Eytazox 250 Mg Prolonged-Release Capsules
PACKAGE LEAFLET
PATIENT INFORMATION LEAFLET
EYTAZOX® 250 MG PROLONGED-RELEASE CAPSULES
(Acetazolamide)
Read all of this leaflet carefully because it contains important information for you.
* 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.
In this leaflet:
1. What are Eytazox Prolonged-Release Capsules and what are they used for?
2. Before you take Eytazox Prolonged-Release Capsules
3. How to take Eytazox Prolonged-Release Capsules
4. Possible side effects
5. Storing Eytazox Prolonged-Release Capsules
6. Further information
1. What are Eytazox Prolonged-Release Capsules and what are they used for?
Eytazox Prolonged-Release Capsules contain the active substance Acetazolamide. This belongs to a group of medicines known as carbonic anhydrase inhibitors.
Eytazox Prolonged-Release Capsules are used to treat, glaucoma (a condition of the eye), by reducing the pressure within the eye.
2. Before you take Eytazox Prolonged-Release Capsules
Do not take Eytazox Prolonged-Release Capsules if:
• You know you are allergic to sulfonamides, sulfonamide 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.
Eytazox Prolonged-Release Capsules should not be used in children. Special Precautions
Check with your doctor or pharmacist before taking your medicine if any of the following apply to you:
• 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 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
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. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines for your heart such as cardiac glycosides (e.g. digoxin)
• Medicines to reduce blood pressure
• Medicines to thin your blood (e.g. warfarin)
• Anti-diabetic medicines to lower the sugar in your blood (e.g. metformin)
• Medicines for epilepsy or fits (in particular, phenytoin, primidone or
carbamazepine ortopiramate)
• 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 (used to treat raised pressure in your eye(s))
• 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 conditions where there is excess acid in your body)
• Ciclosporin (used after transplants to suppress the immune system).
Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules.
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules make you feel drowsy or confused you should not drive or operate machines. Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules
This product contains sunset yellow FCF (E110) which may cause allergic reactions.
3. How to take Eytazox Prolonged-Release Capsules
Always take this medicine exactly as your doctor or pharmacist has told
you. You should check with them if you are not sure. Eytazox Prolonged-
Release Capsules should be taken orally.
Dosage:
• The usual recommended dosage is 1 or 2 capsules a day taken just before or just after a meal.
• Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules is suitable for you.
Eytazox Prolonged-Release Capsules are not recommended for use In children.
If you take more Eytazox Prolonged-Release Capsules than you should:
Get medical help immediately, either by calling your doctor or going to the nearest hospital casualty department. Take any remaining capsules and this leaflet with you so that the medical staff know exactly what you have taken.
If you forget to take Eytazox Prolonged-Release Capsules:
Take the dose as soon as you remember to take it and then continue on as before. 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 to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Eytazox Prolonged-Release Capsules can have 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:
• Reduction in the number of white blood cells and ‘platelets’, these effects may result in unusual bruising or bleeding or increased risk of infection, 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
• Weakness 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
• Liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark colour urine
• Anaemia or bone marrow depression (a condition in which there is a decrease in the number of red blood cells. Symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale).
Tell your doctor as soon as possible If you notice any of the following side effects:
• Pain in your lower back
• Pale stools.
You may also experience the following:
• 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
• 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.
If you take Eytazox Prolonged-Release 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 above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet,
please inform 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Eytazox Prolonged-Release Capsules
Keep all medicines out of the reach and sight of children.
There are no special storage conditions for this medicinal product.
Do not use Eytazox Prolonged-Release Capsules after the expiry date on the carton and blister. The expiry date refers to the 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 Eytazox Prolonged-Release Capsules contains:
Each capsule contains 250 mg of acetazolamide as the active ingredient.
The capsules also contain hypromellose, microcrystalline cellulose, purified talc, colloidal anhydrous silica, ethylcellulose, light liquid paraffin and opaspray orange (hydroxypropylcellulose, titanium dioxide [E171], talc, sunset yellow FCF [E110]).
The capsule shell contains gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
What Eytazox Prolonged-Release Capsules looks like and contents of the pack:
Eytazox Prolonged-Release Capsules are hard gelatin capsules with a clear body and orange cap, printed with ‘AM250’ in black ink, containing round orange pellets.
Eytazox Prolonged-Release Capsules are available in boxes of 30 capsules.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.,
Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.
Manufacturer:
Actavis UK Limited, Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK
This leaflet was last revised in October 2015.
For information in large print, on tape, on CD or in Braille, phone +44 (0)1271 385 257.
