Skip to Content

CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE 16MG/12.5MG TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN CILEXETIL/
HYDROCHLOROTHIAZIDE
8 mg/12.5 mg TABLETS
CANDESARTAN CILEXETIL/
HYDROCHLOROTHIAZIDE
16 mg/12.5 mg TABLETS
(candesartan cilexetil/hydrochlorothiazide)
Read all of this leaflet carefully before you start taking this
medicine.
• 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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Candesartan Cilexetil/Hydrochlorothiazide is and what it is
used for.
2. Before you take Candesartan Cilexetil/Hydrochlorothiazide.
3. How to take Candesartan Cilexetil/Hydrochlorothiazide.
4. Possible side effects.
5. How to store Candesartan Cilexetil/Hydrochlorothiazide.
6. Further information.
1. WHAT CANDESARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT
IT IS USED FOR
The name of your medicine is Candesartan Cilexetil/
Hydrochlorothiazide. It is used for treating high blood pressure
(hypertension). It contains two active ingredients: candesartan
cilexetil and hydrochlorothiazide. These work together to lower
your blood pressure.
• Candesartan cilexetil belongs to a group of medicines known as
angiotensin II receptor antagonists. It makes your blood vessels
relax and widen. This helps to lower your blood pressure. It also
makes it easier for your heart to pump blood to all parts of your
body.
• Hydrochlorothiazide belongs to a group of medicines known as
diuretics (water tablets). It helps your body to get rid of water and
salts like sodium in your urine. This helps to lower your blood
pressure.
Your doctor may prescribe Candesartan Cilexetil/
Hydrochlorothiazide if your blood pressure has not been properly
controlled by candesartan cilexetil or hydrochlorothiazide alone.
2. BEFORE YOU TAKE CANDESARTAN CILEXETIL/
HYDROCHLORTHIAZIDE
Do not take Candesartan Cilexetil/Hydrochlorothiazide if:
• You are allergic (hypersensitive) to candesartan cilexetil or
hydrochlorothiazide or any of the other ingredients of
Candesartan Cilexetil/Hydrochlorothiazide (See Section 6).
• You are allergic to sulphonamide medicines. If you are not sure if
this applies to you, please ask your doctor.
• You are more than 3 months pregnant. (It is also better to avoid
Candesartan Cilexetil/Hydrochlorothiazide in early pregnancy see 'Pregnancy' section).
• You have severe kidney problems.
• You have severe liver disease or biliary obstruction (a problem
with the drainage of the bile from the gall bladder).
• You have persistently low levels of potassium in your blood.
• You have persistently high levels of calcium in your blood.
• You have ever had gout.
If you are not sure if any of these apply to you, talk to your doctor
or pharmacist before taking Candesartan Cilexetil/
Hydrochlorothiazide.
Take special care with Candesartan
Cilexetil/Hydrochlorothiazide - Before you take, or whilst you are
taking Candesartan Cilexetil/Hydrochlorothiazide tell your
doctor if:
• You have diabetes.
• You have heart, liver or kidney problems.
• You have recently had a kidney transplant.
• You are vomiting, have recently had severe vomiting, or have
diarrhoea.
• You have a disease of the adrenal gland called Conn's syndrome
(also called primary hyperaldosteronism).
• You have ever had a disease called systemic lupus erythematosus
( SLE).
• You have low blood pressure.
• You have ever had a stroke.
• You have ever had allergy or asthma.
• You must tell your doctor if you think you are (or might become)
pregnant. Candesartan Cilexetil/Hydrochlorothiazide is not
recommended in early pregnancy, and must not be taken if you
are more than 3 months pregnant, as it may cause serious harm
to your baby if used at that stage (see 'Pregnancy' section).
Your doctor may want to see you more often and do some tests if
you have any of these conditions.
If you are going to have an operation, tell your doctor or dentist
that you are taking Candesartan Cilexetil/Hydrochlorothiazide. This

is because Candesartan Cilexetil/Hydrochlorothiazide when
combined with some anaesthetics, may cause a drop in blood
pressure.
Candesartan Cilexetil/Hydrochlorothiazide may cause increased
sensitivity of the skin to sun.
Use in children
There is no experience with the use of Candesartan
Cilexetil/Hydrochlorothiazide in children (below the age of 18
years). Therefore Candesartan Cilexetil/Hydrochlorothiazide should
not be given to children.

