Levosol

Patient Information Leaflet

Levosol, 60 mg/mL, oral drops, solution
Levodropropizinum
Please read all of this leaflet carefully before taking this medicine, because 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 you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.

Table of Contents

1. What Levosol is and what it is used for
2. Important information before taking Levosol
3. How to use 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 dry cough.
If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.

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 components of this medicine (listed in section 6);
• in patients with excessive bronchial secretion;
• in patients with disorders of the respiratory mucosa with congenitally reduced bronchial secretion and impaired function of bronchial ciliary epithelium (Kartagener syndrome, ciliary dyskinesia), and during treatment with drugs that liquefy/increase respiratory tract secretions;
• in pregnant and breastfeeding women;
• in children under 2 years of age.

Warnings and precautions
Before starting treatment with Levosol, consult a doctor or pharmacist:

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

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. If there is no improvement after 7 days, or if the patient feels worse,
medical advice should be sought.
Children and adolescents
Children under 2 years of age
Levosol must not be used in children under 2 years of age.
Levosol with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines planned for future use.
Levosol must not be used during treatment with drugs that liquefy/increase respiratory tract secretions.
Inform your doctor and use Levosol with caution in particularly sensitive patients and in those taking sedatives.
Levosol with food and drink
Due to lack of information on the effect of food on drug absorption, it is recommended to take Levosol between meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated in women who are pregnant or planning 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.
Levosol may cause drowsiness (see also section 4. Possible side effects).
If drowsiness occurs, driving and operating machinery should be avoided.
Levosol contains liquid maltitol, methyl parahydroxybenzoate (E 218), and propylene glycol (E 1520)
Levosol contains 490 mg of liquid maltitol per 1 mL of solution. If the patient has previously been diagnosed
with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Levosol contains methyl parahydroxybenzoate, which may cause allergic reactions (delayed-type reactions are possible) and, exceptionally, bronchospasm.
Levosol contains 14.5 mg of propylene glycol (E 1520) in each 1 mL of solution.

3. How to use Levosol

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken until the cough subsides or as recommended by the doctor; however, if there is no improvement after 7 days of treatment, treatment should be discontinued and medical advice sought.
Use in adults
20 drops (equivalent to 60 mg), up to 3 times daily, at intervals of at least 6 hours, unless otherwise directed by a doctor. The maximum daily dose is 20 drops three times a day.
Use in children from 2 years of age
Up to 3 doses per day, at intervals of at least 6 hours, according to the following schedule:

Do not exceed the recommended doses.
Instructions for use
Levosol medication should be taken orally. Dilute the drops in half a glass of water.
It is recommended to take Levosol between meals.

The bottle has a child-resistant
closure. To dispense the drops,
gently squeeze the bottle.
To open, press the cap and
turn it counterclockwise at
the same time until it opens.
Ingestion of a higher than recommended dose of Levosol
If a higher than recommended dose of the medication is taken, inform a doctor or pharmacist immediately
or go to the nearest hospital.
If a higher than recommended dose of this medication is taken, abdominal pain and vomiting may occur.
The physician will decide which overdose treatment is most appropriate based on the severity of symptoms.
Missed dose of Levosol
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most of the adverse reactions observed after administration of levodropropizine are not severe, and symptoms resolve after discontinuation of treatment, and in some cases, after pharmacological treatment.

Stop using Levosol and seek immediate medical help if the patient experiences any of the following symptoms:

• severe skin reactions (urticaria, itching) or skin diseases, for example those involving blister formation (epidermolysis);
• irregular heartbeat;
• allergic and allergy-like reactions, such as swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma.

Frequency unknown (frequency cannot be estimated from available data):

• pupil dilation, bilateral blindness;
• allergic and allergy-like reactions, urticaria, eyelid swelling, angioedema (swelling of deeper skin layers and subcutaneous tissue, including mucous membranes);
• irritability, drowsiness, personality changes or personality disorders;
• fainting, loss of balance, dizziness, tremor, paresthesia (abnormal skin sensation, tingling), hypoglycemic coma (loss of consciousness caused by significantly reduced blood glucose concentration);
• seizures – grand mal seizures (clonic-tonic seizures) and petit mal seizures (non-convulsive, so-called petit mal seizures);
• cardiac arrhythmias, e.g. rapid or irregular, abnormal heartbeat, decreased arterial blood pressure;
• shortness of breath, cough, swelling of the airways;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• cholestatic hepatitis (inflammatory condition caused by impaired bile outflow from the liver);
• urticaria, erythema (skin redness), exanthema (skin changes following drug administration), skin itching, glossitis (inflammation of the tongue), aphthous stomatitis (painful ulceration of the oral cavity), epidermolysis (a severe skin disease characterized by blister formation);
• weakness of the lower limbs;
• general malaise, generalized edema, asthenia (lack of strength or energy).

Additional adverse reactions in infants breastfed by mothers taking levodropropizine
In one newborn, drowsiness, decreased muscle tone, and vomiting were reported, which were attributed to transfer of levodropropizine from the mother who was breastfeeding. Symptoms appeared after feeding and resolved spontaneously after skipping several breastfeeding sessions.

Using Levosol according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levosol

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Levosol contains

• The active substance is levodropropizine. 1 mL of solution contains 60 mg of levodropropizine.
• The other ingredients are: liquid maltitol, citric acid, propylene glycol (E 1520), raspberry flavour (containing: corn maltodextrin, glyceryl triacetate (E 1518), flavour enhancers), sucralose, methyl parahydroxybenzoate (E 218), mint flavour (containing: natural menthol, peppermint oil from Mentha piperita L., spearmint oil from Mentha spicata L., maltodextrin, gum arabic (E 414), propylene glycol (E 1520)), purified water.

What Levosol looks like and contents of the pack
Levosol is an oral solution. It is a clear, transparent to slightly yellowish, homogeneous solution free from mechanical particles.
The bottle is made of a mixture of HDPE and LDPE, with a dropper and a tamper-evident cap made of a mixture of HDPE and LDPE, packed in a cardboard box.
Available pack sizes:
1 bottle – 30 mL
Marketing Authorisation Holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
tel.: +48 81 463 48 82
{logo of the marketing authorisation 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