VENO-BIOMO

VENO-BIOMO retard prolonged-release tablets

Important notes (mandatory information)

veno-biomo retard Retard tablets. Active ingredient: Horse chestnut seed dry extract. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), which are characterised by swollen legs, varicose veins, a feeling of heaviness and tension, pain, itching, tiredness in the legs and calf cramps.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

veno-biomo retard Retard tablets for adults
Active ingredient: Horse chestnut seed dry extract standardised to 21 mg triterpene glycosides

Read the entire package leaflet/instructions for use carefully, as it contains important information for you. This medicine is also available without a doctor's prescription. However, in order to achieve the best possible treatment results, veno-biomo retard must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 4 weeks, you must consult a doctor in any case.

This package leaflet contains

1. WHAT IS VENO–BIOMO RETARD AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING VENO–BIOMO RETARD?
3. HOW TO TAKE VENO–BIOMO RETARD?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VENO–BIOMO RETARD?
6. HOW IS VENO–BIOMO RETARD COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS VENO–BIOMO RETARD?

1. WHAT IS VENO-BIOMO RETARD AND WHAT IS IT USED FOR?

veno-biomo retard is a herbal medicine for venous diseases. veno-biomo retard is used to treat complaints in the case of diseases of the leg veins (chronic venous insufficiency), which are characterised by swollen legs, varicose veins, a feeling of heaviness and tension, pain, itching, tiredness in the legs and calf cramps.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING VENO-BIOMO RETARD?

veno-biomo retard must not be taken by patients with known hypersensitivity to horse chestnut seeds or any of the other ingredients.

Special care must be taken when taking veno-biomo retard

In the case of inflammation of the skin, superficial phlebitis or hardening of the subcutaneous tissue, severe pain, skin ulcers, sudden swelling of one or both legs as well as in the case of functional limitations of the heart or kidneys, a doctor should be consulted.

Notes

Other measures prescribed by the doctor, such as wrapping the legs, wearing support stockings or cold water jets, should be strictly adhered to.

Pregnancy and breast-feeding

The safety during pregnancy and breast-feeding has not been investigated. Due to insufficient data, use during pregnancy and breast-feeding is not recommended.

Driving and using machines

There are no sufficient studies on the effect on the ability to drive and use machines.

This medicine contains sodium

veno-biomo retard contains less than 1mmol sodium (23 mg) per retard tablet, i.e. it is almost "sodium-free".

Interactions with other medicines

None known. However, no interaction studies have been conducted for veno-biomo retard. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.

3. HOW TO TAKE VENO-BIOMO RETARD?

Always take veno-biomo retard exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Method of application

For oral use.

Unless otherwise prescribed by your doctor, the usual dose is

You should take 1 retard tablet 2 times a day.

How and when should you take veno-biomo retard?
veno-biomo retard is taken unchewed with a little liquid in the morning and evening before meals.

How long should you take veno-biomo retard?
Initial treatment successes may not be apparent until after a treatment period of 4 weeks. Long-term treatment is possible after consultation with the doctor.

Patients with impaired renal/hepatic function

A dose adjustment is not necessary for patients with impaired renal function. There are no sufficient data for specific dosage recommendations in the case of impaired hepatic function.

Children and adolescents

Use in children and adolescents under 18 years of age is not intended due to the area of application.

If you have taken more veno-biomo retard than you should

If you have taken a larger amount, the side effects mentioned below may possibly occur more frequently. However, no cases of overdose have been reported to date.

If you forget to take veno-biomo retard

Do not take a double dose, but continue taking or using it as stated in this package leaflet or as prescribed by your doctor.

What effects can you expect if treatment with veno-biomo retard is discontinued

An interruption or premature termination of treatment is generally harmless. In case of doubt, please consult your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, veno-biomo retard can have side effects. The list includes all known side effects under treatment with horse chestnut seed dry extract, including those under higher dosage or long-term therapy. Gastrointestinal complaints may occur after taking veno-biomo retard. Headache, dizziness, itching and allergic reactions may occur. The frequency is not known.

Countermeasures

In the case of persistent side effects, consult a doctor who will decide on any necessary measures. At the first signs of a hypersensitivity reaction (e.g. skin rash), the medicine should not be taken any further. If you observe any of the side effects mentioned above, please inform your doctor so that he/she can decide on the severity and any necessary measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE VENO-BIOMO RETARD?

Keep medicines out of the reach of children. The expiry date is printed on the folding box and the container (blister pack). veno-biomo retard should not be used after the expiry date. Do not store above 25°C!

6. HOW IS VENO-BIOMO RETARD COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

1 retard tablet contains

Active ingredient: 178.5 - 263.2 mg dry extract from horse chestnut seeds, corresponding to 21 mg triterpene glycosides, calculated as protoaescigenin; Extraction agent: Ethanol 50 % (m/m). Other ingredients: Calcium hydrogen phosphate; Crospovidone (type A); Dimethicone (350); Highly dispersed silicon dioxide; Sorbic acid (Ph. Eur.); Macrogol stearyl ether-5 (Ph. Eur.); Macrogol 4000; Magnesium stearate [vegetable] (Ph. Eur.); Hypromellose; Ammonium methacrylate copolymer (type B) (Ph. Eur.); Ammonium methacrylate copolymer (type A) (Ph. Eur.); Sodium hydroxide; Polysorbate 80; Povidone (K25); Saccharin sodium; Talc; Triethyl citrate; Vanillin; Titanium dioxide E 171; Iron(III) oxide E 172; Iron(III) hydroxide oxide x H2O E 172.

veno-biomo retard is available in packs of 50 and 100 retard tablets and a bundle pack of 200 (2 x 100) (short-term pack) retard tablets.

7. WHO IS VENO-BIOMO RETARD?

Pharmaceutical entrepreneur and manufacturer

biomo pharma GmbH
Josef-Dietzgen-Str. 3
53773 Hennef
Telephone: 02242/8740 0
Telefax: 02242/8740 499

Marketing authorisation holder

Bioplanta Arzneimittel GmbH
Postfach 226
76256 Ettlingen
Telephone: 07243/939 845
Telefax: 07243/939 846

This package leaflet was last revised in July 2021.

Source: Information from the package leaflet
Status: 11/2021
Active ingredient: Horse chestnut seed dry extract. Areas of application: for the treatment of complaints in the case of diseases of the leg veins (chronic venous insufficiency), which are characterised by swollen legs, varicose veins, a feeling of heaviness and tension, pain, itching, tiredness in the legs and calf cramps.