Midodrine 2.5mg 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.

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

• are allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• have high blood pressure
• have a slow pulse
• have difficulty urinating
• have certain forms of cardiovascular disease
• have elevated pressure in the eye (glaucoma) or poor vision as a result of diabetes
• have an overactive thyroid gland
• have hormonal disorders caused by a tumour in the adrenal medulla (pheochromocytoma)
• have severe kidney disease
• have an enlarged prostate

Talk to your doctor or pharmacist before taking this medicine if you have been told you have high blood pressure when you lie down. If this applies to you then:

Regular monitoring of your blood pressure when you are lying down and when you are standing up will be required as there may be a risk of your blood pressure rising when you lie down, for example, at night. If your blood pressure does go up when you lie down and reducing the dose does not correct the problem, then treatment with this medicine must be stopped.

It is important that you do not take this medicine late in the evening. Take your last daily dose at least 4 hours before you go to bed. By keeping your head elevated at night the potential risk of your blood pressure rising when you lie down is reduced. You should be monitored by your doctor for possible secondary effects of high blood pressure.

Also talk to your doctor if you:

• have a serious disorder of the nervous system (autonomic nervous system disorder), since taking this medicine may lead to a further drop in blood pressure when you stand up. If this occurs, further treatment with this medicine should be stopped.
• suffer from problem with your blood circulation, especially if you have symptoms such as pain or cramps in the stomach after eating, or pain or cramps in the leg while walking.
• suffer from a disease of the prostate, as you may find passing urine is difficult when taking this medicine.

You should have your kidney function and blood pressure checked by your doctor before you start using this medicine. During treatment with this medicine, your blood pressure will be checked from time to time, and if necessary your dose adjusted.

It is important that you immediately report symptoms related to high blood pressure, such as elevated heart rate, headache and blurred vision. Your doctor will then decide whether to adjust dosage or discontinue your treatment with Midodrine.

If any of the warnings apply to you, or have in the past, talk to your doctor.

Do not give this medicine to children and adolescents under the age of 18 because the safety and efficacy of Midodrine tablets in this age group have not been established.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular tell your doctor or pharmacist if you are taking any of the following:

• Reserpine and guanethidine (medicines used to reduce high blood pressure), antihistamines (used to treat allergies), hormones for the thyroid (used when the thyroid is not working properly), tricyclic antidepressants and MAO-inhibitors (both used to treat depression) and other vasoconstrictors (medicines that narrow blood vessels), or sympathomimetic agents (medicines that have a stimulating effect on certain parts of the nervous system), because concomitant use with this medicine may cause a large increase in blood pressure.
• Prazosin and phentolamine (medicines used to treat heart disease) because the effect of this medicine is blocked by these drugs.
• Digitalis preparations (medicines used to treat heart disease) because concomitant use with this medicine may lead to cardiac dysfunction.
• Corticosteroids, such as fludrocortisone acetate (an anti-inflammatory medicine) because this medicine may increase its effect.
• Medicines which directly or indirectly reduce your heart rate because if this medicine is combined with these medicines, it is advisable that your doctor closely monitors you.

Swallow tablets with a drink of water. This medicine may be taken with or without food.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Using this medicine while pregnant is not recommended. Tell your doctor if you are pregnant, or want to be, while you are being treated with this medicine.

Do not use this medicine while breast-feeding.

This medicine should not affect your ability to drive or use machines. However you must be careful if dizziness or light-headedness occurs after taking this medicine.

Your doctor will decide your dose and tell you how long you should take this medicine. The treatment is usually long-term.

The recommended starting dose is normally one tablet of 2.5 mg three times a day. This dose can be increased weekly up to four 2.5 mg tablets three times daily, which is the usual maintenance dose of 30 mg per day.

The recommended total daily dose should be spread evenly into three doses per day.

Avoid taking this medicine in the late evening. The last dose should be taken at least 4 hours before your bedtime. Elevating your head at night reduces the potential risk of high blood pressure when you lie down. More information can be found in the section “Warnings and precautions” of this leaflet.

If you feel that the effect of this medicine is too strong, or too weak, talk to your doctor or pharmacist.

If you have used too much of this medicine please contact your doctor or pharmacist immediately.

Taking too much of this medicine can cause:

High blood pressure (hypertension), e.g palpitations, shortness of breath, chest pain, headache and blurred vision, slow heart rate (bradycardia), difficulty urinating, goosebumps, feeling of coldness.

If you forget to take a dose, take your next dose as usual and then keep taking your medicine as your doctor has told you. Do not take a double dose to make up for a forgotten dose, because this will increase the risk of high blood pressure when you lie down.

There will be no sudden drop in your blood pressure. Always talk to your doctor if you are considering stopping taking this medicine. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist.

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 the 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 midodrine hydrochloride.
• Each tablet contains 2.5 mg midodrine hydrochloride
• The other ingredients are pregelatinised starch (maize), microcrystalline cellulose, silica colloidal anhydrous, talc and magnesium stearate.

Midodrine 2.5 mg tablets are white to off-white, round, flat, 7.0 mm diameter with a score line on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Pack sizes:

Blisters with 30, 30×1, 90, 90×1, 100 and 100×1 tablets

Not all pack sizes may be marketed.