Atacand 4 mg tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Candesartan cilexetil
Available from:
Imbat Limited
ATC code:
C09CA; C09CA06
INN (International Name):
Candesartan cilexetil
Dosage:
4 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Angiotensin II antagonists, plain; candesartan
Authorization status:
Authorised
Authorization number:
PPA1151/109/002
Authorization date:
2012-10-12

Page 1 of 2

Package leaflet: Information for the patient

Atacand

®

4mg tablets

(candesartan cilexetil)

Your medicine is available using the name Atacand 4mg

tablets but will be referred to as Atacand throughout this

leaflet.

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. This

includes any possible side effects not listed in this

leaflet.

What is in this leaflet:

What Atacand is and what it is used for

What you need to know before you take Atacand

How to take Atacand

Possible side effects

How to store Atacand

Contents of the pack and other information

1.

What Atacand is and what it is used for

The name of your medicine is Atacand. The active ingredient

is candesartan cilexetil. This belongs to a group of medicines

called angiotensin II receptor antagonists. It works by making

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.

Atacand can be used to:

treat high blood pressure (hypertension) in adult

patients and in children and adolescents aged 6 to

<18 years.

treat adult heart failure patients with reduced heart

muscle function when Angiotensin Converting Enzyme

(ACE) inhibitors cannot be used or in addition to ACE-

inhibitors when symptoms persist despite treatment and

mineralocorticoid receptor antagonists (MRA) cannot be

used (ACE-inhibitors and MRAs are medicines used to

treat heart failure).

2.

What you need to know before you take

Atacand

Do not take Atacand:

if you are allergic to candesartan cilexetil or any of the

other ingredients of this medicine (listed in section 6).

if you are more than 3 months pregnant (it is also better

to avoid Atacand in early pregnancy – see ‘Pregnancy’

section).

if you have severe liver disease or biliary obstruction (a

problem with the drainage of the bile from the gall

bladder).

if the patient is a child under 1 year of age.

if you have diabetes or impaired kidney function and you

are treated with a blood pressure lowering medicine

containing aliskiren.

If you are not sure if any of these apply to you, talk to your

doctor or pharmacist before taking Atacand.

Warnings and precautions

Talk to your doctor before taking Atacand.

if you have heart, liver or kidney problems, or are on

dialysis.

if you have recently had a kidney transplant.

if you are vomiting, have recently had severe vomiting,

or have diarrhoea.

if you have a disease of the adrenal gland called Conn’s

syndrome (also called primary hyperaldosteronism).

if you have low blood pressure.

if you have ever had a stroke.

you must tell your doctor if you think you are (or might

become) pregnant. Atacand 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).

if you are taking any of the following medicines used to

treat high blood pressure:

an ACE-inhibitor (for example enalapril, lisinopril,

ramipril), in particular if you have diabetes-related

kidney problems.

aliskiren.

if you are taking an ACE-inhibitor together with a

medicine which belongs to the class of medicines known

as mineralocorticoid receptor antagonists (MRA). These

medicines are for the treatment of heart failure (see

“Other medicines and Atacand”).

Your doctor may check your kidney function, blood pressure,

and the amount of electrolytes (e.g. potassium) in your blood

at regular intervals.

See also information under the heading “Do not take

Atacand”.

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 Atacand. This is because Atacand,

when combined with some anaesthetics, may cause an

excessive drop in blood pressure.

Children and adolescents

Atacand has been studied in children. For more information,

talk to your doctor. Atacand must not be given to children

under 1 year of age due to the potential risk to the

developing kidneys.

Other medicines and Atacand

Tell your doctor or pharmacist if you are using, have recently

used or might use any other medicines.

Atacand can affect the way some other medicines work and

some medicines can have an effect on Atacand. If you are

using certain medicines, your doctor may need to do blood

tests from time to time.

In particular, tell your doctor if you are using any of the

following medicines as your doctor may need to change your

dose and/or take other precautions:

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 drugs (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).

Heparin (a medicine for thinning the blood).

Co-trimoxazole (an antibiotic medicine) also known as

trimethoprim/sulfamethoxazole.

Water tablets (diuretics).

Lithium (a medicine for mental health problems).

If you are taking an ACE-inhibitor or aliskiren (see also

information under the headings “Do not take Atacand”

and “Warnings and precautions”).

If you are being treated with an ACE-inhibitor together

with certain other medicines to treat your heart failure,

which are known as mineralocorticoid receptor

antagonists (MRA) (for example: spironolactone,

eplerenone).

Atacand with food, drink and alcohol

You can take Atacand with or without food.

When you are prescribed Atacand, 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 Atacand before you become pregnant or as soon

as you know you are pregnant and will advise you to take

another medicine instead of Atacand.

Atacand 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. Atacand 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 Atacand.

If this happens to you, do not drive or use any tools or

machines.

Atacand contains lactose

Lactose is a type of sugar. If you have been told by your

doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicine.

3.

How to take Atacand

Always take this medicine exactly as your doctor has told

you. Check with your doctor or pharmacist if you are not

sure.

It is important to keep taking Atacand every day.

You can take Atacand with or without food.

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.

High blood pressure:

The recommended dose of Atacand is 8mg once a day.

Your doctor may increase this dose to 16mg once a day

and further up to 32mg once a day depending on blood

pressure response.

In some patients, such as those with liver problems,

kidney problems or those who recently have lost body

fluids, e.g. through vomiting or diarrhoea or by using

water tablets, the doctor may prescribe a lower starting

dose.

Some black patients may have a reduced response to

this type of medicine, when given as the only treatment,

and these patients may need a higher dose.

Use in children and adolescents with high blood

pressure:

Children 6 to <18 years of age:

The recommended starting dose is 4mg once daily.

For patients weighing < 50 kg: In some patients whose blood

pressure is not adequately controlled, your doctor may decide

the dose needs to be increased to a maximum of 8mg once

daily.

For patients weighing ≥ 50 kg: In some patients whose blood

pressure is not adequately controlled, your doctor may decide

the dose needs to be increased to 8mg once daily and to

16mg once daily.

Heart failure in adults:

The recommended starting dose of Atacand is 4mg once

a day. Your doctor may increase your dose by doubling

the dose at intervals of at least 2 weeks up to 32mg

once a day. Atacand can be taken together with other

medicines for heart failure, and your doctor will decide

which treatment is suitable for you.

If you take more Atacand than you should

If you take more Atacand than prescribed by your doctor,

contact a doctor or pharmacist immediately for advice.

If you forget to take Atacand

Do not take a double dose to make up for a forgotten tablet.

Just take the next dose as normal.

If you stop taking Atacand

If you stop taking Atacand, your blood pressure may increase

again. Therefore do not stop taking Atacand without first

talking to your doctor.

If you have any further questions on the use of this medicine,

ask your doctor or pharmacist.

Page 2 of 2

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them. It is important that you

are aware of what these side effects may be.

Stop taking Atacand and seek medical help

immediately if you have any of the following

allergic reactions:

difficulties in 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 itching of the skin (with raised lumps).

Atacand may cause a reduction in the 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 Atacand has had any effect on your

blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

Feeling dizzy/spinning sensation.

Headache.

Respiratory infection.

Low blood pressure. This may make you feel faint or

dizzy.

Changes in blood test results:

An increased 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 heart beat or pins

and needles.

Effects on how your kidneys work, especially if you

already have kidney problems or heart failure. In very

rare cases, kidney failure may occur.

Very rare (affects less than 1 user in 10,000)

Swelling of the face, lips, tongue and/or throat.

A reduction in your red or white blood cells. You may

notice tiredness, an infection or a fever.

Skin rash, lumpy rash (hives).

Itching.

Back pain, pain in joints and muscles.

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.

Nausea.

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.

Cough.

Not known (frequency cannot be estimated from

the available data)

Diarrhoea

Additional side effects in children

In children treated for high blood pressure, side effects

appear to be similar to those seen in adults, but they happen

more often. Sore throat is a very common side effect in

children but not reported in adults and runny nose, fever and

increased heart rate are common in children but not reported

in adults.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes

any possible side effects not listed in this leaflet. You can also

report side effects directly (see details below). By reporting

side effects you can help provide more information on the

safety of this medicine.

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie e-mail: medsafety@hpra.ie

5.

How to store Atacand

Keep this medicine out of the sight and reach of

children.

Do not store above 30°C.

Do not use this medicine after the expiry date (EXP) which is

stated on the carton and blister strips. This refers to the last

day of that month.

Do not use this medicine if you notice discoloration, damage

or any other signs of deterioration.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw away

any medicines you no longer use. These measures will help

protect the environment.

6.

Contents of the pack and other

information

What Atacand contains

The active ingredient is candesartan cilexetil.

Each tablet contains 4mg of candesartan cilexetil.

The other ingredients are carmellose calcium,

hydroxypropyl cellulose, lactose monohydrate,

magnesium stearate, maize starch and macrogol.

What Atacand looks like and contents of the pack

Atacand are round, white tablets with a score line on each

side.

Atacand is available in blister packs containing 28 tablets.

Manufacturer

Manufactured by: Delpharm Novara S.r.l., Via Crosa 86,

28065 Cerano (No), Italy

Takeda Ireland Ltd., Bray Business Park, Kilruddery,

Co. Wicklow, Ireland.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder: Imbat Ltd., Unit L2,

North Ring Business Park, Santry, Dublin 9.

Distributed by: Eurodrug Ltd., Unit L2,

North Ring Business Park, Santry, Dublin 9.

PPA1151/109/002

This medicinal product is authorised in the Member

States of the EEA under the following names:

Member State

Name

Austria, Belgium, Bulgaria, Cyprus, Denmark,

Estonia, Finland, France, Germany, Greece,

Iceland, Ireland, Latvia, Lithuania,

Luxembourg, Malta, The Netherlands, Norway,

Poland, Portugal, Romania, Slovakia, Slovenia,

Spain, Sweden, UK

Atacand

Italy

Ratacand

Leaflet issue and revision date (ref): 13.09.18

Atacand

is a registered trademark of AstraZeneca group of

companies.

Blind or partially sighted?

Is this leaflet hard to see or

read?

Call +44 (0) 1302 365000

(Regulatory)

Please be ready to give the

following information:

Product name:

Atacand 4mg tablets

Reference No:

PPA1151/109/002

Health Products Regulatory Authority

23 July 2019

CRN00968R

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Atacand 4 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 4 mg candesartan cilexetil.

Excipient:

Each 4 mg tablet contains 93.4 mg lactose monohydrate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablets.

Product imported from UK

Round, white tablets with a scoreline on each side.

4 CLINICAL PARTICULARS

As per PA1019/004/001.

5 PHARMACOLOGICAL PROPERTIES

As per PA1019/004/001.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carmellose calcium

Hydroxypropylcellulose

Lactose monohydrate

Magnesium stearate

Maize starch

Macrogol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date of this product shall be the date shown on the blister strips and outer carton of the product as

marketed in the country of origin.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Cardboard outer carton containing blister strips. Pack size 28 tablets.

Health Products Regulatory Authority

23 July 2019

CRN00968R

Page 2 of 2

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Limited

Unit L2

North Ring Business Park

Santry

Dublin 9

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/109/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 12th October 2012

10 DATE OF REVISION OF THE TEXT

July 2019

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