Propranolol 40 mg tablets – patient leaflet, side effects, dosage

1. What Propranolol Tablets are and what they are used for

• Lidocaine
• Quinidine
• Amiodarone or propafenone (for irregular

Propranolol is one of a group of drugs called beta-blockers. Beta-blockers slow the heart and circulation and can affect other parts of the body e.g liver.

heartbeats)

• Digoxin (for heart failure)
• Adrenaline (a heart stimulant)

Propranolol can be used for many conditions including

• Ibuprofen and indometacin (for pain and

  inflammation)

• Hypertension (high blood pressure), angina (chest pains), some arrhythmias (disorders

• Ergotamine, dihydroergotamine or

  rizatriptan (for migraine)

of heart rhythm), protection of the heart after a myocardial infarction (heart attack).

• Chlorpromazine and thioridazine (for

  certain psychiatric disorders)

• Hypertrophic cardiomyopathy (thickening
• Cimetidine (for stomach problems)

heart muscle).

• Rifampicin (for the treatment of

• Prevention of migraine, essential tremor

  tuberculosis)

  and anxiety.

• Theophylline (for asthma)
• Thyrotoxicosis a thyroid condition caused
• Warfarin (to thin the blood) and

by an overactive thyroid gland.

hydralazine (for hypertension).

• Phaeochromocytoma (high blood pressure

  If you are taking clonidine (for hypertension or migraine) and propranolol tablets together, you must not stop taking clonidine unless your doctor tells you to do so. If it becomes necessary for you to stop taking clonidine, your doctor will give you careful instructions on how to do it.

  due to a tumour usually near the kidney).

• Bleeding in the oesophagus caused by high

  blood pressure in the liver.

2. What you need to know before you take Propranolol Tablets

If you have ever had asthma or wheezing, do not take your Propranolol Tablets. Go back to your doctor or pharmacist. Do not take Propranolol Tablets:

Propranolol Tablets with food, drink and alcohol

Propranolol Tablets should be swallowed with a drink of water.

• If you are allergic to Propranolol or any of

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

  If you frequently drink a lot of alcohol, this may reduce the effect of your medicine. Operations

Warnings and precautions

Talk to your doctor or pharmacist before taking Propranolol Tablets.

If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Propranolol Tablets.

Propranolol Tablets should also not be taken by people with heart failure which is not under control or people with certain other conditions such as heart block, very slow or very irregular heartbeats, very low blood pressure or very poor circulation. It should also not be taken by people who are fasting or have been fasting recently, people who have phaeochromocytoma (high blood pressure due to a tumour usually near the kidney) which is not being treated or by people who have metabolic acidosis or a particular type of chest pain called Prinzmetal's angina. Your doctor will know about these conditions. If you have one of these conditions, make sure your doctor knows about it before you take Propranolol Tablets.

Pregnancy, Breastfeeding and Fertility: Before taking these tablets tell your doctor if you are, you think you might be or are planning to become pregnant. You should not use Propranolol Tablets if you are breast-feeding or are planning to breast-feed your baby. Driving and using machines:

Propranolol Tablets may make you feel dizzy or tired. If affected do not drive or operate machinery.

Propranolol Tablets contain lactose:

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

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

3. How to take Propranolol Tablets

• Get allergic reactions to such things as

  insect stings.

  Always take Propranolol Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Propranolol tablets should be swallowed with a drink of water.

• 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.

• Suffer from unstable angina (non exercise-

  induced sharp chest pain).

  doctor's instructions about when and how to take your tablets. Please read the label on the container.

  This will also tell you how many tablets to take and when you should take them. Ask your doctor or pharmacist if you are not sure. The following table shows the usual total daily oral dosage for an adult:-

*Under some circumstances, propranolol tablets can be used to treat children with these conditions. The dosage will be adjusted by the doctor according to the child's age or weight. Older people may be start on a lower dose. If you take more Propranolol Tablets than you should:

If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified. Propranolol is severely toxic if used in overdose. If you have accidently taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention.

If you forget to take Propranolol Tablets: If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take two doses at the same time.

If you stop taking Propranolol Tablets: Do not stop taking Propranolol Tablets without first discussing it with your doctor. In some cases it may be necessary to stop taking the medicine gradually.

If you have any further questions on the use of Propranolol Tablets ask your doctor or pharmacist.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. Common (may affect up to I in 10 people)

• Cold fingers and toes
• The heart beating more slowly

• Numbness and spasm in the fingers which

  is followed by warmth and pain (Raynaud's phenomenon)

• Disturbed sleep/nightmares
• Fatigue.

Uncommon (may affect up to I in 100 people)

• Diarrhoea
• Nausea
• Vomiting.

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

• Worsening of breathing difficulties, if you

  have or have had asthma

• Breathlessness and/or swollen ankles, if

  you also have heart failure

• Heart block which may cause an abnormal

  heart beat, dizziness, tiredness or fainting

• Dizziness, particularly on standing up

• Worsening of your blood circulation, if you

  already suffer from poor circulation

• Hair loss
• Mood changes

• Confusion

  • Memory loss
  • Psychosis or hallucinations (disturbances of the mind)
  • Tingling of the hands
  • Disturbances of vision
  • Dry eyes
  • Skin rash, including worsening of psoriasis
  • Bruising more easily (thrombocytopaenia)
  • Purple spots on the skin (purpura). Very rare (may affect up to 1 in 10,000 people)
  • Severe muscle weakness (myasthenia gravis)
  • There may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Propranolol Tablets has had any effect on your blood. Not known (frequency cannot be estimated from the available data)
  • Low levels of blood sugar may occur in diabetic and non-diabetic patients including the new-born, toddlers and children, elderly patients, patients on artificial kidneys (haemodialysis) or patients on medication for diabetes. It may also occur in patients who are fasting or have been fasting recently or who have a long-term liver disease.
  • Seizure linked to low levels of sugar in the blood.

Do not be alarmed by this list of possible events. You may not have any of them. If you get any other undesirable events or if you think your medicine is causing any problems, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Propranolol Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of the month. Do not store the tablets above 25°C. Store in the original container. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer required. These measures will help protect the environment.

6. Contents of the pack and other information The Propranolol Tablets contain

The active substance is Propranolol hydrochloride.

The other ingredients are lactose, microcrystalline cellulose, talc, stearic acid, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E171) and carmine (El20).

What Propranolol Tablets look like and contents of the pack

The 40mg tablets are pink, film-coated biconvex tablets with breakline on one face embossed '40' on the other.

Propranolol 40mg Tablets are available in pots of 20, 50 and 1000 tablets and blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

Date Leaflet revised in: March 2020.

PL 20395/0082

VERSION XXXXXX DATE 03.03.2020 148 mm

1.2

148 mm

NO. OF COLORS 01

PRODUCT NAME

Propranalol tablets

██ Black

PRODUCT LICENCE NO.

20395-0082

Pil

COUNTRY

UK (English)

148 x 310 mm

MANUFACTURER

MARKSANS

STRENGTH

PACK SIZE

40 mg

NIL

SOFTWARE

ARTIST

Adobe illustrator CC Santosh

FONT & SIZE

Humanst 521Bt 11.6pt, 9pt

REMARKS

NA

REASON FOR CHANGE

Comments received from Shivaraj on 27.02.2020