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Patient Information Leaflet

Read all of this leaflet carefully before you start taking Co-amilozide 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.

This medicine contains the active ingredients amiloride hydrochloride and hydrochlorothiazide. Both active ingredients belong to a group of medicines known as diuretics (sometimes described as “water tablets”). Diuretics work by helping the body to dispose of excess water by urination.

This medicine is prescribed in certain conditions affecting the heart, liver and other organs (e.g. congestive heart failure, hepatic cirrhosis with ascites) where there is a build-up of excess water in the body. This medicine is also prescribed for the treatment of high blood pressure.

Do not take Co-amilozide if:

>    you have previously suffered an allergic reaction to thiazide, a medicine containing amiloride hydrochloride, hydrochlorothiazide or sulphonamide

>    you are allergic to acetazolamide which is a diuretic used to remove fluid from the body and to treat high pressure in the eye (glaucoma), heart problems and sometimes fits or epilepsy

>    you are pregnant, planning to become pregnant or breast feeding

>    you have liver or kidney trouble

>    you have a lung disease or heart trouble

>    you have difficulty in passing urine

>    you suffer from Addison’s disease, gout or diabetes

} you have a condition known as systemic lupus erythematosus

} you have been told that you have high levels of urea, creatinine, calcium or potassium in your blood

} you are taking another potassium-sparing diuretic (e.g. spironolactone, triamterene)you taking potassium supplements, or medicine containing potassium or you eat potassium-rich foods

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-amilozide

Children

This medicine is not suitable for children under 18 years of age.

Other medicines and Co-amilozide

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

>    Potassium supplements

>    Non-steroidal anti-inflammatory drugs (NSAIDS e.g. aspirin, ibuprofen).

>    Medicines used to treat high blood pressure or a heart condition (e.g. captopril, enalapril).

>    Lithium, a treatment for depression.

>    Barbiturates or narcotics (painkillers such as codeine, dihydrocodeine, dextropropoxyphene, diamorphine, morphine, pentazocine and pethidine).

>    Trilostane, a medicine used to treat Cushing’s syndrome (an adrenal disorder) and breast cancer.

>    Ciclosporin and tacrolimus (immunosuppressant drugs used to prevent organ rejection after transplant surgery).

>    Medicines for diabetes such as insulin or chlorpropamide.

>    Colestyramine and colestipol, which are used to reduce the level of fats in the blood.

>    Corticosteroids which are used to treat a number of conditions, including asthma, skin disorders and rheumatic diseases (e.g. prednisolone).

>    ACTH, which is used to test whether your adrenal glands are working properly.

>    A pressor amine such as adrenaline, which is used to treat serious allergic reactions.

>    Muscle relaxants (e.g. tubocurarine).

>    Angiotensin II antagonists, such as Losartan or Olmesartan

>    Amiloride hydrochloride y Hydrochlorothiazide

You should tell any doctor performing a blood test that you are taking or have been taking co-amilozide tablets, because they may affect the results.

In addition, if you are going to have an operation, make sure the doctor treating you knows you are taking Co-amilozide.

Co-amilozide with food and drink

Your doctor may have asked you to change your diet slightly and not to eat certain foods which contain a lot of potassium. These foods include milk, bananas, raisins and prunes. Your doctor will tell you what food you should not eat. If you are unsure about what food you should avoid, ask your doctor before taking Co-amilozide.

Drinking alcohol while taking this medicine may cause dizziness or light-headedness. Your doctor will have advised you to keep your alcohol intake to a minimum. Your doctor may need to carry out simple blood tests while you are taking co-amilozide tablets, to monitor the levels of salts and a chemical called urea in your body.

Pregnancy, breast-feeding and fertility

The use of diuretics in healthy pregnant women with or without mild oedema is not indicated. Thiazides cross the placental barrier and appear in cord blood, use where pregnancy is present or suspected requires that the benefits of the drug be weighed against possible hazards to the foetus. Although it is not known whether amiloride hydrochloride is excreted in human milk, it is known that thiazides do appear in breast milk. If amiloride hydrochloride is used during breast-feeding, doses should be kept as low as possible.

