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PACKAGE LEAFLET: INFORMATION FOR THE USER

CO-AMILOZIDE TABLETS 5/50mg

[amiloride hydrochloride/hydrochlorothiazide]

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, health care provider or pharmacist.

•    This medicine has been prescribed for you.

Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Co-Amilozide Tablets are and what they are used for

2.    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.    Further information

1.    WHAT CO-AMILOZIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Co-Amilozide is one of a group of medicines called diuretics. It is used for the treatment of:

•    High blood pressure

•    Congestive heart failure, heart problems which can cause shortness of breath or ankle swelling

•    Cirrhosis of the liver disease where the liver is damaged

2.    BEFORE YOU TAKE CO-AMILOZIDE TABLETS Do not take Co-Amilozide Tablets if you

•    Have ever had an allergic reaction to Co-Amilozide tablets, amiloride, hydrochlorothiazide or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

•    Have reduced blood volume (hypovolaemia) or are dehydrated or not passing water (urine) due to a condition called anuria

■    High levels of potassium in your blood or are taking potassium supplements or other potassium containing medicines

•    Have high calcium in the blood

■    Have severe kidney problems or kidney failure

•    Have severe liver failure

•    Have Addison’s disease which is a disorder of the adrenal gland

■    Have diabetes or diabetic neuropathy (nerve damage due to diabetes)

•    Are under 18 years of age

Take special care with Co-Amilozide Tablets

Check with your doctor or pharmacist before taking Co-Amilozide Tablets if you:

•    Have low blood sodium, potassium or magnesium levels.

•    Have kidney or liver problems

•    Have gout (crystals build up in the joints)

•    Have Systemic Lupus Erythematosus (SLE) which is a chronic condition causing inflammation of various parts of the body.

•    Have any condition which affects urination (passing water), for example enlarged prostate gland

•    Have low blood pressure

•    Have low protein levels in the blood due to kidney problems

•    Are diabetic

•    Are taking allopurinol

Your doctor may want to monitor you whilst you take this medicine, this may mean having blood or urine tests or an ECG to check your heart.

Taking other medicines

Please tell your doctor before taking this medicine if you are taking or likely to be taking any of the following:-

•    Ace inhibitors used to treat heart problems e.g Captopril, Lisinopril

Anti-arrhythmics used to treat an irregular heart beat e.g digoxin, amiodarone Drugs used to relieve high blood pressure including aliskiren and metolazone Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and indometacin which reduce inflammation and pain Other anti-inflammatory drugs such as corticosteroids or carbenoxolone used in many conditions such as arthritis or asthma Medicines to treat severe asthma Medicines used to treat depression or behavioural problems such as lithium, reboxetine, carbamazepine Cisplatin used to treat various cancers Antibiotics and antifungals to treat infection e.g cephalosporin antibiotics and amphotericin

Ciclosporin used to prevent organ rejection after transplant

Medicines used to treat diabetes such as insulin and chlorpropramide Trilostan used in the treatment of endometriosis, infertility, prostate cancer Pressor amines used for some heart or blood pressure conditions e.g methoxamine, adrenalin

Diuretics used to relieve water retention e.g spironolactone or triamterene Colestipol or colestyramine which are used to reduce cholesterol levels (fat)

Taking alcohol, barbituates or narcotics (Central nervous system depressants) with thiazide diuretics can lead to low blood pressure

Vitamin D, calcium salts or toremifene Adrenaline

Medicines to reduce potassium excretion e.g. drospirenone, tacrolimus Muscle relaxants Allopurinol used to treat gout Fluconazole used to treat fungal infections.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Please tell your doctor if you are pregnant or you may be pregnant before taking this medicine. Your doctor will only prescribe Co-Amilozide tablets if the benefits outweigh the risks to the unborn child. Breast-feeding is not recommended whilst taking Co-Amilozide Tablets. Check with your doctor if you are unsure as breast-feeding should be discontinued if treatment with Co-Amilozide is considered essential.

Driving and using machines

Co-Amilozide Tablets may make you feel dizzy, weak or tired. Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients of Co-Amilozide tablets

Co-Amilozide Tablets contain lactose. Do not take these tablets if you have been told by your doctor that you are lactose intolerant or that you have an intolerance to some sugars.

Co-Amilozide Tablets also contain the colouring sunset yellow (E110), which can cause hypersensitivity (allergic) reactions including asthma, this is more common in people allergic to aspirin. Do not take Co-Amilozide Tablets if you are allergic to sunset yellow.

3. HOW TO TAKE CO-AMILOZIDE TABLETS

Always take Co-Amilozide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor.

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The usual dosage(s) are described below:

For Adult oral use

High blood pressure:

Half a tablet daily increased to one tablet daily if necessary.

Congestive heart failure:

Half a tablet daily increased to two tablets daily if necessary.

Cirrhosis of the liver:

One tablet daily increased to two tablets daily if necessary.

Elderly

The above dosages may sometimes be reduced especially if you have damaged kidneys.

Children under 18 years of age

Not recommended.

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you take more Co-Amilozide Tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If an overdose has been taken there may be signs such as slow or irregular heartbeat, low blood pressure and fainting.

If you forget to take Co-Amilozide Tablets

If you forget to take a tablet; take one as soon as you remember, unless it is nearly time to take the next one.

Do not take a double dose to make up for a forgotten dose.

Take the remaining doses at the correct time.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Co-Amilozide Tablets can cause side effects, although not everybody gets them.

Allergic reactions:

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eye lids, face or lips, rash, reddening of the skin or itching (especially affecting your whole body). Stop taking this medication immediately if you experience any of these symptoms.

Serious side effects:

■    Liver problems (yellowing of the skin or whites of the eyes)

■    Problems with the blood cells in your body, this may show as increased bruising, pale skin, bleeding from the nose or gums or regular infections

■    Abnormal heart beats; this may be fast, slow or fluttering or severe chest pain (angina)

■    Pancreatitis (inflammation of the pancreas) this may show as severe stomach pain, nausea, weight loss and fat in your stools (foul smelling)

■    Serious skin disorders which may give severe skin rash, this may be blistering, red and very painful

•    Breathing difficulty or breathlessness.

If you experience any of the above side effects, contact your doctor immediately.

The following side effects may also occur:

•    Insomnia (unable to sleep) or somnolence (overtired), confusion, nervousness and restlessness, depression (low mood)

•    Headaches, dizziness, lethargy (tiredness), pins and needles, itching, fainting, changes in taste, tremor, brain disorder

•    Impaired vision, hearing disorders, eye pressure, yellowing of vision

•    Vertigo, ringing in ears

•    Low blood pressure (fainting on standing), flushing (warm red skin), vasculitis (inflammation of the arteries)

•    Cough, nasal congestion or hiccups, pneumonia, water on the lung

•    Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, flatulence (wind), stomach pain or discomfort, stomach distension and indigestion, changes in appetite, dry mouth, mouth ulcers, sugar in urine measured by the doctor

•    Rash which can be itchy, blood spots, bruising and discolouring to the skin (purpural) or sensitive to sun, increased sweating, hair loss (alopecia)

•    Muscle or joint pain or spasms or tremor (shaking), pains in arms, legs and neck

•    Increased urine production, urination in the night increased, retention of urine (not passing water), bladder spasms

•    Reduced sex drive (libido) or erectile dysfunction

•    Thirst, general body weakness or feeling of being unwell, chest pain, back pain, fever (high temperature).

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 at: 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 CO-AMILOZIDE TABLETS

Keep out of the reach and sight of children.

Store in the original container below 25°C and protect from light and moisture.

Do not use Co-Amilozide Tablets after the expiry date which is stated on the label. The expiry refers to the last day of that month.

Do not use Co-Amilozide Tablets if you notice visible signs of deterioration.

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

6.    FURTHER INFORMATION What Co-Amilozide Tablets contains

The active substances are amiloride hydrochloride and hydrochlorothiazide.

The tablets also contain: Lactose monohydrate, Microcrystalline cellulose, Maize starch, Magnesium stearate, Purified talc, Sodium starch glycollate and Sunset yellow aluminium lake E110.

What Co-Amilozide Tablets looks like and contents of the pack

Description:

A flat, pale peach bevelled edged tablet, engraved ‘CO breakline AM’ on one side and plain on the other side.

Contents of pack:

Blisters of 28,50 and 100 tablets.

Marketing Authorisr^n Holder and

Manufacturer

Co-Pharma Limited

Unit 4, Metro Centre, Tolpits Lane,

Watford, Herts. UK, WD 18 9SS Tel: 01923 255580 Fax: 01923 255581

This leaflet was last revised in 09/2015

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