Contril

Package Leaflet: Information for the Patient

Contril, 60 mg/10 mL, Syrup

Levodropropizine

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 or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Contril and what is it used for
• 2. Important information before taking Contril
• 3. How to take Contril
• 4. Possible side effects
• 5. How to store Contril
• 6. Contents of the pack and other information

1. What is Contril and what is it used for

Contril contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Contril is indicated for the symptomatic treatment of non-productive (dry) cough.
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 you feel worse, you should contact your doctor.

2. Important information before taking Contril

When not to take Contril

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

Warnings and precautions

Before starting treatment with Contril, you should discuss it with your doctor or pharmacist.
Contril 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 disease causing this cough.
Elderly patients
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Particular caution should be exercised when using levodropropizine in elderly patients, as there is evidence of changed sensitivity to many drugs in this group of patients.
Patients with renal impairment
Care should be taken when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min.).
Children
Contril should not be used in children under 2 years of age.

Contril and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you 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.

Contril 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 machinery.
However, since the medicine may rarely cause drowsiness (see also section 4. Possible side effects), caution should be exercised in patients who intend to drive vehicles or operate machinery and inform them of this possibility.
Contril contains 4 g of sucrose in 10 mL of syrup.This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

Contril contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

The medicine may cause allergic reactions (possible late reactions).

3. How to take Contril

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. Do not take Contril for more than 7 days without consulting a doctor.

Recommended dose

Age (body weight)

Amount of syrup in a single dose

Maximum number of doses per day

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The medicine is not used in children under 2 years of age.

Method of administration

Contril 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 you to measure, among others, 3, 5, and 10 mL.
Treatment should be continued until the cough disappears or as directed by your doctor.
In any case, if the cough does not disappear after 7 days of treatment, it is recommended to stop taking the medicine and consult a doctor. Remember that cough is a symptom of a disease and the disease that causes it should be diagnosed and treated.

Taking a higher dose of Contril than recommended

In case of taking a higher dose of the medicine than recommended, tell your doctor or pharmacist immediately. In case of overdose with clinical symptoms, the doctor will immediately start symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missing a dose of Contril

Do not take a double dose to make up for a missed dose.
If you forget to take Contril, take the next dose at the usual time.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Contril can cause side effects, although not everybody gets them.
During treatment with Contril, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after stopping the treatment, sometimes only requiring specific pharmacological treatment.
You should stop taking Contril and seek medical help immediately if you experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, e.g. those involving blistering (epidermolysis);
• irregular heartbeat (risk of supraventricular bigeminia);
• allergic reaction and/or anaphylactic reaction, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• hypoglycemic coma. You should immediately inform your doctor if you experience any of these side effects, as they may cause life-threatening consequences.

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

• hives, rash, erythema, itching, angioedema (angioedema usually occurring in the face or throat, potentially 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 perceiving oneself and the environment);
• shortness of breath, cough, swelling of the mucous membrane of the respiratory system;
• asthenia and weakness of the lower limbs.

In addition, the following side effects have occurred:

• inflammation of the tongue and aphthous stomatitis with fever;
• inflammatory condition caused by the obstruction of bile flow from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures - grand mal seizures (clonic-tonic seizures) 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, taking into account the simultaneous occurrence of hives.
• drowsiness, decreased muscle tone, and vomiting in newborns, which were 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 Contril according to the recommendations in this package leaflet reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Contril

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light.
Do not store in the refrigerator or freeze.
The shelf life after opening the bottle is 6 months.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
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6. Contents of the pack and other information

What Contril 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, cherry flavor 0527477 (contains, among others, propylene glycol), sodium hydroxide, 10% solution, citric acid monohydrate, 10% solution, purified water.

What Contril looks like and what the pack contains

Contril is a syrup, clear, colorless to light yellow, with a cherry flavor and smell.
The packaging consists of an orange PET bottle with an aluminum cap with a PE foam seal and a guarantee ring and a measuring cup made of PP, scaled every 1 mL, 2 mL, 2.5 mL, 3 mL, 4.5 mL, 5 mL, 7.5 mL, 9 mL, 10 mL, and 15 mL, in a cardboard box.
The packaging contains 120 mL of syrup.

Marketing authorization holder and importer

US Pharmacia Sp. z o.o.,
Ziębicka 40 Street,
50-507 Wrocław
To obtain more detailed information, please contact:
USP Zdrowie Sp. z o.o., Poleczki 35 Street, 02-822 Warsaw, phone: +48 (22) 543 60 00.

Date of the last update of the leaflet:

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