Atenolol 25mg tablets

Main information

  • Trade name:
  • Atenolol 25mg tablets
  • Dosage:
  • 25mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Atenolol 25mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02100100; GTIN: 5012727903514

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 29831/0020
  • Last update:
  • 28-01-2019

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

CHANGE CONTROL : Version changes due to change in:

Size/Layout Regulatory Non-Regulatory

Changes in detail:

New regulatory text

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 Totamol Tablets are and what they

are used for

2. What you need to know before you take

Totamol Tablets

3. How to take Totamol Tablets

4. Possible side effects

5. How to store Totamol Tablets

6. Contents of the pack and other

information

1. What

Totamol

Tablets are

and what

they are

used for

Totamol Tablets

contain a

medicine called atenolol. This belongs to a

group of medicines called beta-blockers.

Totamol Tablets are used to:

Treat high blood pressure (hypertension)

Treat uneven heart beats (arrhythmias).

Help prevent chest pain (angina).

Protect the heart in the early treatment

after a heart attack (myocardial

infarction).

They work by making your heart beat more

slowly and with less force.

2. What you need to know before you

take Totamol Tablets

Do not take Totamol Tablets:

If you are allergic to atenolol or any of the

other ingredients of this medicine (listed

in section 6)

If you have ever had any of the following

heart problems:

heart failure which is not under control

(this usually makes you breathless and

causes your ankles to swell)

second- or third-degree heart block (a

condition which may be treated by a

pacemaker)

very slow or very uneven heart beats,

very low blood pressure or very poor

circulation.

If you have a tumour called

phaeochromocytoma that is not being

treated. This is usually near your kidney

and can cause high blood pressure. If

you are being treated for

phaeochromocytoma, your doctor will

give you another medicine, called an

alpha-blocker, to take as well as Totamol

Tablets.

If you have been told that you have

higher than normal levels of acid in your

blood (metabolic acidosis).

Do not take Totamol Tablets if any of the

above apply to you. If you are not sure, talk

to your doctor or pharmacist before taking

Totamol Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Totamol Tablets:

If you have asthma, wheezing or any

other similar breathing problems, or

you get allergic reactions, for example

to insect stings. If you have ever had

asthma or wheezing, do not take this

medicine without first checking with

your doctor.

If you have a type of chest pain (angina)

called Prinzmetal's angina.

If you have poor blood circulation or

controlled heart failure.

If you have first-degree heart block.

If you have diabetes. Your medicine may

change how you respond to having low

blood sugar. You may feel your heart

beating faster.

If you have thyrotoxicosis (a condition

caused by an overactive thyroid gland).

Your medicine may hide the symptoms of

thyrotoxicosis.

If you have problems with your kidneys.

You may need to have some check-ups

during your treatment.

If you are not sure if any of the above apply

to you, talk to your doctor or pharmacist

before taking Totamol Tablets.

Other medicines and Totamol Tablets

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines. This includes

medicines that you buy without a

prescription and herbal medicines.

This is because Totamol Tablets can affect

the way some other medicines work and

some medicines can have an effect on

Totamol Tablets.

In particular, tell your doctor if you are

taking any of the following medicines:

Clonidine (for high blood pressure or

migraine). If you are taking clonidine and

Totamol Tablets together, do not stop

taking clonidine unless your doctor tells

you to do so. If you have to stop taking

clonidine, your doctor will give you careful

instructions about how to do it.

Verapamil, diltiazem and nifedipine (for

high blood pressure or chest pain).

Disopyramide, quinidine or amiodarone

(for an uneven heart beat).

Digoxin (for heart problems).

Adrenaline, also known as epinephrine (a

medicine that stimulates the heart).

Ibuprofen or indometacin (for pain and

inflammation).

Insulin or medicines that you take by

mouth for diabetes.

Medicines to treat nose or sinus

congestion or other cold remedies

(including those you can buy in the

pharmacy).

Operations

If you go into hospital to have an operation,

tell the anaesthetist or medical staff that

you are taking Totamol Tablets. This is

because you can get low blood pressure

(hypotension) if you are given certain

anaesthetics while you are taking Totamol

Tablets.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist

for advice before taking this medicine.

Driving and using machines

Your medicine is not likely to affect you

being able to drive or use any tools or

machines. However, it is best to wait to

see how your medicine affects you before

trying these activities.

If you feel dizzy or tired when taking this

medicine, do not drive or use any tools or

machines.

3. How to take Totamol Tablets

Always take this medicine exactly as your

doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are

not sure.

Your doctor will tell you how many tablets

to take each day and when to take them.

Read the label on the carton to remind

you what the doctor said.

Swallow your Totamol tablet whole with a

drink of water.

Try to take your tablet at the same time

each day.

Adults

High blood pressure (hypertension):

the recommended dose is 50 mg to 100

mg a day.

Chest pain (angina): the recommended

dose is 100 mg a day or 50 mg twice a

day.

Uneven heart beats (arrhythmias): the

recommended dose is 50 mg to 100 mg a

day.

The early treatment of a heart attack

(myocardial infarction): the recommended

dose is 50 mg to 100 mg a day.

