PACKAGE LEAFLET: INFORMATION FORTHE USER

_ _ _ _ _ _n nogen Pharma I

¹ Bedranol Tablets ¹10mg, 40mg, 80mg and 160mg

| (Propranolol Hydrochloride)

iRead all ofthis 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.

L If you get any side effects, talk to your doctor,

, or pharmacist or nurse. This includes any I 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 balled '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

I* Prevention of a further heart attack if you have already suffered from a heart attack l Controlling an abnormal heart beat

•    Management of tremor L Prevention of migraine

|* Treatment of thyrotoxicosis - in combination with other medicines

|* Management of phaeochromocytoma (a rare tumorofthe adrenal gland) - in combination with other medicines.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEDRANOL TABLETS

Do not take Bedranol Tablets ifyou:

•    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 I* Suffer with heart conduction or rhythm problems

l Suffer from a tight, painful feeling in the chest in I periods of rest (Prinzmetal's angina)

L 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

L Have low blood sugar levels m Suffer from diabetes mellitus l Suffer from increased acidity of the blood i (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 olucose-galactose malabsorption should not take this medicine.

Warnings and precautions

|Talk to your doctor or pharmacist or nurse before taking Bedranol Tablets ifyou:

|* Have a history of allergic reactions

•    Have a heart weakness or first degree heart | block

•    Have kidney or liver disease

L Have muscle weakness (myasthenia gravis)

•    Have blood circulation problems (which may I cause your fingers and toes to tingle or turn

I 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 orfluvoxamine (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 ofwater.

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, 2or3 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.

¹For migraine and tremor

The initial dose is 40mg, 2or3 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

frhe initial dose is 10mg to 40mg, 3or4 times a flay.

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

Ifyou have liver or kidney problems a lower dose may be prescribed.

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.

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 ofthe child's body jWeight. The dose may be given 3to4 times a day.

|For migraine

Children under 12 years ofage. 40mg may be ^iven 2or3 times a day

Children over 12 years ofage. may be given the hame dose as an adult (see the dosage prescribed py your doctor).

e.LWAYS follow the dosage given to you by your octor.

ilf you have any concerns about the dose to take you should contact your doctor or pharmacist.

ifyou take more Bedranol Tablets than you Should

This medicine is to be taken at regular intervals, as hetermined 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.

|lfyou stop taking Bedranol Tablets

Do not stop taking Bedranol Tablets without Consulting your doctor as your condition may worsen.

Many of the above mentioned side effects should disappearwhen 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 ofvia 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

Ifyou forget to take Bedranol Tablets

Ilf 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.

.Ifany ofthese 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 |ow blood pressure, fainting on standing, dizziness and precipitation of heart block.

Ia disorder ofthe 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 Imore easily, prolonged bleeding or bleeding from your gums. You may also feel generally unwell. Changes in kidneyfunction - Symptoms include changes in urination, tiredness, swelling ofhands 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.

luncommon (less than 1 in 100)

m Diarrhoea, feeling sick (nausea) and being sick I (vomiting).

bare (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

l Hair loss (Alopecia), worsening of psoriasis, l skin rashes*. _ _ _ _ _ _ _

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, film-coated 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,

UnitG4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in January 2015.