Unituss Iunior

Leaflet attached to the packaging: information for the user

Unituss Junior, 60 mg/10 mL, syrup

Levodropropizine

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

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

Unituss Junior contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Unituss Junior 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 there is no improvement or the patient feels worse after 7 days, they should consult their doctor.

2. Important information before taking Unituss Junior

When not to take Unituss Junior

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in patients with excessive 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 Unituss Junior, the patient should discuss it with their doctor or pharmacist.
Unituss Junior is a medicine used for the symptomatic treatment of non-productive (dry) cough and should only be used while waiting for the diagnosis of the cause of the cough and/or the effect of the treatment of the underlying disease.

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 using levodropropizine in elderly patients, as there is evidence of changed sensitivity to many drugs in this group of patients.

Patients with renal impairment

Caution is recommended when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min).< p>

Unituss Junior and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In human studies, no changes in EEG recording were found during the administration of levodropropizine in combination with benzodiazepines.
In sensitive individuals, caution should be exercised when taking sedative medicines concurrently.

Unituss Junior 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist 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 machines.
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 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 the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late 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) in 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 in 10 mL of syrup, which means the medicine is considered "sodium-free".

3. How to take Unituss Junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The medicine should not be used for more than 7 days without consulting a doctor.

Use in children from 2 years of age

10-20 kg: 3 mL of syrup 3 times a day
20-30 kg: 5 mL of syrup 3 times a day

Use in adults

10 mL of syrup up to 3 times a day

Method of administration

Unituss Junior should be taken orally, 3 times a day, at intervals of at least 6 hours. A measuring cup is provided with the syrup bottle, allowing the measurement of 3, 5, and 10 mL.
Duration of treatment
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, the use of the medicine should be discontinued and the patient should consult their doctor. It should be remembered that cough is a symptom of a disease and the underlying disease should be diagnosed and treated.

Taking a higher dose of Unituss Junior than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist. 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 Unituss Junior

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

Stopping treatment with Unituss Junior

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Unituss Junior can cause side effects, although not everybody gets them.
During treatment with Unituss Junior, side effects are very rare.
In most cases, they are not serious and the symptoms disappear after stopping the treatment, sometimes only requiring specific pharmacological treatment.
The patient should stop taking Unituss Junior and immediately seek medical attention if they experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those involving blistering (epidermolysis),
• irregular heartbeat (risk of bigeminal atrial rhythm),
• allergic reaction and/or anaphylaxis, in the form of edema, dyspnea, vomiting, and diarrhea,
• hypoglycemic coma.

The patient should immediately inform their doctor if they experience any of the side effects listed, as they may cause life-threatening consequences.
Very rare (less than 1 in 10,000 patients):

• hives, rash, erythema, itching, angioedema (edema usually occurring in the face or throat, which can be life-threatening), skin reactions;
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate, general malaise;
• dizziness, balance disorders, tremors, paresthesia, numbness;
• palpitations, tachycardia, decreased blood pressure;
• irritability, drowsiness, depersonalization (disorder of perception of oneself and the environment);
• dyspnea, cough, edema of the respiratory tract mucosa;
• asthenia and weakness of the lower limbs.

The following side effects have also been reported:

• glossitis and aphthous stomatitis with fever;
• inflammatory condition caused by bile flow obstruction from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures - grand mal seizure (clonic-tonic convulsions) and petit mal seizure (non-convulsive, so-called petit mal seizure);
• 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 concurrent occurrence of hives;
• drowsiness, decreased muscle tone, and vomiting in newborns, which were attributed to the transfer of levodropropizine to the infant through breast milk. The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

Taking Unituss Junior according to the recommendations in the patient leaflet reduces the risk of side effects.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Unituss Junior

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month stated.
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 should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Unituss Junior contains

• The active substance of the medicine 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 flavor 502301T (contains propylene glycol (E 1520) and ethanol), citric acid monohydrate (E 330), sodium hydroxide, purified water.

What Unituss Junior looks like and what the pack contains

Unituss Junior is a strawberry-flavored syrup.
The medicine is available in a 120 mL PET bottle with a HDPE cap and a PP measuring cup with a capacity of 10 mL, graduated to 3, 5, and 10 mL, in a cardboard box.

Marketing authorization 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 content of the Unituss Junior leaflet is available in the Ulotka Audio system at the national, free phone number: 800 706 848.

Date of last revision of the leaflet: