Skip to Content

LONOTEN 10MG TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Ref: 935940/070912/1/F

®

®

Loniten 5mg Tablets / Loniten 10mg Tablets
(minoxidil)
Patient Information Leaflet
Important things that you SHOULD know about your
medicine:
• Loniten is a treatment for very high blood
pressure.
• Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• You should take Loniten regularly to get the
maximum benefit, even if you are feeling well.
• Most people do not have serious problems when
taking Loniten but side effects can occur – see
Section 4 for details. If you experience swelling of
the face, tongue or throat, see your doctor
immediately. If any of the side effects gets
serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
• Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
Please read the rest of this leaflet. It includes other
important information on the safe and effective use
of this medicine that might be especially important to
you. If you have any further questions, ask your
doctor or pharmacist.
Your medicine is called Loniten 5mg Tablets or
Loniten 10mg Tablets, thorughout this leaflet it will
be referred to as Loniten.
In this leaflet:
1

What Loniten is and what it is used for

2

Before you take Loniten

3

How to take Loniten

4

Possible side effects

5

How to store Loniten

6

Further information

1

What Loniten is and what it is used for

Loniten 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 tablets contain the active ingredient
minoxidil.
2

Before you take Loniten

Do not take Loniten:
• If you think you might be allergic to the active
ingredient minoxidil, or any of the other
ingredients listed in Section 6, tell your doctor
and don’t take Loniten.
• If your high blood pressure is caused by
hormones from a tumour (phaeochromocytoma),
usually near the kidneys, tell your doctor and
don’t take Loniten.

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
betablocker or similar medicine to stop your heart
beating too fast.
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.
Taking other medicines:
You should always tell your doctor if you are taking
any other medicine including those obtained without
prescription. It is particularly important you tell your
doctor about any other medicine you are taking to
reduce your high blood pressure. These drugs may
interact with Loniten by causing blood pressure to
drop too low and/or cause a sudden drop in blood
pressure when standing up. You may need to stop
taking them, but ask your doctor first. Your doctor
will tell you when and how to stop.
Pregnancy and Breast-feeding:
Loniten is not recommended if you are pregnant or
trying to become pregnant. You should only take
Loniten if your doctor tells you to. Loniten passes
into breast milk and is not recommended if you are
breast-feeding unless your doctor thinks it is
necessary.
If you are pregnant or breast-feeding you should ask
your doctor for advice before taking any medicine.
Driving and using machinery:
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
machinery.
Important information about some of the
ingredients in Loniten
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

Take special care with 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.

How to take Loniten

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, either
as a 2.5 mg tablet taken twice a day or a 5 mg tablet
taken once a day. It is unusual to need more than 50
mg a day in adults and children aged over 12 years.
Adults over the age of 65
For adults over 65, the usual starting dose is 2.5 mg
each day.
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.
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.
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.
Swallow Loniten tablets whole with water.
Take your tablets as your doctor has told you. If you
are still not sure, ask your doctor or pharmacist.
Do not change the dose or stop taking the tablets
without a doctor’s approval. They help to control
your blood pressure.
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 miss 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 missed dose.

4

Possible side effects

Like all medicines, Loniten 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 (>1/10): Increased heart rate,
Inflammation of the lining that surrounds the heart,
Abnormal electrocardiogram (ECG), Increased hair
growth, Hair colour changes.
Common (≥1/100 to <1/10): Accumulation of fluid
around the heart, Compression of the heart due to a
build up of fluid, Fluid retention
Rare (≥1/10,000 to <1/1,000): 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 (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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5 How to store Loniten








Do not use this medicine after the expiry date
shown on the carton label or blister labels.
If your medicine becomes discoloured or shows
signs of any deterioration, you should seek the
advice of your pharmacist who will advise 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.
Keep out of the sight and reach of children.
Do not store above 25°C.

