FLEBAVEN 1000mg x 30 tabl
FLEBAVEN tablets 1000 mg. * 30
Leaflet: user information
Phlebaven 1000 tablets
Diosmin
Flebaven 1000 tablets
Diosmin
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 or pharmacist 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 or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 6 weeks of treatment of chronic venous disease or after 7 days of treatment of acute hemorrhoidal crisis you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What Flebaven is and what it is used for
2. What you need to know before you take Flebaven
3. How to take Flebaven
4. Possible side effects
5. How to store Flebaven
6. Contents of the package and additional information
1. What Flebaven is and what it is used for
Diosmin belongs to a group of substances called bioflavonoids and is used to stabilize capillaries. Phlebaven contains active substances that influence the activity of the veins and protect the veins; they increase the tone of the veins and the resistance of the capillaries. Phlebaven reduces the appearance of edema and has anti-inflammatory effects.
Flebaven is indicated in adults for the treatment of signs and symptoms of chronic venous disease, such as pain, heaviness, leg fatigue, restless legs, nocturnal cramps, edema and trophic changes. It is also indicated for the treatment of symptoms associated with an acute hemorrhoidal crisis such as pain, bleeding, and swelling in the anal area.
If you are taking Flebaven for the treatment of symptoms of chronic venous disease and after 6 weeks you do not feel better or your condition worsens, you should seek medical advice.
If you take Flebaven for the treatment of symptoms of an acute hemorrhoidal crisis and after 7 days you do not feel better or your condition worsens, you should seek medical help.
2. What you need to know before you take Flebaven
Do not take Flebaven:
if you are allergic to diosmin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Flebaven.
Chronic venous disease
If during treatment your condition worsens, which may manifest as inflammation of the skin or veins, hardening of the tissue under the skin, severe pain, skin ulcers or atypical symptoms such as sudden swelling of one or both legs, you should immediately consult your doctor.
Treatment with Flebaven is most beneficial when accompanied by a balanced lifestyle:
to avoid exposure to the sun and prolonged upright standing;
to maintain an appropriate weight;
wearing special socks may improve circulation in some patients.
Phlebaven will not help reduce swelling in your lower limbs if it is caused by heart, kidney or liver disease.
Acute hemorrhoidal crisis
If you have an acute hemorrhoidal crisis, you can take Flebaven only for a limited period of 15 days. If the symptoms do not go away during this time, consult your doctor.
If during treatment your condition worsens, i.e. if you notice increased bleeding from the rectum, blood in the stool or suspect bleeding hemorrhoids, consult your doctor.
Treatment with Flebaven is not a substitute for specific treatment of other anal disorders.
Children and adolescents
Not recommended for use in children and adolescents.
Other medicines and Flebaven
So far, there are no reports of interactions between diosmin and other medicinal products. However, you should still tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Phlebaven with food
Take Flebaven with food.
Pregnancy and breastfeeding
The safety of using Flebaven during pregnancy and breastfeeding has not been established. Therefore, its use during these periods is not recommended.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Flebaven does not affect or negligibly affects the ability to drive and operate machinery.
3. How to take Flebaven
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dosage
Chronic venous disease
The recommended daily dose is 1 tablet.
You must take this medicine for at least 4 to 5 weeks before the expected improvement occurs. If after 6 weeks of treatment the symptoms of your disease worsen or do not improve, consult your doctor.
Self-treatment without consulting a doctor can continue for a period of 3 months. However, you can continue taking Flebaven for a longer period of time if your doctor considers that you do not need any other specific treatment.
Acute hemorrhoidal crisis
The recommended daily dose during the first 4 days of treatment is 3 tablets.
During the next 3 days, the recommended daily dose is 2 tablets. After that, the recommended dose for maintenance treatment is 1 tablet daily.
If after 7 days of treatment the symptoms do not improve or worsen, consult your doctor. Self-treatment with Flebaven can continue for a period of 15 days; if symptoms persist during this time, consult your doctor.
Application method
Flebaven should be taken with food.
Swallow the tablet with liquid.
If you have taken more than the required dose of Flebaven
If you have taken more tablets than you should, talk to your doctor or pharmacist.
No cases of overdose with diosmin have been reported so far.
If you forget to take Flebaven
Do not take a double dose to make up for a missed dose.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Reported side effects associated with the use of diosmin include:
Common (may affect up to 1 in 10 people):
Diarrhea, indigestion, nausea, vomiting.
Uncommon (may affect up to 1 in 100 people):
Colitis (inflammation of the colon).
Rare (may affect up to 1 in 1,000 people):
Headache, malaise, vertigo (dizziness);
Rash, itching, urticaria (hives).
Not known (frequency cannot be estimated from the available data):
Stomach ache;
Edema (swelling of the face, lips and eyelids), angioedema in extremely rare cases (rapid swelling of tissues such as the face, lips, tongue or throat, which may cause breathing difficulties).
Reporting adverse 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 by:
Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
Phone: +359 2 8903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Flebaven
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.
To be stored below 25 °C.
Store in original packaging to protect from moisture.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Flebaven contains
The active substance is: diosmin. Each film-coated tablet contains 1000 mg of micronized diosmin.
The other ingredients (excipients) are: polyvinyl alcohol, croscarmellose sodium and magnesium stearate.
What Flebaven looks like and contents of the pack
Light green or gray-yellow to light green or gray-brown with a marble structure, slightly biconvex, oblong tablets. The dimensions of the tablets in blisters are 18.0 mm x 9.0 mm.
Flebaven is available in packs containing 20, 30, 60, 90 and 120 tablets in blisters.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer:
KRKAQ, dd, Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenia
