PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Amiloride Hydrochloride 5 mg Tablets

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.

What is in this leaflet

1.    What Amiloride Hydrochloride is and what it is used for

2.    What you need to know before you take Amiloride Hydrochloride

3.    How to take Amiloride Hydrochloride

4.    Possible side effects

5.    How to store Amiloride Hydrochloride

6.    Contents of the pack ana other information

1.    What Amiloride Hydrochloride is and what it is used for

The name of this medicine is Amiloride Hydrochloride. The active ingredient of Amiloride Hydrochloride Tablets 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. Amiloride Hydrochloride 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 Amiloride Hydrochloride 5 mg Tablets then please ask your doctor.

2.    What you need to know before you take Amiloride Hydrochloride

DO NOT take Amiloride Hydrochloride:

- if you are allergic to amiloride hydrochloride, any other thiazide diuretics, or any of the other ingredients of Amiloride Hydrochloride 5 mg Tablets (listed in section 6)

Warnings and precautions

The presence of other medical problems may affect the use of this medicine. Talk to your doctor before taking Amiloride Hydrochloride 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.

Other medicines and Amiloride Hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, whether it is prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere. There are some medicines that can interfere with Amiloride Hydrochloride 5 mg Tablets.

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 nigh 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 (used to treat depression)

•    Chlopropramide (used to treat diabetes)

•    Ciclosporin (suppresses the immune system)

•    Trilostane (used in hormone treatment)

•    Potassium salts (for potassium depletion)

•    NSAIDs (for pain relief)

It is important that your doctor is aware of any other medication you are taking. Your doctor will be able to identify medicines which you should not take with Amiloride Hydrochloride 5 mg Tablets.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Amiloride Hydrochloride 5 mg Tablets should not be used, if in doubt contact your doctor.

Amiloride Hydrochloride contains lactose

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

3. How to take Amiloride Hydrochloride

Always takethis medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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. The recommended dosages are:

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 Amiloride Hydrochloride is not recommended for children

If you take more Amiloride Hydrochloride than you should

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.

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.

If you forget to take Amiloride Hydrochloride If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not take a double dose (two doses at once) to make up for a forgotten dose.

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.

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 heart beat, 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.

Most of the side effects of Amiloride Hydrochloride 5 mg Tablets are more likely to occur in the elderly as they are usually more sensitive to this medicine.

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 the Yellow Card Scheme, website: 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 Amiloride Hydrochloride

a this medicine out of the sight and reach of en.

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.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

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 Amiloride Hydrochloride contains

Each tablet contains 5 mg of the active ingredient, Amiloride Hydrochloride, together with the inactive ingredients lactose, calcium hydrogen phosphate, pregelatinised maize starch, maize starch and magnesium stearate.

What Amiloride Hydrochloride looks like and contents of the pack

Amiloride Hydrochloride 5 mg Tablets are flat cream coloured tablets engraved MP48 on one side and scored on the other.

Amiloride Hydrochloride 5 mg Tablets are available in 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.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited 15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY

Manufacturer

DDSA Pharmaceuticals Limited

310 Old Brompton Road, London SW5 9JQ

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 12/2013