6 Further Information
What Loniten contains
Each 5mg Tablets contains 5mg of minoxidil as the
active ingredient.
Each 10mg Tablets contains 10mg of minoxidil as
the active ingredient.
Inactive ingredients: lactose, microcrystalline
cellulose, maize starch, colloidal silicon dioxide and
magnesium stearate.
What Loniten looks like and contents of the pack
Your medicine is called Loniten 5mg Tablets /
Loniten 10mg Tablets but will be referred to as
Loniten throughout this leaflet.
Loniten 5mg are a white, round film-coated tablet,
engraved with ‘5’ on one side and a score line with
‘U’ on the top and bottom on the other side.
Loniten 10mg Tablets are a white, round film-coated
tablet, engraved with ‘10’ on one side and a score
line with ‘U’ on the top and ‘137’ bottom of the score
line on the other side.
Each blister contains 10 tablets, which comes in
boxes of 40 or 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer
Manufacturing Belgium NV, Puurs, Belgium and are
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Loniten is a registered
trademark of Pharmacia & Upjohn Limited.

POM

PL 15184/0935 Loniten 5mg Tablets
PL 15184/0940 Loniten 10mg Tablets

Leaflet revision date: 07/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 935940/070912/1/B

Ref: 935940/070912/2/F

Lonoten® 5mg Tablets / Lonoten ® 10mg Tablets
(minoxidil)
Patient Information Leaflet
Important things that you SHOULD know about your
medicine:
• Lonoten is a treatment for very high blood
pressure.
• Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• You should take Lonoten regularly to get the
maximum benefit, even if you are feeling well.
• Most people do not have serious problems when
taking Lonoten but side effects can occur – see
Section 4 for details. If you experience swelling of
the face, tongue or throat, see your doctor
immediately. If any of the side effects gets
serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
• Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
Please read the rest of this leaflet. It includes other
important information on the safe and effective use
of this medicine that might be especially important to
you. If you have any further questions, ask your
doctor or pharmacist.
Your medicine is called Lonoten 5mg Tablets or
Lonoten 10mg Tablets, thorughout this leaflet it will
be referred to as Lonoten.
In this leaflet:
1

What Lonoten is and what it is used for

2

Before you take Lonoten

3

How to take Lonoten

4

Possible side effects

5

How to store Lonoten

6

Further information

1

What Lonoten is and what it is used for

Lonoten 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.
Lonoten tablets contain the active ingredient
minoxidil.

2

Before you take Lonoten

Do not take Lonoten:
• If you think you might be allergic to the active
ingredient minoxidil, or any of the other
ingredients listed in Section 6, tell your doctor
and don’t take Lonoten.
• If your high blood pressure is caused by
hormones from a tumour (phaeochromocytoma),
usually near the kidneys, tell your doctor and
don’t take Lonoten.
Take special care with Lonoten:
• 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.
Lonoten 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 Lonoten working properly.
Lonoten also makes your heart beat faster.

To avoid these problems, your doctor will prescribe
two other medicines for you to take with Lonoten.
One will be a water tablet (diuretic) to help your
body get rid of excess water, and the other a
betablocker or similar medicine to stop your heart
beating too fast.
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 Lonoten, as it can change
the results.
Taking other medicines:
You should always tell your doctor if you are taking
any other medicine including those obtained without
prescription. It is particularly important you tell your
doctor about any other medicine you are taking to
reduce your high blood pressure. These drugs may
interact with Loniten by causing blood pressure to
drop too low and/or cause a sudden drop in blood
pressure when standing up. You may need to stop
taking them, but ask your doctor first. Your doctor
will tell you when and how to stop.
Pregnancy and Breast-feeding:
Loniten is not recommended if you are pregnant or
trying to become pregnant. You should only take
Loniten if your doctor tells you to. Loniten passes
into breast milk and is not recommended if you are
breast-feeding unless your doctor thinks it is
necessary.
If you are pregnant or breast-feeding you should ask
your doctor for advice before taking any medicine.
Driving and using machinery:
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
machinery.
Important information about some of the
ingredients in Lonoten
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 Lonoten

