Veinofytol gastro-resistant tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Предлага се от:

Tilman SA ZI Sud 15, Baillonville, 5377, , Belgium

АТС код:

C05CX03

INN (Международно Name):

Horse Chestnut seed 21 mg

Лекарствена форма:

GASTRO-RESISTANT TABLET

Композиция:

Horse Chestnut seed 21 mg

Вид предписание :

OTC

Терапевтична област:

VASOPROTECTIVES

Статус Оторизация:

Authorised

Дата Оторизация:

2023-11-24

Листовка

LEAFLET
PIL
1/4
PACKAGE LEAFLET: INFORMATION FOR THE USER
VEINOFYTOL GASTRO-RESISTANT TABLETS
Horse chestnut dry extract
corresponding to 21 mg triterpene glycosides, calculated as
protoaescigenin
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 have 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 or pharmacist. 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, or if Veinofytol gastro-
resistant tablets is required for more than 8 weeks.
WHAT IS IN THIS LEAFLET :
1.
What Veinofytol gastro-resistant tablets is and what it is used for
2.
What you need to know before you take Veinofytol gastro-resistant
tablets
3.
How to take Veinofytol gastro-resistant tablets
4.
Possible side effects
5.
How to store Veinofytol gastro-resistant tablets
6.
Contents of the pack and other information
1.
WHAT VEINOFYTOL GASTRO-RESISTANT TABLETS IS AND WHAT IT IS USED FOR
Veinofytol gastro-resistant tablets is a herbal medicinal product
containing Horse chestnut dry extract.
Veinofytol gastro-resistant tablets is used for treatment of chronic
venous insufficiency, which is
characterised by swollen legs, varicose veins, a feeling of heaviness,
pain, tiredness, itching, tension
and cramps in the calves.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEINOFYTOL GASTRO-RESISTANT
TABLETS
DO NOT TAKE VEINOFYTOL GASTRO-RESISTANT TABLETS
-
if you are allergic to Horse chestnut or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Veinofytol
gastro-resistant tablets.
-
If there is inflammation of the skin, thrombophlebitis or subcutaneous
induration, severe pain,

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
SmPC
1/5
1.
NAME OF THE MEDICINAL PRODUCT
Veinofytol gastro-resistant tablets
Horse chestnut dry extract, corresponding to 21 mg triterpene
glycosides, calculated as
protoaescigenin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 192 mg - 258 mg of extract (as dry extract) from
_Aesculus hippocastanum_
L.,
semen (Horse chestnut seed) corresponding to 21 mg triterpene
glycosides, calculated as
protoaescigenin.
Extraction solvent: Ethanol 50 % V/V.
Excipient(s) with known effect
Each tablet contains 5.261 mg of Allura Red AC (E129).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Red, oblong, biconvex tablets of 18 x 8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Veinofytol gastro-resistant tablets is indicated in adults.
Herbal medicinal product for treatment of chronic venous
insufficiency, which is characterised by
swollen legs, varicose veins, a feeling of heaviness, pain, tiredness,
itching, tension and cramps in the
calves.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult and elderly _
1 tablet two times daily.
_Paediatric population _
There is no relevant indication in children under 12 years of age.
The use is not recommended in adolescents under 18 years of age due to
a lack of data on safety and
efficacy.
Duration of use
At least 4 weeks of treatment may be required before any beneficial
effect is observed.
Long-term use is possible in consultation with a doctor.
SUMMARY OF PRODUCT CHARACTERISTICS
SmPC
2/5
Method of administration
Oral use.
Swallow the tablets with a large glass of water.
Patients with impaired renal/liver function:
No data are available for a dosing instruction in case of impaired
hepatic and/or renal function.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If there is inflammation of the skin, thrombophlebitis or subcutaneous
induration, severe pain, ulcers