Package leaflet: Information for the user

Levofree, 6 mg/mL, oral solution
Levodropropizinum
For adults, adolescents and children aged 2 years and above.
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as
advised by the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
If there is no improvement after 7 days or if the patient feels worse, consult a doctor.

Table of contents:

What Levofree is and what it is used for
Important information before taking Levofree
How to take Levofree
Possible side effects
How to store Levofree
Contents of the pack and other information

1. What Levofree is and what it is used for

Levofree contains the active substance levodropropizine, which belongs to a group of medicines
known as antitussives (cough suppressants).
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 there is no improvement after 7 days or if the patient feels worse, consult a doctor.

2. Information before using Levofree

When not to use Levofree

if the patient is allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6);
if the patient has productive cough (cough with mucus - phlegm);
if the patient has certain respiratory disorders characterized by reduced ability to eliminate mucus; (Kartagener's syndrome, ciliary dyskinesia);
if the patient has severe liver function disorders;
in children under 2 years of age;
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting to use Levofree, discuss it with your doctor or pharmacist.
If the patient has severe renal impairment, Levofree should be used only after consultation with a doctor.
Caution should be exercised when dosing Levofree in elderly patients.
Children and adolescents
Do not use Levofree in children under 2 years of age.
Levofree and other medicines
Tell 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 use.
Although no interactions with benzodiazepines were reported in clinical studies, caution should be exercised when using Levofree concomitantly with sedatives in particularly sensitive patients.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Levofree during pregnancy or breastfeeding, as animal studies have shown that the active substance crosses the placental barrier and has also been detected in breast milk.
Driving and operating machinery
Caution should be exercised when driving or operating machinery. Even when used as directed, Levofree may alter reaction time in such a way that it impairs the ability to drive vehicles or operate machinery.
Levofree contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml, meaning it is considered "sodium-free".

3. How to take Levofree

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.
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. A 6-hour interval should be maintained 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 body weight). The daily dose should be divided into 3 individual doses, administered at intervals of at least 6 hours. The table below may be used as a guide for individual and daily dosing:

Patient body weight	Single dose	Total daily dose within 24 hours
up to 12 kg	2 ml	up to 6 ml
12.5 – 18 kg	3 ml	up to 9 ml
18.5 – 24 kg	4 ml	up to 12 ml
24.5 – 30 kg	5 ml	up to 15 ml
30.5 – 36 kg	6 ml	up to 18 ml
36.5 – 42 kg	7 ml	up to 21 ml

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 package contains a measuring cup with a capacity of 25 ml for measuring the volume of oral solution.
Duration of treatment:
The medicine should be used until cough subsides; however, Levofree should not be used for longer than 7 days. If cough persists or worsens, consult a physician.
Overdose of Levofree
In case of accidental ingestion or overdose of Levofree, contact a doctor or pharmacist immediately. If symptoms of overdose occur, the physician will decide on necessary measures.
Missed dose of Levofree
If a dose of Levofree is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, Levofree may cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Very rare (may occur in less than 1 in 10,000 people)

dizziness, tremor, abnormal sensations, weakness, fatigue, somnolence, headache, disturbances of consciousness, drowsiness.
palpitations, increased heart rate, decreased blood pressure.
breathing difficulties, cough, swelling of the airways.
gastrointestinal discomfort, nausea, vomiting, diarrhoea.
urticaria, skin redness (erythema), skin rash (exanthema), itching, swelling (angioedema), skin reactions.
weakness, weakness of the lower limbs.
allergic reactions and hypersensitivity reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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 helps to provide more information on the safety of the medicine.

5. How to store Levofree

Keep this medicine out of sight and reach of children.
Do not use Levofree after the expiry date stated on the label of the bottle and the carton, following the words "Expiry date (EXP):" or "EXP". The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from light.
Usable period after first opening of 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 package 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 flavour (containing flavouring substances, corn maltodextrin and gum arabic (E414)), purified water.

What Levofree looks like and contents of the pack
Levofree is a clear, colourless to pale yellowish oral solution, packed in an amber type III glass bottle with a child-resistant PP/HDPE cap and a PP measuring cup with a capacity of 25 ml, graduated at:
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 pack sizes of 100 ml, 120 ml and 200 ml of oral solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland
Tel.: (22) 345 93 00

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic Dituzdin
Germany Levodrop-ratiopharm Hustenstiller
Poland Levofree
Portugal Tussilib