PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-Amilozide 2.5mg/25mg & 5mg/50mg Tablets

Amiloride Hydrochloride and Hydrochlorothiazide

Read all of this leaflet carefully before you start to take

this medicine.

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

-    If you have any further questions, please ask your doctor 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 get 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

The name of your medicine is Co-Amilozide Tablets. This medicine contains two active ingredients, amiloride hydrochloride and hydrochlorothiazide.

Amiloride hydrochloride removes excess water and prevents a reduction in potassium levels. Hydrochlorothiazide removes excess water from the body.

Co-Amilozide Tablets comes in two strengths and is used in the treatment heart failure, high blood pressure and fluid retention due to liver disease (especially when it is important to maintain potassium levels).

2. Before you take Co-Amilozide Tablets

You should not take Co-Amilozide Tablets if you:

•    are allergic (hypersensitive) to amiloride hydrochloride,hydrochlorothiazide or to any of the other ingredients inCo-Amilozide Tablets (see section 6)

•    have high blood potassium or calcium levels

•    have Addison's disease (an adrenal glands disease)

•    have acute kidney failure or are unable to pass water

•    have diabetes related kidney disease

•    have severe, progressive kidney disease

•    have liver failure

•    are taking potassium supplements, potassium sparing diuretics or large amounts of potassium rich foods

•    are taking lithium (used to treat manic depression)

•    are under 18 years.

Talk to your doctor before taking Co-Amilozide Tablets if you:

•    have diabetes mellitus

•    suffer from gout (a condition where too much uric acid in the body causes joint pains)

•    have liver disease

•    have severe asthma

•    suffer from porphyria (a disease of blood proteins that effects the skin, gut and nervous system)

•    suffer from systemic lupus erythematosus (a disease were the immune system attacks the tissues of the body)

•    are seriously ill or have heart disease or lung disease.

•    are due to take a glucose tolerance test (this medicine should be discontinued for at least three days before).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by treatment with Co-Amilozide Tablets:

•    medicines to treat high blood pressure (e.g. prazosin)

•    amphotericin and fluconazole, used to treat fungal infections

•    carbamazepine, used to treat epilepsy

•    quinidine, used to treat abnormal heart rhythms

•    anion-exchange resins used to reduce cholesterol

(e.g.colestyramine and colestipol) - these should be given atleast two hours apart

•    medicines to treat depression (e.g. reboxetine, tricyclic antidepressants and MAOIs)

•    medicines used to suppress the immune system following organ transplant (e.g. ciclosporin and tacrolimus)

•    medicines used to treat inflammation (e.g. indometacin)

•    carbenoxolone, used to treat stomach ulcers

•    medicines called muscle relaxants, such as tizanidine, used to treat muscle pain, spasms and twitching

•    medicines used to treat Parkinson's disease (e.g. amantadine)

•    acetazolamide, used to treat water retention

•    medicines to treat mental illness (e.g. primozide and sertindole)

•    medicines to treat diabetes (e.g. chlorpropamide)

•    medicines to maintain blood pressure in severely ill patients (e.g. adrenaline)

•    aprostadil, used to treat impotence

•    cisplatin, used to treat some cancers

•    allopurinol, used to prevent gout

•    terfenadine, an anti-histamine used to treat allergies

•    steroids (e.g. cortisone and hydrocortisone)

•    hormones or drugs acting on hormones (e.g. trilostane, toremifene, oestrogens and progestrogens)

•    cardiac glycosides medicines used in heart failure

•    barbiturates medicines used in sedation and anaesthesia. Tell your doctor if you are going into hospital for an operation

•    potassium, calcium and vitamin supplements.

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

Taking Co-Amilozide Tablets with food and drink

If you feel dizzy while taking this medicine then alcohol may make the effects worse.

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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Co-amilozide is not recommended for mothers who are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

This medicine can make you feel dizzy, reduce alertness or impair your vision. Do not drive or operate machinery if affected.

Important information about some of the ingredients in Co-Amilozide Tablets

This medicine contains lactose, if you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. How to take Co-Amilozide Tablets

Always take Co-Amilozide Tablets as your doctor has told you. Your doctor will decide the right dose for you. This will be on the pharmacist's label. This medicine should be swallowed whole. The usual starting dose is:

Treatment of high blood pressure:

•    one tablet taken once a day. Your doctor may decide to increase your dose up to two tablets a day.

Treatment of heart failure:

•    one tablet taken once a day. Your doctor may decide to increase your dose up to four tablets a day.

Treatment of water retention in liver disease:

•    two tablets taken once a day. Your doctor may decide to increase your dose up to four tablets a day.

Your doctor may want to monitor your salt levels with regular blood tests, especially if you are elderly or unwell, to check for any possible imbalances.

Children

• This medicine is not recommended for use in children under the age of 18.

If you take more Co-Amilozide Tablets than you should

If you (or anybody else, including a child), takes more Co-Amilozide Tablets than you should then you should contact your nearest hospital casualty department or doctor immediately. Always take the container and this leaflet with you.

If you forget to take Co-Amilozide Tablets

If you forget a dose, take another as soon as you remember.

If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Co-Amilozide Tablets can cause side effects, although not everybody gets them. As can happen with any medicine, a few people may develop an allergic reaction.

If you experience any of the following, seek medical help immediately:

•    inflammation of the pancreas (pancreatitis) which causes severe pain in the abdomen and back (may be associated with nausea, vomiting or fever). If you notice these symptoms talk to your doctor as soon as possible

•    yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice). If you notice these symptoms talk to your doctor as soon as possible

•    rash, itching, difficulty breathing.

Side effects that have been reported:

•    headache

•    weakness

•    fatigue

•    fainting

•    fast heartbeat

•    dizziness

•    vertigo

•    chest pain

•    rash

•    itching

•    hives/”nettle rash”

•    fever

•    difficulty breathing

•    loss of appetite

•    dehydration

•    vomiting

•    feeling sick

•    constipation

•    diarrhoea

•    thirst

•    stomach pains

•    cramps

•    dry mouth

•    indigestion

•    pancreatitis

•    nervousness

•    bruising

•    depression

•    confusion

•    visual disturbances

•    sleepiness

•    impotence

•    restlessness

•    decreased sex drive

•    blurred vision

•    reduced or altered consciousness

•    sensitivity of skin to light

•    need to pass water during night

•    general feeling of being unwell

•    skin tingling and ”pins and needles”

•    changes in the way the liver is working, shown by blood tests

•    jaundice (yellowing of skin and whites of the eyes)

•    a fall in your blood pressure which causes dizziness, light-headedness or fainting on standing up

•    changes in the levels of salts in your blood. Symptoms include nausea, weakness, feeling confused, loss of

appetite, muscle cramps, muscle twitching and an abnormal heart beat

•    anaemia - a condition in which there is a decreased number of red blood cells (symptoms include tiredness, headaches, being short of breath when exercising, dizziness, and looking pale

•    reduction in the number of white blood cells (symptoms include frequent infections, fever, severe chills, sore throat or mouth ulcers)

•    low blood platelet count (symptoms include bleeding or bruising more easily than normal. You may also notice purple or red-brown spots through the skin

•    yellow vision, a condition where everything you see appears to have a yellowish tinge

•    high blood sugar (hyperglycaemia). Symptoms include feeling thirsty, needing to pass water frequently, feeling tired and getting infections such as thrush more often than usual

•    gout, a condition that causes pain, inflammation and swelling of your joints

If you experience any side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

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 sight and reach of children.

•    Do not store above 25°C. Store in the original container and do not transfer to another container.

•    Do not take after the expiry date on the label; the expiry date refers to the last day of the month.

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 protect the environment.

6. Further information

What Co-Amilozide Tablets contains

The active ingredients are: amiloride hydrochloride (2.5mg or 5mg) and hydrochlorothiazide (25mg or 50mg). The other ingredients are: lactose, calcium phosphate dibasic, maize starch, pregelatinised maize startch, magnesium stearate, purified water.

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

Co-Amilozide tablets are cream coloured tablets contained in opaque blister packs or in polyethylene plastic containers.

Marketing Authorisation Holder: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 02/2015.

Twockhardt