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EYTAZOX 250 MG PROLONGED-RELEASE CAPSULES

Active substance(s): ACETAZOLAMIDE

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PACKAGE LEAFLET

Patient leaflet: Information for the user

EYTAZOX® 250 MG PROLONGED-RELEASE CAPSULES
(Acetazolamide)
Read all of this leaflet carefully before you start taking this medicine 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 only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See Section 4.
What is in this leaflet
1. What Eytazox is and what it is used for
2. What you need to know before you take Eytazox
3. How to take Eytazox
4. Possible side effects
5. How to store Eytazox
6. Contents of the pack and other information
• Drugs which interfere with folic acid, e.g. methotrexate,
1. What Eytazox is and what it is used for
pyrimethamine, or trimethoprim
• Steroids such as prednisolone
• Aspirin and related medicines, e.g. salicylic acid or choline
Eytazox contains the active substance Acetazolamide. This
salicylate for mouth ulcers
belongs to a group of medicines known as carbonic
• Other drugs in the group of medicines called carbonic
anhydrase inhibitors.
anhydrase inhibitors (used to treat raised pressure in your
Eytazox is used to treat, glaucoma (a condition of the eye),
eye(s))
by reducing the pressure within the eye.
• Amphetamines (a stimulant), quinidine (treats an irregular
heart beat), methenamine (prevents urine infections) or
2. What you need to know before you take Eytazox
lithium (treats severe mental problems)
• Sodium bicarbonate therapy (used to treat conditions
Do not take Eytazox if:
where there is excess acid in your body)
• You know you are allergic to sulfonamides, sulfonamide
• Ciclosporin (used after transplants to suppress the immune
derivatives including acetazolamide or to any of the
system).
ingredients in the capsules (listed in Section 6 at the end of
Eytazox may affect some medical tests. If you visit a hospital
this leaflet)
or clinic for any medical tests, you should tell the doctor
• You have severe liver problems
concerned that you are taking Eytazox Prolonged-Release
• You have or have ever had severe kidney problems
Capsules.
• You have a particular type of glaucoma known as chronic
non congestive angle closure glaucoma (your doctor will be If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.
able to advise you)
• You have reduced function of the adrenal glands – glands
Pregnancy and breast-feeding
above the kidneys - (also known as Addison’s disease)
If you are pregnant or breast-feeding, think you may be
• You have low blood levels of sodium and/or potassium or
pregnant or are planning to have a baby, ask your doctor or
high blood levels of chlorine (your doctor will advise you)
pharmacist for advice before taking this medicine.
• The person this medicine has been prescribed for is under
It may be taken when breast feeding but only on the advice
the age of 12.
of the doctor.
Children and adolescents
Driving and using machines
Eytazox should not be used in children.
If Eytazox make you feel drowsy or confused you should not
drive or operate machines. Eytazox can occasionally cause
Warnings and precautions
short-sightedness; if this happens and you feel that you can
Talk to your doctor or pharmacist before taking Eytazox if:
no longer drive safely, you should stop driving and contact
• You have or have ever had kidney problems such as
your doctor.
kidney stones
• You have lung problems such as chronic bronchitis or
Eytazox contains sunset yellow FCF (E110)
emphysema, which cause difficulty in breathing
This may cause allergic reactions.
• You have diabetes or problems with your blood sugar level
• You are over the age of 65
3. How to take Eytazox
• A small number of people being treated with anti-epileptics
such as Acetazolamide have had thoughts of harming or
Always take this medicine exactly as your doctor or
killing themselves, if at any time you have these
pharmacist has told you. Check with your doctor or
thoughts, immediately contact your doctor.
pharmacist if you are not sure.
Other medicines and Eytazox
Eytazox should be swallowed whole with a drink of water. Do
Tell your doctor or pharmacist if you are taking, have
not chew or crush the capsules.
recently taken or might take any other medicines.
The recommended dose is:
In particular, tell your doctor or pharmacist if you are taking
• The usual recommended dosage is 1 or 2 capsules a day
any of the following:
taken just before or just after a meal.
• Medicines for your heart such as cardiac glycosides (e.g.
• The dose varies from person to person depending on their
digoxin)
condition. If you are not sure how many capsules to take or
• Medicines to reduce blood pressure
when to take them, ask your pharmacist.
• Medicines to thin your blood (e.g. warfarin)
• Before starting and during treatment your doctor will
• Anti-diabetic medicines to lower the sugar in your blood
monitor your blood to check that treatment with Eytazox
(e.g. metformin)
Prolonged-Release Capsules is suitable for you.
• Medicines for epilepsy or fits (in particular, phenytoin,
primidone or carbamazepine or topiramate)

Use in children and adolescents
Eytazox Prolonged-Release Capsules are not recommended
for use in children.
If you take more Eytazox 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
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 medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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.
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 effect is not known (cannot be estimated from the
available data).
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 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 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.

5. How to store Eytazox
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated
on the carton after “EXP”. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.
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 Eytazox contains
• The active substance is Acetazolamide
• The other ingredients are 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 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.
Not all pack sizes may be marketed.
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 December 2017.

EAS1620b

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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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