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Bumetanide/Amiloride 1mg/5mg Tablets

Bumetanide/Amiloride 1 mg/5mg Tablets


ESSENTIAL GENERICS


Bumetanide and amiloride hydrochloride_F1233 122/L/efi

Please 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 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 become serious, or you notice any side effects not listed in this leaflet please tell your doctor or

pharmacist._


In this leaflet:

1 .What this medicine is and what it is used for

2. Before you take

3. How to take

4. Possible side effects

5. How to store

6. Further information


1. What this medicine is and what it is used for


Bumetanide/Amiloride tablets contain two different medicines. One medicine is called bumetanide and the other medicine is called amiloride hydrochloride. These both belong to a group of medicines called diuretics (water tablets).

Bumetanide/Amiloride works by removing any excess water from your body.

It will make you go to the toilet more.

Bumetanide/Amiloride is used:

• To treat oedema. Oedema means that there is too much water in your body. Oedema can cause symptoms such as swollen ankles or trouble breathing.


2. Before you take


Do NOT take Bumetanide/Amiloride tablets if you:

•    are allergic (hypersensitive) to bumetanide or amiloride hydrochloride.

•    are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

•    know that you have any sugar intolerance. You may have inherited this condition from someone else in your family.

•    cannot pass water (urine) at all.

•    have severe kidney problems or severe liver problems such as cirrhosis.

•    know you have a condition called Addison's disease.

•    have been told that you have high levels of potassium in your blood.

•    have been told that you have low levels of certain salts in your blood.

•    are taking potassium supplements or any medicines that may change the amount of potassium in your body. Ask your doctor if you are not sure.

•    are taking lithium. Check with your doctor or pharmacist if you are not sure whether you are taking lithium.

Take special care with Bumetanide/Amiloride tablets

Before you take Bumetanide/Amiloride tell your doctor if you:

•    have diabetes

•    have gout

•    have prostate problems or have difficulty passing urine

•    are vomiting or have diarrhoea

•    have low blood pressure

•    have a condition called porphyria

•    have liver disease

•    are allergic to medicines called sulfonamides or thiazides

•    are an athlete who undergoes doping testing.

When you are taking Bumetanide/Amiloride your doctor may take regular blood tests. This is very important in the elderly, in diabetics or in seriously ill patients.


If you are going to have a "glucose tolerance test" tell the doctor or nurse you are taking Bumetanide/Amiloride as this may affect the results.

Taking other medicines

Do not take Bumetanide/Amiloride if you are taking potassium supplements or any medicines that may change the amount of potassium in your body.

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

•    medicines for heart conditions, such as digoxin, ACE inhibitors, angiotensin II receptor antagonists. Your doctor may need to change your dose

•    medicines for high blood pressure. This includes alpha-blockers such as prazosin or indoramin which can also be used for prostate problems in men

•    non-steroidal anti-inflammatory drugs, such as ibuprofen, for arthritis or aches or pains

•    lithium, used to treat mood disorders (see Section "Do not take" above)

•    any medicines that make you feel dizzy on standing up e.g. tricyclic antidepressants such as amitriptyline

•    medicines for diabetes. Your doctor may need to change your dose

•    any medicines that may affect your kidneys

•    cephalosporin antibiotics

•    aminoglycoside antibiotics (e.g. gentamicin) or other medicines which may affect your hearing

•    tetracycline antibiotics (e.g. oxytetracycline)

•    probenecid, a medicine used in special cases, to protect the kidneys

•    ciclosporin, a medicine used to suppress the immune system

•    trilostane, a medicine used to stop excessive production of steroids, or in women with breast cancer.

Pregnancy and breast-feeding

DO NOT take Bumetanide/Amiloride if you are pregnant or while breast-feeding unless advised to by your doctor.

Ask your doctor for advice before taking any medicine. Driving and using machines

This medicine may cause dizziness, drowsiness, tiredness or feeling faint as side effects. You must not drive or use machines if you get any of these side effects.

Important information about some of the ingredients of Bumetanide/Amiloride Tablets • Lactose

This is a type of sugar. If you cannot tolerate any sugar (sometimes called sugar intolerance) contact your doctor before taking this medicine.

Please ask your doctor if you are worried about any of the ingredients in this medicine.


