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EYTAZOX 250 MG PROLONGED-RELEASE CAPSULES

Active substance(s): ACETAZOLAMIDE

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PATIENT INFORMATION LEAFLET

• 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® 250 MG PROLONGED-RELEASE CAPSULES
(Acetazolamide)

Eytazox Prolonged-Release Capsules are not recommended for
use in children.

PACKAGE LEAFLET

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


• 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.

doctor or pharmacist.

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.

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
• 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
• 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)

If you have any further questions on the use of this product, ask your
doctor or pharmacist.



4. Possible side effects

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.

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.

print proof no:
origination date:
originated by:
approved for print/date

AAAI3940
1
14.10.15

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

in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body) should be reported to a
doctor immediately.

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.

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


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).

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.

dimensions:

310 x 195

min pt size:

colours/plates
1. black
2.
3.

pharmacode:
7.65pt

4.
5.
6.

DR

Non Printing Colours

Technical Approval

revised by:

date sent:

14.10.15

technically app. date:

04.12.15

Shasun, India

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.

There are no special storage conditions for this medicinal product.

revision date:

supplier:

please inform your doctor or pharmacist.

Keep all medicines out of the reach and sight of children.

Acetazolamide (Eytazox) 250mg prolonged-release capsules PIL - UK
item no:

If any of the above side effects are troublesome or last more than a few

All medicines can cause allergic reactions although serious

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

• A need to pass urine more often than normal
• Tiredness or irritability
• Feeling over-excited

extremities
• Depression

Always take this medicine exactly as your doctor or pharmacist has told
you. You should check with them if you are not sure. Eytazox ProlongedRelease Capsules should be taken orally.

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.

Like all medicines, Eytazox Prolonged-Release Capsules can have
side effects, although not everybody gets them.

Tell your doctor as soon as possible if you notice any of the
following side effects:
• Pain in your lower back
• Pale stools.

3. How to take Eytazox Prolonged-Release
Capsules

• Drowsiness or confusion
• A loss of interest in sex

• Temporary short-sightedness which subsides when the dosage is
reduced or treatment is stopped.

1. Profile
2.

3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

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,
liquid
ioxide
[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
October 2015.

For information in large print, on tape, on CD
or in Braille, phone +44 (0)1271 385 257.

AAAI3940

sulfonamides, sulfonamide derivatives

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.

AAAI3937

colours/plates

Acetaz0lamide 250mg capsule leaflet - UK
item no:

AAAI3937

dimensions:

print proof no:

2

pharmacode:

origination date: 15.10.15

min pt size:

1. black
195 x 310

2.
3.
4.

7.65

originated by:

jh

revision date:

23.10.15

Technical Approval

revised by:

jh

date sent:

supplier:

Shasun

technically app. date: 22.10.15

5.
6.

15.10.15

Non Printing Colours
1. Profile
2.

3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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