Uncommon side effects (probably occuring in less than 1 in 100 people) are:

treatment is stopped.

•    low Platelet count

•    decrease in cells production responsible for providing immunity

•    low potassium levels

in 1000 people) 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 Moxaid SR Capsules 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, 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

•    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

Rare cases (probably occuring in less than 1

5. HOW TO STORE MOXAID SR 250MG CAPSULES

Store below 30°C.

Store in the original package in order to protect from light and moisture.

Keep out of the reach and sight of children.

Do not use after the expiry date. This date is printed on your pack.

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.

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. FURTHER INFORMATION

What Moxaid SR Capsules Contain

The active substance is Acetazolamide. Each capsule contains acetazolamide.

The other ingredients are microcrystalline cellulose (E460), sodium lauryl sulphate, purified water, ethylcellulose, hydroxypropyl methylcellulose (E464), mineral oil, opaspray K-1R-2506 orange [hydroxypropyl cellulose, titanium dioxide (E171), FD & C yellow No.6 (E110)].

Capsule shell contains gelatin, titanium dioxide (E171), yellow iron oxide (E172) and erythrosine (E127). What Moxaid SR Capsules look like and contents of the pack

Moxaid SR Capsules have a clear body and orange cap, and are printed with ‘GS 250' in black. They usually come in blister packs of 28 or 30 capsules.

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT UK Manufacturer:

Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT UK Moxaid is a trademark of Amdipharm International Limited

This leaflet was last revised in September 2014    XXXXX/LF/1

©

C~

MercuryPharma PATIENT INFORMATION LEAFLET

Moxaid™ SR 250mg Prolonged-release capsules

(Acetazolamide)

Read all of this leaflet carefully before you start taking this medicine.

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. 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Moxaid SR 250mg prolonged-release capsules. It will be referred to as Moxaid SR capsules for ease of use hereafter.

In this leaflet:

1.    What Moxaid SR Capsules are and what they are used for

2.    Before you take Moxaid SR Capsules

3.    How to take Moxaid SR Capsules

4.    Possible side effects

5.    How to store Moxaid SR Capsules

6.    Further information

1. WHAT MOXAID SR CAPSULES ARE AND WHAT ARE THEY USED FOR

Moxaid SR Capsules contain the active substance Acetazolamide. This belongs to a group of medicines known as carbonic anhydrase inhibitors.

Moxaid SR Capsules are used to treat, glaucoma (a condition of the eye), by reducing the pressure within the eye.

2. BEFORE YOU TAKE MOXAID SR CAPSULES

DO NOT take Moxaid SR Capsules if:

•    you know you are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients in the capsules (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)

•    the person this medicine has been prescribed for is under the age of 12.

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

Take special care and speak to your doctor before taking Moxaid SR Capsules if:

•    you have or have ever had kidney problems such as kidney stones

continued over

•    you have lung problems such as chronic bronchitis or emphysema, which cause difficulty in breathing

•    you have diabetes or problems with your blood sugar level

•    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.

Taking other medicines

Moxaid SR 250mg Capsules 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 Moxaid SR Capsules.

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

•    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

•    amphetamines (a stimulant), quinidine (treats an irregular heart beat), methenamine (prevents urine infections) or lithium (treats severe mental problems)

•    sodium bicarbonate therapy

•    ciclosporin (used to suppress the immune system).

Pregnancy and breast feeding

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

Moxaid SR Capsules 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 Moxaid SR Capsules make you feel drowsy or confused you should not drive or operate machines. Moxaid SR Capsules 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 some of the ingredients of Moxaid SR Capsules

This medicine contains the ingredient sunset yellow FCF (E110) which may cause allergic reactions.

3. HOW TO TAKE MOXAID SR 250MG CAPSULES

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

•    The usual recommended dosage is 1 or 2 capsules a day taken just before or just after a meal

•    Moxaid SR Capsules should be swallowed whole with a drink of water. Do not chew or crush the capsules

•    The dose varies from person to person depending on their condition. If you are not sure how many capsules to take or when to take them, ask your pharmacist

©

•    Before starting and during treatment your doctor will monitor your blood to check that treatment with Moxaid SR Capsules is suitable for you

•    Moxaid SR Capsules are not for use in children.

If you take more Moxaid SR Capsules 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 Moxaid SR Capsules:

You should take it as soon as you remember. However, if this is within 2 hours of your next dose you should skip the missed capsule and carry on taking the rest of your capsules as usual.

DO NOT take a double dose of capsules 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, Moxaid SR Capsules 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.

Tell your doctor immediately if you notice any of the following side effects:

•    fever, severe chills, sore throat or mouth ulcers

•    bruises or tiny red or purple spots on your skin

•    a severe condition of the skin that may affect the mouth and other parts of the body. This may progress to a severe skin reaction which starts with painful red areas, then large blisters and ends up with peeling of layers of skin, mouth, nose, eyes or genitals. This may be accompanied by fever and chills, aching muscles and generally feeling unwell

•    your muscles feel weak or paralysis, and reduced muscle tone

•    you have fits

•    pain or burning when you pass urine, have difficulty in passing urine or you stop passing urine, or have blood in your urine

•    your stools are black or tarry, or if you notice blood in your stools.

•    nausea, vomiting, loss of appetite, feeling generally unwell, itching, yellowing of the skin and eyes, and dark colour urine

•    decrease in the number of red blood cells. tiredness, headaches, being short of breath when exercising, dizziness and looking pale

•    decrease in white blood cells

•    Softening of bones when used along with drugs used to treat fits/ convulsions

•    kidney problems.

Tell your doctor as soon as possible if you notice any of the following side effects:

•    pain in your lower back

•    pale stools

•    your skin or eyes look slightly yellow.

You may also experience the following:

Common side effects (probably occuring in less than 1 in 10 people) are:

•    low blood sugar

•    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.

©

continued over