Patient leaflet - Clonidine 25 micrograms tablets BP

what they are used for

Clonidine Tablets contain a medicine called clonidine. This belongs to a group of medicines called vasodilators. Vasodilators widen the blood vessels and this helps the blood to flow more easily.

Clonidine Tablets are used to prevent migraine attacks and similar types of headache. It is also used to prevent hot flushes that may occur in women during the menopause (change of life).

2 What you need to know before you

take Clonidine Tablets

Do not take Clonidine Tablets if:

You are pregnant, likely to get pregnant or are
breast-feeding
You are allergic to active substance or any of
the other ingredients of this medicine (listed in section 6)
You have a slow heart rate due to heart
problems.
You are already taking other medicines that
contain clonidine

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Clonidine Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Clonidine Tablets if:

You have Raynaud’s disease (a problem with
circulation to the fingers and toes) or other blood circulation problems, including circulation to the brain
You have heart or kidney problems
You have or have ever had depression
You have constipation
You have a nerve disorder that causes your
hands and feet to feel different (‘altered sensation’)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Clonidine Tablets.

As you may get dry eyes whilst taking this medicine, this may be a problem if you wear contact lenses.

Other medicines and Clonidine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Clonidine Tablets can affect the way some other medicines work. Also some other medicines can affect the way Clonidine Tablets work.

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

Other medicines that make you drowsy
Medicines for depression such as imipramine or
mirtazapine
Medicines for severe mental illness such
as schizophrenia. These are also known as ‘antipsychotics’ and include chlorpromazine
Beta blockers such as atenolol
Water tablets (‘diuretics’) such as furosemide
Alpha blockers such as prazosin or doxazosin
(these can also be used for prostate problems in men)
Vasodilators such as diazoxide or sodium
nitroprusside
Cardiac glycosides such as digoxin
Medicines to lower blood pressure

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Clonidine Tablets.

Taking Clonidine Tablets with food, drink and alcohol

You may feel drowsy while taking Clonidine Tablets. Drinking alcohol while taking Clonidine Tablets can make this worse.

Pregnancy, breast-feeding and fertility

Do not take Clonidine Tablets if you are pregnant, likely to get pregnant or are breast-feeding.

Driving and using machines

You may feel drowsy, dizzy or could have some disturbances of vision. If affected, you should not drive, operate machinery or take part in any activities where these may put you or others at risk.

Clonidine Tablets contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3 How to take Clonidine Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended doses for Clonidine Tablets are given below. Sometimes doctors prescribe different doses to those mentioned below. If this applies to you discuss it with your doctor if you have not already done so.

Taking this medicine

Take this medicine by mouth
The recommended starting dose is
50 micrograms (two tablets), two times a day
- If necessary, after two weeks, your doctor may increase the dose to 75 micrograms (three tablets), two times a day

It may take 2 - 4 weeks before you notice the full benefit from this treatment.

Clonidine Tablets is not recommended for children and adolescents under 18 years.

If you take more Clonidine Tablets than you should

If you take more Clonidine Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you, even if there are no tablets left.

If you forget to take Clonidine Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Clonidine Tablets

Do not stop taking Clonidine Tablets without first talking to your doctor.

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 side effects are listed as either very common, common, uncommon, rare or not known.

Very common (may affect more than 1 in 10 people)

Dizziness, feeling tired and more relaxed than usual (sedation)
Feeling dizzy when you stand up (because your blood pressure has fallen sharply)
Dry mouth

Common (may affect up to 1 in 10 people)

Depression, sleeping problems
Headache
Constipation, feeling sick (nausea), pain below the ear (from the salivary gland), being sick (vomiting)
Erectile dysfunction
Fatigue

Uncommon (may affect up to 1 in 100 people)

Problems with understanding what is happening around you, hallucinations, nightmares
Your hands and feet feeling different (‘altered sensation’)
Regular unusually slow heart beat
Raynaud’s phenomenon (a problem with circulation to the fingers and toes)
Itching, rash, urticaria (nettle rash)
A feeling of discomfort and fatigue (‘malaise’)

Rare (may affect up to 1 in 1,000 people)

Breast growth (‘gynaecomastia’) in men
Dry eyes
Irregular heartbeat
Drying out of the lining of the nose
Pseudo-obstruction of the large bowel, which causes colicky pain, vomiting and constipation. Contact your doctor straight away if you have all these side effects.
Hair loss
Increase in your blood sugar

Not known (frequency cannot be estimated from the available data)

Confusion, loss of libido
Blurred vision
Abnormally slow heart beat

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 (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 Clonidine Tablets

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store these tablets above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other

information

What Clonidine Tablets contains

The active ingredient is clonidine hydrochloride. Each tablet contains 25 micrograms of clonidine hydrochloride.

The other ingredients are microcrystalline cellulose, maize starch, lactose monohydrate, pregelatinised maize starch, sodium starch glycolate, magnesium stearate and talc.

Mockup for Variation type IA/G - pl Pg. 1

SZ00000LT000 What Clonidine Tablets look like and contents of the pack.

Clonidine tablets are white biconvex uncoated tablets, available in a pack size of 112 Tablets.

Marketing authorization holder and manufacturer

Marketing Authorization Holder:

Sandoz Limited

Maxis 1

Western Road

Bracknell United Kingdom

RG12 1RF

Manufacturer:

Sandoz Limited,

Maxis 1,

Western Road,

Bracknell,

United Kingdom