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LONITEN 5 MG TABLETS

Active substance(s): MINOXIDIL

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Package leaflet: Information for the
patient

LONITEN® 2.5 mg,
5 mg and 10 mg
Tablets
Minoxidil

LONITEN® 2.5 mg,
5 mg and 10 mg
Tablets
Minoxidil

FPO 128 - 10 MIL

LONITEN® 2.5 mg,
5 mg and 10 mg
Tablets
Minoxidil

GLUE

FPO 128 - 10 MIL

GLUE

NO COPY

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 (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 in your body. Too much
salt and water in the body can make
you feel breathless, wheezy, sick and
tired, and can stop LONITEN working
properly. LONITEN also makes your
heart beat faster.

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 failure and
undergoing haemodialysis may need
smaller doses of LONITEN, which
should be used with special care in
these patients to maintain electrolyte
balance in body.
❀❀ Other medicines and LONITEN
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines,
including medicines obtained without a
prescription.
It is particularly important you tell your
doctor about any other medicine you
are taking to reduce your high blood
pressure. These medicines may interact
with LONITEN by causing blood
pressure to drop too low. In particular,
tell your doctor if you are taking

guanethidine or betanidine so you can
be monitored whilst on treatment with
LONITEN or your doctor may consider
stopping these therapies before starting
treatment with LONITEN.
Your doctor will tell you when and how
to stop taking this medicine.
❀❀ Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have baby, ask your doctor
or pharmacist for advice before taking
this medicine. LONITEN passes into
breast milk and is not recommended
if you are breast-feeding unless your
doctor thinks it is necessary.
❀❀ Driving and using machines
LONITEN tablets may make you feel
faint or dizzy, particularly when you
first start treatment or your dose is
increased. If affected do not drive or
operate machines.
❀❀ LONITEN contains lactose
This medicine contains lactose (a type
of sugar). If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicinal product.
3. How to take LONITEN
Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
Swallow LONITEN tablets whole with
water.
The score line is not intended for
breaking the tablet.
Adults and children over the age
of 12
Your doctor might change your daily
dose gradually to get the best results.
There should be at least three days
between each change of dose. Don’t
wait until your tablets are finished
before seeing your doctor.
The usual starting dose of LONITEN for
adults and children aged over 12 years
is 5 mg each day. The dose can be
increased to 20 mg and then 40 mg
as single or divided doses if required
for optimum blood pressure control.
It is unusual to need more than 50 mg
a day in adults and children aged
over 12 years. In very rare instances
your doctor can decide to use up to a
maximum of 100 mg.
Elderly
For adults over 65, the usual starting
dose is 2.5 mg each day.
Use in children 12 years and under
For children of 12 and under, the dose
depends on their weight but they
should not be given more than 1 mg per
kilogram of body weight each day. The
starting dose is normally 0.2 mg each
day for each kilogram of their weight.

During treatment with minoxidil the
child should be under specialist
supervision. The daily dose of minoxidil
will be determined by the specialist
and it may be adjusted according to
the child’s needs. During treatment
the child will be additionally treated
with other medicines as decided by
the specialist to prevent rapid heart
beat and accumulation of fluid in the
body. You should contact the doctor
if the child has any of the following: a
very rapid heart beat, rapid breathing,
swelling of the legs, rapid weight gain,
and reduced urine. While on treatment
with minoxidil the child will need to be
regularly seen by the doctor.
Patients on dialysis
If you are on dialysis you may need a
lower dose, even though dialysis can
remove LONITEN from your blood. Do
not take your tablets in the two hours
before your dialysis session. Take them
after the dialysis, or more than two
hours before.
Rapid reduction of blood pressure
LONITEN may also be given to you in
hospital to reduce your blood pressure
very quickly. It would be given by a
doctor or nurse under strictly monitored
conditions at increasing doses of
5 mg every six hours until your blood
pressure is normal.
If you take more LONITEN than you
should
Taking too many tablets may make you
unwell. If you take too many tablets,
tell your doctor straight away. If you
feel faint or dizzy, or your skin gets
unusually cold and pale, you may need
to go to hospital.
If you forget to take a dose of
LONITEN
Do not worry. If you forget to take a
tablet, miss out the forgotten dose
completely and take the next dose at
the normal time. Do not take a double
dose to make up for a forgotten dose.
If you stop taking LONITEN
Do not stop taking your medicine
or alter the dose you are currently
taking without seeing your doctor first.
LONITEN helps to control your blood
pressure.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine
can cause side effects although not
everybody gets them.
The following events have been
reported in patients with high blood
pressure being treated with LONITEN:
Contact your doctor immediately if any
of the following occur.

