Unituss junior

Patient Information Leaflet

Unituss Junior, 60 mg/10 mL, syrup
Levodropropizinum
Please read this leaflet 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 the physician 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 adverse reactions 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 feels worse, consult a doctor.

Table of Contents

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

1. What Unituss Junior is and what it is used for

Unituss Junior contains the active substance levodropropizine, which has antitussive and bronchodilatory properties.
Unituss Junior is indicated for the symptomatic treatment of non-productive (dry) cough.
A large body of evidence indicates 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 pertussis.
If there is no improvement after 7 days, or if the patient feels worse, a doctor should be consulted.

2. Important information before taking Unituss Junior

When not to take Unituss Junior

• 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 Junior, consult your doctor or pharmacist.
Unituss Junior 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 disease causing the cough.
Children under 2 years of age
Unituss Junior should 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 Junior and other medicines
Inform your doctor or pharmacist about any medicines currently taken or recently taken, as well as any medicines planned for future use.
In human studies, no changes in EEG patterns were observed during co-administration of
levodropropizine with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.
Unituss Junior 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.
This medicine is contraindicated in women who are pregnant or planning to become pregnant, as well as during breastfeeding.
Driving and operating machinery
No studies have been conducted to evaluate 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 devices, and they should be informed of this possibility.
Unituss Junior contains sucrose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol (E 1520), ethanol, and sodium
Unituss Junior 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 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 cause 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 Junior

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

Use in children aged 2 years and older
10-20 kg: 3 mL of syrup 3 times daily
20-30 kg: 5 mL of syrup 3 times daily

Use in adults
10 mL of syrup up to 3 times daily

Method of administration
Unituss Junior should be taken orally, 3 times daily at intervals of at least 6 hours. The bottle of syrup comes with a measuring device allowing measurement of, among others, 3, 5, and 10 mL.

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

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

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

Stopping treatment with Unituss Junior
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions to Unituss Junior occur very rarely.
In most cases, they are not serious complications and symptoms subside after discontinuation of treatment,
sometimes requiring only specific pharmacological treatment.
You should stop using Unituss Junior and seek immediate medical help if the patient experiences any of the following symptoms:

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

You should immediately inform a doctor if the patient experiences any of the adverse reactions listed above, as they may lead to life-threatening consequences.
Very rarely (less frequently than in 1 out of 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, diarrhoea;
• allergic reactions, including immediate, general malaise;
• dizziness, impaired balance, tremors, tingling, numbness;
• palpitations, tachycardia, hypotension;
• irritability, drowsiness, depersonalization (disturbance in perception of self and surroundings);
• shortness of breath, cough, oedema of the respiratory mucosa;
• lack of strength or weakness (asthenia) and lower limb weakness.

In addition, the following adverse reactions have been reported:

• glossitis and aphthous stomatitis with fever;
• inflammation caused by impaired bile outflow from the liver (cholestatic hepatitis);
• cases of generalized oedema, fainting and weakness;
• seizures – major epileptic seizure (clonic-tonic convulsions) and minor epileptic seizure (non-convulsive, so-called petit mal seizure);
• pupillary dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the medicine;
• cases of eyelid oedema, which in most cases can be considered as angioedema, considering the concurrent occurrence of urticaria;
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the transfer of levodropropizine taken by a breastfeeding mother to the infant’s body. Symptoms appeared after breastfeeding and resolved spontaneously after skipping several feeds.

Using Unituss Junior according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 enables the collection of additional information on the safety of the medicine.

5. How to store Unituss Junior

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in a 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 Junior can be used for 6 months after the first opening of the bottle, without exceeding the expiry date stated 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 Junior 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), monohydrate citric acid (E 330), sodium hydroxide, purified water.

What Unituss Junior looks like and contents of the pack
Unituss Junior is a strawberry-flavoured syrup.
The medicine is available in a PET bottle containing 120 mL of syrup, with an HDPE screw 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
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 Junior is available in the Audio Leaflet system via the nationwide, free telephone number: 800 706 848.