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BEDRANOL TABLET 160MG

Active substance(s): PROPRANOLOL HYDROCHLORIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

030713/1

Colours Used

Customer

Ennogen

Black

Description

Bedranol Leaflet

Keyline

Market

UK

Language

English

Size

160 x 430 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

11

Date

02-02-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bedranol Tablets
10mg, 40mg, 80mg and 160mg
(Propranolol Hydrochloride)
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 or nurse.
! 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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Bedranol Tablets are and what they
are used for
2. What you need to know before you take
Bedranol Tablets
3. How to take Bedranol Tablets
4. Possible side effects
5. How to store Bedranol Tablets
6. Contents of the pack and other information
1. WHAT BEDRANOL TABLETS ARE AND
WHAT THEY ARE USED FOR
Bedranol Tablets contain a medicine called
Propranolol. It belongs to a group of medicines
called 'Beta-blockers' and works by controlling
blood pressure and thus reducing the demand on
the heart.
Bedranol Tablets are useful for:! Treatment of high blood pressure
! Management of angina pectoris - pain in the
chest caused by blockages in the arteries
leading to the heart
! Prevention of a further heart attack if you have
already suffered from a heart attack
! Controlling an abnormal heart beat
! Management of tremor
! Prevention of migraine
! Treatment of thyrotoxicosis - in combination
with other medicines
! Management of phaeochromocytoma (a rare
tumor of the adrenal gland) - in combination
with other medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BEDRANOL TABLETS
Do not take Bedranol Tablets if you:
! Are hypersensitive (allergic) to Propranolol or
any of the other ingredients in these tablets
(listed in section 6)
! Have untreated/uncontrolled heart failure or are
in shock caused by heart problems
! Suffer with heart conduction or rhythm
problems
! Suffer from a tight, painful feeling in the chest in
periods of rest (Prinzmetal's angina)
! Have a history of bronchospasm and asthma
! Have a history of chronic lung disease (chronic
obstructive pulmonary disease)
! Suffer from untreated phaeochromocytoma
(high blood pressure due to a tumour near the
kidney)
! Are on a strict fasting diet
! Have low blood sugar levels
! Suffer from diabetes mellitus
! Suffer from increased acidity of the blood
(metabolic acidosis)
! Have a slow heart beat
! Have low blood pressure
! Have problems with your circulation.
Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take
this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
taking Bedranol Tablets if you:
! Have a history of allergic reactions
! Have a heart weakness or first degree heart
block
! Have kidney or liver disease
! Have muscle weakness (myasthenia gravis)
! Have blood circulation problems (which may
cause your fingers and toes to tingle or turn
pale or blue)
! Have symptoms of hyperthyroidism (increased
appetite, weight loss, sweating)
! Have or have a history of psoriasis

!

!

Have Raynaud's disease (cold sensations in
fingers and toes) or intermittent claudication
(narrowing of arteries in the legs causing pain
on walking)
Smoke.

Other medicines and Bedranol Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. In particular:
! Verapamil and diltiazem (to treat heart
diseases)
! Disopyramide, quinidine and amiodarone (to
treat irregular heartbeat (arrhythmia)
! Ergotamine derivates (to treat migraine)
! Adrenaline (epinephrine, used in anaphylactic
shock)
! Medicines to treat diabetes including insulin
! Lidocaine, propafenine or flecanide (to treat
irregular heartbeat (arrhythmia) or as a local
anaesethetic
! Indometacin (Non-Steroidal Anti-Inflammatory
Drug (NSAID))
! Digitalis glycosides such as digoxin (to treat
heart conditions)
! Chlorpromazine (for mental illness)
! Cimetidine (to treat stomach ulcers)
! Other drugs treating high blood pressure
(alpha blockers, clonidine, moxonidine,
methyldopa or hydralazine)
! Monoamine-oxidase inhibitors, imipramine
or fluvoxamine (to treat depression)
! Warfarin (to prevent clotting)
! Rizatriptan (to treat migraine)
! Rifampicin (to treat infection)
! Barbiturates (to treat severe insomnia)
! Theophylline (treating asthma and reversible
airways obstruction)
! Diuretics (to clear excess water from the
body).
If you are going to have surgery, including dental
surgery, you should tell your doctor or nurse that
you are taking this medicine. They may need to
adjust the amount of anaesthetic you need.
If you need to have any blood or urine tests you
should tell the doctor or nurse you are taking
Bedranol Tablets as they may interfere with the
results.
Pregnancy and breast-feeding
Bedranol Tablets are not recommended for use
during pregnancy or breast-feeding. Ask your
doctor or pharmacist for advice if you are pregnant,
planning on becoming pregnant or are breastfeeding.
Driving and using machines
These tablets can cause visual disturbances,
hallucinations, fatigue, mental confusion, dizziness
or tiredness in some people. If you are affected do
not drive or operate machinery as your alertness
may be impaired.
Bedranol Tablets with food, drink and alcohol
Alcohol may enhance the effect of the medicine.
Bedranol Tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars you should talk to
your doctor before you take this medicine.
3. HOW TO TAKE BEDRANOL TABLETS
Always take Bedranol Tablets exactly as your
doctor has instructed you. You should check with
your doctor or pharmacist if you are unsure.
Swallow the tablets whole with a glass of water.
Adults
For high blood pressure (hypertension)
The initial dose is 80mg twice a day.
This dose may be increased by your doctor at
weekly intervals.
The usual maintenance dose is 160mg to 320mg
daily.
For angina pectoris
The initial dose is 40mg, 2 or 3 times a day.
This dose may be increased by your doctor by the
same amount, at weekly intervals.
The maximum daily dose is 480mg.
Following a heart attack
Treatment with Bedranol will start between day 5
and 21 after the heart attack.
The initial dose will be 40mg, 4 times a day, for a
period of 2-3 days.
This dose may then be changed by your doctor to
80mg, twice a day.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

030713/1

Colours Used

Customer

Ennogen

Black

Description

Bedranol Leaflet

Keyline

Market

UK

Language

English

Size

160 x 430 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

11

Date

02-02-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

For migraine and tremor
The initial dose is 40mg, 2 or 3 times a day.
This dose may be increased by your doctor.
A maximum daily dose of between 80mg and
160mg can be given.
For abnormal heart beat and thyrotoxicosis
The initial dose is 10mg to 40mg, 3 or 4 times a
day.
For phaeochromocytoma
Before an operation: 60mg daily for 3 days
before the operation.
This is always given with another medicine.
For non-operable cases: 30mg a day.
Liver or kidney problems
If you have liver or kidney problems a lower dose
may be prescribed.
Your doctor will tell you what dose to take.
Children
For abnormal heart beats,
phaeochromocytoma and thyrotoxicosis:
The exact dose for your child will be dependent on
the condition being treated and will be determined
by your doctor.
The minimum effective dose will be calculated on
0.25mg to 0.5mg per kilogram of the child's body
weight. The dose may be given 3 to 4 times a day.
For migraine
Children under 12 years of age: 40mg may be
given 2 or 3 times a day
Children over 12 years of age: may be given the
same dose as an adult (see the dosage prescribed
by your doctor).
ALWAYS follow the dosage given to you by your
doctor.
If you have any concerns about the dose to take
you should contact your doctor or pharmacist.
If you take more Bedranol Tablets than you
should
This medicine is to be taken at regular intervals, as
determined by the doctor. If you take too many
tablets by mistake contact your nearest hospital
casualty department or tell your doctor
immediately. Take your tablet pack with you.
If you stop taking Bedranol Tablets
Do not stop taking Bedranol Tablets without
consulting your doctor as your condition may
worsen.
If you forget to take Bedranol Tablets
If you have forgotten to take a dose, leave out that
dose completely. Take your next dose at the
normal time. If you have trouble remembering to
take the tablets, tell your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of these occur, STOP taking the medicine
and contact a doctor immediately.
Allergic Reactions -Symptoms include rash,
itching, swelling of the face, wheeziness,
shortness of breath, tightness in the chest and
fever.
Worsening of heart failure - Symptoms include
low blood pressure, fainting on standing, dizziness
and precipitation of heart block.
A disorder of the brain - Caused by liver damage
(hepatic encephalopathy) - Symptoms include
confusion, forgetfulness, changes in mood or
personality, changes in sleep patterns.
Changes in mental state such as psychosis and
mood changes.
Slowing of the heart beat - Bradycardia.
Changes in the types and numbers of your
blood cells - Symptoms may include bruising
more easily, prolonged bleeding or bleeding from
your gums. You may also feel generally unwell.
Changes in kidney function - Symptoms include
changes in urination, tiredness, swelling of hands
and feet, muscle cramps and loss of appetite.
Common (less than 1 in 10)
! Sleep disturbances, nightmares
! Cold hands and feet, Raynaud's syndrome
! Fatigue and lack of energy.
Uncommon (less than 1 in 100)
! Diarrhoea, feeling sick (nausea) and being sick
(vomiting).
Rare (less than 1 in 1,000)
! Seeing and hearing things that are not there
(Hallucinations)
! Visual disturbances and dry eyes
! Worsening of muscle pains and cramps after
exercise (intermittent claudication)
! Patients with asthma or a history of breathing
problems may experience difficulty in breathing
! Memory loss, pins and needles
! Hair loss (Alopecia), worsening of psoriasis,
skin rashes.

Quality Control (QC)

Production

Very rare (less than 1 in 10,000)
! Changes in blood sugar levels
(Hypoglycaemia)
! Muscle weakness with droopy
eyelids, eye problems, headache and
feeling tired may indicate you have a
condition called 'Myasthenia gravis'.
Frequency unknown
! Signs of hyperthyroidism may be
masked
! Changes in blood fats
! Muscle weakness, numbness
! Depression, confusion, headache
! Conjunctivitis - Symptoms include redness of
the eyes and watery eyes
! Worsening of angina - Chest pain
! Constipation, dry mouth
! Joint pain
! Changes in sex drive or potency
! Fits (seizures) linked to low blood sugar levels.
Many of the above mentioned side effects should
disappear when treatment is stopped. Tell your
doctor if you have any other unwanted side effects
not mentioned above.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE BEDRANOL TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Do not store above 25°C. Store in the original
package.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Bedranol Tablets contain:
Bedranol Tablets 10mg, 40mg, 80mg and 160mg
contain the active substance Propranolol
hydrochloride 10mg, 40mg, 80mg and 160mg
respectively in each tablet.
The other ingredients are: lactose, maize starch,
soluble starch, sodium starch glycollate,
microcrystalline cellulose, magnesium stearate,
hypromellose 50, ethylcellulose 45,
diethylphthalate and erythrosine (E127).
What Bedranol Tablets look like and contents
of the pack
Bedranol Tablets 10mg are pink, round, film-coated
tablets with P1 embossed on one side and
breakline on reverse.
Bedranol Tablets 40mg are pink, round, film-coated
tablets with P2 embossed on one side and
breakline on reverse.
Bedranol Tablets 80mg are pink, round, film-coated
tablets with P3 embossed on one side and
breakline on reverse.
Bedranol Tablets 160mg are pink, round, filmcoated tablets with P4 embossed on one side and
breakline on reverse.
Bedranol Tablets 10mg, 40mg, 80mg and 160mg
are supplied in packs of 500.
Manufacturer
Contract Pharmaceutical Services Limited
Swain Park Industrial Estate, Park Road, Overseal
Burton Upon Trent, Staffordshire, DE12 6JT,
United Kingdom
Marketing Authorisation Holder
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in January 2015.

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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.

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