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LONITEN 5MG TABLETS

Active substance(s): MINOXIDIL

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LONITEN® 5mg TABLETS / MINOXIDIL 5mg TABLETS
(minoxidil)
This product is available as 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 10mg Tablets).
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
• Do not store above 25°C.
• Keep 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.
• If the tablets become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist who will tell you what to do.
• 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 Loniten contains and its package:
Each tablet contains 5mg of the active ingredient, minoxidil in a white round tablet.
The Loniten are marked ‘U’ breakline ‘U’ on one side and ‘5’ on the reverse.
Loniten also contain the following:
Lactose, microcrystalline cellulose, maize starch, silicon dioxide and magnesium stearate.
Loniten are available as 30 tablets in each bottle pack.
PL No: 15814/0838

POM

Loniten is manufactured by Pfizer Manufacturing Belgium N.V., Rijksweg 12, B-2870 - Puurs,
Belgium. Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial way, Watford, Herts, WD24 4PR.
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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