_PATIENT INFORMATION LEAFLET_

CO-AMILOZIDE 5mg/50mg TABLETS

Amiloride hydrochloride and Hydrochlorothiazide

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, please ask your doctor or your pharmacist.

-    The medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects becomes serious, or if you notice any side effects not listed in this list, please tell your doctor or pharmacist. What is in this leaflet:

1.    What Co-amilozide tablets are and what they are used for

2.    What you need to know before you take Co-amilozide tablets

3.    How to take Co-amilozide tablets

4.    Possible side effects

5.    How to store Co-amilozide tablets

6.    Contents of the pack and other information

1. What Co-amilozide tablets are and what they are used for

The name of your medicine is Co-Amilozide 5mg/50mg tablets. The active ingredients are Amiloride hydrochloride and Hydrochlorothiazide

Co-amilozide belongs to a group of medicines called diuretics (water tablets).

This medicine is used to treat:

•    high blood pressure

•    congestive heart failure

•    liver cirrhosis with fluid retention (oedema) and swelling of the abdomen (ascites).

2. What you need to know before you take Co-amilozide tablets

Do not take Co-amilozide tablets if you are:

•    allergic (hypersensitive) to amiloride hydrochloride, hydrochlorothiazide, other sulphonamide related drugs, or to any of the other ingredients in Co-amilozide tablets (see section 6)

•    under 18 years of age or if you have

•    high blood levels of potassium (hyperkalaemia) or other chemicals such as calcium (hypercalcaemia), urea or creatinine

•    difficulty passing water

•    suffering from kidney and/or liver disease, diabetes or Addison's disease (failure of the adrenal glands leading to low blood pressure, tiredness and weakness).

Warnings and Precautions

Talk with your doctor or pharmacist before taking Co-amilozide tablets if you have:

•    liver cirrhosis with swelling of the abdomen (ascites) and abnormally high levels of alkalinity in the body (metabolic alkalosis)

•    or have had high levels of acid in the body (metabolic or respiratory acidosis) caused by heart disease or poorly controlled diabetes.

•    water retention causing swelling (resistant oedema)

•    severe liver disease

•    impaired kidney function

•    had surgery affecting nerves

•    become pregnant or are breast-feeding

•    or have had systemic lupus erythematosus (SLE).

Other medicines and Co-amilozide tablets

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines. Especially:

•    All medicines taken for high blood pressure and/or heart disease (particularly those called ACE-inhibitors) as these either may need to be stopped or have their dose reduced.

•    lithium (for some mental illnesses)

•    antidiabetic drugs such as insulin or chlorpropramide

•    noradrenaline (norepinephrine)

•    barbiturates (for sleeping difficulties)

•    narcotics e.g. dihydrocodeine

•    corticosteroids e.g. hydrocortisone

•    corticotrophin (ACTH)

•    tubocurarine (a muscle relaxant)

•    non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or naproxen

•    antacids (indigestion remedies)

•    nephrotoxic drugs e.g. NSAIDs (non-steroidal anti-inflammatory drugs) or cisplatin (used in some types of cancer)

•    colestyramine (used to reduce cholesterol)

•    tetracycline (used to treat bacterial infections)

•    ciclosporin and tacrolimus (used to suppress the immune system)

•    digoxin (to treat some heart conditions).

Taking this medicine with alcohol

Talk to your doctor before taking alcohol (particularly if you have liver problems)

•    It may cause you to become dizzy or faint on standing up from a resting position.

Pregnancy breast-feeding and fertility Pregnancy

You must tell your doctor if you are pregnant or if you think that you are. Usually, your doctor will advise you to take another medicine instead of Co-amilozide, as Co-amilozide is not recommended during pregnancy. This is because Co-amilozide crosses the placenta and its use after the third month of pregnancy may cause potentially harmful foetal and neonatal effects.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breastfeeding. Co-amilozide is not recommended for mothers who are breast-feeding. Co-amilozide tablets contain Lactose and Sunset yellow

•    Co-amilozide tablets contain LACTOSE

If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

•    These tablets also contains    which

may cause allergic reactions in some people.

Diabetic tests

If you are to be tested for diabetes or need to have other tests related to diabetes, tell your doctor that you are taking Co-amilozide tablets. The tablets may need to be stopped at least three days before the test, as they can interfere with the results.

_3. How to take Co-amilozide tablets_

•    Always take these tablets exactly as advised by your doctor.

You should check with your doctor or pharmacist if you are not sure.

•    The tablets should be swallowed with a glass of water.

•    You should not, take potassium supplements or eat foods with a high potassium content (such as bananas) whilst taking this medicine.

Doses:

High blood pressure & heart failure:

Usually half a tablet a day, which may be increased to one tablet a day, given as a single or divided dose.

