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Acetazolamide Tablets Bp 250mg

PATIENT INFORMATION LEAFLET

ACETAZOLAMIDE Tablets 250mg


Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet tell your doctor or pharmacist.

In this leaflet:

1.    What Acetazolamide Tablets are and what they are used for

2.    Before you take Acetazolamide Tablets

3.    How to take Acetazolamide Tablets

4.    Possible side effects

5.    How to store Acetazolamide Tablets

6.    Further information

1.    What Acetazolamide Tablets are and what they are used for

These tablets contain the active ingredient Acetazolamide, which is one of the group of medicines called carbonic anhydrase inhibitors.

These are used in the treatment of abnormal retention of fluids and epilepsy.

They are also used to treat chronic simple glaucoma, secondary glaucoma and before an operation in acute angle closure glaucoma.

2.    Before you take Acetazolamide Tablets

Do not take these tablets if:

•    you are allergic to Acetazolamide, sulphonamides or any of the ingredients in the tablets

•    you have low blood levels of sodium or potassium

•    you have kidney disease or kidney problems

•    you have liver disease including cirrhosis, or liver problems

•    you have an underactive adrenal gland

•    you have hyperchloremic acidosis (high levels of chloride in the blood).

Do not take these tablets for a long term if:

•    you suffer from chronic congestive angle-closure glaucoma.

Check with your doctor before taking these tablets if:

•    you have lung problems such as bronchitis, asthma, wheezing or emphysema

•    you have a history of kidney stones as this medicine may cause further kidney stones

•    you are pregnant, think you may be pregnant or are breast-feeding.

Taking other medicines:

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription.

This is particularly important if you are taking:

•    medicines used for heart problems, e.g. digoxin

•    medicines used to control high blood pressure

•    medicines to treat blood clotting such as warfarin

•    medicines to lower blood sugar levels

•    folic acid antagonists such as methotrexate

•    aspirin

•    phenytoin, carbamazepine, primidone (for epilepsy)

•    ciclosporin used to prevent organ rejection following a transplant

•    lithium used to treat mental illness

•    methanamine used to treat urinary tract infections

•    medicines containing sodium bicarbonate.

Other special warnings:

If you are taking this medicine for a long time your doctor may want to do some tests to check your blood cell count and electrolyte levels.

Some medicines used for treating epilepsy have been reported to cause some people to think about harming themselves; you must tell your doctor if you start to have any thoughts about harming yourself whilst you are taking this medicine.

Driving and using machinery:

This medicine may cause drowsiness, dizziness and confusion and may affect your eyesight. Do not drive or operate machinery if this medicine has this effect on you.

3.    How to take Acetazolamide Tablets

The tablets should be swallowed with a drink of water.

Your doctor will decide the dose that is best for you. The pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Adults

Glaucoma and epilepsy: 1 - 4 tablets daily in divided doses.

Abnormal retention of fluids (for example in heart failure): 1-11/2 tablets daily, in the morning for 2 days, rest a day and then repeat, or every other day.

In premenstrual tension: Half to 1/ tablets daily.

Children

Epilepsy: 8 to 30mg/kg body weight daily in divided doses.

The maximum daily dose is 750mg.

Elderly: Caution should be exercised in older patients.

If you forget to take a dose: take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule.

DO NOT DOUBLE THE DOSES.

If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department.

Take with you any remaining tablets and the pack so that the medicine can be identified.

4.    Possible side effects

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

If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor:

•    Difficulty breathing or dizziness; a rash, itching or hives (raised red weals) on the skin; or sudden swelling of the face, throat or lips. These are signs of a serious

allergic reaction

•    Other serious skin reactions including blistering, swelling, or Stevens-Johnson syndrome (symptoms are blisters on the skin, eyes, mouth and genitals).

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

•    Yellowing of the skin or whites of the eyes, pale or dark tarry stools, dark urine, loss of appetite, confusion, feeling sick, itching, fever, trembling, weight loss. These may be symptoms of liver problems or failure, liver disease, or a type of jaundice due to bile in the blood

•    Light-headedness, muscle twitching or cramps, feeling or being sick, rapid breathing, confusion or tiredness. These may be symptoms of changes in your body’s electrolyte levels or metabolic acidosis (a condition where your blood contains too much acid) and may occur following a long course of this medicine.

The following side effects have also been reported:

•    Passing large volumes of urine

•    Excessive thirst, loss of appetite, taste disturbances, feeling or being sick, diarrhoea

•    Tingling, numbness or burning sensation in the hands and feet

•    Flushing, headache, dizziness, tiredness, irritability, depression

•    Short-sightedness which lasts only a short time and which usually subsides when the medicine is withdrawn or the dose reduced

•    Severe lower back or groin pain caused by stones in the kidney or ureter (the tube through which urine passes), or crystals in the urine or kidney tissue damage

•    Decreased sex drive.

Uncommon effects (that may happen to less than 1 in 100 people):

•    Blood disorders which may cause symptoms such as fever, tiredness, bruising and sometimes abnormal bleeding or makes infections more likely

•    Black tarry stools, blood or excess sugar in the urine

•    Kidney failure (symptoms include difficulty in passing urine or no urine output)

•    Paralysis with loss of muscle tone

•    Convulsions (fits)

•    Drowsiness, confusion, fever

•    Ringing in the ears or difficulty in hearing.

Rare effects (that may happen to less than 1 in 1000 people):

•    Increased skin sensitivity to sunlight.

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 Tablets

Keep the tablets in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the tablets if the expiry date on the pack has passed. If you have any

medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Acetazolamide Tablets 250mg contain 250mg of Acetazolamide as the active ingredient. Other ingredients are: dicalcium phosphate, maize starch, pregelatinised maize starch, sodium starch glycolate and magnesium stearate.

What the medicine looks like:

Acetazolamide Tablets are white, round tablets engraved with R and crescent moon logo on one side and A303 on the other. They are supplied to your pharmacist in packs containing 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may be available.

Who makes this medicine and holds the product licence:

The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED and the Manufacturer is Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 OYZ, UK.

Date leaflet revised: August 2014

If you would like this leaflet in a different format please contact the licence holder at the above address.

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