iMedi.co.uk

Bedranol (Propranolol Hydrochloride) Sr Capsule 160mg

Document: label-leaflet ALMUS PHARMACEUTICALS_PL 04416-0068 change
PATIENT INFORMATION LEAFLET

BEDRANOL® (PROPRANOLOL HYDROCHLORIDE) SR CAPSULES 160 mg

(Propranolol Hydrochloric!o)

Read dl of this leaflet illy before you start taking this raadldno bacovso It caitdis laportaat iaforaatiaa (or yii.

•    Keep this leaflet. You may need to mod it again.

■ If you have ary further questions, please ask your doctor, pharmacist or nurse.

•    This medicine has been proscribed far you only. Do not pass it on to others, as 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 indudes any side efforts not listed in this leaflet. See section 4.

Whit is m this leaflet:

1.    What Bedranol SR Capsules are and    what they    are    used    far

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 ihey are usad (or

The name of your medicine is Bedranol (Propranolol Hydrochloride) SR Capsules 160 mg.

, belongs to a group of medicines known as


are used to cc


e and reduce the demands on the heart.


Bedranol SR Capsules are presaibed 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 y«i iwd to know before yo> take Bodraaol11’ SR Capsalos

DO NOT tiki this mdldie afore tiling year dorter H any of fhs falawtag 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 asthmo

•    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 ate prone to hypeglytaemia (low levels of glucose in your blood)


Severe blood vessel disease


Sick sinus syndrome (abnormal function of the sinoatrial node in your heart)

Untreated phoeochromocytoma (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 origin n/va riant 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 preciatiois

Tolk to your doctor, phormocist or


re using Bedranol SR Capsules.

ive to allergens (e.g. dust, pollen and pet hair).

>n (severe reaction to allergens). i - this should be gradual; talk to your doctor especially


This product may make you more sr This may lend to an anaphylactic re If you need to stop taking this med 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 (lew blood sugar, seizures or coma). If you have thyrotoxicosis (a condition caused hy an overactive thyroid gland). Your medidne may hide the symptoms of th


Other itedidies and ledninal SR Capsules

Tell your doctor or pharmacist if you are taking or have recently token or might take any ol It is especially importont for

•    Clonidine (to treat high blood pressure and migraine);

•    Disopyramide, quinidine, propafenone and other similar drugs such as amiodarone use


nifedipine (to treat high blood pressure, angina and al Digitmdn or digoxin (for heart failure);

Udocoine (totreotobna


al heart rhythms);


is (for migraine);



Rizatiiptan (used to treat migraines); i (to (tear poor arculation);

known as Alpha-hlockers or Angiotensin-ll Antagonists used to treat high blood pressure (e.g. prazosin or telmisortan);

Aldesleukin (to treat some cancers)^


Fluvoxamine (for depression) Theophylline (for osthma) Warfarin (to thin the blood)


If you go into hospital to hove on operation, tell the ai SR Capsules. This is because you can get low blood pro while you are taking Bedranol SR Capsules. lataracfleB with had aad drtak

Alcohol may enhance the effect of propranolol. You should not diink alcohol when raking this m Pregnaaqr and breastfeediig

Bedranol SR Capsules should not be used in pregnancy ond breast-feeding.

Ask your doctor or pharmacist for advice before raking any medicines.


or medical stuff that you are taking Bi i) if you are given certoin am


Do not drive or operate machines if you feel dizzy or tired while taking Bedranol SR Capsules, ledranol SR Capsules caataas sue rase

Bedranol SR Capsules contain suaase and you should not take this medicine if you have a heredr intolerance to some sugars.

3. Haw to take Bedranol SR Capsules

You should always follow your doctor's instructions as to how and when to tab your medicine. Your pharmacist may he able to advise if you are not sure. Exactly how many capsules, and how must tab them, will be written on the label. Please read it carefully.


Page 2 - Reverse of top visible panel


Page 3


Page 4


Page 5


Page 6


Page 7


Page 8


Page 9


Page 10


Page 11


Page 12


Page 13


Place the capsule on your tongue and swallow it whole with a little liquid.

AMs

High blood pressure: The initial dose is 160 mg daily, taken in the morning or evening.

If necBssoiy, your donor moy presaibe a doss of 320 mg daily, tabn in the morning or evening.

Angina, prevention of migraines; thyroid problems, tremors: The usual dose is 80 mg daily, tobn in the morning or evening. Your doctor may increase the dose Inter to a maximum of 240 mg daily.

Sihialionol and generalised anxiety: Some times the doctor will prescribe one Bedranol SR capsule T60 mg, however treatment of this condition usually begins with a lower dose capsule.

Forml hypertension (bleeding from the stomach and oesophagus (gullet) in lim disease): The doctor will c


nent on a lower dose capsule, however, it might be decided by your doctor that you should tab one anal SR Capsules 160 mg.


If you are already established on 160 mg pi if you are new to propra


le daily, 16Qmg daily may be giver. However,


and it might be preferable to tab an alternative prep*

or liwt problem;

A reduced initial dose, ar an alternative preparation, may be given. Siren

Bedranol SR Capsules are not recommended for children.


