Loniten 10mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Minoxidil

Доступна з:

Lexon (UK) Ltd

Код атс:

C02DC01

ІПН (Міжнародна Ім'я):

Minoxidil

Дозування:

10mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 02050100

інформаційний буклет

PATIENT INFORMATION LEAFLET
LONITEN® 10 MG TABLETS
(minoxidil)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
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.
Your medicine is also available in the following strengths 2.5mg
and 5mg Tablets.
The name of your medicine is Loniten 10mg Tablets, but will be
referred to as Loniten throughout the remainder of the leaflet.
WHAT IS IN THIS LEAFLET:
1. What Loniten is and what it is used for
2. What you need to know before you take Loniten
3. How to take Loniten
4. Possible side effects
5. How to store Loniten
6. Contents of the pack and other information
1. WHAT LONITEN IS AND WHAT IT IS USED FOR
This medicine contains minoxidil, which is one of a group of
medicines called ‘vasodilators’. It can be used to treat very high
blood pressure (hypertension), and works by relaxing blood
vessels so that blood passes through them more easily. This
helps to lower blood pressure.
You must talk to your doctor or pharmacist if you do not feel
better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LONITEN
DO NOT TAKE LONITEN:
•
If you are allergic to minoxidil or any of the other ingredients
of this medicine (listed in section 6).
•
If your high blood pressure is caused by hormones from a
tumour (phaeochromocytoma), usually near the kidneys.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Loniten:
•
If you are pregnant or trying to become pregnant.
•
If you have heart failure (you may feel breathless, wheezy or
tired and your ankles may swell up);
•
If you have ever had a heart attack. Loniten tablets

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loniten 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Loniten tablet contains 10 mg minoxidil.
Excipients with known effect:
Each tablet contains 90 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round white to light tan biconvex tablets, with ‘10' imprinted on
one side, scored on
the reverse with a‘U’ on one side of the score and ‘137’ on
the other side.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minoxidil is indicated for the treatment of severe hypertension.
It should not be used as the sole agent to initiate therapy. It is a
peripheral vasodilator
and should be given in conjunction with a diuretic, to control salt
and water retention,
and a beta-adrenergic blocking agent, or appropriate substitute, to
control reflex
tachycardia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
_Patients over 12 years and adults _
The recommended starting dose is 5 mg per day. If required, this
dosage can later be
increased up to 20 mg, and then to 40 mg daily (given as a single dose
or in two
divided doses). Dose increases should be made at increments of 5 mg to
10 mg
minoxidil per day at intervals of three or more days. If a dose of 50
mg of minoxidil
has been reached, the dose may be increased by 25 mg minoxidil per day
to a
maximum dose of 100 mg per day.
If the desired decrease of diastolic blood pressure exceeds 30 mmHg,
dosage should
be divided to two daily doses to keep daily blood pressure
fluctuations as low as
possible.
_Patients younger than 12 years of age _
The use of minoxidil in children is restricted to children with severe
hypertension
associated with target organ damage where other treatment has failed.
The data
regarding the use of minoxidil in children is very limited, especially
in infants. The
dosage recommendations can only be considered as a rough guide to
treatment at
present as this is based o