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 Lonoten for adults and
children aged over 12 years is 5 mg each day, either
as a 2.5 mg tablet taken twice a day or a 5 mg tablet
taken once a day. It is unusual to need more than 50
mg a day in adults and children aged over 12 years
Adults over the age of 65
For adults over 65, the usual starting dose is 2.5 mg
each day.
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.
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.
Lonoten 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.
Swallow Lonoten tablets whole with water.
Take your tablets as your doctor has told you. If you
are still not sure, ask your doctor or pharmacist.
Do not change the dose or stop taking the tablets
without a doctor’s approval. They help to control
your blood pressure.
If you take more Lonoten 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 miss a dose of Lonoten:
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 missed dose.
4

Possible side effects

Like all medicines, Lonoten can cause side effects
although not everybody gets them.
The following events have been reported in patients
with high blood pressure being treated with Lonoten:
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 Lonoten may cause are:
Very common (>1/10): Increased heart rate,
Inflammation of the lining that surrounds the heart,
Abnormal electrocardiogram (ECG), Increased hair
growth, Hair colour changes.
Common (≥1/100 to <1/10): Accumulation of fluid
around the heart, Compression of the heart due to a
build up of fluid, Fluid retention
Rare (≥1/10,000 to <1/1,000): 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 (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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5 How to store Lonoten








Do not use this medicine after the expiry date
shown on the carton label or blister labels.
If your medicine becomes discoloured or shows
signs of any deterioration, you should seek the
advice of your pharmacist who will advise 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.
Keep out of the sight and reach of children.
Do not store above 25°C.

6 Further Information
What Lonoten contains
Each 5mg Tablets contains 5mg of minoxidil as the
active ingredient.
Each 10mg Tablets contains 10mg of minoxidil as the
active ingredient.
Inactive ingredients: lactose, microcrystalline
cellulose, maize starch, colloidal silicon dioxide and
magnesium stearate.
What Lonoten looks like and contents of the pack
Your medicine is called Lonoten 5mg Tablets /
Lonoten 10mg Tablets but will be referred to as
Lonoten throughout this leaflet.
Lonoten 5mg are a white, round film-coated tablet,
engraved with ‘5’ on one side and a score line with
‘U’ on the top and bottom on the other side.
Lonoten 10mg Tablets are a white, round film-coated
tablet, engraved with ‘10’ on one side and a score
line with ‘U’ on the top and ‘137’ bottom of the score
line on the other side.
Each blister contains 10 tablets, which comes in
boxes of 40 or 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer
Manufacturing Belgium NV, Puurs, Belgium and are
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Lonoten is a registered
trademark of Pharmacia & Upjohn Limited.

POM PL 15184/0935 Lonoten 5mg Tablets

PL 15184/0940 Lonoten 10mg Tablets

Leaflet revision date: 07/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 935940/070912/2/B

Ref: 935940/070912/3/F

Minoxidil 5mg Tablets / Minoxidil 10mg Tablets
Patient Information Leaflet
Important things that you SHOULD know about your
medicine:
• Minoxidil is a treatment for very high blood
pressure.
• Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• You should take Minoxidil regularly to get the
maximum benefit, even if you are feeling well.
• Most people do not have serious problems when
taking Minoxidil but side effects can occur – see
Section 4 for details. If you experience swelling of
the face, tongue or throat, see your doctor
immediately. If any of the side effects gets
serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
• Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
Please read the rest of this leaflet. It includes other
important information on the safe and effective use
of this medicine that might be especially important to
you. If you have any further questions, ask your
doctor or pharmacist.
Your medicine is called Minoxidil 5mg Tablets or
Minoxidil 10mg Tablets, thorughout this leaflet it will
be referred to as Minoxidil.
In this leaflet:
1

What Minoxidil is and what it is used for

2

Before you take Minoxidil

3

How to take Minoxidil

4

Possible side effects

5

How to store Minoxidil

6

Further information

1

What Minoxidil is and what it is used
for

Minoxidil 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.
Minoxidil tablets contain the active ingredient
minoxidil.

