Levosol

Package leaflet: Information for the patient

Levosol, 6 mg/ml, syrup
Levodropropizinum
Please read carefully the entire leaflet 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 the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If advice or additional information is needed, consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a physician.

Table of contents of the leaflet

1. What Levosol is and what it is 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 Levosol is and what it is used for

Levosol contains the active substance levodropropizine, which has antitussive
and bronchospasmolytic properties.
Levosol 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 infections of the upper and lower respiratory tract, or whooping cough.
If there is no improvement after 7 days of treatment, or if the patient feels worse, medical advice should be sought.

2. Important information before using Levosol

When not to use Levosol

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• in patients with abundant bronchial secretion and impaired bronchial ciliary function (Kartagener's syndrome, ciliary dyskinesia);
• in pregnant and breastfeeding women;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Levosol, consult your doctor or pharmacist.
Levosol 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 and adolescents
Children under 2 years of age
Levosol must not be used in children under 2 years of age.

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 this medicine to patients with severe renal impairment (creatinine clearance < 35 ml/min).

Levosol 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 intends to use.
Human studies have not shown changes in EEG patterns when levodropropizine was administered concomitantly with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.

Levosol with food and drink
Due to lack of information on the effect of food on drug absorption, administration between meals is recommended.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine is contraindicated in women who are pregnant or intend 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 who intend to drive or operate mechanical devices, and they should be informed of this possibility.

Levosol contains sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium, and propylene glycol (E1520).
Levosol contains 400 mg of sorbitol in 1 ml of syrup. The sorbitol contained in Levosol may affect the bioavailability of other medicines administered orally at the same time.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or his/her child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—has been previously diagnosed, the patient should consult a doctor before taking this medicine or giving it to a child. Patients with hereditary fructose intolerance must 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 (delayed-type reactions are possible) and, exceptionally, bronchospasm.
Levosol contains less than 1 mmol (23 mg) of sodium per 30 ml of syrup, meaning the medicine is considered "sodium-free".
Levosol contains 15 mg of propylene glycol (E1520) in each 1 ml of syrup.

3. How to use Levosol

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Levosol for longer than 7 days without consulting a doctor.
Use in children aged 2 years and older
10-20 kg: 3 ml of syrup three times daily;
20-30 kg: 5 ml of syrup three times daily.
Use in adults
10 ml of syrup up to three times daily.
Method of administration
Levosol should be taken orally, three times daily at intervals of at least 6 hours. A measuring device is provided with the syrup bottle to measure, among others, 3 ml, 5 ml, and 10 ml doses.
Treatment should be continued until cough resolves or as directed by a doctor.
In any case where cough persists after 7 days of treatment, discontinue use and seek medical advice. It should be remembered that cough is a symptom of disease, and the underlying condition causing the cough should be diagnosed and treated accordingly.
Overdose of Levosol
If more medicine has been taken than recommended, inform a doctor or pharmacist immediately.
In case of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g., gastric lavage, activated charcoal, intravenous fluid replacement, etc.).
Missed dose of Levosol
Do not take a double dose to make up for a missed dose.
If a patient forgets to take a dose of Levosol, the next dose should be taken at the usual time.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Adverse reactions to Levosol occur very rarely. In most cases, they are not serious complications, and symptoms resolve after discontinuation of treatment, sometimes requiring only specific pharmacological therapy.

Treatment with Levosol should be discontinued and immediate medical help sought if the patient develops any of the following symptoms:

• severe skin reactions (urticaria, itching) or skin diseases, for example those involving blister formation (epidermolysis);
• irregular heartbeat (risk of occurrence of atrial bigeminy);
• allergic or anaphylactic reaction, presenting as swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma (blood sugar level too low).

If any of the listed adverse reactions occur, a doctor should be informed immediately, as they may lead to life-threatening consequences.
Very rarely (less frequently than in 1 in 10,000 patients), the following events have been observed:

• urticaria, erythema, exanthema, pruritus, angioedema (swelling usually affecting the face or throat, potentially life-threatening), skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate reactions, general malaise;
• dizziness, impaired balance, tremors, tingling, numbness;
• palpitations, tachycardia, decreased blood pressure;
• irritability, drowsiness, depersonalization (a disturbance in the perception of self and surroundings);
• shortness of breath, cough, edema of the respiratory mucosa;
• lack of energy (asthenia) and weakness of the lower limbs.

Additionally, the following adverse reactions have been reported:

• glossitis and aphthous stomatitis with fever;
• inflammatory condition caused by impaired bile outflow from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures – major epileptic seizure (clonic-tonic convulsions) and minor epileptic seizure (non-convulsive, so-called petit mal seizure);
• pupil dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the drug;
• cases of eyelid edema, which in most cases can be considered angioedema, considering the concurrent occurrence of urticaria;
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the transfer of levodropropizine from the breastfeeding mother to the infant. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feedings.

Using Levosol according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather additional information on the safety of the medicine.

5. How to store Levosol

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
The shelf life after first opening the bottle is 3 years, but not beyond the expiry date stated on the packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 is levodropropizine. 1 ml of syrup contains 6 mg of levodropropizine.
• Other ingredients are: sorbitol (E420), propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), levomenthol; Raspberry flavour AR0616 [flavouring substances, propylene glycol (E1520)], Raspberry flavour AR2103 [flavouring substances, triacetin (E1518)], glycerol, sucralose (E955), anhydrous citric acid, 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 free from mechanical impurities.
The pack consists of a PET bottle with a nominal capacity of 125 ml containing 120 ml of syrup, with an HDPE screw-cap with a tamper-evident closure and a polypropylene measuring spoon with a capacity of 10 ml, allowing measurement of 3, 5 or 10 ml of syrup. The outer packaging is a cardboard box.
Available pack sizes:
1 bottle - 120 ml

Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
{logo of the marketing authorisation 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