• If you are allergic to the active substance or any of the other ingredients of this medicine;

• In patients with excessive bronchial secretions and impaired ciliary function of the bronchial epithelium (Kartagener’s syndrome, ciliary dyskinesia);

• In pregnant and breastfeeding women.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Levodril.
Levodril is a medicine indicated for the symptomatic treatment of non-productive (dry) cough and should be used only until the cause of the cough and/or the effect of treatment of the underlying disease is determined.

Children:Levodril must not be used in children under 2 years of age.
Elderly patients:Special caution is required when using levodropropizine in elderly patients, as there is evidence of altered sensitivity to various medicines in this population.

Patients with impaired renal function:Caution is recommended in patients with severe renal impairment (creatinine clearance < 35 ml/min).

Other medicines and Levodril:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In human studies, no changes in the EEG curve were observed when levodropropizine was taken together with benzodiazepines.
Particular caution is required in especially sensitive patients when sedative medicines are used concomitantly.

Taking Levodril with food and drink:It is recommended to take Levodril between meals.

Pregnancy and breastfeeding:

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• This medicine is contraindicated in women who are pregnant or planning to become pregnant, as well as during breastfeeding.

Driving and using machines:
Drowsiness may rarely occur. Patients intending to drive or operate machinery should be advised and informed about this possibility.

Contains: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and geraniol and citral (components of the orange liquid flavoring).

• 10 ml of Levodril syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

• This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed) and rarely bronchospasm.

• The orange liquid flavoring contains, for example, geraniol and citral – components of the flavoring additive. Geraniol and citral may cause allergic reactions.

• Levodril contains a small amount of ethanol, which is a component of the orange liquid flavoring.

1 ml of this medicine contains 1.39 mg of alcohol (ethanol). At the maximum daily dose, the amount of alcohol is equivalent to:
• In children from 2 years (body weight 10–20 kg) – less than 1 ml of beer and less than 1 ml of wine;
• In children from 2 years (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.

Method of administration:

• Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

• Do not take Levodril for more than 7 days without consulting a doctor.

Use in children from 2 years according to body weight:
10–20 kg: 3 ml syrup 3 times daily,
20–30 kg: 5 ml syrup 3 times daily.

Use in adults:
10 ml syrup 3 times daily.

• Levodril is taken orally, 3 times daily at intervals of at least 6 hours.

• The syrup bottle is supplied with a measuring cup that allows measurement of, for example, 3, 5, and 10 ml.

• Treatment should continue until the cough disappears or as directed by a doctor.

• If the cough does not improve within 7 days after starting treatment, stop taking the medicine and consult a doctor. It is important to remember that cough is a symptom of a disease and the underlying cause must be identified and treated.

If you take more Levodril than you should: Immediately contact your doctor or pharmacist. In case of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency measures (gastric lavage, activated charcoal, parenteral fluids, etc.).
If you forget to take Levodril: Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

Possible side effects:
Stop taking Levodril and seek immediate medical attention if any of the following symptoms occur:

• Skin reactions (urticaria, itching) or severe skin disorders, e.g., with blistering (epidermolysis);

• Irregular heartbeat (risk of atrial bigeminy);

• Allergic and anaphylactic reactions with swelling, shortness of breath, vomiting, and diarrhea;

• Hypoglycemic coma (loss of consciousness due to dangerously low blood glucose levels).
  Inform your doctor immediately if any of the listed side effects occur, as they may lead to life-threatening consequences.

Very rare:

• Urticaria, erythema, exanthema, itching, angioedema (usually swelling of the face or throat, which may be life-threatening), skin reactions;

• Stomach pain, abdominal pain, nausea, vomiting, diarrhea;

• Allergic reactions, including immediate allergic reactions, general weakness;

• Dizziness, balance disorders, tremor, tingling, numbness;

• Palpitations, tachycardia, low blood pressure;

• Irritability, drowsiness, depersonalization (disturbance in perception of self and surroundings);

• Shortness of breath, cough, swelling of the respiratory mucosa;

• Lack or loss of strength (asthenia) and weakness of the lower limbs.

In addition, the following side effects have been reported:

• Glossitis and aphthous stomatitis with fever;

• Inflammation caused by impaired bile flow from the liver (cholestatic hepatitis);

• Cases of generalized edema, fainting, and weakness;

• Epileptic seizures – major epileptic seizure (clonic-tonic convulsions) and minor epileptic seizure;

• Pupil dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the medicine;

• Cases of eyelid swelling, most of which may be considered angioedema, given the concomitant development of urticaria;

• Drowsiness, decreased muscle tone, and vomiting in a newborn due to levodropropizine taken by a breastfeeding mother passing into the infant’s body. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feedings.

When Levodril is used according to the instructions in the leaflet, the risk of side effects is reduced.

Storage conditions:

• Keep this medicine out of the reach of children.

• Store at a temperature not exceeding 25°C. Keep in the original package in order to protect from light.

• Do not use this medicine after the expiry date stated on the package.

• Shelf life after first opening: 2 years, but not beyond the stated expiry date. The expiry date refers to the last day of the indicated month.

• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

  
  

Dispensing conditions: Pharmaceutical product group II, dispensed with prescription form №3.

Marketing authorization holder and manufacturer:
Polfarmex S.A.
9 Józefów Street
99-300 Kutno
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
E-mail: polfarmex@polfarmex.pl