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BEDRANOL (PROPRANOLOL HYDROCHLORIDE) SR CAPSULES 80MG

Active substance(s): PROPRANOLOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Bedranol® (Propranolol Hydrochloride) SR Capsules 80 mg

(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, 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, pharmacist or nurse. This includes any side effects not listed in this leaflet. See
section 4.

What is in this leaflet
1.
What Bedranol® SR Capsules are and what they are used for
2.
What you need to know before you take Bedranol® SR
Capsules
3.
How to take Bedranol® SR Capsules
4.
Possible side effects
5.
How to store Bedranol® SR Capsules
6.
Contents of the pack and other information

1

What Bedranol® SR Capsules are and what
they are used for

Bedranol SR Capsules contain the active ingredient, propranolol
hydrochloride, which belongs to a group of medicines known as
beta-blockers which are used to control blood pressure and
reduce the demands on the heart.

Bedranol SR Capsules are prescribed for treating high blood pressure
and angina (chest pains from heart disease), anxiety, prevention of
migraines, specific thyroid problems, bleeding from the stomach
and oesophagus (gullet) in liver disease and certain forms of tremor.

2

What you need to know before you take
Bedranol® SR Capsules

DO NOT take this medicine before telling your doctor if any of the
following applies to you:
• An allergy to propranolol hydrochloride, propranolol, or any of
the other ingredients in this medicine (see section 6 ‘Further
Information’).
• You are or might be pregnant, or you are breast-feeding
• History of wheezing or asthma
• Low blood pressure (hypotension)
• Metabolic acidosis (your blood had a low pH- you will know if
you have this)
• You have not eaten for a long time or you are prone to
hypoglycaemia (low levels of glucose in your blood)
• Severe blood vessel disease
• Thyroid problems, or are being treated with thyroxine
• The balance of acidity and salts in the blood is disturbed due
to fasting or uncontrolled diabetes
• Very poor circulation
• Sick sinus syndrome (abnormal function of the sinoatrial node
in your heart)
• Untreated phaeochromocytoma (a rare tumour of the adrenal
gland which causes high blood pressure)
• Missed heart beats (heart block) or heart failure
• Very slow heart beat (bradycardia)
• Prinzmetal’s angina/variant angina (a type of chest pain
experienced at rest)

Do not take this medicine if you allergic to propranol hydrochloride
or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Bedranol SR
Capsules.







This product may make you more sensitive to allergens (e.g.
dust, pollen and pet hair). This may lead to an anaphylactic
reaction (severe reaction to allergens).
If you need to stop taking this medicine – this should be
gradual, talk to your doctor especially if you have heart disease.
If you have heart problems and severe blood vessel disease,
heart block or problems with your circulation
If you have kidney or liver disease.
If you are going to have an operation, or any procedure
needing anaesthetic, please check with the doctor or dentist
beforehand. It may be necessary to withdraw Bedranol SR
Capsules 24 hours before the operation.
Adrenaline injections may cause unwanted effects in patients






taking this medicine, make sure that anyone treating you is
made aware of your treatment.
The results of blood tests, especially those for checking liver
function, may be affected by Bedranol therapy. If you do have
any blood taken for testing, let your doctor know you are taking
Bedranol SR Capsules.
If you suffer from diabetes, this medicine may hide the signs of
hypoglycaemia (low blood sugar) and slow your recovery from it.
Even if you are not diabetic this medicine may cause
hypoglycaemia (low blood sugar, seizures or coma).
If you have thyrotoxicosis (a condition caused by an overactive
thyroid gland). Your medicine may hide the symptoms of
thyrotoxicosis.

Other medicines and Bedranol SR Capsules
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines. It is especially important for:
• Clonidine (to treat high blood pressure and migraine);
• Disopyramide, quinidine, propafenone and other similar drugs
such as amiodarone used to treat abnormal heart rates;
• Calcium channel blockers such as verapamil, diltiazem,
nisoldipine, isradipine, lacidipine or nifedipine (to treat high
blood pressure, angina and abnormal heart rhythms);
• Digitoxin or digoxin (for heart failure);
• Lidocaine (to treat abnormal heart rhythms);
• Ergotamine, dihydroergotamine or related medicines (for migraine);
• Anti-inflammatory pain relievers (e.g. ibuprofen or
indomethacin) for arthritis and similar conditions;
• Chlorpromazine or thioridazine (for certain psychiatric disorders);
• Rifampicin (an antibiotic);
• Thyroxine (for certain thyroid disorders);
• Cimetidine (to treat stomach ulcers);
• Corticosteroids (e.g. hormone replacement);
• The contraceptive pill;
• Insulin
• Adrenaline (a heart stimulant);
• Muscle relaxants (used to treat multiple sclerosis);
• Parasympathomimetics (e.g. pyridostigmine used to treat
myasthenia gravis);
• Rizatriptan (used to treat migraines)
• Moxisylyte (to treat poor circulation);
• Medicines known as Alpha-blockers or Angiotensin-II Antagonists
used to treat high blood pressure (e.g. prazosin or telmisartan),
• Xamoterol (a heart stimulant),
• Tropisetron (for nausea and vomiting),
• Aldesleukin (to treat some cancers)
• Alprostadil (for sexual problems)
• Fluvoxamine (for depression)
• Theophylline (for asthma)
• Warfarin (to thin the blood)

Operations
If you go into hospital to have an operation, tell the anaesthetist or
medical staff that you are taking Bedranol SR Capsules. This is
because you can get low blood pressure (hypotension) if you are
given certain anaesthetics while you are taking Bedranol SR Capsules.
Interaction with food and drink
Alcohol may enhance the effect of propranolol. You should not
drink alcohol when taking this medicine
Pregnancy and breast-feeding
Bedranol should not be used in pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicines.

