Levofree

Package Leaflet: Information for the User

Levofree, 60 mg, Coated Tablets

Levodropropizine

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 for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

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 short-term, symptomatic treatment of dry cough (non-productive cough).
Levofree is indicated for use in adults and adolescents aged 12 years and older.
If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

2. Important information before taking Levofree

When not to take Levofree

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

Warnings and precautions

Before starting treatment with Levofree, the doctor or pharmacist should be consulted.
Caution should be exercised when dosing Levofree in elderly patients due to their altered sensitivity to many medicines.
If the patient has severe renal impairment, Levofree should only be used after consulting a doctor.
In sensitive individuals, caution should be exercised when taking Levofree with sedatives due to the possibility of enhanced sedative effect.

Children

Levofree, 60 mg, coated tablets should not be used in children under 12 years of age, see section 3.

Levofree and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Although no interactions with benzodiazepines have been reported in clinical trials, caution should be exercised when taking Levofree with sedatives in sensitive patients due to the possibility of enhanced sedative effect.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Levofree should not be takenduring pregnancy or breastfeeding, as animal studies have shown that the active substance crosses the placental barrier and is also detected in breast milk.

Driving and using machines

Caution should be exercised when driving or operating machines. Levofree can cause drowsiness (see section 4. Possible side effects). If the patient feels drowsy after taking the medicine, they should not drive or operate machines. Even when used as intended, Levofree may alter reaction time, impairing the ability to drive or operate machines.

Levofree contains sodium

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

3. How to take Levofree

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The recommended dose is:
Adults and adolescents aged 12 years and older
1 coated tablet three times a day, with an interval of at least 6 hours between doses.

Use in children

Due to the strength of the active substance and the recommended dosage, Levofree, 60 mg, coated tablets are not recommended for use in children under 12 years of age.
For children under 12 years of age, other strengths/formulations are available.
Method of administration
Levofree is intended for oral use.
The medicine should be taken between meals, with a glass of water.
The dividing line on the tablet is only intended to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
Duration of treatment:
For short-term use only. The medicine should be used until the cough subsides, but Levofree should not be used for more than 7 days. If the cough does not subside or worsens, a doctor should be consulted.

Taking a higher dose of Levofree than recommended

In case of overdose, a doctor should be informed immediately. If symptoms of overdose occur, the doctor will decide on the necessary measures.

Missing a dose of Levofree

If a dose of Levofree is missed, the next dose should be taken at the usual time.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine 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)

• urticaria, skin redness, rash, itching, angioedema (swelling that occurs in different parts of the body, face, mucous membranes of the respiratory and gastrointestinal tracts), skin reactions.
• one fatal case of skin exfoliation (separation of the outer layer of the skin with blistering) has been reported.
• abdominal pain, nausea, vomiting, diarrhea.
• one case of tongue inflammation and one case of aphthous ulceration (small, shallow lesions that develop on the soft tissues in the mouth or at the base of the gums) have been reported.
• cholestatic hepatitis (a form of jaundice) and hypoglycemic coma (loss of consciousness due to low blood sugar levels) have been reported in women taking glucose-lowering drugs at the same time.
• hypersensitivity and acute allergic reactions
• isolated cases of edema (swelling) of the whole body and general weakness have been reported.
• dizziness, vertigo of labyrinthine origin, fainting, tremors, tingling, drowsiness, headache.
• one case of seizures and one case of a minor epileptic seizure have been reported.
• palpitations, accelerated heart rate, decreased blood pressure.
• one case of arrhythmia has been reported.
• irritability, drowsiness, depersonalization/derealization (feeling of detachment or separation from oneself/environment).
• breathing difficulties, cough, swelling of the airways
• general fatigue and muscle weakness.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the doctor or pharmacist should be informed.
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Levofree

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and blister after the expression "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Levofree contains

• The active substance is levodropropizine. Each coated tablet contains 60 mg of levodropropizine.
• The other ingredients are: Core:mannitol (E 421), microcrystalline cellulose (E 460), sodium carboxymethylcellulose (type A),colloidal anhydrous silica (E 551), magnesium stearate (E 470b) Coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171),macrogol 3350 (E 1521), talc (E 553b)

What Levofree looks like and contents of the pack

Levofree is white or almost white, biconvex, round coated tablets with a dividing line on both sides.
Levofree is available in a cardboard box of 10 or 20 coated tablets in PVC/PVDC/Al blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva BV, Swensweg 5, 2031 GA Haarlem, Netherlands,
For more information about the medicine, the representative of the marketing authorization holder should be contacted:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

• 1)Teva Operations Poland Sp. z.o.o, ul. Mogilska 80, 31-546 Krakow
• 2) Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

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

Czech Republic:
Dituzdin
Germany:
Levodrop-ratiopharm Hustenstiller
Luxembourg:
Levodrop-ratiopharm Hustenstiller
Poland:
Levofree
Portugal:
Tussilib
Slovakia:
Ditustat Neo film-coated tablets

Date of last revision of the package leaflet: