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PACKAGE LEAFLET: INFORMATION FOR THE USER

Diamox® 250mg Tablets

(acetazolamide)

In this leaflet:

1.    What Diamox 250mg Tablets are and what they are used for

2.    Before you take Diamox 250mg Tablets

3.    How to take Diamox 250mg Tablets

4.    Possible side effects

5.    How to store Diamox 250mg Tablets

6.    Further information

1. WHAT DIAMOX 250MG TABLETS ARE AND WHAT THEY ARE USED FOR

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

Diamox 250mg Tablets are used to treat:

•    glaucoma (a condition of the eye), by reducing the pressure within the eye

•    abnormal retention of fluids (Diamox 250mg Tablets acts as a diuretic)

•    epilepsy (fits or convulsions).

2. BEFORE YOU TAKE DIAMOX 250MG TABLETS

DO NOT take Diamox 250mg 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 at the end of this leaflet)

•    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).

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

Take special care and speak to your doctor before taking Diamox 250mg 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.

Diamox 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 Diamox 250mg Tablets.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 heart beat), 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:

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

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

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

Driving and using machines:

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

3. HOW TO TAKE DIAMOX 250MG TABLETS

•    Always take the number of tablets your doctor has told you to take. This information will also be on the label.

•    Diamox 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.

•    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.

USUAL DOSES:

Glaucoma:

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

Retention of fluid:

Adults: starting dose is 250-375mg (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: 250-1 OOOmg 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 750mg (3 tablets) per day.

• Before starting and during treatment your doctor may monitor your blood to check that treatment with Diamox 250mg Tablets is suitable for you. If you take more Diamox 250mg 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 your Diamox 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 tablets and carry on taking the rest of your tablets as usual.

DO NOT take a double dose of tablets to make up the missed dose.

If you have any further questions about these tablets, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Diamox 250mg Tablets 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.

Extremely rarely, Diamox 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.

Very rarely, Diamox 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.

Common side effects are:

•    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.

Uncommon side effects are:

•    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.

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 Diamox 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.

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 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.aov.uk/vellowcard or Tel: Freephone 0808 100 3352. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DIAMOX 250MG TABLETS

Do not store above 25oC. Store in the original pack or in containers which prevents the access of moisture.

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

Do not use after the expiry date. This date is printed on your pack. The Expiry date refers to last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Diamox 250mg Tablets contains

Each tablet contains 250mg acetazolamide.

The other ingredients are maize starch, sodium starch glycolate, calcium hydrogen phosphate dihydrate, magnesium stearate and povidone.

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

Diamox 250 mg Tablets are round, convex, white tablets engraved with ‘FW 147’ one one side and scored in quarters on the other. Diamox 250mg Tablets come in tamper evident plastic bottle containing 112 tablets.

Manufacturer: Custom Pharmaceuticals Limited, Conway, Hove, East Sussex, BN3 3LW, UK.

Procured from within the EU by the Product Licence Holder: Millsdale Pharmaceuticals, John Street, Warrington, Cheshire, WA2 7UB. UK.

PL No. 08811/0047

This leaflet was prepared 13^th October 2015.