Continued on the next page >>

Driving and using machines
Do not drive or operate machines if you feel dizzy or tired while
taking Bedranol* SR.

Bedranol SR Capsules contains sucrose
Bedranol SR Capsules contain sucrose and you should not take
this medicine if you have a hereditary intolerance to some sugars.

3

How to take Bedranol® SR Capsules

Recommended doses follow. Doctors sometimes prescribe
different doses to these: if this applies to you, discuss it with the
doctor, if you have not already done so. You should always follow
your doctor’s instructions as to how and when to take your medicine.
Your pharmacist may be able to advise if you are not sure. Exactly
how many capsules, and how often you must take them, will be
written on the label. Please read it carefully.
Place the capsule(s) on your tongue and swallow whole with a
little liquid.

Adults:
High blood pressure:
The initial dose is 160 mg daily, taken in the morning or evening.
If necessary, your doctor may prescribe a dose of 320 mg daily,
taken in the morning or evening.
Angina, prevention of migraines, thyroid problems, tremors:
The usual dose is 80 mg daily, taken in the morning or evening.
Your doctor may increase the dose later.

Situational and generalised anxiety:
One Bedranol* SR 80mg capsule per day for short term relief on
situational anxiety. For generalised anxiety the dosage usually
begins with one 80mg capsule, in some cases may be increased
to 160mg.

Portal hypertension (bleeding from the stomach and oesophagus
(gullet) in liver disease):
Initial dosage is one Bedranol SR 80 mg capsule, your doctor will
often may decide to increase your dosage to suit you.
Older people
If you are already established on 160 mg propranolol
hydrochloride daily, 160 mg daily may be given. However, if you
are new to propranolol hydrochloride treatment you may need
smaller starting doses.

Patients with kidney or liver problems
A reduced initial dose, or an alternative preparation, may be given.
Children
Bedranol SR Capsules are not recommended for children.

If you take more Bedranol* SR Capsules than you should
If you take more than the recommended dose, contact your doctor.
If you or someone else has taken several, or a large overdose of
capsules, low blood pressure and slowing of the heartbeat may
occur: contact your doctor or hospital accident and emergency
department straight away.
If you forget to take Bedranol* SR Capsules
Take it as soon as you remember. If your next dose is due within
12 hours, take a single dose now and skip the next. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Bedranol* SR Capsules
Do NOT stop taking the capsules until the doctor has told you to.
Consult your doctor if you want to discontinue treatment with
bedranol* SR capsules as your original symptoms may recur
when you stop taking the capsules. Bedranol* SR capsules
should be discontinued gradually over a period of days.

If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking this medicine and contact your doctor
immediately if you experience any of the following serious
side effects:

Rare may affect up to 1 in 1,000 people
• Reduced numbers of platelets in your blood which may make you
bruise more easily.
The following side effects may occur with this medicine:

Common may affect up to 1 in 10 people
• You may notice that your pulse rate becomes slower while you
are taking the capsules. This is normal, but if you are
concerned please tell your doctor about it.
• Cold hands and feet.
• Numbness and spasm in your fingers which is followed by
warmth and pain (Raynaud’s disease).




Disturbed sleep or nightmares.
Feeling tired.

Uncommon may affect up to 1 in 100 people
• Diarrhoea.
• Feeling sick (nausea).
• Being sick (vomiting).

Rare may affect up to 1 in 1,000 people
• Heart block (which may cause an abnormal heart beat,
dizziness, tiredness or fainting).
• Dizziness, particularly on standing up.
• Thinning of your hair.
• Mood changes.
• Feeling confused.
• Memory loss.
• Changes in personality (psychoses).
• Hallucinations.
• Tingling of your hands.
• Disturbances of vision.
• Dry eyes.
• Skin rash.
• Purplish marks on your skin.

Very rare may affect up to 1 in 10,000 people
• Severe muscle weakness (myasthenia gravis).
• Changes to some of the cells or other parts of your blood.
Your doctor may take blood samples every so often to check
whether Bedranol SR has had any effect on your blood.

Not known frequency cannot be estimated from the
available data
• Low levels of sugar in the blood (hypoglycaemia). This can
happen in people with or without diabetes. This includes older
people, people on artificial kidneys (haemodialysis) or people
taking medicines for diabetes. It may also happen if you are
fasting or in people with a long-term liver disease.


Seizure linked to hypoglycaemia

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.

Do not be concerned by this list of side effects. You may not get
any of them. If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5

How to store Bedranol® SR Capsules

Keep this medicine out of the sight and reach of children.

Do not take Bedranol SR Capsules after the expiry date shown on
the carton. The expiry date refers to the last day of that month.

If you notice any defects in the capsules such as split capsules,
you must take them to your pharmacist for advice before taking them.
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 to protect the environment.

6

Contents of the pack and other information

What Bedranol SR Capsules contains
Each capsule contains 80 mg of the active ingredient propranolol
hydrochloride in a slow release formulation.

The other ingredients are: sucrose, maize starch, shellac and talc.
The capsule shells contain gelatin and indigotine (E132) and the
capsule ink contains shellac, black iron oxide (E172) propylene
glycol and ammonium hydroxide.
What Bedranol SR Capsules looks like
Bedranol SR Capsules are hard modified release gelatine
capsules with a blue transparent cap and body contain white and
whitish/cream pellets.
These capsules are available in packs of 28, 30, 56, 60 and 100
(not all pack sizes are marketed).

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is:
Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR.
This leaflet was last revised in: 05/2016.

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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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