• You may feel faint or dizzy, especially
when you stand up.
• Your body could hold on to more
water than normal: you may notice
that your ankles get puffy, or your
rings get tight, or you put on weight.
• You may find that you get more
wheezy, breathless and tired,
especially if you already have a weak
heart.
• You may notice angina (usually pains
in your chest) for the first time, or if
you have angina already it could get
worse.
Other side effects LONITEN may
cause are:
Very common: may affect more than
1 in 10 people
Increased heart rate, inflammation of
the lining that surrounds the heart,
abnormal electrocardiogram (ECG),
increased hair growth, hair colour
changes.
Common: may affect up to 1 in 10
people
Accumulation of fluid around the heart,
compression of the heart due to a build
up of fluid, fluid retention.
Rare: may affect up to 1 in 1,000
people
Decrease in white blood cells, reduction
in blood platelets, which increases risk
of bleeding or bruising, serious illness
with blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson
syndrome), inflammation and blistering
of the skin, rash.
Not known: frequency cannot be
estimated from the available data
Accumulation of fluid between the
layers of tissue that line the lungs and
chest cavity, chest pains (angina),
gastrointestinal disorders, swelling of
the ankles, feet or fingers associated
with or independent of weight gain,
breast tenderness, reduced kidney
function resulting in increased
creatinine and urea levels in your blood.
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store LONITEN
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the
expiry date which is stated on the
carton after EXP. The expiry date refers
to the last day of that month.

Blisters:
Store below 25˚C.
Store in the original package in order to
protect from moisture.
Bottles:
Store below 25˚C.
Keep the bottle tightly closed in order
to protect from moisture.
Do not throw away medicines via
wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What LONITEN contains
The active substance is minoxidil. Each
tablet contains either 2.5 mg, 5 mg or
10 mg minoxidil.
The other ingredients are: lactose
hydrous, microcrystalline cellulose,
starch, colloidal silicon dioxide and
magnesium stearate (see section 2
LONITEN contains lactose).
What LONITEN looks like and the
contents of the pack
LONITEN are round white to light tan
biconvex tablets.
They are available in strengths of
2.5 mg, 5 mg and 10 mg.
The 2.5 mg tablet is imprinted with
‘2 ½’ on one side, scored on the
reverse with a ‘U’ on one side of the
score and ‘121’ on the other side.
The 5 mg tablet is imprinted with ‘5’ on
one side, scored on the reverse with a
‘U’ on either side of the score.
The 10 mg tablet is imprinted with ‘10’
on one side, scored on the reverse with
a ‘U’ on one side of the score and ‘137’
on the other side.
The score line is not intended for
breaking the tablet.
LONITEN is available in blisters of
60 tablets or bottles of 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ,
United Kingdom.
Manufacturer
Pfizer Service Company BVBA,
10 Hoge Wei, Zaventem 1930, Belgium.
Company Contact Address
For further information on your
medicine, please contact Medical
Information at Pfizer Limited,
Walton Oaks, Tadworth, Surrey,
KT20 7NS. Tel: 01304 616161
This leaflet was last revised in 05/2016.
Ref: LN 10_1

14403400

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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