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ACETAZOLAMIDE 250 MG TABLETS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ACETAZOLAMIDE 250 MG TABLETS

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 only. Do not pass iton 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

  • 2. What you need to know before you take Acetazolamide Tablets

  • 3. How to take Acetazolamide Tablets

  • 4. Possible side effects

  • 5. How to store Acetazolamide Tablets

  • 6. Contents of the pack and other information

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

Acetazolamide 250 mg Tablets (referred to as Acetazolamide Tablets throughout this leaflet) contain the active substance acetazolamide. This belongs to a group of medicines known as carbonic anhydrase inhibitors. Acetazolamide Tablets are used to treat:

  • glaucoma (a condition of the eye), by reducing the pressure within the eye
  • abnormal retention of fluids (Acetazolamide Tablets acts as a diuretic)
  • epilepsy (fits or convulsions).

2. what you need to know before you take acetazolamide tablets

Do not take Acetazolamide Tablets if:

  • you know you are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients in the medicine (listed in Section 6)
  • you have severe liver problems
  • you have or have ever had severe kidney problems
  • you have a particular type of glaucoma known as chronic non congestive angle closure glaucoma (your doctor will be able to advise you)
  • you have reduced function of the adrenal glands – glands above the kidneys – (also known as Addison’s disease)
  • you have low blood levels of sodium and/or potassium or high blood levels of chlorine (your doctor will advise you).

If you suffer from any of the above, speak to your doctor or pharmacist before taking Acetazolamide Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acetazolamide Tablets if:

  • you have or have ever had kidney problems such as kidney stones
  • you have lung problems such as chronic bronchitis or emphysema, which cause difficulty in breathing
  • you are over the age of 65
  • 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.

Acetazolamide Tablets may affect some medical tests. If you visit a hospital or clinic for any medical tests, you should tell the doctor concerned that you are taking Acetazolamide Tablets.

If you are not sure if any of above applies to you, talk to your doctor or pharmacist before taking this medicine.

Other medicines and Acetazolamide Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effects of any of these medicines may change, particularly if you are taking, or using, any of the following:

  • medicines for your heart such as cardiac glycosides (e.g. digoxin)
  • medicines to reduce blood pressure
  • medicines to thin your blood (e.g. warfarin)
  • medicines to lower the sugar in your blood (e.g. metformin, gliclazide)
  • medicines for epilepsy or fits (in particular, phenytoin, primidone or carbamazepine or topiramate)
  • drugs which interfere with folic acid, e.g. methotrexate, pyrimethamine, or trimethoprim
  • steroids such as prednisolone
  • aspirin and related medicines, e.g. salicylic acid or choline salicylate for mouth ulcers
  • other drugs in the group of medicines called carbonic anhydrase inhibitors (e.g. dorzolamide or brinzolamide which are also used to treat glaucoma)
  • amphetamines (a stimulant), quinidine (treats an irregular heartbeat), methenamine (prevents urine infections) or lithium (treats severe mental problems)
  • sodium bicarbonate therapy (used to treat high states of acid in your body)
  • ciclosporin (used to suppress the immune system).

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.

Pregnancy

Acetazolamide Tablets SHOULD NOT be taken if you are pregnant, think you are pregnant or are planning to become pregnant.

Breast-feeding

It may be taken when breast-feeding but only on the advice of the doctor.

Driving and using machines

If Acetazolamide Tablets make you feel drowsy or confused, you should not drive or operate machines. Acetazolamide Tablets can occasionally cause short-sightedness; if this happens and you feel that you can no longer drive safely, you should stop driving and contact your doctor.

Important information about Acetazolamide Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take acetazolamide tablets

Always take Acetazolamide Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

  • This information will also be on the label.
  • Acetazolamide Tablets should be swallowed with a drink of water, just before or just after a meal. Do not chew or crush the tablets. The tablet can be divided into equal doses (2 or 4).
  • The dose varies from person to person depending on their condition. Your doctor will decide on the most appropriate dose. If you are not sure how many tablets to take or when to take them, ask your doctor or pharmacist.

The recommended dose is

Glaucoma :

Adults : 250 – 1000 mg (1 – 4 tablets) every 24 hours, in divided doses.

Retention of fluid :

Adults : starting dose is 250 – 375 mg (1 –

  • 1.5 tablets) once daily in the morning. Your doctor will adjust the dose and tell you how often to take your dose.

Epilepsy :

Adults : 250 – 1000 mg daily in divided doses. Children : the dose will depend on the bodyweight of the child, to be taken in divided doses. Dose should not be more than 750 mg (3 tablets) per day.

  • Before starting and during treatment your doctor may monitor your blood to check that treatment with Acetazolamide Tablets is suitable for you.

If you take more Acetazolamide Tablets than you should

Get medical help immediately, either by calling your doctor or going to the nearest hospital casualty department. Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you forget to take Acetazolamide Tablets You should take it as soon as you remember. However, if this is within two hours of your next dose you should skip the missed tablet and carry on taking the rest of your tablets as usual. 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.

All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Acetazolamide Tablets can affect the cells in your blood. This could mean that you are more likely to catch infections and that your blood may not clot properly. If you have a sore throat or fever or you notice bruises or tiny red or purple spots on your skin, you should contact your doctor immediately. If your muscles feel weak or you have fits, you should see your doctor immediately.

Acetazolamide Tablets can affect the liver and kidneys. If you experience pain in your lower back, pain or burning when you pass urine, have difficulty in passing urine, or you stop passing urine, have blood in your urine, pale stools, or if your skin or eyes look slightly yellow, you should contact your doctor. You should also contact your doctor if your stools are black or tarry, or if you notice blood in your stools.

Not known: frequency cannot be estimated from the available data

  • headache
  • diarrhoea
  • feeling or being sick, loss of appetite, thirst, or a metallic taste in the mouth
  • dizziness, loss of full control of arms or legs
  • looking flushed
  • a need to pass urine more often than normal
  • tiredness or irritability
  • feeling over-excited
  • a tingling or numbness in the fingers or toes, or coldness in the extremities.
  • depression
  • drowsiness or confusion
  • a loss of interest in sex
  • ringing in the ears or difficulty in hearing
  • temporary short-sightedness which subsides when the dosage is reduced, or treatment is stopped.

5. how to store acetazolamide tablets

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 carton and blister foil after “EXP”. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in the original pack in order to protect from light and moisture.

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 to protect the environment.

6. contents of the pack and other informationwhat acetazolamide tablets containeach tablet contains 250 mg of acetazolamide as the active ingredient.

The other ingredients are maize starch, calcium hydrogen phosphate, povidone K-30, sodium starch glycolate (Type A) and magnesium stearate.

What Acetazolamide Tablets look like and contents of the pack

Acetazolamide 250 mg Tablets are white to off-white, round, biconvex tablets debossed with cross breakline on one side and ‘250’ debossed on other side

The tablets are packaged in a white opaque PVC/ PVDC-aluminium blister in packs of 112 tablets.

Marketing Authorisation Holder

Morningside Healthcare Ltd.

Unit C, Harcourt Way

Leicester, LE19 1WP

UK

Manufacturer

Morningside Pharmaceuticals Ltd.

5 Pavilion Way, Castle Business Park

Loughborough, LE11 5GW

UK

This leaflet was last revised in October 2021.

M0381LAMUKNA-P1–001

Area for pharmacode

Sources: Original (products.mhra.gov.uk)