Patient leaflet - Acetazolamide Dawa 250 mg tablets

1. What are and what they are used for

Acetazolamide 250mg Tablets

2. What you need to know before you take Acetazolamide 250mg Tablets
3. How to take Acetazolamide 250mg Tablets
4. Possible side eﬀects
5. How to store Acetazolamide 250mg Tablets
6. Contents of the pack and other information
1. What Acetazolamide 250mg Tablets are and what they are used for

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

Acetazolamide 250mg Tablets are used to treat:

ŸGlaucoma (a condition of the eye), by reducing the pressure within the eye.

ŸAbnormal retention of ﬂuids (Acetazolamide 250mg Tablets act as a diuretic).

ŸEpilepsy (ﬁts or convulsions).

2. What you need to know before you take Acetazolamide 250mg Tablets

Do not take Acetazolamide 250mg Tablets if:

Ÿ you know you are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients in the medicine (listed in Section 6 at the end of this leaﬂet)

Ÿ you have severe liver problems

Ÿ you have or have ever had severe kidney problems

Ÿ you have a particular type of glaucoma known as chronic non congestive angle closure glaucoma (your doctor will be able to advise you) Ÿ you have reduced function of the adrenal glands – glands above the kidneys – (also known as Addison's disease)

Ÿ you have low blood levels of sodium and/or potassium or high blood levels of chlorine (your doctor will advise you).

Speak to your doctor if any of the above applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acetazolamide 250mg Tablets:

Ÿ if you have or have ever had kidney problems such as kidney stones Ÿ if you are over the age of 65

Ÿ if you experienced lung or breathing problems such as ﬂuid in the lungs, chronic bronchitis or emphysema, which cause diﬃculty in breathing following acetazolamide intake in the past

Ÿ 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.

If you develop shortness of breath or diﬃculty breathing after taking Acetazolamide 250mg Tablets, seek medical attention immediately (see section 4).

A decrease in vision or eye pain could be symptoms of ﬂuid accumulation in the vascular layer of the eye (choroidal eﬀusion or choroidal detachment). This can happen within hours of taking Acetazolamide 250mg Tablets. Talk to your doctor promptly if you experience these symptoms.

Acetazolamide 250mg 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 250mg Tablets.

Other medicines and Acetazolamide 250mg 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: Ÿ medicines for your heart such as cardiac glycosides (e.g. digoxin) Ÿ medicines to reduce blood pressure

Ÿ medicines to thin your blood (e.g. warfarin)

Ÿ medicines to lower the sugar in your blood (e.g. metformin, gliclazide) Ÿ medicines for epilepsy or ﬁts (in particular, phenytoin, primidone, carbamazepine or topiramate)

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

Ÿ steroids such as prednisolone

Ÿ aspirin and related medicines, e.g. salicylic acid or choline salicylate for mouth ulcers

Ÿ other drugs in the group of medicines called carbonic anhydrase inhibitors (e.g. dorzolamide or brinzolamide which are also used to treat glaucoma) Ÿ amphetamines (a stimulant), quinidine (treats an irregular heart beat), methenamine (prevents urine infections) or lithium (treats severe mental problems)

Ÿ sodium bicarbonate therapy (used to treat high states of acid in your body)

Ÿ 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 250mg Tablets SHOULD NOT be taken if you are pregnant, think you are pregnant or are planning to become pregnant.

Breast-feeding

Acetazolamide 250mg Tablets may be taken when breast-feeding but only on the advice of your doctor.

Driving and using machines

If Acetazolamide 250mg Tablets make you feel drowsy or confused you should not drive or operate machines. Acetazolamide 250mg 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.

Acetazolamide 250mg Tablets contain lactose

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

Acetazolamide 250mg Tablets contain sodium

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

3. How to take Acetazolamide 250mg Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This information will also be on the label.

Ÿ Acetazolamide 250mg Tablets should be swallowed whole with a drink of water, just before or just after a meal. Do not chew or crush the tablets. Ÿ 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.

ŸBefore starting and during treatment your doctor may monitor your blood to check that treatment with Acetazolamide 250mg Tablets is suitable for you.

If you take more Acetazolamide 250mg Tablets than you should

If you forget to take your Acetazolamide 250mg 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 250mg 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 250mg 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.

Contact a doctor immediately if you develop shortness of breath or diﬃculty breathing. These can be symptoms of accumulation of ﬂuid in the lungs (pulmonary oedema). The frequency of this side eﬀect is not known (cannot be estimated from the available data).

Not known: frequency cannot be estimated from the available data

Ÿheadache

Ÿdiarrhoea

Ÿfeeling or being sick, loss of appetite, thirst, or a metallic taste in the mouth

Ÿdizziness, loss of full control of arms or legs

Ÿlooking ﬂushed

Ÿa need to pass urine more often than normal

Ÿtiredness or irritability

Ÿfeeling over-excited

Ÿa tingling or numbness in the ﬁngers or toes, or coldness in the extremities

Ÿdepression

Ÿdrowsiness or confusion

Ÿa loss of interest in sex

Ÿringing in the ears or diﬃculty in hearing

Ÿtemporary short-sightedness which subsides when the dosage is reduced or treatment is stopped

Ÿdecrease in vision or pain in your eyes due to accumulation of ﬂuid in the vascular layer of the eye (choroidal eﬀusion or choroidal detachment).

Rare cases of skin rashes including an increased sensitivity to sunlight have been reported. If you experience any unusual skin rashes, inform your doctor.

If you take Acetazolamide 250mg Tablets for a long time it can occasionally aﬀect the amount of potassium or sodium in your blood. Your doctor will probably take blood tests to check that this does not happen. You might also experience bone thinning or the risk of kidney stones with long-term therapy. High or low blood sugar levels may occasionally occur.

Contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this side eﬀect is not known (cannot be estimated from the available data).

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.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via the Yellow Card Scheme website:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store Acetazolamide 250mg Tablets

Keep this medicine out of the sight and reach of children. Store in the original pack in order to protect from light.

Do not use after the expiry date which is stated on the carton after EXP. The Expiry date refers to the last day of that month.

Bottle Pack

Once opened: Use within 3 months.

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.

REMEMBER

This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else; it could harm them, even if their symptoms seem the same as yours.

6. Contents of the pack and other information

What Acetazolamide 250mg Tablets contain

The active substance is acetazolamide. Each tablet contains 250 mg acetazolamide.

The other ingredients are sodium starch glycolate, maize starch, lactose monohydrate, povidone K30, puriﬁed water, anhydrous calcium hydrogen phosphate and magnesium stearate.

What Acetazolamide 250mg Tablets look like and contents of the pack

Acetazolamide 250mg Tablets are white colour, round shaped tablets with a break line on one side & plain on the other side.

Acetazolamide 250mg Tablets are available in bottles or blisters containing 100 or 112 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK

Manufacturer

Drugsrus Limited