Unituss

Package leaflet: Information for the user

Unituss, 60 mg/10 mL, syrup
Levodropropizinum
Read the following information carefully before using 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 for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement after 7 days or if the patient's condition worsens, consult a doctor.

Table of contents

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

1. What Unituss is and what it is used for

Unituss contains the active substance levodropropizine, which has antitussive and bronchodilatory properties.
Unituss is indicated for the symptomatic treatment of non-productive (dry) cough.
Extensive data indicate that this medicine effectively suppresses cough of various origins, such as cough associated with lung cancer, cough due to infections of the upper and lower respiratory tract, or whooping cough.
If there is no improvement after 7 days or if the patient's condition worsens, medical advice should be sought.

2. Important information before taking Unituss

When not to take Unituss

• 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 bronchial ciliary function (Kartagener syndrome, ciliary dyskinesia),
• in pregnant and breastfeeding women.

Warnings and precautions

Before starting treatment with Unituss, consult your doctor or pharmacist.
Unituss 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 condition causing the cough.

Children under 2 years of age
Unituss must not be used in children under 2 years of age.

Elderly patients
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 administering this medicine to patients with severe renal impairment (creatinine clearance <35 mL/min).

Unituss and 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 patterns were observed during administration of levodropropizine in combination with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.

Unituss 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 a doctor or pharmacist before using 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
No studies have been conducted to assess the ability to drive or operate machinery. 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.

Unituss contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), ethanol, and sodium

Unituss 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 certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

The medicine contains 7.5 mg of propylene glycol in 10 mL of syrup.

This medicine contains less than 0.0009 mg of alcohol (ethanol) per 10 mL of syrup. The amount of alcohol in 10 mL of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.

The small amount of alcohol in this medicine will not produce noticeable effects.

The medicine contains less than 1 mmol (23 mg) of sodium per 10 mL of syrup, meaning the medicine is considered "sodium-free".

3. How to take Unituss

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Do not use Unituss for longer than 7 days without consulting a physician.

Use in children aged 2 years and older
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

Instructions for use
Unituss 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, 5, and 10 mL.

Duration of treatment
Treatment should be continued until cough subsides or as directed by a physician.
If cough persists after 7 days of treatment, discontinue use and consult a physician. Remember that cough is a symptom of an underlying disease, which should be diagnosed and appropriately treated.

Overdose of Unituss
In case of taking more than the recommended dose, inform a physician or pharmacist immediately. In cases of overdose with clinical symptoms, the physician will initiate symptomatic treatment and, if necessary, standard emergency procedures (e.g., gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missed dose of Unituss
Do not take a double dose to make up for a missed dose.
If a patient forgets to take Unituss, the next dose should be taken at the usual time.

Discontinuation of Unituss
If you have any further questions regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions during treatment with Unituss occur very rarely. In most cases, they are not severe complications, and symptoms resolve after discontinuation of treatment, sometimes requiring only specific pharmacological treatment.
Treatment with Unituss must be discontinued and immediate medical help sought if the patient develops any of the following symptoms:

• severe skin reactions (urticaria, itching) or skin diseases, for example, those involving blister formation (epidermolysis),
• irregular heartbeat (risk of atrial bigeminy),
• allergic and/or anaphylactic reaction, manifesting as swelling, shortness of breath, vomiting, and diarrhea,
• hypoglycemic coma.

Immediate medical advice must be sought if any of the listed adverse reactions occur, as they may lead to life-threatening consequences.
Very rarely (less frequently than in 1 in 10,000 patients), the following occur:

• urticaria, erythema, exanthema, itching, angioedema (swelling usually affecting the face or throat, potentially life-threatening), skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate reactions, general malaise;
• dizziness, balance disturbances, tremors, tingling, numbness;
• palpitations, tachycardia, hypotension;
• irritability, drowsiness, depersonalization (impaired perception of self and surroundings);
• shortness of breath, cough, edema of the respiratory mucosa;
• lack of energy (asthenia) and weakness of the lower limbs.

Additionally, the following adverse reactions have been reported:

• glossitis and aphthous stomatitis with fever;
• inflammation due to impaired bile drainage from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• epileptic 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, symptoms resolved after discontinuation of the drug;
• cases of eyelid edema, which in most cases can be considered angioedema, especially considering concurrent urticaria;
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to levodropropizine passing into the infant’s body through breast milk from mothers taking the medicine. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feeds.

Using Unituss according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.
Reporting adverse reactions
If any adverse symptoms occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Unituss

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator or freeze.
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.
Unituss medicine can be used for 6 months after the first opening of the bottle, provided this does not exceed the expiry date printed on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Unituss contains

• The active substance is levodropropizine. 10 mL of syrup contains 60 mg of levodropropizine.
• The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucrose, strawberry flavour 502301T (containing propylene glycol (E 1520) and ethanol), citric acid monohydrate (E 330), sodium hydroxide, purified water.

What Unituss looks like and contents of the pack
Unituss is a clear, viscous syrup with a strawberry odour.
The medicine is supplied in a PET bottle containing 120 mL of syrup, with an HDPE cap with tamper-evident ring and a PP measuring cup with a capacity of 10 mL, graduated at 3, 5 and 10 mL, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The package leaflet of Unituss is available in the Audio Leaflet system via a nationwide, toll-free telephone number: 800 706 848.