Acetazolamide 500mg Powder for solution for injection

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Acetazolamide Sodium 500mg Powder for Solution for Injection. It will be referred to as Acetazolamide Injection for ease of use hereafter.

1. What Acetazolamide injection is and what it is used for
2. What you need to know before you are given Acetazolamide injection
3. How you are given Acetazolamide injection
4. Possible side effects
5. How to store Acetazolamide injection
6. Contents of the pack and other information

• you are allergic to acetazolamide or to any of the ingredients in the medicine (listed in section 6.)
• you are allergic to sulphonamides or sulphonamide derivatives
• you have or have ever had severe liver disease
• 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.

Talk to your doctor or nurse before are given Acetazolamide injection if:

• you have or have ever had kidney problems such as kidney stones
• you have trouble passing urine.
• you experienced lung or breathing problems such as fluid in the lungs or chronic bronchitis or emphysema, which causes difficulty in breathing following acetazolamide intake in the past.
• you have diabetes or problems with your blood sugar level
• you have a history of generalised red, scaly rash (acute generalised exanthematous pustulosis [AGEP]) when treated with acetazolamide.

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

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.

• you have muscle weakness.
• you have any allergic reaction (anaphylaxis)
• you have or had unusual skin rash.
• you are receiving treatment or a special diet for low levels of sodium or potassium.

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 Injection. Talk to your doctor promptly if you experience these symptoms.

Tell your doctor or nurse if you are taking or 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
• medicines for epilepsy or fits (in particular, phenytoin, primidone or carbamazepine or topiramate)
• drugs which interfere with folic acid, eg 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
• amphetamines (a stimulant), quinidine (treats an irregular heartbeat), methenamine (prevents urine infections) or lithium (treats severe mental problems)
• sodium bicarbonate therapy (used to treat acidity)
• ciclosporin (used to suppress the immune system)

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 any medicines.

Pregnancy

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

Breastfeeding

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

If Acetazolamide injection makes you feel drowsy or confused, you should not drive or operate machines. Acetazolamide injection 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.

This medicine contains less than 1 mmol sodium (23mg) per dose, i.e. essentially “sodium-free”.

As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary.

• skin rashes including an increased sensitivity to sunlight
• Acetazolamide injection 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.
• sore throat or fever
• bruises or tiny red or purple spots on your skin,
• muscles feel weak or you have fits
• 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, stools are black or tarry, or blood in your stools.
• 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 cannot be estimated from the available data (not known).

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 effects is not known (cannot be estimated from the available data).

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
• glucose in the urine or cloudy urine
• 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
• low amount of potassium, or sodium in your blood.
• kidney stones.
• high or low blood sugar levels.
• Decrease in vision or pain in your eyes due to accumulation of fluid in the vascular layer of the eye (choroidal effusion or choroidal detachment).

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 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.

The active substance is acetazolamide. Each vial contains 500mg acetazolamide.

The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.

Acetazolamide injection is a white powder, packed in glass vials with a rubber ring and aluminium seal. Before use, it is made into a solution, using at least 5ml water for injection.