If you laka aare Badraaal SR Capsalos that you should

If you tab more than the recommended dose, contact your doctor. If you or someone else has tabn 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 Target ta taka ladmol* SR Capsulas

Tab it as soon as you remember. If your next dose is due within 12 hours, tab a single dose now and skip the next. Do not tab a double dose to mab up fonforgoni dm

If you stop tokng lodrcnel SR Capsules:

Consult your doctor if you want to discontinue treatment with this medicine as your original symptoms may recur


when you stop taking the capsules. Bedranol SR Capsules should be


govern period of d.


If you have any further questions on the use of this medians, nsk your doctor, phaimarist or nurse.

4. Passible side effects

Lib all medicines, this medicine can cause side effects, although not everybody gets them.

Step taking this nadidii and contact yaar dieter baaadlatofy H you ncpwlinn any if tiro falawtag serins side effects:

Rare any affact up to 1 in 1,000 paapli

• Reduced numbers ol platelets in your blood which may make you bruise more easily.

The following side effects may occur with this medicine:


Clause any affect ap ta 1 In 10 paopla

•    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 bonds and feet.

■    Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease).

•    Disturbed sleep or nightmares.

•    Feeling tired.

Uacaamii may affect ap to 1 in 100 people

•    Diarrhoea.

■    Feeling skk (nausea).

•    Being sick (vomiting).


re may affect up to 1 in 1,000 people

Heart block (which may cause an abnormal heal beat, dizziness, tiredness or fainting). Dizziness, particularly on standing up.

Thinning of your hair.


ig of your hands.


Dry eyes. Skin rash.


jr skin.


Vary ran aay affect ap to 1 in 10,000 paopla

•    Severe muscle weabess (myasthenia gravis).

•    Changes to some of the cells or other parts of your blood. Your doctor may tab blood samples every so often to check whether Bedranol SR has had any effect on your blood.

Nat kiawa frequency caaaat ba estimated from the available data

■ Low levels of sugar in the blood (hypoglycaemia). This can happen in people with or without diabe includes older people, people an artificial kidneys (haemodialysis) or people taking medicines lor di It may also happen if you are fasting or in people with a long-term liver disease.


•    Seizure linbd to hypoglycaemia Conditions that aay get worse

H you have any of the following conditions, they may get worse when you start to tab your medidne. 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).


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.


w ta stare Bedranol SR Capsules


6. Contents al the pork aid other lalonnatlaa


Do noth day of ft


nediane out of the sight and reach of children, e Bedranol* SR Capsules after the expiry dote di


is should be stored in a cool, dry place, pi


Do not throw away ar


in the label. The expiry dote refers to the last ,m light.

waste. Ask your pharmadst how to throw


« will help to protect the or


What Badranol SR CiqHilei contain

Each capsule contains 160mg of the active in


le in a si


formulation, tin and the :k iron oxide


The other ingredients are: sucrose, maize starch, shellac and talc The capsule shells. colours erythrosine (ET27) and titanium dioxide (ET7T) and the capsule ink contains (E172), propylene glycol and ammonium hydroxide.

What Bedriaal SR Capsules look like aid content of the pack

Bedranol SR Capsules are a sustained release capsule. They are available in parks of 28, 30, 56, 60 and 100.


Marketing Authorisation Holder aid Maiifacturen

The marketing authorisation holder and manufacturer is: Sondoz ltd, Frimley Business Park, Frimley, Ccmberley, Surrey, GUI 6 7SR, UK.

This leaflet was revised on 05/2016.


Bedranol® SR Capsules


160



mg


Larger text version of Hie leaflet can be made available upon request.


Keep out of the sight and reach of children. Oral use. Use as directed by your doctor. Read the attached leaflet. Warning: Do not take this medicine if you have a history of wheezing or asthma. Each capsule contains 160 mg of the active ingredient, propranolol hydrochloride BP in a slow release formulation.

Other ingredients, include sucrose and colours E127 and E171. Store in a cool, dry place. Protect from light. PL Holder: Sandoz Ltd, Frimley, Surrey, GU16 7SR PL 04416/0068 A0017a/6


Page 14


Page 15


Page 16


Page 1 7


Page 1 8


Page 19


Page 20


Page 21


Page 22


Page 23


Page 24


Page 1 - Top visible panel


Bedranol® SR Capsules


160




mg


Keep out of the sight and reach of children. Oral use. Use as directed by your doctor.    r^jjjn

Read the attached leaflet. Warning: Do not take this medicine if you have a history of wheezing or asthma. I—-I

Each capsule contains 160 mg of the active ingredient, propranolol hydrochloride BP in a slow release formulation. Other ingredients, include sucrose and colours E127 and E171. Store in a cool, dry place. Protect from light.

PL Holder: Sandoz Ltd, Frimley, Surrey, GU16 7SR PL 04416/0068 A0017a/6


Base Label