DETRALEX 500mg x 36 film tabl
DETRALEX tablets 500 mg * 36
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRALEX 500 mg film-coated tablets
DETRALEX 500 mg film-coated tablets
Flavonoid fraction, purified and micronized,
(amount corresponding to flavonoids expressed as Hesperidin 10%; Diosmin 90%)
Micronized and purified flavonoid fraction
(quantity corresponding to: flavonoids, expressed as Hesperidine 10%; Diosmin 90%)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
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 you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What DETRALEX 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. Additional information
1. What DETRALEX is and what it is used for
DETRALEX is a venotonic (increases venous tone) and vasoprotector (increases the resistance of small blood vessels).
DETRALEX is recommended for the symptomatic treatment of venous-vascular disorders (swollen legs, pain, tired legs) and for the symptomatic treatment of acute hemorrhoidal crises.
2. What you need to know before you take DETRALEX
Do not take DETRALEX
If you are allergic (hypersensitive) to micronized purified flavonoid fraction or to any of the excipients of DETRALEX.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking DETRALEX.
Hemorrhoids:
If the hemorrhoids do not disappear within 15 days, you should seek your doctor's advice.
Venous-vascular disorders:
The treatment leads to the best possible result if combined with a healthy lifestyle. Avoid exposure to the sun, heat, prolonged standing, excess weight. Walking and wearing special (compression) stockings improve 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.
DETRALEX with food, drink and alcohol
It is recommended that DETRALEX be taken with food (see section 3 How to take DETRALEX) Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
As a precautionary measure, it is preferable to avoid the use of DETRALEX during pregnancy.
Breastfeeding
Due to the lack of data on excretion in breast milk, treatment with DETRALEX during breastfeeding should be avoided.
Driving and using machines
DETRALEX does not affect the ability to drive or use machines.
Important information about some of the ingredients of DETRALEX
Not applicable.
3. How to take DETRALEX
Oral administration.
Always take DETRALEX exactly as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure about anything.
The usual dosage is:
Venous insufficiency:
2 tablets daily, 1 tablet at lunch and 1 tablet in the evening, during meals.
Hemorrhoids:
A 4-day course of 6 tablets daily, followed by 4 tablets daily for the next 3 days, during meals.
If you take more DETRALEX than you should
If you have taken more DETRALEX tablets than you should, contact your doctor or pharmacist immediately.
Experience with overdose with DETRALEX is limited, but 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 medicinal product, please ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
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, indigestion, 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 cannot be estimated from the available data):
isolated cases of edema (swelling) of the face, lips and eyelids. In extremely rare cases, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat, which may lead to difficulty breathing), abdominal pain.
Reporting adverse drug reactions
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (at the address below). By reporting side effects, you can help to obtain more information on the safety of this medicine.
Bulgarian Medicines Agency (BMA)
8 Damyan Gruev Street
1303, Sofia
Tel.: +359 2 8903 417
website: www.bda.bg.
5. How to store DETRALEX
Keep out of the reach of children.
Do not use DETRALEX after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. Contents of the pack and other information
What DETRALEX contains
The active substance is a flavonoid fraction, purified and micronized. One tablet contains 500 mg of flavonoid fraction, purified and micronized, an amount corresponding to: flavonoids expressed as hesperidin: 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 sulfate, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
What DETRALEX looks like and what the pack contains
DETRALEX are pink-orange, oval film-coated tablets. One tablet contains 500 mg of flavonoid fraction, purified and micronized. The tablets are available in boxes of 30, 36, 60, 90 or 120 film-coated tablets in PVC/Aluminium blisters.
Not all packaging types may be available.
Marketing Authorisation Holder:
Les Laboratoires Servier, France.
Manufacturer:
Les Laboratoires Servier Industrie, France.
Servier (Ireland) Industries Ltd, Ireland.
