Minoxidil 10mg Tablets
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 called Loniten 10mg Tablets but will be referred to as Loniten throughout the leaflet. Please note that the leaflet also contains information about other strength of the medicine, Loniten 2.5mg Tablets and Loniten 5mg Tablets.
The leaflet contains information on:
^ What Loniten is and what they it is used for.
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
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.
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 Lonoten, 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.
[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.
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.
Loniten® 10mg Tablets
(minoxidil)
Patient Information Leaflet (continued)
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.
[5) How to store Loniten
Keep out of the sight and reach of children.
Do not store above 25°C
Store in the original package in order to protect from moisture Do not take this medicine after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.
If the medicine becomes discoloured or shows 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 that are no longer required. These measures will help to protect the environment.
[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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
[6) Contents of the pack and other information
What Loniten contains:
Each tablet contains 10mg minoxidil.
Also contains lactose monohydrate, microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate.
What Loniten looks like and contents of the pack Loniten Tablets are a round white biconvex tablets, with 10 imprinted 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.
Each pack contains 60 Tablets.
Manufacturer and Licence Holder
Manufactured by Pfizer Service Company, Hoge Wei 10, Zaventem, Vlaams Brabant, Belgium and is 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.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1674 Loniten 10mg Tablets
Loniten is a registered trademark of Pharmacia Limited Revision date: 11/08/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Ref: 1674/110816/2/F
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 called Minoxidil 10mg Tablets but will be referred to as Minoxidil throughout the leaflet. Please note that the leaflet also contains information about other strength of the medicine, Minoxidil 2.5mg Tablets and Minoxidil 5mg Tablets.
The leaflet contains information on:
^ What Minoxidil is and what they it is used for.
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
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.
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 Lonoten, 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.
[2) What you need to know before you take Minoxidil
Do not take Minoxidil
* 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 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.
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.
Patient Information Leaflet (continued)
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.
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.
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.
[5) How to store Minoxidil
Keep out of the sight and reach of children.
Do not store above 25°C
Store in the original package in order to protect from moisture Do not take this medicine after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused capsules to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.
If the medicine becomes discoloured or shows 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 that are no longer required. These measures will help to protect the environment.
[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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
Contents of the pack and other information
What Minoxidil contains:
Each tablet contains 10mg minoxidil.
Also contains lactose monohydrate, microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate.
What Minoxidil looks like and contents of the pack
Minoxidil Tablets are a round white biconvex tablets, with 10 imprinted 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.
Each pack contains 60 Tablets.
Manufacturer and Licence Holder
Manufactured by Pfizer Service Company, Hoge Wei 10, Zaventem, Vlaams Brabant, Belgium and is 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.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1674 Minoxidil 10mg Tablets
Revision date: 11/08/16