Package leaflet: Information for the patient

LABOTEQLEK ANTI-RED, 600 mg, tablets
Diosminum
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 directed by
the doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If your symptoms do not improve or if you feel worse, contact your doctor.

Leaflet contents

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

1. What LABOTEQLEK ANTI-RED is and what it is used for

LABOTEQLEK ANTI-RED increases venous tone and exerts a protective effect on blood vessels.
It enhances lymphatic drainage by stimulating peristalsis (motility) of lymphatic vessels and lymph flow.
The drug acts on the microcirculation by reducing permeability of small blood vessels, perivascular inflammatory conditions, and stasis in the microcirculation. It also reduces the susceptibility of small blood vessels to rupture.
Indications
Chronic venous insufficiency, manifested, among others, by dilation of small blood vessels (so-called capillary spider veins), redness (erythema) or bluish discoloration of the skin.
If there is no improvement after 5 weeks of treatment, or if you feel worse, consult your doctor.

2. Important information before taking LABOTEQLEK ANTI-RED

When not to take LABOTEQLEK ANTI-RED

if the patient is allergic to diosmin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
LABOTEQLEK ANTI-RED and other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions with other medicines have been reported.
LABOTEQLEK ANTI-RED with food and drink
This medicine should be taken during meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if clearly necessary and under medical prescription. If the patient becomes pregnant while taking this medicine, she should consult her doctor, as only the doctor can decide whether treatment should be continued.
Breastfeeding
Due to lack of data on passage into human milk, this medicine should not be used during breastfeeding.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.
LABOTEQLEK ANTI-RED contains sodium
This medicine contains 0.515 mg of sodium per tablet.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take LABOTEQLEK ANTI-RED

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dose
1 tablet per day, taken with food.
To achieve improvement, this medicine should be used for at least 4 to 5 weeks. If after 5 weeks of treatment the severity of disease symptoms has increased or has not changed, medical advice should be sought.
Do not take more than the recommended dose of this medicine.
Taking more LABOTEQLEK ANTI-RED than recommended
There have been no reported cases of poisoning due to overdose of this medicine.
Taking more than the recommended dose may cause gastrointestinal disturbances, vomiting, and nausea.
If you miss a dose of LABOTEQLEK ANTI-RED
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist. There is no data available on the consequences of discontinuing treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
The following adverse reactions may occur
Rarely (occur in 1 to 10 people in 10,000):

diarrhoea;
indigestion;
nausea;
vomiting;
dizziness;
headache;
malaise;
rash (itchy, red bumps on the skin);
itching;
urticaria (pinkish, itchy blisters on the skin).

Observed adverse reactions do not necessarily require discontinuation of the medicine.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 enables further information on the safety of this medicine to be collected.

5. How to store LABOTEQLEK ANTI-RED

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
Lot – batch number.
Medicines must 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 LABOTEQLEK ANTI-RED contains

The active substance is diosmin.
One tablet contains 600 mg of diosmin.
The other ingredients are: microcrystalline cellulose, mannitol, polyvinyl alcohol, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.

What LABOTEQLEK ANTI-RED looks like and contents of the pack
LABOTEQLEK ANTI-RED is in the form of tablets.
The pack contains 20, 30 or 60 tablets.
Marketing authorisation holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów