Atacand Plus 16 mg/12.5 mg tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Candesartan cilexetil; Hydrochlorothiazide
Available from:
PCO Manufacturing Ltd.
ATC code:
C09DA; C09DA06
INN (International Name):
Candesartan cilexetil; Hydrochlorothiazide
Dosage:
16 mg/12.5 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Angiotensin II antagonists and diuretics; candesartan and diuretics
Authorization status:
Authorised
Authorization number:
PPA0465/117/001
Authorization date:
2004-01-26

Package leaflet: Information for the user

Atacand Plus

®

16 mg/12.5 mg tablets

candesartan cilexetil/hydrochlorothiazide

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

What Atacand Plus is and what it is used for

What you need to know before you take Atacand Plus

How to take Atacand Plus

Possible side effects

How to store Atacand Plus

Contents of the pack and other information

1.

What Atacand Plus is and what it is used for

The name of your medicine is Atacand Plus. It is used for treating high blood

pressure (hypertension) in adult patients. 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 called angiotensin II

receptor antagonists. It makes your blood vessels relax and widen. This

helps to lower your blood pressure.

Hydrochlorothiazide belongs to a group of medicines called 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 Atacand Plus if your blood pressure has not been

properly controlled by candesartan cilexetil or hydrochlorothiazide alone.

2.

What you need to know before you take Atacand Plus

Do not take Atacand Plus:

if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of

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

if you are allergic to sulphonamide medicines. If you are not sure if this

applies to you, please ask your doctor.

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

Plus in early pregnancy – see pregnancy section).

if you have severe kidney problems.

if you have severe liver disease or biliary obstruction (a problem with the

drainage of bile from the gall bladder).

if you have persistently low levels of potassium in your blood.

if you have persistently high levels of calcium in your blood.

if you have ever had gout.

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 Plus.

Warnings and precautions

Talk to your doctor or pharmacist before taking Atacand Plus:

if you have diabetes.

if you have heart, liver or kidney problems.

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 ever had a disease called systemic lupus erythematosus

(SLE).

if you have low blood pressure.

if you have ever had a stroke.

if you have ever had allergy or asthma.

you must tell your doctor if you think you are (or might become) pregnant.

Atacand Plus 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, etc.), in

particular if you have diabetes-related kidney problems.

aliskiren

if you have had skin cancer or if you develop an unexpected skin lesion

during the treatment. Treatment with hydrochlorothiazide, particularly long

term use with high doses, may increase the risk of some types of skin and

lip cancer (non-melanoma skin cancer). Protect your skin from sun

exposure and UV rays while taking Atacand Plus.

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 Plus:”.

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 Plus. This is because Atacand Plus, when combined with

some anaesthetics, may cause an excessive drop in blood pressure.

Atacand Plus may cause increased sensitivity of the skin to sun.

Children

There is no experience with the use of Atacand Plus in children (below the

age of 18 years). Therefore Atacand Plus should not be given to children.

Other medicines and Atacand Plus

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

use any other medicines. Atacand Plus can affect the way some other

medicines work and some medicines can have an effect on Atacand Plus. 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, aliskiren-containing medicines, diazoxide and Angiotensin

Converting Enzyme (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).

Calcium or Vitamin D supplements.

Medicines to lower your cholesterol, such as colestipol or cholestyramine.

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 or co-trimoxazole also known as trimethoprim/sulfamethoxazole

(antibiotic medicines).

Amphotericin (for the treatment of fungal infections).

Lithium (a medicine for mental health problems).

Steroids such as prednisolone.

Pituitary hormone (ACTH).

Medicines to treat cancer.

Amantadine (for the treatment of Parkinson’s disease or for serious

infections caused by viruses).

Barbiturates (a type of sedative also used to treat epilepsy).

Carbenoxolone (for treatment of oesophageal disease, or oral ulcers).

Anticholinergic agents such as atropine and biperiden.

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 relief of spasticity), amifostin (used

in cancer treatment) and some antipsychotic medicines.

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

the headings “Do not take Atacand Plus” and “Warnings and

precautions”).

Atacand Plus with food and drink and alcohol

You can take Atacand Plus with or without food.

When you are prescribed Atacand Plus, 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 Plus before you

become pregnant or as soon as you know you are pregnant and will advise

you to take another medicine instead of Atacand Plus. Atacand Plus 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 Plus 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 Plus. If this

happens to you, do not drive or use any tools or machines.

Atacand Plus contains lactose

Atacand Plus contains lactose which 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 Plus

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 Plus every day.

The recommended dose of Atacand Plus is one tablet once a day.

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.

If you take more Atacand Plus than you should

If you take more Atacand Plus than prescribed by your doctor, contact a

doctor or pharmacist immediately for advice.

If you forget to take Atacand Plus

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 Plus

If you stop taking Atacand Plus, your blood pressure may increase again.

Therefore do not stop taking Atacand Plus without first talking to your doctor.

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 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 Atacand Plus are caused by

candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Atacand Plus 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 Plus 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 Atacand Plus 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. This may make you feel faint or dizzy.

Loss of appetite, diarrhoea, constipation, stomach irritation.

Skin rash, lumpy rash (hives), rash caused by sensitivity to sunlight.

Rare (affects less than 1 user in 1,000)

Jaundice (yellowing of the 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 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 time.

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.

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

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

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.

Cough.

Nausea.

Not known (frequency cannot be estimated from the available data)

Skin and lip cancer (Non-melanoma skin cancer).

Sudden short-sightedness.

Sudden eye pain (acute angle-closure glaucoma).

Systemic and cutaneous lupus erythematosus (allergic condition which

causes fever, joint pain, skin rashes which may include redness, blistering,

peeling and lumps).

Diarrhoea

Reporting of side effects

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

side effects not listed in this leaflet. You can also report side effects directly

via HPRA Pharmacovigilance, Earlsfort Terrace,

IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Atacand Plus

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 which is stated on the carton

and blister. The expiry date refers to the last day of that month.

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 Atacand Plus contains

The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each

tablet contains 16 mg of candesartan cilexetil and 12.5 mg of

hydrochlorothiazide.

The other ingredients are carmellose calcium, hyprolose, lactose

monohydrate, iron oxide (E172), magnesium stearate, maize starch and

macrogol.

What Atacand Plus looks like and contents of the pack

Atacand Plus tablets are pink, oval, tablets marked 16/C and scored on both

sides or peach, oval tablets marked A/CS and scored on both sides.

Atacand Plus Tablets are available in blister packs of 28 or 30 tablets.

Not all pack sizes may be marketed.

Manufacturer

Takeda Italia SpA/Delpharm Novara S.r.l., Via Crosa 86- 28065 Cerano, Italy

or Takeda Ireland Ltd., Bray Business Park, Kilruddery, Co. Wicklow or

AstraZeneca AB, AstraZeneca Sweden, Gartunavagen, S-151 85 Södertälje,

Sweden or AstraZeneca SA-NV, Schaessestraat 15, 9070 Destelbergen,

Belgium.

Product procured from within the EU and repackaged by the Parallel

Product Authorisation Holder:

PCO Manufacturing Ltd., Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath, Ireland.

Parallel Product Authorisation Number: PPA 465/117/1

Atacand Plus is a registered trademark of AstraZeneca AB

As the days of the week are not listed on the blister foil in English,

please use the following table should you require a translation:

English

Italian shorthand

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

This medicinal product is authorised in the Member States of the EEA

under the following names:

Name

Member State

Atacand Plus

Austria, Belgium, Cyprus, Estonia, Germany,

Greece, Finland, Iceland, Ireland, Latvia,

Luxembourg, Malta, The Netherlands, Norway,

Romania, Slovakia, Slovenia, Spain, Sweden

Hytacand

France, Portugal

Atacand Zid

Denmark

Ratacand Plus

Italy

This leaflet was last revised in September 2019

Health Products Regulatory Authority

07 May 2019

CRN008Y8X

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Atacand Plus 16 mg/12.5 mg tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One Atacand Plus 16 mg/12.5 mg tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

Excipient(s) with known effect:

Lactose Monohydrate

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Product imported from the Netherlands

Peach, oval, biconvex tablets marked ‘A/CS’ on one side and scored on both sides.

Product imported from Italy

Peach, oval, biconvex tablets marked A/CS on one side and scored on both sides or Pink, oval tablets marked 16/C and scored

on both sides.

4 CLINICAL PARTICULARS

As per PA1019/005/002

5 PHARMACOLOGICAL PROPERTIES

As per PA1019/005/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carmellose calcium

Hyprolose

Lactose monohydrate

Magnesium stearate

Maize starch

Macrogol

Iron Oxide (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the blister and outer carton of the product on the market in the

country of origin.

6.4 Special precautions for storage

Health Products Regulatory Authority

07 May 2019

CRN008Y8X

Page 2 of 2

Do not store above 30 °C.

6.5 Nature and contents of container

Product imported from Italy presented as 28 tablets in a blister pack contained in an outer cardboard carton.

Product imported from The Netherlands presented as 30 tablets in a blister pack contained in an overlabelled outer carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing Ltd.

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/117/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 26

January 2004

Date of last renewal: 26

January 2009

10 DATE OF REVISION OF THE TEXT

May 2019

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