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MINOXIDIL 10 MG TABLETS

Active substance(s): MINOXIDIL

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Loniten® 10mg Tablets

2309
25.04.16[14

(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 the following leaflet.
Other strengths (2.5mg and 5mg) are also available.
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

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.

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.

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.

You must talk to your doctor or pharmacist if you do not feel better or if you
feel worse.

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.

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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Loniten contains:
The active ingredient in Loniten is called minoxidil.
Each tablet contains 10 mg minoxidil.

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.

Also contain lactose, microcrystalline cellulose, maize starch, colloidal
silicon dioxide and magnesium stearate.

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
Always keep all your medicines in a safe place and Keep out of the sight
and reach of children.
Do not store above 25oC.
Do not take any of these tablets after the Expiry date on the pack.
Remember to return any unused medicine to your pharmacist
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment

What Loniten looks like and contents of the pack
Loniten are white round bi-convex tablets marked with ‘U scoreline 137’ on
one side and marked with ‘10’ on other side.
Loniten is available in blister packs of 30 and 60 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Pfizer Manufacturing Belgium NV/SA., Rijksweg 12, B2870 Puurs, Belgium and is procured from the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2309

Leaflet revision and issue date (Ref) 25.04.16[14]
Loniten is a trademark of Pharmacia & Upjohn Limited

Minoxidil 10mg Tablets

2309
25.04.16[14]

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 the above name but will be referred to as
Minoxidil throughout the following leaflet.
Other strengths (2.5mg and 5mg) are also available.
What is in this leaflet
1. What Minoxidil is and what it is used for
2. What you need to know before you take Minoxidil
3. How to take Minoxidil
4. Possible side effects
5. How to store Minoxidil
6. Contents of the pack and other information
1. WHAT MINOXIDIL 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 MINOXIDIL
Do not take Minoxidil:
- If you are allergic to the 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 Minoxidil:
- 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.
Minoxidil 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 Minoxidil working properly. Minoxidil also makes your
heart beat faster.
To avoid these problems, your doctor will prescribe two other medicines for
you to take with Minoxidil. 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 Minoxidil, 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 Minoxidil.

Patients with kidney failure and undergoing haemodialysis may need
smaller doses of Minoxidil, which should be used with special care in these
patients to maintain electrolyte balance in body.
Other medicines and Minoxidil
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 Minoxidil 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 Minoxidil or your doctor may
consider stopping these therapies before starting treatment with Minoxidil.
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. Minoxidil passes into breast milk and is not
recommended if you are breast-feeding unless your doctor thinks it is
necessary.
Driving and using machines
Minoxidil 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.
Minoxidil 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 MINOXIDIL
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 Minoxidil 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 Minoxidil 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 Minoxidil 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
Minoxidil 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 Minoxidil 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Minoxidil contains:
The active ingredient in Minoxidil is called minoxidil.
Each tablet contains 10 mg minoxidil.

If you forget to take a dose of Minoxidil
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.

Also contain lactose, microcrystalline cellulose, maize starch, colloidal
silicon dioxide and magnesium stearate.

If you stop taking Minoxidil
Do not stop taking your medicine or alter the dose you are currently taking
without seeing your doctor first. Minoxidil 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 Minoxidil:
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 Minoxidil 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 MINOXIDIL
Always keep all your medicines in a safe place and Keep out of the sight
and reach of children.
Do not store above 25oC.
Do not take any of these tablets after the Expiry date on the pack.
Remember to return any unused medicine to your pharmacist
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.

What Minoxidil looks like and contents of the pack
Minoxidil are white round bi-convex tablets marked with ‘U scoreline 137’ on
one side and marked with ‘10’ on other side.
Minoxidil is available in blister packs of 30 and 60 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Pfizer Manufacturing Belgium NV/SA., Rijksweg 12, B2870 Puurs, Belgium and is procured from the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2309

Leaflet revision and issue date (Ref) 25.04.16[14]

Expand view ⇕

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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