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

2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETAMOKS TABLETS

DO NOT take Cetamoks Tablets if:

• you know you are allergic to sulphonamides, sulphonamide derivatives including acetazolamide or to any of the ingredients of this 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, which are situated 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.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Cetamoks 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

Cetamoks 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 Cetamoks Tablets.

Other medicines and Cetamoks Tablets:

Please tell your doctor or pharmacist if you are taking, have recently taken or might take 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, carbamazepine or topiramate)
• drugs which interfere with folic acid, e.g. methotrexate, pyrimethamine or trimethoprim
• steroids such as prednisolone
• aspirin and related medicines, eg 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), methenam-ine, (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, breast feeding and fertility:

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

Cetamoks 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 a doctor.

Fertility: there are no human or animal data available on the effect of acetazolamide on fertility.

Driving and using machines:

If Cetamoks Tablets make you feel drowsy or confused you should not drive or operate machines. Cetamoks 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 CETAMOKS TABLETS

Always take the number of tablets your doctor has told you to take. Check with your doctor or pharmacist if you are not sure. This information will also be on the label.

• Cetamoks 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 tablet can be divided into equal halves but should not be divided into quarters.
• 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 doses are:

Glaucoma:

Adults: 250mg-1000mg (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: 250–1000mg 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 Cetamoks Tablets is suitable for you

If you take more Cetamoks 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 Cetamoks 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 of tablets to make up the missed 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.

If you experience any of the following serious reactions, contact your doctor immediately:-

• Serious allergic reactions (very rare). Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
• Effects on your blood cells (extremely rare) which could mean that you are more likely to catch infections and that your blood may not clot properly. Any sore throat or fever, bruises or tiny red or purple spots on your skin, your muscles feel weak or you have fits.
• Effects on your liver or kidneys (very rare). Pain in your lower back, pain or burning when you pass urine, difficulty in passing urine, you stop passing urine, have blood in your urine, pale stools, your stools are black or tarry, or you notice blood in your stools. Or your skin or eyes look slightly yellow.
• A serious skin reaction. A red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis). The frequency of this side effect is not known (cannot be estimated from the available data)

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 side effects are:

• a change in the amount of potassium or sodium in your blood on long term therapy. Your doctor will probably take blood tests to check that this does not happen
• changes to blood sugar levels on long term therapy
• bone thinning on long term therapy
• kidney stones on long term therapy
• skin rash including increased sensitivity to light
• convulsions

5. how to store cetamoks 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 pack after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any discolouration or any sign of deterioration of the tablets.

This medicinal product does not require any special storage conditions but please store in the original packaging 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 protect the environment.

6. contents of the pack and other information

What Cetamoks Tablets Contain:

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

The other ingredients are Crospovidone, Maize starch, Povidone, Anhydrous Calcium Hydrogen Phosphate, Magnesium Stearate.

What Cetamoks Tablets look like and contents of the pack:

Cetamoks Tablets are white to off-white, round tablets with „250“ debossed on one side and cross scored on the other. They are marketed in either a blister pack containing 10 or 12 tablets or a plastic bottle pack containing 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Blumont Pharma Ltd, 23 Moortown Close, Grantham, Lincs, NG31 9GG, UK Manufacturer: Mobius Laboratories Ltd, Unit 7, Bourne End Mills, Hemel Hempstead, HP1 2UJ

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This leaflet was last revised in 07/2021