Levosol

Package Leaflet: Information for the Patient

Levosol, 60 mg, Tablets

Levodropropizinum

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 for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects 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, contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Levosol and what is it used for
• 2. Important information before taking Levosol
• 3. How to take Levosol
• 4. Possible side effects
• 5. How to store Levosol
• 6. Package contents and other information

1. What is Levosol and what is it used for

Levosol contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Levosol 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, consult your doctor.

2. Important information before taking Levosol

When not to take Levosol:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in patients with abundant bronchial secretion and disorders of ciliary function of the bronchial epithelium (Kartagener syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women;
• in children with a body weight below 30 kg.

Warnings and precautions

Before starting treatment with Levosol, discuss it with your doctor or pharmacist.
Levosol 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.

Children and adolescents

Levosol should not be used in children with a body weight below 30 kg.

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 patient group.

Patients with renal impairment

Caution is recommended when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min).< p>

Levosol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 concomitantly.

Levosol 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 are planning to have a baby, 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 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 or operate machinery and inform them of this possibility.

3. How to take Levosol

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not take Levosol for more than 7 days without consulting a doctor.

Adults and children over 30 kg (approximately 9 years old)

1 tablet orally every 6 hours between meals (maximum 3 tablets per day).
Tablets should not be crushed or chewed. To facilitate swallowing, the tablet can be taken with water.
If the child has difficulty swallowing the tablet, it is recommended to use a syrup with the same active substance and equivalent strength.
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, discontinue the medicine and consult a doctor. Remember that cough is a symptom of a disease and the underlying disease should be diagnosed and treated.

Taking a higher dose of Levosol than recommended

In case of taking a higher dose of the medicine than recommended, 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 Levosol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Levosol, 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 Levosol and seek medical help 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/anaphylactic reaction, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma (too low blood sugar level).

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 occurs in the face or throat and can be 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 angioedema, given the concurrent occurrence of hives;
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the transfer of levodropropizine to the baby through breast milk. Symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

Taking Levosol as directed in the package leaflet for the patient reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including any possible side effects 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Levosol

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.
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. Package contents and other information

What Levosol contains

• The active substance of Levosol is levodropropizine. One tablet contains 60 mg of levodropropizine.
• The other ingredients are: colloidal anhydrous silica, calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, maize starch, sucralose (E955).

What Levosol looks like and contents of the pack

Levosol is a white, round, biconvex tablet.
One pack of Levosol contains 10, 20, or 30 tablets, in a cardboard box.

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
{logo of the marketing authorization holder}

Manufacturer:

Mako Pharma Sp. z o.o.
ul. Kolejowa 231 A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
Date of last revision of the package leaflet:07.2023