Bedranol tablets 160 mg – patient leaflet, side effects, dosage

1. WHAT PROPRANOLOL TABLETS ARE AND WHAT THEY ARE USED FOR

imipramine or fluvoxamine (to treat depression)

Propranolol Tablets contain the active substance propranolol hydrochloride. It belongs to a group of medicines called 'beta-blockers' and works by controlling blood pressure and thus reducing the demand on the heart.

! Barbiturates (to treat severe insomnia) ! 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.

Propranolol Tablets are used for:-

! Treatment of high blood pressure ! Management of angina pectoris - pain in the

chest caused by blockages in the arteries leading to the heart

Propranolol Tablets with alcohol

Alcohol may enhance the effect of this medicine.

! Prevention of a further heart attack if you

have already suffered from a heart attack ! Controlling an abnormal heart beat ! Management of tremor

Pregnancy and breast-feeding

Propranolol Tablets are not recommended for use during pregnancy or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a

! Prevention of migraine

! Treatment of thyrotoxicosis - in combination

with other medicines

baby, ask your doctor or pharmacist

! Management of phaeochromocytoma (a rare

for advice before taking this

tumor of the adrenal gland) - in combination with other medicines.

medicine.

Driving and using machines

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

These tablets can cause visual

disturbances, hallucinations, fatigue,

mental confusion, dizziness or

Do not take Propranolol Tablets if you:

tiredness in some people. If you are

! Are allergic to propranolol hydrochloride or

affected do not drive or operate

any of the other ingredients of this medicine (listed in section 6)

machinery as your alertness may be

impaired.

! Have untreated/uncontrolled heart failure or

are in shock caused by heart problems ! Have heart conduction or rhythm problems ! Have a tight, painful feeling in the chest in

Propranolol Tablets contain lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

periods of rest (Prinzmetal's angina) ! Have a history of bronchospasm and asthma ! Have untreated phaeochromocytoma (high

blood pressure due to a tumour near the kidney)

Sodium content

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.

! Are on a strict fasting diet

! Have low blood sugar levels

! Have diabetes mellitus

! Have increased acidity of the blood

3. HOW TO TAKE PROPRANOLOL TABLETS

(metabolic acidosis)

! Have a slow heart beat

! Have low blood pressure

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

! Have problems with your circulation ! Have a history of chronic lung disease

(chronic obstructive pulmonary disease) ! Smoke.

Swallow the tablets whole with a glass of water.

Do not take this medicine if you have wheezing or asthma. Talk to your doctor or pharmacist first.

Adults

For high blood pressure (hypertension)

Warnings and precautions:

The initial dose is 80mg twice a day.

Talk to your doctor or pharmacist or nurse before taking Propranolol Tablets if you:

This dose may be increased by your doctor at weekly intervals. The usual maintenance dose is 160mg to 320mg daily.

! Have a history of allergic reactions ! Have a heart weakness or first-degree heart

block

! Have kidney or liver problems

For angina, migraine and tremor

! Have muscle weakness (myasthenia gravis) ! Have blood circulation problems (which may

The initial dose is 40mg, 2 or 3 times a day.

cause your fingers and toes to tingle or turn pale or blue)

This dose may be increased by your doctor by the same amount, at weekly intervals. The usual dose for migraine and tremor is in the range of 80mg to 160mg daily.

! Have or have had a history of psoriasis ! Have thyrotoxicosis as Propranolol Tablets

may mask symptoms of thyrotoxicosis ! Have Raynaud's disease (cold sensations in

The usual dose for angina is in the range of 120mg to 240mg daily.

fingers and toes) or intermittent claudication (narrowing of arteries in the legs causing pain on walking)

Following a heart attack

Treatment with Propranolol Tablets will start between day 5 and day 21 after the heart attack. The initial dose will be 40mg, 4 times a day, for a period of 2-3 days.

! Have diabetes as Propranolol Tablets may

change your normal response to low blood sugar, which usually involves an increase in heart rate. Propranolol Tablets may cause low blood sugar levels even in patients who are not diabetic.

This dose may then be changed by your doctor to 80mg, twice a day.

For abnormal heart beat and thyrotoxicosis

If you need to have any blood or urine tests you should tell your doctor or nurse that you are taking Propranolol Tablets as they may interfere with the results.

The recommended dose is 10mg to 40mg, 3 or 4 times a day.

For phaeochromocytoma

Other medicines and Propranolol Tablets

Before an operation: 60mg daily for 3 days before the operation. This is always given with another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:

! Medicines to treat diabetes including insulin ! Ergotamine, dihydroergotamine and

rizatriptan (to treat migraine)

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.

Use in 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 by your doctor based on the child's body weight. The usual dose is 0.25mg to 0.5mg per kilogram of body weight, given 3 or 4 times a day.

For migraine

Children under 12 years of age: 20mg may be given 2 or 3 times a day

Children over 12 years of age: 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.

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 Propranolol Tablets than you should

Propranolol Tablets are severely toxic if used in overdose. If you have accidentally taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention. The symptoms of overdose may include a slow or fast heart rate, low blood pressure, difficulty breathing, fainting, severe heart problems, coma, drowsiness, confusion, fits (seizures), pupils that are larger than normal in size, a high level of potassium in your blood, seeing and hearing things that are not there (hallucinations).

If you forget to take Propranolol 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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Propranolol Tablets

Do not stop taking Propranolol Tablets without consulting your doctor as your condition may worsen. In some cases it may be necessary to stop taking the medicine gradually.

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.

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 (may affect up to 1 in 10 people)

! Sleep disturbances, nightmares

! Cold hands and feet, Raynaud's syndrome ! Fatigue and lack of energy.

Uncommon (may affect up to 1 in 100 people)

! Diarrhoea, feeling sick (nausea) and being

sick (vomiting).

Rare (may affect up to 1 in 1,000 people)

! 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.

ENV05 Very rare (may affect up to 1 in 10,000 people)

! Severe muscle weakness (myasthenia gravis).

Frequency not known (frequency cannot be estimated from the available data)

! Low blood sugar levels (hypoglycaemia) in children, the elderly, patients with kidney and liver problems, patients taking medicines to treat diabetes and patients that are on a strict fasting diet

! Fits (seizures) linked to low blood sugar levels (hypoglycaemia)

! Changes in blood fats

! 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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PROPRANOLOL TABLETS

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Propranolol Tablets contain

The active substance is propranolol hydrochloride. Each tablet contains either 10mg, 40mg, 80mg or 160mg propranolol hydrochloride.

The other ingredients are: lactose monohydrate, maize starch, pregelatinised starch, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), Ethylcellulose, triacetin (E1518) and erythrosine aluminium lake (E127).

What Propranolol Tablets look like and contents of the pack

Propranolol 10mg Tablets 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.

Propranolol 40mg Tablets 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.

Propranolol 80mg Tablets are pink, round, film-coated tablets with an approximate diameter of 9.50mm, marked with P and 3 on either side of a score line on one side and plain on the other side.

Propranolol 160mg Tablets are pink, round, film-coated 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.

Propranolol 10mg, 40mg and 80mg Tablets are supplied in either PVC/PVDC blisters with Aluminium foil or Propranolol 10mg, 40mg,80mg and 160mg Tablets in securitainers with polyethylene closures.

Propranolol Tablets are supplied in the following pack sizes.

10mg and 40mg: 28 Tablets

80mg and 160mg: 56 Tablets

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited,

Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised in December 2023.