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BEDRANOL TABLET 160MG

Active substance(s): PROPRANOLOL HYDROCHLORIDE / PROPRANOLOL HYDROCHLORIDE / 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.

18

Date

07-07-17

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
!
Have Raynaud's disease (cold sensations in
taking this medicine because it contains
fingers and toes) or intermittent claudication
important information for you.
(narrowing of arteries in the legs causing pain
!
Keep this leaflet. You may need to read it
on walking)
again.
!
Smoke.
!
If you have any further questions, ask your
doctor or pharmacist or nurse.
Other medicines and Bedranol Tablets
Tell your doctor or pharmacist if you are taking,
!
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
have recently taken or might take any other
them, even if their signs of illness are the same
medicines. In particular:
!
Verapamil and diltiazem (to treat heart
as yours.
diseases)
!
If you get any side effects, talk to your doctor,
!
Disopyramide, quinidine and amiodarone (to
or pharmacist or nurse. This includes any
treat irregular heartbeat (arrhythmia)
possible side effects not listed in this leaflet.
!
Ergotamine derivates (to treat migraine)
See section 4.
!
Adrenaline (epinephrine, used in anaphylactic
shock)
What is in this leaflet:
1. What Bedranol Tablets are and what they
!
Medicines to treat diabetes including insulin
!
Lidocaine, propafenine or flecainide (to treat
are used for
2. What you need to know before you take
irregular heartbeat (arrhythmia) or as a local
Bedranol Tablets
anaesethetic
3. How to take Bedranol Tablets
!
Indometacin (Non-Steroidal Anti-Inflammatory
4. Possible side effects
Drug (NSAID))
5. How to store Bedranol Tablets
!
Digitalis glycosides such as digoxin (to treat
6. Contents of the pack and other information
heart conditions)
!
Chlorpromazine (for mental illness)
1. WHAT BEDRANOL TABLETS ARE AND
!
Cimetidine (to treat stomach ulcers)
WHAT THEY ARE USED FOR
!
Other drugs treating high blood pressure
(alpha blockers, clonidine, moxonidine,
methyldopa or hydralazine)
Bedranol Tablets contain a medicine called
Propranolol Hydrochloride. It belongs to a group of
!
Monoamine-oxidase inhibitors, imipramine
medicines called 'Beta-blockers' and works by
or fluvoxamine (to treat depression)
controlling blood pressure and thus reducing the
!
Warfarin (to prevent clotting)
demand on the heart.
!
Rizatriptan (to treat migraine)
!
Rifampicin (to treat infection)
Bedranol Tablets are useful for:!
Barbiturates (to treat severe insomnia)
!
Treatment of high blood pressure
!
Theophylline (treating asthma and reversible
!
Management of angina pectoris - pain in the
airways obstruction)
chest caused by blockages in the arteries
!
Diuretics (to clear excess water from the
leading to the heart
body).
!
Prevention of a further heart attack if you have
If you are going to have surgery, including dental
already suffered from a heart attack
!
surgery, you should tell your doctor or nurse that
Controlling an abnormal heart beat
!
you are taking this medicine. They may need to
Management of tremor
!
adjust the amount of anaesthetic you need.
Prevention of migraine
!
Treatment of thyrotoxicosis - in combination
If you need to have any blood or urine tests you
with other medicines
!
should tell the doctor or nurse you are taking
Management of phaeochromocytoma (a rare
Bedranol Tablets as they may interfere with the
tumor of the adrenal gland) - in combination
results.
with other medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BEDRANOL TABLETS

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,
Do not take Bedranol Tablets if you:
!
planning on becoming pregnant or are breastAre hypersensitive (allergic) to Propranolol or
feeding.
any of the other ingredients in these tablets
(listed in section 6)
!
Driving and using machines
Have untreated/uncontrolled heart failure or are
These tablets can cause visual disturbances,
in shock caused by heart problems
!
hallucinations, fatigue, mental confusion, dizziness
Suffer with heart conduction or rhythm
or tiredness in some people. If you are affected do
problems
!
not drive or operate machinery as your alertness
Suffer from a tight, painful feeling in the chest in
may be impaired.
periods of rest (Prinzmetal's angina)
!
Have a history of bronchospasm and asthma
!
Bedranol Tablets with food, drink and alcohol
Have a history of chronic lung disease (chronic
Alcohol may enhance the effect of the medicine.
obstructive pulmonary disease)
!
Suffer from untreated phaeochromocytoma
Bedranol Tablets contain lactose
(high blood pressure due to a tumour near the
If you have been told by your doctor that you have
kidney)
!
an intolerance to some sugars you should talk to
Are on a strict fasting diet
!
your doctor before you take this medicine.
Have low blood sugar levels
!
Suffer from diabetes mellitus
3. HOW TO TAKE BEDRANOL TABLETS
!
Suffer from increased acidity of the blood
(metabolic acidosis)
!
Always take Bedranol Tablets exactly as your
Have a slow heart beat
!
doctor has instructed you. You should check with
Have low blood pressure
!
your doctor or pharmacist if you are unsure.
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.

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
Warnings and precautions
weekly intervals.
Talk to your doctor or pharmacist or nurse before
The usual maintenance dose is 160mg to 320mg
taking Bedranol Tablets if you:
!
daily.
Have a history of allergic reactions
!
Have a heart weakness or first degree heart
For angina pectoris
block
The initial dose is 40mg, 2 or 3 times a day.
!
Have kidney or liver disease
!
This dose may be increased by your doctor by the
Have muscle weakness (myasthenia gravis)
same amount, at weekly intervals.
!
Have blood circulation problems (which may
The maximum daily dose is 480mg.
cause your fingers and toes to tingle or turn
pale or blue)
Following a heart attack
!
Have symptoms of hyperthyroidism (increased
Treatment with Bedranol will start between day 5
appetite, weight loss, sweating)
and day 21 after the heart attack.
!
Have or have had a history of psoriasis
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.

18

Date

07-07-17

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.

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,
pregelatinised starch, sodium starch glycolate,
microcrystalline cellulose, magnesium
stearate,hypromellose, titanium dioxide E171,
ethylcellulose, triacetin E1518 and erythrosine
aluminum lake E127.
What Bedranol Tablets look like and contents
of the pack
Bedranol Tablets 10mg are pink, round, film-coated
tablets with an approximate diameter of 6.0mm,
marked with P and 1 on either side of a score line
on one side and plain on the other side.
Bedranol Tablets 40mg are pink, round, film-coated
tablets with an approximate diameter of 8.50mm,
marked with P and 2 on either side of a score line
on one side and plain on the other side.
Bedranol Tablets 80mg are pink, round, film-coated
tablets with an approximate diameter of 9.50 mm,
marked with P and 3 on either side of a score line
on one side and plain on the other side.
Bedranol Tablets 160mg are pink, round, filmcoated tablets with an approximate diameter of
11.50mm, marked with P and 4 on either side of a
score line on one side and plain on the other side.
The score line is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.

Common (less than 1 in 10)
Bedranol Tablets are supplied in the following pack
!
Sleep disturbances, nightmares
sizes.
!
Cold hands and feet, Raynaud's syndrome
10mg and 40mg: 28 Tablets
!
Fatigue and lack of energy.
80mg and 160mg: 56 Tablets
Uncommon (less than 1 in 100)
Manufacturer and Marketing Authorisation
!
Diarrhoea, feeling sick (nausea) and being sick
Holder
(vomiting).
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Rare (less than 1 in 1,000)
Riverside Way, Dartford, DA1 5BS, UK.
!
Seeing and hearing things that are not there
(Hallucinations)
This leaflet was last revised in July 2017.
!
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.

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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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