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Acetazolamide Tablets 250mg

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ACETAZOLAMIDE 250 mg TABLETS

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, 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 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 LEAFLET CONTAINS

1.    What Acetazolamide is for

2.    Before you take Acetazolamide

3.    How to take Acetazolamide

4.    Possible side effects

5.    How to store Acetazolamide

6.    Further information

1. WHAT ACETAZOLAMIDE IS FOR

Acetazolamide 250 mg Tablets contain the active substance acetazolamide, which belongs to a group of medicines known as carbonic anhydrase inhibitors. Acetazolamide is used to treat:

•    glaucoma, a condition associated with increased pressure in the eye

•    fluid retention, the build-up of fluid in the body

•    epilepsy, a neurological condition characterised by seizures (fits), in particular absence seizures (petit mal), in children

If you are not sure why you have been prescribed Acetazolamide, please ask your doctor.

2. BEFORE YOU TAKE ACETAZOLAMIDE

DO NOT take Acetazolamide, and tell your doctor, if you:

•    are allergic to sulphonamides (a related group of medicines), acetazolamide, or any of the other ingredients of these tablets (listed in section 6)

•    have low levels of potassium or sodium in your blood

•    have hyperchloraemic acidosis, a condition in which the plasma becomes too acidic due to an increased chloride concentration and/or a decreased bicarbonate concentration

•    have liver or kidney problems

•    have problems with your adrenal glands (small hormone-producing glands near the kidneys), such as Addison's disease

•    need long-term treatment for a particular type of glaucoma known as chronic non congestive angle closure glaucoma

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor before taking Acetazolamide.

Take special care with Acetazolamide

Talk to your doctor before taking Acetazolamide if you:

•    have, or have previously had, kidney stones

•    are at greater risk of your blood becoming too acidic, this includes if you:

-    suffer from diabetes

-    are over the age of 65

-    have kidney problems

-    have lung problems which may cause shortness of breath, a persistent cough, wheezing or tightness of the chest

A small number of people being treated with anti-epileptics such as acetazolamide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Operations and tests

Taking Acetazolamide may affect the results of some clinical tests. If you are going to have a test, it is important to tell your doctor or nurse that you are taking Acetazolamide.

If you are taking Acetazolamide for a long time your doctor may want you to have some blood tests to check your blood cell counts and electrolyte levels.

Taking other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines bought without a prescription.

This is because Acetazolamide can affect the way some medicines work, and some medicines can affect the way Acetazolamide works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    any other carbonic anhydrase inhibitors for glaucoma, such as dorzolamide or brinzolamide

•    other medicines to treat epilepsy or fits, such as carbamazepine, phenytoin, phenobarbital or primidone

•    medicines to treat high blood pressure, such as captopril, enalapril (ACE inhibitors), doxazosin, prazosin (alpha-blockers), candesartan, losartan (angiotensin-II receptor antagonists), clonidine, diazoxide, guanethidine, hydralazine, methyldopa, minoxidil, moxonidine or sodium nitroprusside

•    medicines to treat diabetes, such as gliclazide, metformin or insulin

•    medicines used to treat an irregular or uneven heartbeat, or heart failure, such as quinidine or cardiac glycosides like digoxin

•    aspirin to treat pain, inflammation or fever

•    ciclosporin to suppress the immune system and stop the rejection of organs after transplants

•    lithium for mental health problems

•    methenamine, an anti-bacterial used to treat infections

•    methotrexate to treat cancer

•    sodium bicarbonate therapy used to treat high levels of acid in the body

•    steroids, such as hydrocortisone or prednisolone, to treat swelling and allergies

•    amphetamines, stimulants sometimes used to treat Attention Deficit Hyperactive Disorder (ADHD)

•    sympathomimetics, such as bambuterol, fenoteral, formoterol, salbutamol, salmeterol and terbutaline, or theophylline used to treat asthma

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take Acetazolamide if you are pregnant, planning to become pregnant, or are breast-feeding, unless your doctor has told you to. Follow your doctor's advice.

Driving and using machines:

While taking Acetazolamide you may experience fatigue, drowsiness, dizziness, tingling or numbness ('pins and needles'), a lack of muscle coordination, disorientation, or short-sightedness. If this happens, do not drive or operate machinery, tell your doctor.