Older people

If you are an older person, your doctor may

decide to give you a lower dose, particularly

if you have problems with your kidneys.

pg 1/2

Package leaflet: Information for the user

Totamol 25mg Tablets

Totamol 50mg Film-Coated Tablets

Totamol 100mg Film-Coated Tablets

Atenolol (Referred to as Totamol Tablets in this leaflet)

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Neutral code not required on the leaflet artworks.

ART WORK CHECK BOX

PRODUCT :

Totamol 25, 50 & 100mg Tablets (Atenolol) - 28 Tabs

CUSTOMER :

Wockhardt UK

FP CODE:

FP2130; FP2131; FP2132

PLANT LOCATION :

Common (L1 & EOU)

DIMENSIONS :

(w)148 x (h)420mm

PHARMACODE No. :

2619

SAP CODE No. :

223264

TEXT FONT SIZE :

9 pt.

FILE NAME :

Totamol_Leaflet_106772-3.ai

SOFTWARE :

Adobe Illustrator CS5

TYPEFACES :

Arial Regular / Bold

ARTWORK (DETAILS)

25th November & 1st December, 2016

RECEIVED ON :

PROOF REVISION :

R 1st PDF sent on

- 6TH DEC. 2016

R 2nd PDF sent on

- 16TH DEC. 2016

Process

Black

People with severe kidney problems

If you have severe kidney problems your

doctor may decide to give you a lower

dose.

Use in Children

This medicine must not be given to

children.

If you take more Totamol Tablets than

you should

If you take more Totamol Tablets than

prescribed by your doctor, talk to a doctor

or go to a hospital straight away. Take the

medicine pack with you so that the tablets

can be identified.

If you forget to take Totamol Tablets

If you forget to take a dose, take it as soon

as you remember. However, if it is almost

time for the next dose, skip the missed

dose. Do not take a double dose to make

up for a forgotten dose.

If you stop taking Totamol Tablets

Do not stop taking Totamol Tablets without

talking to your doctor. In some cases, you

may need to stop taking it gradually.

4. Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

Allergic reactions:

If you have an allergic reaction, see a

doctor straight away. The signs may include

raised lumps on your skin (weals), or

swelling of your face, lips, mouth, tongue or

throat.

Other possible side effects:

Common (may affect up to 1 in 10

people)

You may notice that your pulse rate

becomes slower while you are taking the

tablets. This is normal, but if you are

concerned please tell your doctor about it.

Cold hands and feet.

Diarrhoea.

Feeling sick (nausea).

Feeling tired.

Uncommon (may affect up to 1 in 100

people)

Disturbed sleep.

Rare (may affect up to 1 in 1,000 people)

Heart block (which can cause dizziness,

abnormal heart beat, tiredness or

fainting).

Numbness and spasm in your fingers

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).

Tingling of your hands.

Being unable to get an erection

(impotence).

Dry mouth.

Dry eyes.

Disturbances of vision.

Thinning of your hair.

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 (may affect up to 1 in 10,000

people)

Changes to some of the cells or other

parts of your blood. Your doctor may take

blood samples every so often to check

whether Totamol has had any effect on

your blood.

Not known (frequency cannot be

estimated from the available data)

Lupus-like syndrome (a disease where

the immune system produces antibodies

that attacks mainly skin and joints).

Conditions that may get worse

If you have any of the following conditions,

they may get worse when you start to take

your medicine. 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.

Reporting of side effects

If you get any side effects, talk to your

doctor, or pharmacist or nurse. This

includes any possible side effects not listed

in this leaflet. You can also report side

effects directly via the national reporting

systems listed below:

United Kingdom:

Yellow Card Scheme at

www.mhra.gov.uk/yellowcard.

Malta:

ADR Reporting

Website:

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help

provide more information on the safety of

this medicine.

5. How to store Totamol Tablets

Keep this medicine out the sight and

reach of children.

Do not store above 25°C. Store in the

original container to protect from

moisture; do

not transfer

your tablets to

another

container.

Do not use

this medicine

after the

expiry date

which is stated

on the carton.

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 Totamol Tablets contains

The active substance is: atenolol 25mg,

50mg or 100mg.

The other ingredients are: maize starch,

heavy magnesium carbonate, povidone

K30, sodium starch glycollate and

magnesium stearate.

Totamol 50mg and 100mg Tablets also

contain: purified water, opadry orange

OY-3455.

What Totamol Tablets looks like and

contents of the pack

Totamol Tablets are supplied in blister

packs of 28 tablets or in polypropylene or

polyethylene containers of 500 tablets.

Marketing Authorisation Holder and

Manufacturer:

Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North,

Wrexham, LL13 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North,

Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet

in Braille, large print or audio please call,

free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following

information:

Product name

Reference

number

Totamol 25mg Tablets

PL 29831/0020

Totamol 50mg

Film-Coated Tablets

PL 29831/0018

Totamol 100mg

Film-Coated Tablets

PL 29831/0019

This is a service provided by the Royal

National Institute of Blind People.

This leaflet was last revised in

December 2016

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