Driving and using machines

If you feel dizzy or tired after taking this medicine you should not drive or operate machinery.

Co-amilozide contains Lactose

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

Your doctor will have advised you to avoid eating potassium rich foods such as bananas, milk and prunes while taking this medicine. Co-amilozide tablets may also cause an increase in the amount of cholesterol and triglycerides (fats) in the blood.

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

The recommended dose is:

Adults

High Blood Pressure: The usual does is half a tablet given once a day. If required, your doctor may increase the does to a maximum of l tablet per day.

Congestive heart failure: The usual starting dose is half a tablet per day. If required, your doctor may increase the dose to a maximum of 2 tablets per day.

Fluid retention associated with liver disease: The usual starting dose is l tablet given once a day. If required, your doctor may increase the dose to maximum of 2 tablets per day.

All patients, especially elderly patients, should be under regular supervision by their doctor while taking this medicine.

Children

This medicine is not suitable for children under l8 years of age.

Method of administration

Swallow the tablets with a drink of water.

If you take more Co-amilozide than you should

If you take more Co-amilozide than you should, contact your nearest hospital casualty department or doctor immediately. You should take this leaflet and any remaining tablets with you to show the doctor.

If you forget to take Co-amilozide

Keep taking your medicine until the course is finished. If you forget to take a dose, Skip the missed dose. Take the next dose as normal. Do not take a double dose to make up for the missed dose.

If you stop taking Co-amilozide

Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following tell your doctor IMMEDIATELY.

>    Anaphylactic reaction which includes symptoms such as skin rashes, itching for the first time, wheezing or swelling of the face.

>    Bleeding or bruising easily.

>    Muscle pains or cramps.

>    Yellowing of your skin or the whites of your eyes (Jaundice).

The following side effects are more often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor.

*    Headache, dizziness (including dizziness on standing up)

*    Dehydration

*    Unresponsive

*    Light-headedness due to drop in blood pressure

*    Weakness or tiredness, looking pale    * Chest pain or back pain

*    Reddish spots on the skin    * Over-sensitivity to light

*    Upset stomach such as nausea, indigestion, constipation, bloated feeling, diarrhoea, vomiting, stomach pain

*    Pancreatitis

*    Flatulence

*    Hiccups *Sore mouth

*    Difficulty in breathing, cough

*    Leg ache, joint pain feet

*    Difficulty sleeping

*    Depression

*    Confusion

*    Lack or loss of appetite

*    Difficulty passing urine

*    Incontinence

*    Blurred vision/ yellow vision

*    Irregular/ increased heart beat

*    Restlessness

*    Urge to urinate

*    Renal Failure

*    Inflamed blood vessels

Other side effects that have been reported occasionally are feeling faint, shaking, abnormally low levels of sodium, chloride, magnesium or potassium or high levels of calcium or uric acid in the blood, glucose in the urine, kidney problems, which may lead to a reduction in the amount of urine, passed as well as impaired liver function. Decreased sex drive, severe rash with blisters and peeling of the skin. There have been isolated cases of hair loss, heart block, which may cause dizziness, fainting or unusual tiredness, and tinnitus (ringing in the ears)

This medicine may occasionally alter the composition of your blood (causing anaemia, neutropenia etc.) and your doctor may want to do some blood tests from time to time. Remember to tell any doctor who does a blood test on you that you are taking 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use this medicine after the expiry date shown on the pack your medicine came in.

Do not store above 25^oC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Co-amilozide tablets contain

Each tablet contains amiloride hydrochloride equivalent to 5mg anhydrous amiloride hydrochloride and 50mg of hydrochlorothiazide.

The tablets also contain lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, talc, sodium starch glycollate, magnesium stearate and colour, certolake sunset yellow (Ell0).

What Co-amilozide tablets look like and contents of the pack

Co-amilozide tablets 5/50mg are pale peach, circular tablets with the company logo on one face and the code 237 and a break line on the reverse.

Pack sizes: 28, l00, 250, 500 and l000 tablets.

Marketing Authorisation Holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, WA8 ORP.

Marketing authorisation number: PL 20395/0104 POM

Date leaflet last revised: May 20l4