Venoruton Forte 500 mg tablets, N30 - leg pain, venous insufficiency

Venoruton Forte 500 mg tablets, N30 - leg pain, venous insufficiency

Venoruton forte 500 mg tablets

O-(  -hydroxyethyl)-rutosides

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.

Do not throw this leaflet away as you may need to read it again.

If you want to know more or consult, ask your pharmacist.

If you experience side effects (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4 .

If your condition has not improved or even worsened within 2 weeks, consult a doctor.

What is this leaflet about?

1. What Venoruton is and what it is used for

2. What you need to know before you take Venoruton

3. How to take Venoruton

4. Possible side effects

5. How to store Venoruton

6. Package contents and other information

1. What Venoruton is and what it is used for
Venoruton contains O-(  -hydroxyethyl)-rutosides, which belong to drugs that protect blood vessels (so-called systemic vasoprotectors). Venoruton works on the small blood vessels (capillaries) by reducing the passage of water and other substances through the walls, thereby reducing vascular permeability and swelling (edema).

The drug is intended for alleviating the symptoms of chronic venous insufficiency, reducing the symptoms of hemorrhoids and additional treatment of diabetic retinopathy (retinal vascular damage as a complication of diabetes) and lymphatic system.

Patients with varicose veins of the superficial veins of the legs have increased vascular conductance, resulting in swelling of the ankle. Venoruton reduces the swelling (edema) of the ankles caused by chronic venous insufficiency (LVN) and other associated symptoms such as pain, fatigue, leg heaviness, swelling, tenderness, paraesthesia (pins and needles) and cramps.

For hemorrhoids, Venoruton reduces swelling around the anus and other symptoms such as itching, bleeding or oozing.

Venoruton reduces the conductivity of retinal capillaries in the case of a complication of diabetes mellitus, retinal vascular damage (diabetic retinopathy).

It reduces swelling in lymph nodes (lymphedema).

If your condition has not improved or even worsened within 2 weeks, consult a doctor.

2. What you need to know before you take Venoruton
Venoruton should not be used:

- if you are allergic to the active ingredient or any of the excipients of this medicine (they are listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Venoruton. Tell your doctor if:

- have leg edema (swelling) due to heart, kidney or liver disease. You should not use Venoruton because it is ineffective in these diseases.

FOR CHILDREN AND TEENAGERS
Venoruton is not intended for use by children.

Other medicines and Venoruton

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines or supplements, or if you are not sure.

Pregnancy, lactation and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine. According to generally accepted safety recommendations, Venoruton should not be used during the first three months of pregnancy.

Driving and machine control

Venoruton tablets have no or negligible influence on the ability to drive and use machines.

Fatigue and dizziness have been reported rarely with this medicine. If you experience these effects, do not drive or operate machinery.

3. How to take Venoruton
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist. Follow these requirements strictly.

For adults

Chronic venous insufficiency (LVN)

Initial dose

It is necessary to take 1 tablet 2 times a day. The drug should be used until the symptoms and edema completely disappear. Symptoms usually subside within 2 weeks.

Maintenance doses

For maintenance treatment, you can use the same dose or reduce it to the lowest maintenance dose of 500 mg of Venoruton per day (one tablet of Venoruton Forte once a day).

When the symptoms and edema completely disappear, the treatment is stopped. If symptoms recur, treatment should be restarted at the same dose or at the lowest maintenance dose of Venoruton of 500 mg per day.

If there is no improvement within 2 weeks or if the symptoms even worsen, the treatment should be stopped and a doctor should be consulted.

Hemorrhoids

The recommended dose is 2 tablets per day for 1-4 weeks.

Diabetic retinopathy

The recommended dose is 6 tablets per day (3 tablets 2 times a day).

Composition of lymph

The recommended daily dose is 6 tablets (3 Venoruton forte 500 mg tablets 2 times a day).

For patients with impaired heart, kidney and/or liver function

Venoruton should not be used in patients with impaired heart, kidney and/or liver function.

For elderly patients

There are no special dosage recommendations.

What to do if you overdose on Venoruton?

In case of accidental ingestion, consult a doctor immediately.

If you forget to take Venoruton

Do not take a double dose to make up for a missed dose. If you have any further questions about 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.

Some side effects can be serious and occur very rarely ( may affect up to 1 in 10,000 people ).

STOP taking Venoruton and contact your doctor immediately if any of the following occur, as this may be a sign of an allergic reaction:

- difficulty breathing or swallowing;

- swelling of the face, lips, tongue or throat;

- severe itching of the skin with a red rash, hives or hives.

If you experience such an effect, stop taking the medicine and contact your doctor immediately.

Other adverse reactions are usually mild.

Some side effects are rare (may affect up to 1 in 1,000 people)

Gastrointestinal disturbances (including gas, diarrhoea, abdominal pain, stomach discomfort or dyspepsia), rash, itching or hives.

Some side effects are very rare (may affect up to 1 in 10,000 people)

Dizziness, headache, fatigue, redness of the face and neck.

Side effect reporting

If you get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects to the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania by toll-free phone number 8 800 73568 or fill out the form on the website www.vvkt.lt and submit it to the State Medicines Control Service under the Ministry of Health Protection of the Republic of Lithuania by one of the following ways: in writing (address Žirmūnų st. 139A, LT-09120 Vilnius), free fax number 8 800 20131 , e-mail by mail NegeidaujamaR@vvkt.lt, as well as through the website of the State Drug Control Service under the Ministry of Health of the Republic of Lithuania (at http://www.vvkt.lt ). By reporting side effects, you can help us get more information about the safety of this medicine."

5. How to store Venoruton
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The drug is suitable for use until the last day of the indicated month.

No special temperature conditions are required for the storage of this medicine .

Store in the manufacturer's packaging to protect from moisture.

Medicines must not be disposed of in the sewer or with household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.

6. Package contents and other information
Composition of Venoruton

The active substance is O-(  -hydroxyethyl)-rutosides. Each tablet contains 500 mg of O-(  -hydroxyethyl)-rutosides.

Excipients are macrogol 6000, magnesium stearate.

What Venoruton looks like and contents of the pack

Tablets are greenish-yellow, marble, biconvex, round.

The pack contains 30 tablets packed in PVC/PE/PVDC/Al blisters.

Registrant and manufacturer