Package leaflet: Information for the patient

LevoDril
60 mg/10 mL, syrup
Levodropropizine
Please read this leaflet carefully 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 needed.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

What LevoDril is and what it is used for
Important information before taking LevoDril
How to take LevoDril
Possible side effects
How to store LevoDril
Contents of the pack and other information

1. What LevoDril is and what it is used for

LevoDril contains the active substance levodropropizine, which has antitussive and bronchospasmolytic properties.
LevoDril is indicated for the symptomatic treatment of non-productive (dry) cough in adults and children aged 2 years and older.
Numerous data indicate that this medicine effectively suppresses cough of various origins, such as cough associated with lung cancer, cough related to upper and lower respiratory tract infections, or whooping cough.
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before using LevoDril

When not to use LevoDril:

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 excessive bronchial secretion and impaired ciliary function of the bronchial epithelium (Kartagener syndrome, ciliary dyskinesia);
in pregnant and breastfeeding women.

Warnings and precautions
Before starting treatment with LevoDril, discuss it with your doctor or pharmacist.
LevoDril 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
LevoDril should not be used in children under 2 years of age.
Elderly patients
Particular caution is required 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 using this medicine in patients with severe renal impairment (creatinine clearance < 35 mL/min).
LevoDril 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 the patient plans to take. In human studies, no changes in EEG tracings were observed when levodropropizine was administered concomitantly with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.
Use of LevoDril 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 have a baby, she should consult her 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.
However, since the medicine may rarely cause drowsiness (see also section 4. Possible side effects), caution should be exercised in patients intending to drive or operate mechanical equipment, and they should be informed of this possibility.

LevoDril contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and geraniol and citral (from the flavour composition), components of liquid orange flavour.
10 mL of LevoDril syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes.
If intolerance to certain sugars has previously been diagnosed, the patient should consult a doctor before taking the medicine.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (delayed-type reactions are possible) and, exceptionally, bronchospasm.
Liquid orange flavour contains, among others, geraniol and citral – components of the flavour composition. Geraniol and citral may cause allergic reactions.
LevoDril contains a small amount of ethanol, a component of liquid orange flavour.
This medicine contains 1.39 mg of alcohol (ethanol) per 1 mL of syrup. At the maximum daily dose, the amount of alcohol is equivalent to:

in children from 2 years of age (child's body weight 10–20 kg) – less than 1 mL of beer and less than 1 mL of wine,
in children from 2 years of age (child's body weight 20–30 kg) – less than 1 mL of beer and less than 1 mL of wine,
in adults – less than 2 mL of beer and less than 1 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take LevoDril
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use LevoDril for longer than 7 days without consulting a doctor.
Use in children from 2 years of age with body weight:
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
LevoDril should be taken orally, three times daily, at intervals of at least 6 hours.
A measuring device is provided with the syrup bottle, allowing accurate measurement of 3 mL, 5 mL, and 10 mL doses.
Treatment should be continued until cough resolves or as directed by the physician.
In any case, if cough persists after 7 days of treatment, discontinue use and consult a doctor. Remember that cough is a symptom of disease and the underlying condition causing the cough should be diagnosed and treated accordingly.
If more than the recommended dose of LevoDril has been taken
If a higher than recommended dose has been taken, inform your doctor or pharmacist immediately. In cases of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).
Missed dose of LevoDril
Do not take a double dose to make up for a missed dose.
If the patient forgets to take LevoDril, the next dose should be taken at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

severe skin reactions (urticaria, pruritus) or skin disorders, e.g. those involving blister formation (epidermolysis);
irregular heartbeat (risk of atrial bigeminy);
allergic and anaphylactic reactions, presenting as swelling, shortness of breath, vomiting, and diarrhoea;
hypoglycaemic coma (loss of consciousness due to life-threatening low blood glucose levels).

Immediate medical advice must be sought if any of the listed adverse reactions occur, as they may lead to life-threatening consequences.

Very rare (occurring in fewer than 1 in 10,000 patients):

urticaria, erythema, exanthema, pruritus, angioedema (swelling usually affecting the face or throat, potentially life-threatening), skin reactions;
stomach pain, abdominal pain, nausea, vomiting, diarrhoea;
allergic reactions, including immediate systemic reactions and general malaise;
dizziness, impaired balance, tremor, paraesthesia, numbness;
palpitations, tachycardia, hypotension;
irritability, drowsiness, depersonalisation (disturbance in perception of self and surroundings);
dyspnoea, cough, oedema of the respiratory mucosa;
weakness (asthenia) and lower limb weakness.

Additionally, the following adverse reactions have been reported:

glossitis and aphthous stomatitis with fever;
inflammatory condition caused by impaired bile drainage from the liver (cholestatic hepatitis);
cases of generalised oedema, fainting, and weakness;
seizures – major epileptic seizure (clonic-tonic convulsions) and minor epileptic seizure (non-convulsive, so-called petit mal seizure);
pupillary dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the drug;
cases of eyelid oedema, which in most cases can be considered angioedema, considering the concurrent occurrence of urticaria;
somnolence, reduced muscle tone, and vomiting in a newborn, attributed to the transfer of levodropropizine taken by a breastfeeding mother into the infant’s body. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feeds.

Using LevoDril according to the recommendations provided in the patient information leaflet reduces the risk of adverse reactions occurring.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse reactions not listed in this leaf combust, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warszawa,
Tel.: +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 authorisation holder.

Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store LevoDril

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container.
Shelf life after first opening of the bottle: 2 years, but not beyond the expiry date.
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 packaging and other information

What LevoDril contains

The active substance is levodropropizine. 10 mL of syrup contains 60 mg of levodropropizine.
The other ingredients are: sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, orange flavour, liquid ORANGE 02 278 NF (containing, among others, ethanol (68-74%), flavour composition – geraniol, citral), purified water.

What LevoDril looks like and contents of the pack
LevoDril is a clear syrup, colourless to straw-coloured, with a characteristic orange taste.
The packaging consists of a brown glass type III bottle or a PET bottle with an aluminium cap
with a tamper-evident seal and a polyethylene liner with a polyethylene foam seal (LDPE),
and a measuring cup made of polypropylene (PP) with a capacity of 16 mL, graduated at 2 mL; 2.5 mL; 3 mL;
4 mL; 5 mL; 6 mL; 7 mL; 7.5 mL; 8 mL; 9 mL; 10 mL; 11 mL; 12 mL; 12.5 mL; 13 mL; 14 mL;
15 mL; 16 mL, packed in a cardboard box.
The measuring cup has a scale allowing measurement of, for example, 3, 5, 10 mL of the syrup.
Available pack sizes:
1 glass or PET bottle – 120 mL
1 glass bottle – 150 mL

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]