Levofree

Package Leaflet: Information for the User

Levofree, 6 mg/mL, Oral Solution

Levodropropizinum
For adults, adolescents, and children aged 2 years and above.

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet:

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

1. What is Levofree and what is it used for

Levofree contains the active substance levodropropizine, which belongs to the group of cough suppressants (antitussives).
Levofree is used for the symptomatic treatment of dry cough (non-productive cough).
Levofree is indicated for use in adults, adolescents, and children aged 2 years and above.
If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before taking Levofree

When not to take Levofree

• if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
• if you have a productive cough (cough with phlegm);
• -if you have certain respiratory disorders characterized by reduced ability to expel phlegm; (Kartagener syndrome, ciliary dyskinesia);
• -if you have severe liver function disorders;
• in children under 2 years of age;
• -if you are pregnant or breastfeeding.

Warnings and precautions

Before taking Levofree, discuss it with your doctor or pharmacist.
If you have severe kidney impairment, Levofree should only be taken after consulting a doctor.
Caution should be exercised when administering Levofree to elderly patients.

Children and adolescents

Do not give Levofree to children under 2 years of age.

Levofree and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Although no interactions with benzodiazepines have been reported in clinical trials, caution should be exercised when taking Levofree with sedatives in particularly sensitive patients.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not takeLevofree during pregnancy or breastfeeding, as animal studies have shown that the active substance passes through the placental barrier and has also been detected in breast milk.

Driving and using machines

Caution should be exercised when driving or operating machinery. Even when taken as directed, Levofree may alter reaction time, impairing the ability to drive or operate machinery.

Levofree contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, which is considered "sodium-free".

3. How to take Levofree

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults and adolescents over 12 years
The recommended dose is a single dose of 10 ml of Levofree (equivalent to 60 mg of levodropropizine) up to three times a day. Maintain an interval of 6 hours between doses.
Children aged 2 to 12 years.
The recommended total daily dose is 0.5 ml of oral solution per kg of body weight (equivalent to 3 mg of levodropropizine/kg of body weight). The daily dose is divided into 3 single doses, with an interval of at least 6 hours between doses. The following table can serve as a guide for individual and daily doses:
In justified cases, the total daily dose may be increased to 1 ml of oral solution per kg of body weight.
Method of administration
Levofree is intended for oral use.
It is recommended to take the medicine between meals.

The packaging includes a 25 ml measuring cup for measuring the oral solution.

Duration of treatment:

The medicine should be taken until the cough disappears, but do not take Levofree for more than 7 days. If the cough does not disappear or worsens, consult a doctor.

Overdose of Levofree

In case of accidental ingestion or overdose of Levofree, immediately inform your doctor or pharmacist. If symptoms of overdose occur, the doctor will decide on the necessary measures.

Missed dose of Levofree

If you miss a dose of Levofree, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
In case of further doubts about taking the medicine, consult your doctor.

4. Possible side effects

Like all medicines, Levofree can cause side effects, although not everybody gets them.
The following side effects may occur:
Very rare (may occur less frequently than 1 in 10,000 people)

• dizziness, tremors, abnormal sensations, weakness, fatigue, lethargy, impaired consciousness, somnolence, headache.
• palpitations, accelerated heart rate, decreased blood pressure.
• breathing difficulties, cough, swelling of the airways.
• gastrointestinal disorders, nausea, vomiting, diarrhea.
• urticaria, skin redness (erythema), skin rashes (exanthema), itching, swelling (angioedema), skin reactions.
• weakness, weakness of the lower limbs.
• allergic reactions and hypersensitivity reactions.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofree

Keep the medicine out of the sight and reach of children.
Do not take Levofree after the expiry date stated on the label and carton after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.
There are no special storage precautions for the medicine.
Store in the original packaging to protect from light.
Shelf life after first opening the bottle: 1 year.
Medicines should 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.

6. Contents of the pack and other information

What Levofree contains

• The active substance is levodropropizine.
• 1 ml of oral solution contains 6 mg of levodropropizine.
• The other ingredients are: sodium citrate, citric acid monohydrate, hypromellose 2910, sucralose, potassium sorbate, raspberry flavor (containing flavoring ingredients, corn maltodextrin, and gum arabic (E414)), purified water.

What Levofree looks like and contents of the pack

Levofree is a clear, colorless to pale yellowish oral solution packaged in a type III orange glass bottle with a PP/HDPE child-resistant closure and a 25 ml PP measuring cup scaled:
2, 4, 6, 8, 12, and 16.5 ml,
3, 5, 7, 10, 13, 15, 20, and 25 ml,
2.5, 3.5, 7.5, 12.5, and 17.5 ml.
Available in packs of 100 ml, 120 ml, 200 ml of oral solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands,
For further information on this medicine, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Balkanpharma Troyan AD, 1 Krayrechna Str., 5600 Troyan, Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic

Dituzdin

Germany

Levodrop-ratiopharm Hustenstiller

Poland

Levofree

Portugal

Tussilib
Date of last revision of the package leaflet:September 2023