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Amiloride Tablets Bp 5mg

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PATIENT INFORMATION LEAFLET

AMORIDE 5 mg TABLETS

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF AMORIDE

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE

INFORMATION

What is in your medicine?

The name of this medicine is Amoride. Each tablet contains 5 mg of the active ingredient Amiloride Hydrochloride BP, together with the inactive ingredients lactose, calcium phosphate, pregelatinised maize starch, maize starch and magnesium stearate.

The active ingredient of Amoride belongs to a group of drugs known as potassium sparing diuretics. They act    through    increasing

the flow of urine without reduction in the loss of potassium from the body.

Amoride 5 mg tablets are flat cream coloured tablets engraved AMORIDE on one side and scored on the other.

Amoride is available in containers of containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets, and in    blister    packs of    28,

30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets. Not all pack sizes may be marketed.

The Product Licence holder is:

Chelonia Healthcare Limited, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus The Manufacturer of Amoride is:

Meridian Healthcare (UK) Ltd., Chatfield Road, off York Road, London SW11 3SE

Why have you been prescribed Amoride?

Amoride is mainly used together with medicines that increase urine flow in order to conserve potassium. If you are not sure why you have been prescribed Amoride then please ask your doctor.

Before taking this medicine

reactions to Amoride or other thiazide

preservatives or dyes.

doctor if you have any other medical


Before taking this medicine, tell your doctor if you have ever had any unusual or allergic diuretics or any of the other ingredients of Amoride tablets.

Also tell your doctor or pharmacist if you are allergic to any other substances such as foods,

The presence of other medical problems may affect the use of this medicine. Tell your problems, especially if you have:

•    high blood pressure,

•    heart problems,

•    kidney disease,

•    difficulty passing urine

•    lung disease,

•    liver disease,

•    increased blood potassium,

•    diabetes

Your doctor may decide to monitor your blood potassium and/or sodium levels.

Also tell your doctor if you have any intolerance for some sugars (including lactose).

Can you take Amoride with other medicines?

There are some medicines that can interfere with Amoride. It is very important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.

It is important that your doctor is aware of any other medication you are taking, whether it is prescribed or bought without a prescription. Your doctor will be able to identify medicines, which you should not take with Amoride.

Tell your doctor whether you are taking other diuretics or any of the following medicines.

•    ACE inhibitors (such as Captopril and Enalapril), Alpha-blockers or Angiotensin-II receptor antagonists (to treat high blood pressure or heart failure)

•    Medicines that affect blood pressure

•    Tacrolimus (to suppress the immune system)

•    Pimozide (to control tics)

•    Amisulpride, Sertindole (to treat mental disorders)

•    Lithium (to treat depression)

•    Chlorpropramide (to treat diabetes)

•    Ciclosporin, Trilostane (for hormone treatment)

•    Potassium salts (for potassium depletion)

•    NSAIDs (for pain relief)

Use in pregnancy and while breast-feeding

Tell your Doctor if you are pregnant, planning a pregnancy or are breast-feeding.

Amoride should not be used if you are pregnant, planning a pregnancy or breast-feeding. If in doubt contact your doctor.

When and how to take this medicine

Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it, and do not take it more often or for a longer time than your doctor ordered. You will be prescribed the lowest dose necessary to control your symptoms.

Dosages:

Adults:

Take this medicine as instructed by your doctor. The dose will depend on your condition and may need to be increased or decreased over time to control your symptoms.

Children:

The use of Amoride is not recommended for children.

What to do if too many tablets are taken at the same time.

If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take any remaining tablets with you and keep in the original container or packaging so that they can be identified.

What if you miss a dose?

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take two doses at once.

If you feel this medicine is not working as well after you have taken it for a short time (1 -2 weeks) do not increase the dose, instead check with your doctor.

What side effects can occur when taking Amoride?

The majority of patients taking this medicine will experience no ill effects or will only experience those minor ones associated with diuretics (medicines to increase the flow of urine).

Other side effects affecting the:

   Body as a whole

Include headache, weakness, fatigue, back pain, chest pain, neck and shoulder ache, pain in the arms and legs.

   Heart and circulation

Include alteration of heartbeat, palpitations, angina, fall in blood pressure when rising from sitting or lying down, increased levels of potassium in the blood.

   Skin and hair

Include itching, mild skin rashes, dryness of the mouth, hair loss.

   Muscles and bones

Include muscle cramps, joint pain.

   Nervous system

Include dizziness, a feeling of spinning, pins and needles in fingers and toes, particularly uncontrolled shaking, mental confusion, continual sleepy feeling, difficulty in sleep, a decrease in sexual desire, depression.

   Respiratory system

Include cough, difficulty in breathing.

   Special senses

Include nasal congestion, disturbances of vision, increased eyeball pressure, ringing in the ears

   Urinary system

Include increased passing of urine, painful passing of urine, increased frequency of passing of urine, impotence.

Digestive system

Include loss of appetite, sickness, thirst, flatulence, diarrhoea, constipation, pain in the stomach, bleeding from the stomach, jaundice (yellowing of eyes and skin), heartburn.

If any of the above effects become troublesome, check with your doctor as soon as possible.

Most of the side effects of Amoride are likely to occur in the elderly, as they are usually more sensitive to this medicine.

If you notice any of the above reactions or side effects, or if you notice other unusual or worrying changes to your health contact your doctor.

Storing your medicine

You must keep this medicine in a safe place where children cannot get at it. Your medicine could harm them.

Keep your medicine in a dry place, below 25°C. Protect from light. Keep the tablets in the container in which they were given to you.

If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist.

On the container you will find the words "expiry date" followed by numbers indicating the day, month and year.

This is the date after which the medicine is no longer fit for use. Do not use the medicine after this date but return it to your doctor or pharmacist.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

PL No. 33414/0004

This leaflet was revised in March 2010