Levosol

Package Leaflet: Information for the Patient

Levosol, 60 mg/mL, Oral Drops, Solution

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 leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should consult a 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 dry cough.
If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Levosol

When not to take Levosol

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in patients with abundant bronchial secretion;
• if the patient has disorders of the mucous membrane of the respiratory tract with reduced mucociliary clearance and ciliary dysfunction (Kartagener's syndrome, ciliary dyskinesia) and during treatment with mucolytic or expectorant drugs;
• in pregnant or breastfeeding women;
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Levosol, the patient should discuss it with their doctor or pharmacist:

• if the patient has severe renal impairment (severe renal failure with creatinine clearance below 35 mL/min);
• if the patient is elderly, as sensitivity to various drugs is altered in older people;
• if the patient is taking sedative drugs and is particularly sensitive (see also "Levosol and other medicines").

Levosol is a medicine used for the symptomatic treatment of non-productive (dry) cough and can only be used while waiting for a diagnosis of the cause of the cough and/or the effect of treatment of the underlying disease.
If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.

Children and adolescents Children under 2 years of age

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

Levosol and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Levosol should not be used during treatment with mucolytic or expectorant drugs.
The doctor should be informed and Levosol should be used with caution in patients who are particularly sensitive and taking sedative drugs.

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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine is contraindicated in pregnant or breastfeeding women.

Driving and using machines

No studies have been conducted to assess the ability to drive or operate machinery.
Levosol may cause drowsiness (see also section 4. Possible side effects).
In case of drowsiness, the patient should avoid driving or operating machinery.

Levosol contains maltitol liquid, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)

Levosol contains 490 mg of maltitol liquid in 1 mL of solution. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Levosol contains methyl parahydroxybenzoate, which may cause allergic reactions (including late-type reactions) and bronchospasm.
Levosol contains 14.5 mg of propylene glycol (E 1520) in each 1 mL of solution.

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. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken until the cough disappears or as recommended by the doctor, but if after 7 days of treatment there is no improvement, the treatment should be discontinued and the doctor consulted.

Administration in adults

20 drops (corresponding to 60 mg) up to 3 times a day, at intervals of at least 6 hours, unless otherwise directed by the doctor. The maximum daily dose is 20 drops three times a day.

Administration in children from 2 years of age

Up to 3 doses a day, at intervals of at least 6 hours, according to the following scheme:

Do not exceed the recommended doses.

Method of administration

Levosol should be taken orally. Dilute the drops in half a glass of water.
It is recommended to take Levosol between meals.

Overdose of Levosol

In case of overdose, the patient should immediately inform their doctor or pharmacist or go to the nearest hospital.
The bottle has a child-resistant closure.
To open, press the cap and turn it counterclockwise until it opens.
To dose the drops, gently press the bottle.
In case of overdose, abdominal pain and vomiting may occur.
The doctor will decide which overdose therapy is best based on the severity of the symptoms.

Missed dose of Levosol

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Levosol can cause side effects, although not everybody gets them.
Most side effects that occurred after taking levodropropizine were not serious, and the symptoms disappeared after discontinuation of treatment, and in some cases after pharmacological treatment.
The patient should stop taking Levosol and seek medical help immediately if they experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those with blistering (epidermolysis);
• irregular heartbeat;
• allergic reactions and similar to allergic reactions, such as edema, dyspnea, vomiting, and diarrhea;
• hypoglycemic coma.

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

• pupil dilation, bilateral blindness;
• allergic reactions and similar to allergic reactions, hives, eyelid edema, angioedema (swelling of deeper skin layers and subcutaneous tissue, including mucous membranes);
• irritability, drowsiness, personality changes or personality disorders;
• fainting, balance disorders, dizziness, tremors, paresthesia (abnormal sensation on the skin, tingling), hypoglycemic coma (loss of consciousness due to significantly decreased blood glucose levels);
• seizures - grand mal seizure (clonic-tonic seizures) and petit mal seizure (non-convulsive, so-called petit mal seizure);
• heart rhythm disorders, such as rapid or irregular heartbeat, decreased blood pressure;
• dyspnea, cough, bronchial edema;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• cholestatic hepatitis (inflammation caused by bile flow obstruction from the liver);
• hives, rash (skin redness), exanthema (skin changes after taking medicines), itching, tongue and aphthous stomatitis (painful oral ulcers), epidermolysis (severe skin disease with blistering);
• weakness of the lower limbs;
• general malaise, generalized edema, asthenia (lack of strength or energy).

Additional side effects in breastfed infants whose mothers are taking levodropropizine
One newborn was reported to have drowsiness, decreased muscle tone, and vomiting, which was attributed to the transfer of levodropropizine from the breastfeeding mother.
The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few breastfeeds.
Taking Levosol as directed in the package leaflet for the patient reduces the risk of side effects.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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
Aleje Jerozolimskie 181 C
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

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The shelf life after first opening the bottle is 9 months. 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 solution contains 60 mg of levodropropizine.
• The other ingredients are: maltitol liquid, citric acid, propylene glycol (E 1520), raspberry flavor (containing: corn maltodextrin, glycerol triacetate (E 1518), flavor enhancers), sucralose, methyl parahydroxybenzoate (E 218), peppermint flavor (containing: natural menthol, peppermint oil Mentha piperita L., spearmint oil Mentha spicata L., maltodextrin, arabic gum (E 414), propylene glycol (E 1520)), purified water.

What Levosol looks like and contents of the pack

Levosol is an oral drop solution. It is a clear, transparent to slightly yellowish, homogeneous solution without mechanical impurities.
The bottle is made of HDPE and LDPE, with a dropper and a screw cap with a guarantee ring made of HDPE and LDPE, in a cardboard box.
Available packs:
1 bottle - 30 mL

Marketing authorization holder:

Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
phone: +48 81 463 48 82
{logo of the marketing authorization holder}

Manufacturer:

Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom
Mako Pharma Sp. z o.o.
ul. Kolejowa 231 A
05-092 Dziekanów Polski

Date of last revision of the leaflet: