Atehexal

Main information

  • Trade name:
  • Atehexal Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Atehexal Tablet
    Malaysia
  • Language:
  • English

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL20021163, MAL20021164, MAL20021165
  • Last update:
  • 28-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Consumer Medication Information Leaflet (RiMUP)

ATEHEXAL TABLET

®

Atenolol (25mg, 50mg, 100mg)

What is in the leaflet

What Atehexal is used for

How Atehexal works

Before you use Atehexal

How to use Atehexal

While you are using it

Side effects

Storage and Disposal of Atehexal

Product Description

Manufacturer and Product Registration

Holder

Date of Revision

What Atehexal

is used for

Atehexal contains the active ingredient

atenolol.

Atehexal is used to:

Treat high blood pressure (hypertension)

Treat uneven heart beats (arrhythmias)

Help relieve chest pain (angina)

Protect the heart in the early treatment after

a heart attack (myocardial infarction)

How Atehexal

works

Atehexal belongs to a group of medicines

known as beta-blockers.

It works by decreasing the heart rate and

force of contraction of the heart which

resulting in decreased blood pressure.

Before you use Atehexal

When you must not use it

Have ever had a reaction or been told that

you are allergic to atenolol or to any of the

excipients

Have ever had swelling of the face, lips

tongue, throat, hands or feet

Have a slow heart beat or serious problems

with the heart rhythm (second or third degree

heart block)

Your heart is not pumping efficiently

despite medication (uncontrolled heart

failure)

Have been told that you have acidosis

(excess acid in the blood)

Have been told that you have tumor in

adrenal gland (phaeochromocytoma) and are

not being treated

Very slow or very uneven heart beats, very

low blood pressure or very poor circulation

Before you start to use it

Tell your doctor if you:

Suffer from any heart disease

Have chest pain (angina pectoris) eg.

Prinzmetal’s angina

Have poor blood circulation or controlled

heart failure

Have first-degree heart block

Have coronary artery disease (narrowing of

blood vessels to the heart)

Have diabetes

Suffer from hyperthyroidism (over

production of thyroid hormone)

Suffer from any type of breathing problems

such as asthma

Suffer from kidney problems

About to undergo surgery involving use of

anaesthesia

Have a family history of swelling of the

face, lips, tongue, throat, hands or feet

Are pregnant, planned to become pregnant

or are breast feeding.

If you are not sure whether you should start

taking this medicine, consult your doctor.

Taking other medicines

Tell your doctor if you are taking any other

medicine, including any that you buy without

a prescription. You may need to use different

amounts of these medicines, or you may

need to take different medicines. Your doctor

will advise you. In particular, tell your doctor

if you take any of the following:

Verapamil, diltiazem and nifedipine (for

high blood pressure or chest pain)

Medicines for irregular heartbeat (eg.

disopyramide, amiodarone)

Medicines to treat diabetes, including

insulin. Taking together with Atehexal may

increase the risk of low blood sugar

Epinephrine, used in treating severe allergic

reactions and to stimulate the heart

Certain medicines for muscles problems

(eg. baclofen)

Anesthetics

Non-steroidal anti-inflammatory drugs

(NSAIDS) for pain relief (eg. indomethacin

and ibuprofen)

Digoxin (for heart problems)

Clonidine, for lowering blood pressure and

to treat migraine.

This may not be a complete list of all

interactions that may occur. Ask your doctor

or pharmacist if atenolol may interact with

other medicines that you take.

Pregnancy and lactation

Avoid these tablets if you are pregnant. Ask

your doctor or pharmacist for advice before

taking any medicine.

If you are breast feeding, you should not take

Atehexal as it will be excreted in the breast

milk.

How to use Atehexal

Follow all directions given to you by your

doctor and pharmacist carefully. They may

differ from the information contained in this

leaflet. If you do not understand the

instructions on the label, ask your doctor or

pharmacist for help.

Swallow the Atehexal tablet whole with a

drink of water and about the same time each

day.

How much to use

Your doctor will decide your dose as it

depends on your conditions.

Adults

High blood pressure (hypertension): the

usual dose is 50mg to 100mg a day.

Chest pain (angina): the usual dose is

100mg a day or 50mg twice a day.

Uneven heart beats (arrhythmias): the usual

dose is 50mg to 100mg a day.

The early treatment of a heart attack

(myocardial infarction): the usual dose is

50mg to 100mg a day.

Elderly

If you are an elderly person, your doctor may

decide to give you a lower dose, particularly

if you have problems with your kidneys.

Patient with severe kidney problems

If you have severe kidney problems your

doctor may decide to give you a lower dose.

Patient with liver problems

Dosage adjustment is not required.

Children

Your medicine must not be given to children.

When to use it

Take your medicine as directed and the

duration of treatment is to be determined by

your doctor or pharmacist.

How long to use it

Continue to take your medicine as long as

your doctor tells you. This medicine helps to

control your condition but does not cure it. It

is important to keep taking this medicine

even if you feel well.

Consumer Medication Information Leaflet (RiMUP)

If you forget to use it

Consult your doctor or pharmacist on what

you should do if you forget to use it.

Take the missed dose as soon as you

remember. If it is almost time for your next

dose, wait until then to take the medicine and

skip the missed dose. Do not take a double

dose to make up for the missed dose.

If you use too much (overdose)

Contact your doctor immediately or go to the

nearest Emergency Department of your

nearest hospital, if you think you or anyone

else may have taken too much of this

medicine. Do this even if there are no signs

of discomfort or poisoning. You may need

urgent medical attention.

The following symptoms may be observed in

overdose:

Excessive fall of blood pressure

Slow pulse and heart blocks of various

degree (including cardiac arrest)

Heart failure and shock because of cardiac

arrest

Dizziness

Breathing difficulties (wheezing, etc)

Vomiting

Loss of consciousness

If you have any further questions on the use

of this product, ask your doctor or

pharmacist.

While you are using it

Things you must do

Always take Atehexal exactly according to

the instructions given to you by your doctor

or pharmacist. If you are unsure, check with

your doctor or pharmacist.

Inform your doctor or pharmacist if you are

taking or if you have recently taken any other

medicines, including medicines obtained

without a prescription such as supplements

or traditional medicines.

Tell your doctor or pharmacist immediately

if you notice any side effects, or if the side

effects gets serious or anything else that

make you feel unwell.

If you become pregnant, or plan on

becoming pregnant while taking Atehexal,

tells your doctor immediately.

If you are about to be started on a new

medicine, remind your doctor and pharmacist

that you are taking Atehexal.

Things you must not do

Do not stop taking your medicines without

consulting your doctor. It is important to

keep taking your medicine even if you feel

well.

Do not use Atehexal after the expiry date

which is stated on the carton and blister.

Do not give this medication to anyone else,

even if they have the same condition as you.

Things to be careful of

Taking Atehexal may cause dizziness or

light-headedness, particularly at the first dose

or after dose is increased. Drinking alcohol

may worsen the symptoms. If you have any

of these symptoms, do not drive or operate

any machinery.

Side effects

Like many medicines, Atehexal may cause

side effects in some patients, particularly

when you first taking them but not everyone

will get it.

Tell your doctor or pharmacist if you notice

the following common side effects and it

worries you:

Cold extremities (feeling cold at hands and

feet)

Fatigue

Diarrhoea

Slow heart beat

Gastrointestinal disturbance eg. nausea and

stomachache

Uncommon:

Sleep disturbances

Liver problem (eg. increased liver

enzymes)

Rare:

Heart block (which can cause dizziness,

abnormal heart beat, tiredness or fainting)

Numbness and spasm in your finger which

is followed by warmth and pain (Raynaud’s

disease)

Mood changes

Nightmares

Feeling confused

Changes in personality (psychoses) or

hallucinations

Headache

Dizziness (particularly when standing up)

Abnormal sensation of skin eg. tingling of

hands

Being unable to get an erection (impotence)

Dry mouth

Dry eyes

Disturbances of vision

Hair loss

Skin rash

Reduced numbers of platelets in your blood

(this may make you bruise more easily)

Purplish marks on your skin

Jaundice (causing yellowing of your skin or

the whites of your eyes)

Very rare:

Changes to some of the cells or other parts

of your blood. Your doctor may take blood

samples every so often to check whether

Atehexal has had any effect on your blood.

Conditions that may get worsen:

If you have any of the following conditions,

they may get worse when you start to take

your medicines. This happens rarely

affecting less than 1 in 1,000 people.

Psoriasis (a skin condition)

Being short of breath or having swollen

ankles (if you have heart failure)

Asthma or breathing problems

Poor circulation

Please consult doctor immediately as you

may need medical attention.

Allergic reactions:

If you have an allergic reaction, see a doctor

straight away. The signs may include

swelling of your face, lips, mouth, tongue or

throat.

Tell your doctor or pharmacist if you notice

anything else that makes you feel unwell.

Other side effects not listed above may also

occur in some people.

You may report any side effects or adverse

drug reactions directly to the National Centre

for Adverse Drug Reaction Monitoring by

calling Tel: 03-78835550, or visiting the

website npra.moh.gov.my

Public

–>

Reporting Medicinal Problems / Side Effects

/ AEFI / Vaccine Safety

Storage and Disposal of Atehexal

Storage

Store in a cool, dry place below 25°C.

Protect from heat, light and moisture.

Keep out of the reach and sight of children.

Disposal

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.

Product Description

What it looks like

Atehexal tablet comes in white, round and

biconvex film-coated tablets with one sided

score notch.

Consumer Medication Information Leaflet (RiMUP)

Ingredients

Active ingredient

Atehexal

25: It contains 25mg of Atenolol.

Atehexal

50: It contains 50mg of Atenolol.

Atehexal

100: It contains 100mg of

Atenolol.

Inactive ingredients

Maize starch, sodium dodecyl sulphate,

gelatin, heavy magnesium carbonate,

magnesium stearate, opadry white (colouring

agent).

Packing

Atehexal tablet comes in original packages

of box with 30, 50 and 100 film coated

tablets.

MAL Number

Atehexal

25: MAL20021163AZ

Atehexal

50: MAL20021164AZ

Atehexal

100: MAL20021165AZ

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben, Germany

For:

HEXAL AG

Industriestraβe 25

D-83607 Holzkirchen

Germany.

Product Registration Holder

IMEKS Pharma Sdn. Bhd.

No. 5&9, Jalan Udang Harimau 2,

Medan Niaga Kepong,

51200 Kuala Lumpur, Malaysia.

Date of revision

02/10/2017

Serial number

NPRA(R4/1)280917/00257