2

Before you take Minoxidil

Do not take Minoxidil:
• If you think you might be allergic to the active
ingredient minoxidil, or any of the other
ingredients listed in Section 6, tell your doctor
and don’t take Minoxidil.
• If your high blood pressure is caused by
hormones from a tumour (phaeochromocytoma),
usually near the kidneys, tell your doctor and
don’t take Minoxidil.
Take special care with 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
betablocker or similar medicine to stop your heart
beating too fast.
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.
Taking other medicines:
You should always tell your doctor if you are taking
any other medicine including those obtained without
prescription. It is particularly important you tell your
doctor about any other medicine you are taking to
reduce your high blood pressure. These drugs may
interact with Loniten by causing blood pressure to
drop too low and/or cause a sudden drop in blood
pressure when standing up. You may need to stop
taking them, but ask your doctor first. Your doctor
will tell you when and how to stop.
Pregnancy and Breast-feeding:
Loniten is not recommended if you are pregnant or
trying to become pregnant. You should only take
Loniten if your doctor tells you to. Loniten passes
into breast milk and is not recommended if you are
breast-feeding unless your doctor thinks it is
necessary.
If you are pregnant or breast-feeding you should ask
your doctor for advice before taking any medicine.
Driving and using machinery:
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
machinery.
Important information about some of the
ingredients in Minoxidil
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

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, either
as a 2.5 mg tablet taken twice a day or a 5 mg tablet
taken once a day. It is unusual to need more than 50
mg a day in adults and children aged over 12 years.
Adults over the age of 65
For adults over 65, the usual starting dose is 2.5 mg
each day.
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.
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.
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.
Swallow Minoxidil tablets whole with water.
Take your tablets as your doctor has told you. If you
are still not sure, ask your doctor or pharmacist.
Do not change the dose or stop taking the tablets
without a doctor’s approval. They help to control
your blood pressure.
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.
If you miss 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 missed dose.

4

Possible side effects

Like all medicines, Minoxidil 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 (>1/10): Increased heart rate,
Inflammation of the lining that surrounds the heart,
Abnormal electrocardiogram (ECG), Increased hair
growth, Hair colour changes.
Common (≥1/100 to <1/10): Accumulation of fluid
around the heart, Compression of the heart due to a
build up of fluid, Fluid retention
Rare (≥1/10,000 to <1/1,000): 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 (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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5








How to store Minoxidil
Do not use this medicine after the expiry date
shown on the carton label or blister labels.
If your medicine becomes discoloured or shows
signs of any deterioration, you should seek the
advice of your pharmacist who will advise 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.
Keep out of the sight and reach of children.
Do not store above 25°C.

6 Further Information
What Minoxidil contains
Each 5mg Tablets contains 5mg of minoxidil as the
active ingredient.
Each 10mg Tablets contains 10mg of minoxidil as
the active ingredient.
Inactive ingredients: lactose, microcrystalline
cellulose, maize starch, colloidal silicon dioxide and
magnesium stearate.
What Minoxidil looks like and contents of the
pack
Your medicine is called Minoxidil 5mg Tablets /
Minoxidil 10mg Tablets but will be referred to as
Minoxidil throughout this leaflet.
Minoxidil 5mg are a white, round film-coated tablet,
engraved with ‘5’ on one side and a score line with
‘U’ on the top and bottom on the other side.
Minoxidil 10mg Tablets are a white, round
film-coated tablet, engraved with ‘10’ on one side
and a score line with ‘U’ on the top and ‘137’ bottom
of the score line on the other side.
Each blister contains 10 tablets, which comes in
boxes of 40 or 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer
Manufacturing Belgium NV, Puurs, Belgium and are
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 15184/0935 Minoxidil 5mg Tablets
PL 15184/0940 Minoxidil 10mg Tablets

Leaflet revision date: 07/09/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 935940/070912/3/B

Expand Transcript

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.

Hide