DETRALEX 500mg x 90 film tabl
DETRALEX tablets 500 mg. * 90
LEAFLET: INFORMATION FOR THE USER
DETRALEX 500 mg film-coated tablets
DETRALEX 500 mg film-coated tablets
Flavonoid fraction, purified and micronized,
(quantity 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, tell your doctor, pharmacist or nurse. This also includes any possible side effects not described in this leaflet. See point 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 taking 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 a 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 the micronized purified flavonoid fraction or to any of the excipients of DETRALEX.
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 consult your doctor for advice.
Venous-vascular disorders: Treatment leads to the best possible result if it is combined with a healthy lifestyle. Avoid exposure to the sun, heat, prolonged standing, excess weight. Walking and wearing special (compression) socks improves 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 to take DETRALEX with food (see item 3 How to take DETRALEX).
Pregnancy, lactation and fertility
Due to the lack of data on exposure to breast milk, treatment with DETRALEX during breast-feeding should be avoided.
Ask your doctor or pharmacist before using any medicine.
Driving and using machines
DETRALEX does not affect the ability to drive and operate machinery.
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: 4-day course of 6 tablets daily, followed by 4 tablets daily for the next 3 days, during meals.
If you have taken more than the required dose of DETRALEX
Not applicable.
If you forget to take DETRALEX
Do not take a double dose to make up for a forgotten dose.
If you have stopped taking DETRALEX
Not applicable.
If you have any further questions related to the use of this medicinal product, please ask your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, DETRALEX can cause side effects. 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 become serious, or if you notice any side effects not described in this leaflet, please tell your doctor or pharmacist.
Not known (frequency can 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, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly (at the address below). By reporting side effects, you can contribute to getting more information about the safety of this medicine.
Bulgaria,
Medicines Executive Agency (EMA),
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 marked on the carton after "EXP". The expiration date refers to the last day of the given month.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. Contents of the package and additional information
What DETRALEX contains
The active substance is: flavonoid fraction, purified and micronized. One tablet contains 500 mg of the 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, glycerol, hypromellose, macrogol 6000, sodium lauryl sulfate, yellow iron oxide (E172), titanium dioxide (E 171).
What DETRALEX looks like and what it 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 types of packaging may be available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Les Laboratoires Servier, France.
Manufacturer:
Les Laboratoires Servier Industrie, France;
Servier (Ireland) Industries Ltd., Ireland.
Date of last approval of leaflet: 12.2014.
