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MINOXIDIL 10MG TABLETS

Active substance(s): MINOXIDIL

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Loniten® 10mg Tablets / Minoxidil 10mg Tablets
(minoxidil)
This product is available as any of the above names but will be
referred to as Loniten throughout the remainder of this leaflet.
Please note that the leaflet also contains information about other
strengths (Loniten 2.5mg and 5mg Tablets).
Package leaflet: Information for the patient
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 your tablets out of the sight and reach of children.
Do not store above 25°C.
Do not take any of these tablets after the use-by date on the
pack. The expiry date refers to the last day of that month.
If you notice that your tablets have become discoloured or show
any other signs of deterioration, you should seek the advice of
your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in Loniten Tablets?
Each tablet contains 10 mg of the active ingredient minoxidil. The
tablets also contain several inactive ingredients. They are
lactose, microcrystalline cellulose, maize starch, colloidal silicon
dioxide and magnesium stearate.
Your medicine is a small, white, round tablet marked ‘10’ on one
side and ‘U’ and ‘137’ on the other side separated by a breakline.
There are 30 tablets in each bottle.
Who has made your medicine?
Loniten is manufactured by Pfizer Manufacturing Belgium NV/SA,
Rijksweg 12, Puurs 2870, Belgium and are procured from within
the EU by the Product Licence holder: Caseview (PL) Ltd., 20
Alliance Court, Alliance Road, London W2 0RB and repackaged
by O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts
WD24 4PR.
PL 13826/1403

POM

Loniten® 10mg Tablets / Minoxidil 10mg Tablets
Leaflet revision and issue date (ref): 18/04/2016.
Loniten is a registered Trade mark of Pharmacia & Upjohn
Limited, UK.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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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