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3. How to take


Always use Bumetanide/Amiloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Bumetanide/Amiloride to take

Your doctor will tell you how many tablets to take.

You are likely to need the toilet more often after you have taken your tablets. Remember that this may be inconvenient if you are going on a long journey or want to go to sleep.

Remember to always take this medicine with at least half a glass of water. Take your tablets at the same time each day. This makes it easier to remember them.

Adults and the elderly:

The usual dose is one or two tablets each day. Your doctor may change your dose depending on your test results.

If you forget how many tablets to take, look at the label on your pack.

If you are still not sure, ask your doctor or pharmacist. Children:

This medicine is NOT suitable for children or adolescents (under the age of 18 years).

If you take more Bumetanide/Amiloride than you should

Tell your doctor straight away. You may need to stop taking this medicine.

If you forget to take Bumetanide/Amiloride

If you forget to take your medicine, and you are less than 12 hours late, you can still take it. If you are more than 12 hours late taking your medicine then leave out this dose. Take the next dose at the usual time.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, Bumetanide/Amiloride tablets can cause side effects, although not everybody gets them.

STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions:

•    difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

•    severe itching of the skin, with a red rash or raised lumps.

Seek immediate medical attention if you have any of the following symptoms:

•    you feel shaky, faint or your heart starts to beat fast or irregularly. This may be due to a shock-like reaction

•    fever, rash, feeling sick, aches and pains, loin pain, passing more or less urine than usual, passing red urine or passing urine at night, difficulty or inability to pass urine. This may be due to changes in your kidneys

•    you have liver problems and you feel confused, forgetful or faint, or if your skin or eyes become yellow, or if you have pale faeces, dark urine or itchy skin

•    unusual or increased bleeding or bruising

•    fever, sore throat, mouth ulcers, repeated infections that keep coming back

•    feeling tired, breathless, looking pale.

Tell your doctor if you get any of the following side effects:

Digestive problems:

•    feeling or being sick

•    indigestion, heartburn

•    stomach pain or cramps, wind

•    diarrhoea, constipation.

Skin problems:

•    rash, including dermatitis

•    itching skin


•    itchy raised skin (hives)

•    reactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sunbed, or expose your skin to UV light.

Other problems:

•    noticing your heart beats which may be slower or faster than usual

•    chest pain (angina)

•    swollen or painful breasts (sometimes in men)

•    erectile problems, decreased sexual drive

•    muscle cramps or pain

•    pain in your bones and muscles. This may happen if you are taking high doses and have severe kidney problems

•    pain and swelling in one or more joints (gout)

•    tingling or numbness sensation

•    headache

•    confusion

•    ringing or buzzing in the ears (tinnitus), deafness

•    you feel unusually thirsty with dry skin, dark urine, dry mouth, headache. This may be due to dehydration

•    you feel dizzy or have 'head spins'

•    light-headedness or dizziness when standing up from a sitting or lying position

•    a collection of symptoms including thirst, frequent urination, tiredness, and increased susceptibility to infection, such as thrush. This may be due to too much glucose in the body. Your doctor can test for this

•    you feel drowsy or tired.

Blood tests: tell your doctor if you are having blood tests as your medicine may cause changes in the level of some substances in your blood (including salts, sugar, waste products and body fats such as cholesterol and triglycerides).

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


•    Keep out of the reach and sight of children.

•    Do not use the tablets after the expiry date on the carton. The expiry date is the last day of that month.

•    Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.


6. Further information


What Bumetanide/Amiloride Tablets contain

•    The active ingredients are bumetanide (1 milligram) and amiloride hydrochloride (5 milligrams) in each tablet.

•    The other ingredients are:

lactose, magnesium stearate, maize starch and microcrystalline cellulose.

What Bumetanide/Amiloride Tablets look like and contents of the pack

Bumetanide/Amiloride Tablets are cream oval tablets, with a break line on one side and marked '149' on the reverse. They are available in blister packs of 28 tablets.

Marketing Authorisation Holder

Chemidex Pharma Ltd, trading as Essential Generics,

7 Eqham Business Villaqe, Crabtree Road, Eqham, Surrey TW20 8RB.

Manufacturer

Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW.

This leaflet was last revised in

05/2015


F1233 122/L/e/6    ESSENTIAL GENERICS


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