Hexopal Forte 750mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Inositol nicotinate

Доступна с:

Genus Pharmaceuticals Ltd

код АТС:

C04AC03

ИНН (Международная Имя):

Inositol nicotinate

дозировка:

750mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02060400

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEXOPAL FORTE 750MG TABLETS
(INOSITOL NICOTINATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side-effects get serious, or if you notice any
side-effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Hexopal Forte 750mg Tablets are and what they are used for
2. Before you use Hexopal Forte 750mg Tablets
3. How to use Hexopal Forte 750mg Tablets
4. Possible side-effects
5. How to store Hexopal Forte 750mg Tablets
6. Further information
1. WHAT HEXOPAL FORTE 750MG TABLETS ARE AND WHAT THEY ARE
USED FOR
Hexopal Forte 750mg Tablets contain inositol nicotinate, which works
by relaxing the blood
vessels.
Hexopal Forte 750mg Tablets are used to treat intermittent
claudication (pain in the legs
whilst walking) and Raynaud’s phenomemon (fingers and toes which go
white and bloodless
in the cold).
2. BEFORE YOU USE HEXOPAL FORTE 750MG TABLETS
DO NOT USE HEXOPAL FORTE 750MG TABLETS IF YOU:
• are allergic (hypersensitive) to inositol nicotinate or any of the
other ingredients of Hexopal
Forte
750mg Tablets (see section 6 – Further information for details)
• have recently had a heart attack or stroke
TAKE SPECIAL CARE WITH HEXOPAL FORTE 750MG TABLETS IF YOU HAVE:
• poor circulation to the brain (cardiovascular insufficiency)
• chest pains (unstable angina).
USING OTHER MEDICINES
The risk of bleeding can be increased when taken with warfarin.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Hexopal should not usually be used during pregnancy. If you are
pregnant or planning to
become pregnant

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hexopal Forte 750mg Tablets
Inositol Nicotinate 750mg Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Inositol Nicotinate BP 750 mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hexopal is indicated for the symptomatic relief of severe intermittent
claudication and Raynauds phenomenon.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults: The usual dose is 3g daily (two Hexopal Forte Tablets twice
daily).
The dose of Hexopal may be increased up to 4g daily if necessary.
Oral administration.
4.3.
CONTRAINDICATIONS
Use in patients who have suffered a recent myocardial infarction or
are in the
acute phase of a cerebrovascular accident.
Use in patients hypersensitive to the active ingredient.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with caution in the presence of
cerebrovascular
insufficiency or unstable angina.
Ingredients with specified warnings
This medicine contains less than 1mmol sodium (23mg) per dose, that is
to say
essentially ‘sodium-free’.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The risk of bleeding can be increased when concomitantly taken with
warfarin.
4.6.
PREGNANCY AND LACTATION
There is no evidence of the safety of Hexopal in human pregnancy nor
is there
any evidence from animal work that it is free from hazard. The use of
Hexopal in pregnancy should therefore be avoided unless there is no
safer
alternative.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8.
UNDESIRABLE EFFECTS
Nicotinic acid can cause myalgia, the risk of myalgia due to intake of
lipid-
lowering agents, especially statins, can be increased.
Uncommon side effects include flushing, dizziness, headache, nausea,
vomiting, syncope, paraesthesia, rash, oedema, and postural
hypotension.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
pr