DETRALEX 500 mg film-coated tablets

Patient Information Leaflet (PL)

Micronized and purified flavonoic fraction (amount corresponding to: flavonoids, expressed as Hesperidine 10%; Diosmin 90%).

Read all of this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

Always take this medicine exactly as your doctor, pharmacist or nurse has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • If do not feel better or the symptoms get worse you should seek medical care.

In this leaflet:

  1. What Detralex 500 mg is and what it is used for
  2. Before you take DETRALEX
  3. How to take DETRALEX
  4. Possible side effects
  5. How to store DETRALEX
  6. Further information

1. What DETRALEX is and what it is used for

DETRALEX is a venotonic (it increases venous tone) and a vasculooprotector (it increases resistance in small blood vessels).

DETRALEX is recommended for symptomatic treatment of venous circulation disorders (swollen legs, pain, tired legs) and for symptomatic treatment of acute hemorrhoidal crises.

2. What you need to know before taking DETRALEX

Do not takeDETRALEX

– If you are allergic (hypersensitive) to a micronised purified flavonoid fraction or to any of the other ingredients of DETRALEX.
– If you are pregnant or breastfeeding, if think that you might be pregnant or are planning pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Warnings and precautions for use:
Talk to your doctor or pharmacist or nurse before taking DETRALEX.

Haemorroids:
If the hemorrhoid disorder persists for more than 15 days, you should consult your doctor.

Venous circulation disorders:
Treatment is most effective when combined with a healthy lifestyle.Avoid exposure to sun, heat, standing for too long, excess weight. Walking, and wearing special (compression) stockings improves blood circulation.

Other medicines and DETRALEX
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking DETRALEX with food, beverages and alcohol
It is recommended that DETRALEX be taken during meals (see section 3 How to take DETRALEX).

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if think that you might be pregnant or are planning pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
As a precuation it is preferable to avoid use of DETRALEX during pregnancy.

Breastfeeding
Due to the absence of data concerning excretion into breast milk, treatment with DETRALEX during breast-feeding should be avoided.

Driving and using machines
DETRALEX does not affect the ability to drive and use machines.

Important information about some of the ingredients of DETRALEX
Not applicable

3. How to take DETRALEX

Oral use.

Always take DETRALEX exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

The usual dosage is:

  • Venous insufficiency:
    2 tablets daily, 1 tablet at noon and 1 tablet at night, during meals.
  • Hemorrhoids:
    A 4-day course of 6 tablets a day, followed by 4 tablets a day for the next 3 days during a meal.

If you take more DETALLEX than you should
If you take more DETRLEX tablets than you should, contact your doctor or pharmacist..
Experience with DETRLEX overdose is limited, still reported symptoms include diarrhea, nausea, abdominal pain, pruritus and rash.

If you forget to take DETRALEX
Do not take a double dose to make up for a forgotten dose.

If you stop taking DETRALEX
Not applicable

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, DETRALEX can cause side effects although not everybody gets them.

These side effects may include:

Common (may affect up to 1 in 10 people):

  • diarrhea, difficult digestion, nausea, vomiting

Uncommon (may affect up to 1 in 100 people):

  • colitis

Rare (may affect up to 1 in 1,000 people):

  • dizziness, headache, malaise
  • rash, pruritus, urticaria

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Not known (frequency can not be estimated from the available data):

– isolated cases of swelling of the face, lips and eyelids. Extremely rare cases of swelling of Quincke (rapid swelling of tissues like face, lips, mouth, tongue or throat that can cause difficulty in breathing),

– abdominal pain.

Reporting of side effects

If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

Bulgaria

Bulgarian Drug Agency (BDA)

8, Damyan Gruev St.

1303 Sofia Center, Sofia

Phone.: +359 2 8903 417

web page: www.bda.bg

5. How to store DETRALEX

Keep out of the reach and sight of children.

Do not use DETRALEX after the expiry date which is stated on the carton after EXP.
The expiration date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package contents and additional Information

What DETRALEX contains

– The active substance is: flavonoid fraction, purified and micronised. One tablet contains 500 mg of flavonoid fraction, purified and micronized, amount corresponding to: flavonoids expressed as hexeridine; 10% – 50 mg; diosmin: 90% – 450 mg.

– The other ingredients are: sodium glycolate, microcrystalline cellulose, gelatin, magnesium stearate, talc, glycerol, hypromellose, macrogol 6000, sodium lauryl sulphate, yellow iron iron oxide (E172), red iron oxide (E 172), titanium dioxide (E171).

What DETRALEX looks like and contents of the pack

DETRALEX are pink-orange, oval film-coated tablets. One tablet contains 500 mg of flavonoid fraction, purified and micronised. The tablets are available in cartons of 30, 36, 60, 90 or 120 film-coated tablets in PVC / Aluminum blisters.


Not all pack sizes may be available.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Les Laboratoires Servier

50, rue Carnot,

92284 Suresnes cedex

France

Manufacturer:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy

France

and

Servier (Ireland) Industries Ltd

Gorey Road

Arklow – Co. Wicklow – Ireland

Local representative of the Marketing Authorisation Holder:.

SERVIER MEDICAL EOOD

Tel.: 02/ 921 57 00

Sofia

Date of last approval of the leaflet: 10/2019

If you consider that you have observed an adverse drug reaction using a Servier product, please contact us at e-mail: pharmacovigilance.bg@servier.com; Tel.: 02/ 921 57 55, or Fax: 02/ 921 57 38