Loniten 2.5mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Minoxidil

Доступна з:

Pfizer Ltd

Код атс:

C02DC01

ІПН (Міжнародна Ім'я):

Minoxidil

Дозування:

2.5mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 02050100; GTIN: 5012882005139

інформаційний буклет

17.5” X 10” (FOLDED: 2.5” X 1”)
DWG-100534-01
MULTIPLE
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EDITOR’S COPY
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DATE:
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rev. 08JUN11
ADDITIONAL INFO:
COLORS:
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D. M. GUERIN
B. NOEL
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NO CONDENSED.
Dieline
To avoid these problems, your doctor
will prescribe two other medicines for
you to take with LONITEN. One will be
a water tablet (diuretic) to help your
body get rid of excess water, and the
other a beta-blocker or similar medicine
to stop your heart beating too fast or
angina pain in the chest.
If your doctor gives you a low salt diet,
follow it carefully. You should weigh
yourself daily and keep an accurate
record of your weight while you are
taking this medicine. Tell your doctor if
you put on more than 1 to 1.5 kg. The
cause could be extra fluid in your body.
Tell your doctor if you think you have
gained weight – even though it may not
be due to the medicine. Your doctor
will want to monitor fluid and salt
(electrolyte) levels in your body.
You may recognise increased hair
growth (hypertrichosis) after starting
treatment, this usually emerges in the
face but may subside with continued
treatment. This side effect is reversible
upon stopping treatment but may take
one to six months.
Your doctor will want to make regular
checks on your blood pressure and
general health. You should also have
occasional checks on your heart.
If you have an ECG test (to check the
electrical activity of your heart) or any
blood tests, remind your doctor that
you are taking LONITEN, as it can
change the results.
Your doctor may monitor your blood for
the very rare possibility of decreased
white blood cells and platelets cells.
In some patients, inflammation
of membrane around heart, fluid
accumulation under the membrane
around heart (cardiac tamponade) can
occur. Your doctor should monitor
these carefully and may try to drain
the fluid or may consider stopping
treatment with LONITEN.
Patients with kidney failur

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loniten 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Loniten tablet contains 2.5 mg minoxidil.
Excipients with known effect:
Each tablet contains 95.8 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 ‘2½' imprinted on
one side, scored on
the reverse with a ‘U’ on one side of the score and ‘121’ 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
base