3. HOW TO TAKE CANDESARTAN CILEXETIL/
HYDROCHLOROTHIAZIDE
Always take Candesartan Cilexetil/Hydrochlorothiazide exactly as
your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. It is important to keep taking
Candesartan Cilexetil/Hydrochlorothiazide every day. The usual
dose of Candesartan Cilexetil/Hydrochlorothiazide is one tablet
once daily.
Swallow the tablet with a drink of water. Try to take the tablet at
the same time each day. This will help you to remember to take it.

• Changes in how your liver is working, including inflammation of
the liver (hepatitis). You may notice tiredness, yellowing of your
skin and the whites of your eyes and flu-like symptoms.
• Cough.
• Nausea.
Not known (frequency cannot be estimated from available data):
• Sudden short-sightedness.
• Sudden eye pain (acute angle-closure glaucoma).
If any side effect gets serious, or if you notice any side effects
not mentioned in this leaflet, please tell your pharmacist or
doctor.

Using 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.

If you take more Candesartan Cilexetil/Hydrochlorothiazide
than you should
If you take more Candesartan Cilexetil/Hydrochlorothiazide than
prescribed by your doctor, contact a doctor or pharmacist
immediately for advice.

Candesartan Cilexetil/Hydrochlorothiazide can affect the way some
other medicines work and some medicines can have an effect on
Candesartan Cilexetil/Hydrochlorothiazide. If you are using certain
medicines, your doctor may need to do blood tests from time to
time.

If you forget to take Candesartan Cilexetil/Hydrochlorothiazide
Do not take a double dose to make up for a forgotten dose. Just
take the next dose as normal.

Do not use Candesartan Cilexetil/Hydrochlorothiazide after the
expiry date, which is stated on the carton, blister or bottle after
'EXP'. The expiry date refers to the last day of that month.

If you stop taking Candesartan Cilexetil/Hydrochlorothiazide
If you stop taking Candesartan Cilexetil/Hydrochlorothiazide,
your blood pressure may increase again. Therefore do not stop
taking this medicine without first talking to your doctor.

Do not store above 25°C.
Store in the original package in order to protect from light and
moisture.
The in-use shelf life of the product when stored in HDPE bottles is
90 days. Do not remove the desiccant contained in the bottle.

