Contril

Package leaflet: Information for the patient

Contril, 60 mg/10 mL, syrup
Levodropropizine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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 you feel worse, consult your doctor.

Table of contents

1. What Contril is and what it is 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 Contril is and what it is used for

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

2. Important information before using Contril

When not to use Contril

• 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 abundant 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 Contril, consult your doctor or pharmacist.
Contril is a medicine used for symptomatic treatment of non-productive (dry) cough and should be used only while awaiting diagnosis of the underlying cause of cough and/or response to treatment of the disease causing the cough.
Elderly patients
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Particular caution should be exercised 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 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 with other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Human studies have not shown any changes in EEG tracings during administration of levodropropizine in combination with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.
Contril 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine is contraindicated in pregnant women or women 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 adverse effects), caution should be exercised in patients who intend to drive or operate mechanical devices, and they should be informed 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 a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Contril contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Contril

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Do not use Contril for longer than 7 days without consulting a doctor.
Recommended dose
Amount of syrup per dose Maximum number of
Age (body weight)
single dose doses per day
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The drug should not be used in children under 2 years of age.
Directions for use
Contril should be taken orally, 3 times daily at intervals of at least 6 hours.
The bottle of syrup is supplied with a measuring device allowing measurement of, among others, 3.5 and 10 mL.
Treatment should be continued until cough subsides or as directed by a physician.
In any case, if cough persists after 7 days of treatment, it is recommended to discontinue use of the drug and consult a doctor.
Bear in mind that cough is a symptom of disease and the underlying condition causing it should be diagnosed and treated accordingly.
Overdose of Contril medication
In case of ingestion of a higher than recommended dose, inform your doctor or pharmacist immediately.
In the event of overdose with clinical symptoms, the physician will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g. gastric lavage, activated charcoal, parenteral fluid administration, etc.).
Missed dose of Contril medication
Do not take a double dose to make up for a missed dose.
If a patient forgets to take Contril, they should take the next dose at the usual time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
Adverse reactions to Contril 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 Contril should be discontinued and immediate medical help sought if the patient develops any of the following symptoms:

• severe skin reactions (e.g. urticaria, pruritus) or skin disorders, such as those involving blister formation (epidermolysis);
• irregular heartbeat (risk of atrial bigeminy);
• allergic and/or anaphylactic reaction, manifesting as swelling, dyspnoea, vomiting, and diarrhoea;
• hypoglycaemic coma. The physician should be informed immediately if any of the listed adverse reactions occur, as they may lead to life-threatening consequences.

Very rare (less than 1 in 10,000 patients):
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• 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 reactions, general malaise;
• dizziness, loss of balance, tremors, paraesthesia, numbness;
• palpitations, tachycardia, hypotension;
• irritability, drowsiness, depersonalization (a disorder of perception of self and surroundings);
• dyspnoea, cough, oedema of the respiratory mucosa;
• lack of strength (asthenia) and weakness of the lower limbs.

In addition, the following adverse reactions have been reported:

• glossitis and aphthous stomatitis with fever;
• inflammation due to impaired bile outflow from the liver (cholestatic hepatitis);
• cases of generalized oedema, fainting, and weakness;
• epileptic seizures – grand mal seizures (clonic-tonic convulsions) and petit mal seizures (non-convulsive, so-called petit mal seizures);
• mydriasis and loss of vision. In both cases, symptoms resolved after discontinuation of the drug.
• cases of eyelid oedema, which in most instances can be considered angioedema, considering the concurrent occurrence of urticaria.
• somnolence, muscle hypotonia, and vomiting in newborns, attributed to the transfer of levodropropizine into the infant’s body via breast milk from the nursing mother. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feeds.

Using Contril as directed in the patient information leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, 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 authorization holder.
Reporting adverse reactions helps to enhance knowledge about the medicine’s safety profile.

5. How to store Contril

Keep the medicine out of sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from light.
Do not store in the refrigerator or freeze.
The shelf life after first 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 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.
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6. Contents of the pack and other information

What Contril contains

• The active substance is levodropropizine. 10 mL of syrup contains 60 mg of levodropropizine.
• Other ingredients are: sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, cherry flavour 0527477 (containing, among others, propylene glycol), sodium hydroxide 10% solution, citric acid monohydrate 10% solution, purified water.

What Contril looks like and contents of the pack
Contril is a clear, colourless to pale yellow syrup with a cherry odour and taste.
The pack consists of an amber-coloured PET bottle with a child-resistant PP cap and an LDPE sealing liner, together with a PP measuring cup graduated at 1 mL, 2 mL, 2.5 mL, 3 mL, 4.5 mL, 5 mL, 7.5 mL, 9 mL, 10 mL and 15 mL, packed in a cardboard box.
The pack contains 120 mL of syrup.
Marketing Authorisation Holder and Importer
US Pharmacia Sp. z o.o.,
ul. Ziębicka 40,
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel. +48 (22) 543 60 00.
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