Venaforce Varicose Veins gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Extract (as dry extract) from fresh horse chesnut seeds (aesculus hippocastanum l. semen)

Available from:

A.Vogel Ireland Limited

INN (International Name):

Extract (as dry extract) from fresh horse chesnut seeds (aesculus hippocastanum l. semen)

Dosage:

.

Pharmaceutical form:

Gastro-resistant tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

2011-12-16

Patient Information leaflet

A.Vogel Ireland
Aesculaforce Tablets 50mg
IE - Dublin
CTD Module 1
November 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2598.e05
Page 1 of 6
Aesculus-Filmtabletten (2)
Art. No. 01149300
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENAFORCE
Varicose Veins
gastro-resistant tablets
Horse Chestnut seed dry extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this product 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.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
WHAT IS IN THIS LEAFLET
1.
What Venaforce is and what it is used for
2.
What you need to know before you take Venaforce
3.
How to use Venaforce
4.
Possible side effects
5.
How to store Venaforce
6.
Contents of the pack and other information
1.
WHAT VENAFORCE IS AND WHAT IT IS USED FOR
Venaforce is a traditional herbal medicinal product containing the
extract of fresh Horse Chestnut seeds.
It is used for relieving the symptoms of varicose veins such as:
•
Tired, heavy legs
•
Aching legs
This is exclusively based on long-standing use.
A.Vogel Ireland
Aesculaforce Tablets 50mg
IE - Dublin
CTD Module 1
November 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2598.e05
Page 2 of 6
Aesculus-Filmtabletten (2)
Art. No. 01149300
Venaforce is for relieving the symptoms of varicose veins in adults.
Varicose veins appear when veins lose their elasticity. Blood then
gathers, causing swelling and discomfort.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENAFORCE
DO NOT TAKE VENAFORCE
•
If you are allergic

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2022
CRN00D7VG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venaforce Varicose Veins gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 157.5 - 225.0 mg of extract (as
dry extract) from fresh _Aesculus hippocastanum_ L, semen
(horse chestnut seed) corresponding to 50 mg triterpene glycosides,
calculated as anhydrous β-aescin. Extraction solvent:
Ethanol 60 % m/m.
Excipient with known effect:
Each gastro-resistant tablet contains 12.5 mg of soya polysaccharide.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
It is a biconvex, oval-shaped, yellowish-beige coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for relieving the symptoms of
varicose veins such as tired, aching or heavy legs
exclusively based on long standing use.
This product is indicated for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and older people: one tablet twice daily taken immediately
after food.
Tablet should be swallowed whole.
Do not exceed the recommended dose.
This product should not be given to children and adolescents under the
age of 18 years.
If symptoms persist, worsen or do not improve after 2 weeks use of
Venaforce a qualified healthcare professional e.g. a doctor
or pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
This product should not be used by patients who have an allergy or are
hypersensitive to horse chestnut seed or any of the
other ingredients listed in section 6.1.
Contains soya. If you are allergic to peanut or soya, do not use this
medicinal product.
Health Products Regulatory Authority
14 November 2022
CRN00D7VG
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist, worsen or do not improve after 2 weeks use of
Venaforce a qualified healthcare professional e.g. a doc