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Acetazolamide Tablets 250mg

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Acetazolamide Product: 250 mg Tablets

MA Holder: Chelonia

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Chelonia

HEALTHCARE

Final Preparation Date For Submission: 11/08/2016

PL No.: 33414/0001

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Pack Size: All Packs

Dimensions: 148 x 297 mm

Livery: Chelonia

Created By: DTawde

Manufacturer: -Market: UK Component: Leaflet

Artwork Code: CL0001/O/PIL/CL3

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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 or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. j

WHAT IS IN THIS LEAFLET

1.    What Acetazolamide is and what it is used for

2.    What you need to know before you take Acetazolamide

3.    How to take Acetazolamide

4.    Possible side effects

5.    How to store Acetazolamide

6.    Contents of the pack and other information

1. WHAT ACETAZOLAMIDE IS AND WHAT IT IS USED 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

•    abnormal 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACETAZOLAMIDE

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

•    if you are allergic to acetazolamide or any of the other ingredients of this medicines (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.

Warnings and Precautions

Talk to your doctor or pharmacist or nurse 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.

Other medicines and Acetazolamide tablets:

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

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

•    drugs which interfere with folic acid, e.g. methotrexate, pyrimethamine, or trimethoprim

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 - 1% 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 (/ - 1/ 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

•    effects on the ears: hearing disturbances, ringing in the ears

•    effects on the stomach and intestines: 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)

•    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

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, tingling or numbness (‘pins and needles'), difficulty in controlling movements, depression, confusion, drowsiness, reduced sex drive, fits

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

Effects on the stomach and intestines: feeling or being sick, diarrhoea, some loss of appetite, thirst, taste disturbances

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 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 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. CONTENTS OF THE PACK AND OTHER 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 round, odourless, white biconvex uncoated tablets with crossed score-lines on one side and plain on the other 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 08/2016

CL0001/O/PIL/CL3