Loniten 5 mg tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Minoxidil

Tillgänglig från:

Pfizer Healthcare Ireland

ATC-kod:

C02DC; C02DC01

INN (International namn):

Minoxidil

Dos:

5 milligram(s)

Läkemedelsform:

Tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Pyrimidine derivatives; minoxidil

Bemyndigande status:

Marketed

Tillstånd datum:

1980-02-07

Bipacksedel

Page 1 of 6
PfLEET 2021-0069264
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LONITEN® 5 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.
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 (severe hypertension), and
works by relaxing blood
vessels so that blood passes through them more easily. This helps to
lower blood pressure.
Loniten should be used in combination with a diuretic (water tablet),
to prevent fluid retention and
oedema, and a beta-blocker or similar medicine, to stop your heart
beating too fast or angina pain
in the chest.
You must talk to a 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

Produktens egenskaper

Health Products Regulatory Authority
13 October 2020
CRN009Z64
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loniten 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg minoxidil
Excipient(s) with known effect:
Each tablet contains 94 mg of lactose Monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white to light tan, biconvex tablet, 5 imprinted on one side,
scored on the reverse with a ‘U’ on either side of the score.
The score line has no practical function; these tablets should not be
broken in half.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minoxidil is indicated for the treatment of severe hypertension that
is symptomatic or associated with target organ damage. It
is indicated for the treatment of hypertension not controlled
adequately by a combination of a diuretic and a sympathetic
suppressant agent such as a beta blocker. Additionally, it is
indicated in hypertension that is not manageable with maximum
therapeutic doses of a diuretic plus two other antihypertensive drugs.
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 betaadrenergic
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
dail