Loniten 10mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Minoxidil

Disponível em:

Pfizer Ltd

Código ATC:

C02DC01

DCI (Denominação Comum Internacional):

Minoxidil

Dosagem:

10mg

Forma farmacêutica:

Oral tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050100; GTIN: 5012882005153

Folheto informativo - Bula

LONITEN
® 5 MG TABLETS
LONITEN
® 10 MG TABLETS
(minoxidil)
PATIENT INFORMATION LEAFLET
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 available using any of the above names but will be
referred
to as Loniten throughout this leaflet. Also available in 2.5 mg
tablets.
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 encourage salt and water to remain i

Características técnicas

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 90.3 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 on