Minoxidil 2.5 mg Tablets

• 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.

The name of your product is Minoxidil 2.5 mg, 5 mg or 10 mg Tablets, but it will be referred to as Minoxidil Tablets throughout this leaflet.

1. What Minoxidil Tablets are and what they are used for
2. What you need to know before you take Minoxidil Tablets
3. How to take Minoxidil Tablets
4. Possible side effects
5. How to store Minoxidil Tablets
6. Contents of the pack and other information

• 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.

Talk to your doctor or pharmacist before using Minoxidil Tablets:

• 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 Tablets working properly. Minoxidil Tablets also makes your heartbeat faster.

To avoid these problems, your doctor will prescribe two other medicines for you to take with Minoxidil Tablets. 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 1.5kg. 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 Tablets, 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 Tablets.

Patients with kidney failure and undergoing haemodialysis may need smaller doses of Minoxidil Tablets, which should be used with special care in these patients to maintain electrolyte balance in body.

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 Tablets 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 Tablets or your doctor may consider stopping these therapies before starting treatment with Minoxidil Tablets.

Your doctor will tell you when and how to stop taking this medicine.

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.

There are no fertility data from the use of minoxidil in humans.

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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these medicines.

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 Tablets 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.

For adults over 65, the usual starting dose is 2.5 mg each day.

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 heartbeat and accumulation of fluid in the body. You should contact the doctor if the child has any of the following: a very rapid heartbeat, 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 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.

Minoxidil Tablets 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.

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.

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.

Do not stop taking your medicine or alter the dose you are currently taking without seeing your doctor first. Minoxidil Tablets helps to control your blood pressure.

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is minoxidil. Each tablet contains either 2.5 mg, 5 mg or 10 mg minoxidil.
  The other ingredients are lactose monohydrate, cellulose microcrystalline (E460), maize starch, silica colloidal anhydrous, magnesium stearate (E572).

Minoxidil 2.5 mg Tablets are round, white to off white tablets, approximately 5.5mm in diameter, with score line on one side and "2.5" debossed on the other side.

Minoxidil 5 mg Tablets are oval, white to off white tablets, approximately 5.3mm in width by 10.5mm in length, with score line on one side and "5" debossed on the other side.

Minoxidil 10 mg Tablets are round, white to off white tablets, approximately 9mm in diameter, with score line on one side and "10" debossed on the other side.

Your tablets are supplied in blister strips of 10 tablets in cartons containing 60 tablets.

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