Congestive heart failure:

Initially half a tablet a day, which may be adjusted up to a maximum of 2 tablets a day. Your doctor may change your dose depending on your response.

Liver cirrhosis with swelling of the abdomen (ascites):

Initially 1 tablet a day as a single dose, which may be adjusted up to a maximum of 2 tablets a day. Your doctor may increase your dose depending on your response.

Elderly:

The dosage will depend on your kidney function, blood chemical levels and response to treatment. If you are elderly, it is important to take this medicine exactly as prescribed.

Children:

Not recommended for children under 18 years old.

If you take more tablets than you should

If you (or someone else) swallows a lot of the tablets all at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or doctor immediately. Symptoms of overdose include dehydration and changes in the levels of certain chemicals in the blood.

If you forget to take the tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose, to make up for a forgotten dose.

If you stop taking these tablets

Do not stop taking these tablets without first talking to your doctor. Treatment should continue for as long as your doctor feels it is needed. If you have any further questions on the use of this product, ask your doctor or pharmacist.

|    4. Possible Side Effects    |

Like all medicines, these tablets can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist if you notice any of the following side effects, they get worse or if you notice anything not listed.

•    Altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low blood pressure, difficulty passing water, fast heart rate and feeling and being sick.

•    Blood: altered numbers and types of blood cells causing increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin (you may need a blood test).

•    Metabolism: dehydration, gout, changes in levels of body chemicals (increased blood potassium, glucose or uric acid or decreased blood sodium), glucose in the urine.

•    Nervous system: depression, difficulty sleeping or sleepiness, confusion, nervousness and restlessness, dizziness, pins and needles or tingling, near unconsciousness including reduced mental activity and response to stimulation (stupor), feeling of dizziness or spinning (vertigo), tremors and brain disease (characterised by poor concentration, confusion and delirium).

•    Heart: chest pain (angina), irregular (arrhythmia), fast (tachycardia) or pounding (palpitation) heart beats, dizziness on standing due to low blood pressure and inflammation of blood vessels (necrotising angiitis).

•    Breathing: cough, difficulty breathing, fluid in the lungs and lung inflammation (pneumonitis).

•    Stomach and intestines: feeling of stomach fullness, cramps, stomach irritation or pain, activation of stomach ulcers, bleeding in the stomach or intestines, indigestion, wind, loss or other appetite changes, constipation or diarrhoea, hiccups, feeling or being sick.

•    Liver and pancreas: inflammation of the pancreas (pancreatitis) and changes in liver function, jaundice (yellow skin or eyes).

•    Skin: blood spots, bruising and discolouring to the skin (purpura), loss of hair, itching, skin rash, pale or red irregular raised patches with severe itching (hives), flushing, sensitivity of the skin to sunlight or artificial light (e.g. sunbeds), sweating and swelling of the salivary glands.

•    Muscles and joints: joint pain, aching legs and muscle cramps.

•    Urinary and genital: pain on passing water, getting up in the night to pass water, frequent or copious water production, inability to control bladder movements, bladder pain, impaired kidney function, kidney failure or inflammation, decreased desire for sex and inability to maintain an erection. You should consult your doctor if these are troublesome or continue.

•    Senses: bad taste, stuffy nose, ringing in the ears, increased pressure in the eyes, visual disturbances and yellow vision.

•    Other: dry mouth, thirst, allergic (anaphylactic) reactions (rash, swelling, difficulty breathing), back chest neck and shoulder pain, pain in the hands and feet, tiredness, a feeling of general discomfort and illness, weakness, fever, headache and fainting.

If any of the side effects become serious, or if you notice any side

effects not listed in this leaflet, please tell your doctor or

pharmacist.

5. How to store Co-amilozide tablets_

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

•    Containers: Do not store above 25⁰C. Store in the original container and keep the container tightly closed in order to protect the tablets from light and moisture.

•    Blister carton: Do not store above 25⁰C. Store in the original package and in the outer carton.

•    Do not use the tablets after the expiry date shown on the carton or label. 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 Co-amilozide tablets contain

•    The active substance is 5mg of Amiloride Hydrochloride and 50mg of Hydrochlorothiazide.

•    The other ingredients are: lactose, microcrystalline cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycollate and sunset yellow (E110).

What Co-amilozide tablet looks like and contents of the pack

•    Co-amilozide tablet are pale, peach coloured, with a breakline on one side and marked ‘BL' on the other.

•    Co-amilozide tablets are available in Securitainers packs of 100 or 500 tablets and Blister packs of 28, 50 or 100 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder/Manufacturer

Name and address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG,

United Kingdom

Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Co-amilozide 5mg/50mg Tablets; PL 17907/0227

This leaflet was last revised in July 2012

To request a copy of this leaflet in Braille, large print or audio, please

contact the licence holder at the address (or telephone, fax, email)

above.