Acetazolamide contains lactose and sucrose

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

3. HOW TO TAKE ACETAZOLAMIDE

Always take this medicine exactly as your doctor has told you. The dose of Acetazolamide will vary from person to person, and depend on the condition being treated. Your doctor will decide on the most appropriate dose for you. Check with your doctor or pharmacist if you are not sure.

Acetazolamide tablets should be swallowed whole with a drink of water.

The recommended doses are:

Adults:

Glaucoma:

250 mg - 1000 mg (1 - 4 tablets) in a 24 hour period, taken in divided doses for amounts over 250 mg

Fluid retention:

The typical starting dose is 250 mg - 375 mg (1 - 1k tablets) daily in the morning, after which your doctor may adjust the dose and/or how often you take it, depending on your response.

A single dose of 125 mg - 375 mg (k - 1k tablets) daily is recommended for fluid retention associated with pre-menstrual tension.

Epilepsy:

250 mg - 1000 mg (1 - 4 tablets) daily, in divided doses Elderly:

Acetazolamide should be used with particular caution in elderly patients as they are at greater risk of their blood becoming too acidic. Follow your doctor's advice.

Children:

Epilepsy:

Your doctor will advise you of the dose, to be taken in divided doses, depending on your child's bodyweight. The dose should not exceed 750 mg (3 tablets) daily.

If you take more Acetazolamide than you should:

If you, or someone else, takes more tablets than you should, contact your doctor or go to the nearest hospital casualty department immediately. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

Increased doses of Acetazolamide may cause drowsiness or tingling or numbess ('pins and needles').

If you forget to take Acetazolamide:

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, STOP TAKING Acetazolamide and tell your doctor or go to the nearest hospital emergency department immediately:

•    an allergic reaction to acetazolamide, the signs of which can include red raised lumps (hives), rashes, itching, swelling of the hands, feet, face, lips, tongue or throat which may cause difficulty in swallowing or breathing

•    severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin.

If you get any of the following side effects, stop taking Acetazolamide and tell your doctor as soon as possible:

•    changes to your blood such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness. A blood test can be taken to check.

•    temporary loss of hearing

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

Effects on the brain and central nervous system:

headache, irritability, dizziness, excitement, tingling or numbness ('pins and needles'), difficulty in controlling movements, depression, confusion, drowsiness, reduced sex drive, loss of muscle control, fits

Effects on the eyes: temporary short-sightedness (this will resolve when the dosage is reduced or the treatment is stopped)

Effects on the ears: hearing disturbances, ringing in the ears

Effects on the respiratory system: breathing that is deeper and more rapid than normal

Effects on the stomach and intestines: feeling or being sick, diarrhoea, loss of appetite, thirst, taste disturbances, passing black tarry stools (faeces) or blood in your stools

Effects on the liver: abnormal liver function, inflammation of the liver (hepatitis), which causes yellowing of the skin or white of the eyes (jaundice), liver damage or failure

Effects on the kidneys: crystals in the urine (crystalluria), which may be seen as cloudy urine or cause difficulty in passing urine, kidney stones, pain radiating from the kidney to the groin, damaged kidney tissue, passing large amounts of urine, sugar in the urine, blood in the urine, kidney failure

Effects on the skin: sensitivity of the skin to sunlight

Other general effects: fatigue, fever, flushing Taking Acetazolamide for a long time may cause changes to the electrolytes in your body, and can cause your blood to become too acidic. A blood test can be taken to check.

Reporting of side effects

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

Also, you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays), or fill in a paper form available from your local pharmacy.

5. HOW TO STORE ACETAZOLAMIDE

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

Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Store below 25°C. Store in the original container, and keep the container tightly closed in order to protect from light.

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. FURTHER INFORMATION

What Acetazolamide contains:

The active substance (the ingredient which makes the medicine work), is acetazolamide. Each tablet contains 250 mg of acetazolamide.

The other ingredients are lactose, maize starch, pregelatinised starch, povidone, sucrose, sodium starch glycolate and magnesium stearate.

What Acetazolamide looks like and contents of the pack:

Acetazolamide 250 mg Tablets are white, round, biconvex uncoated tablets with crossed score-lines on one side.

They come in plastic containers of 100, 112 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Chelonia Healthcare Limited,

11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus

Manufacturer:

DDSA Pharmaceuticals Limited

310 Old Brompton Road, London, SW5 9JQ

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2014

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