Unituss

Leaflet attached to the packaging: information for the user

Unituss, 60 mg/10 mL, syrup

Levodropropizine

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

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

Table of contents of the leaflet

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

Unituss contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Unituss 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 the patient feels worse, they should consult their doctor.

2. Important information before taking Unituss

When not to take Unituss

• 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 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 Unituss, you should discuss it with your doctor or pharmacist.
Unituss 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.

Children under 2 years of age

Unituss 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 medicines 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 and other medicines

You should tell your doctor or pharmacist about all 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 sedative medicines concurrently.

Unituss 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 she may be pregnant, or plans to have a child, she should consult her 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 machinery.
However, since the medicine can rarely cause drowsiness (see also section 4. Possible side effects), caution should be exercised in patients who intend to drive vehicles 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 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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist. You should not use Unituss for more than 7 days without consulting your 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 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, allowing you to measure 3, 5, and 10 mL.
Duration of treatment
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, you should stop taking the medicine and consult your doctor. Remember that cough is a symptom of a disease, and you should diagnose and treat the disease that is causing it.

Taking a higher dose of Unituss than recommended

If you have taken a higher dose of the medicine than recommended, you should immediately tell your doctor or pharmacist. In case of overdose with clinical symptoms, your 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

You should not take a double dose to make up for a missed dose.
If you forget to take a dose of Unituss, you should take the next dose at the usual time.

Stopping treatment with Unituss

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Unituss can cause side effects, although not everybody gets them.
During treatment with Unituss, side effects occur very rarely. In most cases, they are not serious and the symptoms disappear after stopping treatment, sometimes only requiring specific pharmacological treatment.

You should stop taking Unituss and seek medical help immediately if you experience any of the following symptoms:

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

You should immediately inform your doctor if you experience any of the following 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 perception of oneself and the environment);
• shortness of breath, cough, swelling of the mucous membrane of the respiratory system;
• 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 obstruction of bile flow 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 angioedema, given the concurrent occurrence of hives;
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the passage of levodropropizine into the baby through breast milk. The symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Unituss

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 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. You should ask your 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 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 looks like and what the pack contains

Unituss is a clear and viscous syrup with a strawberry odor.
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
phone: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Unituss leaflet is available in the Ulotka Audio system at the national, toll-free phone number: 800 706 848.

Date of last revision of the leaflet: