

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, as the medicine may rarely cause drowsiness (see also section 4), caution should be exercised in patients who intend to drive or operate mechanical equipment, and they should be informed of this possibility.

• Caution should be exercised in patients who intend to drive or operate mechanical equipment, and they should be informed of this possibility.

Levopront contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Levopront contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Levopront

Take this medicine always exactly as described in this package leaflet for the patient or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Do not take Levopront for more than 7 days without consulting a doctor.

Administration in adults and children with a body weight of over 30 kg

1 tablet (corresponding to a dose of 60 mg) 3 times a day.

Method of administration

Levopront should be taken orally, 3 times a day, 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 are unable to swallow tablets.
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, the use of the medicine should be discontinued and medical advice should be sought.
Remember that cough is a symptom of a disease and the disease that causes it should be diagnosed and treated.

Overdose of Levopront

In case of overdose, tell your doctor or pharmacist immediately.
In most cases of overdose, patients experienced stomach pain and vomiting.
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.).

Missed dose of Levopront

Do not take a double dose to make up for a missed dose.
If you forget to take Levopront, take the next dose at the usual time.
In case of any further doubts about the use of this medicine, consult 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 discontinuation of treatment, sometimes only requiring specific pharmacological treatment.
Stop taking Levopront and seek medical help immediately if you experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, e.g., those involving blistering (epidermolysis);
• irregular heartbeat (risk of atrial bigeminia);
• allergic and anaphylactic reactions, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma (loss of consciousness due to a significant decrease in blood sugar levels).

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

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

Frequency not known (frequency cannot be estimated from the available data):

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

Taking Levopront in accordance with the recommendations in the package leaflet for the patient reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including any not listed in the 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Levopront

Keep the 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 month stated.
The batch number is stated after "Lot".
There are no special precautions for storage.
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 of the medicine is levodropropizine. Each tablet contains 60 mg of levodropropizine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (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 pack consists of a PVC/Aluminum blister in a cardboard box.
The pack contains 10 or 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 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 package leaflet for the patient 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: