Levosol

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Levosol, 6 mg/ml, syrup

Levodropropizine

Read the 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 patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this 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 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. Contents of the pack 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 suggest 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's syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women;
• in children under 2 years of age.

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 should 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 Children under 2 years of age

Levosol should not be used in children under 2 years of age.

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 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 EEG recording were found during administration of levodropropizine in combination with benzodiazepines.
In sensitive individuals, caution should be exercised when taking sedatives.

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 and/or use machines.
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.

Levosol contains sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium, and propylene glycol (E1520).

Levosol contains 400 mg of sorbitol per 1 ml of syrup. Sorbitol in Levosol may affect the bioavailability of other orally administered medicines.
Sorbitol is a source of fructose. If you or your child have previously been diagnosed with intolerance to some sugars or have a rare genetic disorder, hereditary fructose intolerance, in which the body cannot break down fructose, you should consult your doctor before taking the medicine or giving it to your child. Patients with hereditary fructose intolerance should not take this medicine.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including late-type reactions) and, exceptionally, bronchospasm.
Levosol contains less than 1 mmol (23 mg) of sodium per 30 ml of syrup, which means the medicine is considered "sodium-free".
Levosol contains 15 mg of propylene glycol (E1520) per 1 ml of syrup.

3. How to take Levosol

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Do not take Levosol 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

Levosol 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 3 ml, 5 ml, and 10 ml.
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, stop taking the medicine and consult your doctor. Remember that cough is a symptom of a disease and the disease that causes it should be diagnosed and treated.

Taking a higher dose of Levosol than recommended

If you take more than the recommended dose, 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 a dose of 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, Levosol 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 stopping 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 bigeminy);
• allergic reaction/anaphylaxis, with symptoms such as swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma (very low blood sugar level).

Tell your doctor immediately if you experience any of these side effects, as they can 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 system;
• 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 obstruction of bile flow from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures - grand mal seizures (clonic-tonic convulsions) 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 Levosol according to the recommendations in this patient leaflet reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help 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.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
The shelf life after first opening the bottle is 28 days. 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. Contents of the pack and other information

What Levosol contains

• The active substance of the medicine is levodropropizine. 1 ml of syrup contains 6 mg of levodropropizine.
• The other ingredients are: sorbitol (E420), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), levomenthol; Raspberry flavor AR0616 [flavoring ingredients, propylene glycol (E1520)], Raspberry flavor AR2103 [flavoring ingredients, triacetin (E1518)], glycerol, sucralose (E955), citric acid anhydrous, sodium hydroxide, purified water.

What Levosol looks like and contents of the pack

Levosol is a syrup. It is a clear, transparent to slightly yellowish, homogeneous solution without mechanical impurities.
The packaging consists of a 125 ml PET bottle containing 120 ml of syrup, with an HDPE cap with a tamper-evident closure and a 10 ml polypropylene measuring cup, allowing you to measure 3, 5, or 10 ml of syrup. The outer packaging is a cardboard box.
Pack sizes:
1 bottle - 120 ml

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 leaflet:07.2023