O
Auden Mckenzie
AAAI 3940
PATIENT INFORMATION LEAFLET
EYTAZOX® 250 MG PROLONGED-RELEASE CAPSULES
(Acetazolamide)
Read all of this leaflet carefully because it contains important information for you.
• 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.
In this leaflet:
1. What are Eytazox Prolonged-Release Capsules and what are they used for?
2. Before you take Eytazox Prolonged-Release Capsules
3. How to take Eytazox Prolonged-Release Capsules
4. Possible side effects
5. Storing Eytazox Prolonged-Release Capsules
6. Further information
1. What are Eytazox Prolonged-Release Capsules and what are they used for?
Eytazox Prolonged-Release Capsules contain the active substance Acetazolamide. This belongs to a group of medicines known as carbonic anhydrase inhibitors.
Eytazox Prolonged-Release Capsules are used to treat, glaucoma (a condition of the eye), by reducing the pressure within the eye.
2. Before you take Eytazox Prolonged-Release Capsules
Do not take Eytazox Prolonged-Release Capsules if:
• You know you are allergic to sulfonamides, sulfonamide 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.
Eytazox Prolonged-Release Capsules should not be used in children. Special Precautions
Check with your doctor or pharmacist before taking your medicine if any of the following apply to you:
• 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 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
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. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Medicines for your heart such as cardiac glycosides (e.g. digoxin)
• Medicines to reduce blood pressure
• Medicines to thin your blood (e.g. warfarin)
• Anti-diabetic medicines to lower the sugar in your blood (e.g. metformin)
• 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 (used to treat raised pressure in your eye(s))
• 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 conditions where there is excess acid in your body)
• Ciclosporin (used after transplants to suppress the immune system).
Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules.
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules make you feel drowsy or confused you should not drive or operate machines. Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules
This product contains sunset yellow FCF (E110) which may cause allergic reactions.
3. How to take Eytazox Prolonged-Release Capsules
Always take this medicine exactly as your doctor or pharmacist has told
you. You should check with them if you are not sure. Eytazox Prolonged-
Release Capsules should be taken orally.
Dosage:
• The usual recommended dosage is 1 or 2 capsules a day taken just before or just after a meal.
• Eytazox Prolonged-Release 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 Eytazox Prolonged-Release Capsules is suitable for you.
Eytazox Prolonged-Release Capsules are not recommended for use in children.
If you take more Eytazox Prolonged-Release Capsules than you should:
Get medical help immediately, either by calling your doctor or going to the nearest hospital casualty department. Take any remaining capsules and this leaflet with you so that the medical staff know exactly what you have taken.
If you forget to take Eytazox Prolonged-Release Capsules:
Take the dose as soon as you remember to take it and then continue on as before. 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 to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Eytazox Prolonged-Release Capsules can have 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:
• Reduction in the number of white blood cells and ‘platelets', these effects may result in unusual bruising or bleeding or increased risk of infection, 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
• Weakness 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
• Liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark colour urine
• Anaemia or bone marrow depression (a condition in which there is a decrease in the number of red blood cells. Symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale).
Tell your doctor as soon as possible if you notice any of the following side effects:
• Pain in your lower back
• Pale stools.
You may also experience the following:
• 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
• 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.
If you take Eytazox Prolonged-Release 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 above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Eytazox Prolonged-Release Capsules
Keep all medicines out of the reach and sight of children.
There are no special storage conditions for this medicinal product.
Do not use Eytazox Prolonged-Release Capsules after the expiry date on the carton and blister. The expiry date refers to the 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 Eytazox Prolonged-Release Capsules contains:
Each capsule contains 250 mg of acetazolamide as the active ingredient.
The capsules also contain hypromellose, microcrystalline cellulose, purified talc, colloidal anhydrous silica, ethylcellulose, light liquid paraffin and opaspray orange (hydroxypropylcellulose, titanium dioxide [E171], talc, sunset yellow FCF [E110]).
The capsule shell contains gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
What Eytazox Prolonged-Release Capsules looks like and contents of the pack:
Eytazox Prolonged-Release Capsules are hard gelatin capsules with a clear body and orange cap, printed with ‘AM250' in black ink, containing round orange pellets.
Eytazox Prolonged-Release Capsules are available in boxes of 30 capsules.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.,
Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK.
Manufacturer:
Auden Mckenzie (Pharma Division) Ltd.,
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL UK
This leaflet was last revised in October 2015.
For information in large print, on tape, on CD or in Braille, phone +44 (0)1271 385 257.
O
Auden Mckenzie
AAAI 3937