In particular, tell your doctor if you are using any of the following
medicines:
• Other medicines to help lower your blood pressure, including
beta-blockers, diazoxide and ACE inhibitors such as enalapril,
captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory painkillers (NSAIDs) such as
ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib
(medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g each day)
(medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium
(medicines that increase the amount of potassium in your blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or colestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control your heart beat (antiarrhythmic agents) such
as digoxin and beta-blockers.
• Medicines that can be affected by potassium blood levels such as
some antipsychotic medicines.
• Heparin (a medicine for thinning the blood).
• Water tablets (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH or corticotropin).
• Medicines to treat cancer (e.g. cyclophosphamide, methotrexate).
• Amantadine, (for the treatment of Parkinson's disease or for
serious infections caused by viruses).
• Barbiturates (a sedative also used to treat epilepsy).
• Carbenoxolone (for treatment of oesophageal disease, or oral
ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Muscle relaxants (e.g. tubocurarine).
• Cyclosporine, a medicine used for organ transplant to avoid organ
rejection.
• Other medicines that may lead to enhancement of the
antihypertensive effect such as baclofen (a medicine for the relief
of spasticity), amifostin (used in cancer treatment) and some
antipsychotic medicines.
Taking Candesartan Cilexetil/Hydrochlorothiazide with food and
drink (in particular with alcohol)
• You can take Candesartan Cilexetil/Hydrochlorothiazide with or
without food.
• When you are prescribed Candesartan Cilexetil/
Hydrochlorothiazide, discuss with your doctor before drinking
alcohol. Alcohol may make you feel faint or dizzy.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Candesartan Cilexetil/Hydrochlorothiazide before you become
pregnant or as soon as you know you are pregnant and will advise
you to take another medicine instead of Candesartan Cilexetil/
Hydrochlorothiazide. Candesartan Cilexetil/Hydrochlorothiazide is
not recommended in early pregnancy, and must not be taken
when more than 3 months pregnant, as it may cause serious harm
to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Candesartan Cilexetil/Hydrochlorothiazide is not
recommended for mothers who are breast-feeding, and your
doctor may choose another treatment for you if you wish to
breast-feed, especially if your baby is newborn, or was born
prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking Candesartan
Cilexetil/Hydrochlorothiazide. If this happens to you, do not drive
or use any tools or machines.
Important information about some of the ingredients of
Candesartan Cilexetil/Hydrochlorothiazide
This medicine contains lactose which is a type of sugar. If you have
been told by your doctor that you have an intolerance to some
sugars, such as lactose, contact your doctor before taking this
medicine.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Candesartan Cilexetil/Hydrochlorothiazide can
cause side effects, although not everybody gets them. It is
important that you are aware of what these side effects may be.
Some of the side effects of Candesartan Cilexetil/
Hydrochlorothiazide are caused by candesartan cilexetil and
some are caused by hydrochlorothiazide.
Stop taking Candesartan Cilexetil/Hydrochlorothiazide and
seek medical help immediately if you have any of the following
allergic reactions:
• Difficulty breathing, with or without swelling of the face, lips,
tongue and/or throat.
• Swelling of the face, lips, tongue and/or throat, which may cause
difficulties in swallowing.
• Severe itchy swollen skin (with raised lumps).
Candesartan Cilexetil/Hydrochlorothiazide may cause a reduction
in number of white blood cells. Your resistance to infection may
be decreased and you may notice tiredness, an infection or a
fever. If this happens contact your doctor. Your doctor may
occasionally do blood tests to check whether Candesartan
Cilexetil/Hydrochlorothiazide has had any effect on your blood
(agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100):
• Changes in blood test results:
* A reduced amount of sodium in your blood. If this is severe
then you may notice weakness, lack of energy, or muscle
cramps.
* An increased or reduced amount of potassium in your blood,
especially if you already have kidney problems or heart failure.
If this is severe you may notice tiredness, weakness, irregular
heartbeat or pins and needles.
* An increased amount of cholesterol, sugar, or uric acid in your
blood.
• Sugar in your urine.
• Feeling dizzy/spinning sensation or weak.
• Headache.
• Respiratory infection.
Uncommon (affects less than 1 user in 100):
• Low blood pressure.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, lumpy rash (hives), rash caused by sensitivity to light.
Rare (affects less than 1 user in 1,000):
• Jaundice (yellowing of your skin or the whites of your eyes).
If this happens to you, contact your doctor immediately.
• Effects on how your kidneys work, especially if you already have
kidney problems or heart failure.
• Difficulty in sleeping, depression, being restless.
• Tingling or prickling in your arms or legs.
• Blurred vision for a short period.
• Abnormal heart beat.
• Breathing difficulties (including lung inflammation and fluid in
the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe
pain in the stomach.
• Muscle cramps.
• Damage to blood vessels causing red or purple dots in the skin
• A reduction in your red or white blood cells or platelets. You may
notice tiredness, an infection, fever or easy bruising.
• A severe rash, that develops quickly, with blistering or peeling of
the skin and possibly blistering in the mouth.
• Worsening of existing lupus erythematous-like reactions or
appearance of unusual skin reactions.
Very rare (affects less than 1 users in 10,000):
• Swelling of the face, lips, tongue and/or throat.
• Itching.
• Back pain, pain in joints and muscles.

5. HOW TO STORE CANDESARTAN CILEXETIL/
HYDROCHLOROTHIAZIDE
Keep out of the reach and sight of children.

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 Candesartan Cilexetil/Hydrochlorothiazide tablets contain
The active substances are candesartan cilexetil and
hydrochlorothiazide.
Each tablet contains 8 mg /16 mg of candesartan cilexetil and
12.5 mg of hydrochlorothiazide.
The other ingredients are carmellose calcium, glycerol
monostearate, hydroxypropyl cellulose, lactose monohydrate,
magnesium stearate, maize starch, iron oxide yellow (E172). In
addition, 16 mg/12.5 mg tablets also contain iron oxide red (E172).
What Candesartan Cilexetil/Hydrochlorothiazide looks like and
contents of the pack
Candesartan Cilexetil/Hydrochlorothiazide 8 mg/12.5 mg tablets
are yellow, mottled, round, biconvex tablets marked with 'M' on
one side and 'CH1' on the other side.
Candesartan Cilexetil/Hydrochlorothiazide 16 mg/12.5 mg tablets
are peach, mottled, round, biconvex tablets marked with 'M' on
one side and 'CH2' on the other side.
Candesartan Cilexetil/Hydrochlorothiazide is available in blisters
of 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets and in
plastic bottles of 30, 90 tablets.
Not all pack sizes may be marketed.
Any unused product or waste should be disposed of in
accordance with local requirements.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

Expand Transcript

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.

Hide