Levodril

Leaflet attached to the packaging: patient information

LevoDril

60 mg/10 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 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 contact their doctor.

Table of contents of the leaflet

• 1. What is LevoDril and what is it used for
• 2. Important information before taking LevoDril
• 3. How to take LevoDril
• 4. Possible side effects
• 5. How to store LevoDril
• 6. Package contents and other information

1. What is LevoDril and what is it used for

LevoDril contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
LevoDril is indicated for the symptomatic treatment of non-productive (dry) cough in adults and children from 2 years of age.
Many data indicate 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 the patient feels worse, they should consult their doctor.

2. Important information before taking LevoDril

When not to take LevoDril:

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

Warnings and precautions

Before starting treatment with LevoDril, the patient should discuss it with their doctor or pharmacist.
LevoDril is a medicine used for the symptomatic treatment of non-productive (dry) cough and can 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

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

Elderly patients

Special caution should be exercised when using levodropropizine in elderly patients, as there is evidence of changed sensitivity to many medicines in this group of patients.

Patients with renal impairment

Caution is recommended when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min).< p>

LevoDril 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.
In human studies, no changes in the EEG recording were found during the administration of levodropropizine in combination with benzodiazepines.
In sensitive individuals, caution should be exercised when taking sedatives.

Taking LevoDril 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 she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist 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 operate machines.
However, since the medicine may rarely cause drowsiness (see also section 4), caution should be exercised in patients who intend to drive vehicles 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 orange flavor composition), which are components of the orange flavor, liquid.

10 mL of LevoDril syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (late-type reactions are possible) and, exceptionally, bronchospasm.
The orange flavor, liquid, contains geraniol and citral in its composition - components of the flavor composition. Geraniol and citral may cause allergic reactions.

LevoDril contains small amounts of ethanol, which is a component of the orange flavor, liquid.

This medicine contains 1.39 mg of alcohol (ethanol) per 1 mL of syrup. In the case of 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 a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist. The medicine should not be taken for more than 7 days without consulting a doctor.

Use in children from 2 years of age with a body weight:

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

LevoDril should be taken orally, 3 times a day, at intervals of at least 6 hours.
A measuring cup is attached to the bottle with the syrup, which allows measuring, among others, 3, 5, and 10 mL.
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, the use of the medicine should be discontinued and the patient should consult their doctor. It should be remembered that cough is a symptom of a disease and the disease that causes it should be diagnosed and treated.

Taking a higher dose of LevoDril than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist. In case 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.).

Missing a dose of LevoDril

A double dose should not be taken to make up for a missed dose.
If the patient forgets to take LevoDril, they should take the next dose at the usual time.
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, LevoDril can cause side effects, although not everybody gets them.
During treatment with LevoDril, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after discontinuation of treatment, sometimes only requiring specific pharmacological treatment.
The patient should stop taking LevoDril and immediately seek medical attention if they experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those involving blistering (epidermolysis);
• irregular heartbeat (risk of supraventricular bigeminia);
• allergic reaction and anaphylaxis, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma (loss of consciousness due to life-threatening low blood glucose levels).

The patient should immediately inform their doctor if they experience any of the above side effects, as they may cause life-threatening consequences.
Very rare (less than 1 in 10,000 patients) side effects include:

• hives, rash, erythema, itching, angioedema (angioedema usually occurring in the face or throat, which 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 one's own person and 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:

• inflammation of the tongue 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, given the concurrent occurrence of hives;
• drowsiness, decreased muscle tone, and vomiting in newborns, which was attributed to the transfer of levodropropizine to the baby through breast milk. The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

Taking LevoDril according to the recommendations in the patient leaflet reduces the risk of side effects.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 LevoDril

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
Shelf life after first opening the bottle: 2 years, but no longer than the expiry date stated on the packaging.
The expiry date stated on the packaging means the last day of the given 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. Package contents and other information

What LevoDril contains

• The active substance of the medicine 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 flavor, liquid ORANGE 02 278 NF (contains, among others, ethanol (68-74%), flavor composition - geraniol, citral), purified water.

What LevoDril looks like and what the package contains

LevoDril is a clear syrup, colorless to straw-colored, with a characteristic orange flavor.
The packaging consists of a brown glass type III bottle or a PET bottle with an aluminum cap with a guarantee seal and a polyethylene plug with a foam polyethylene (LDPE) seal, and a PP measuring cup with a capacity of 16 mL, graduated to 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, in a cardboard box.
The measuring cup has a measuring scale that allows measuring, for example, 3, 5, 10 mL of the medicine.
Available packages:
1 brown glass or PET bottle - 120 mL
1 brown glass bottle - 150 mL

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Date of the last update of the leaflet: