Propranolol 80mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPRANOLOL 10 mg, 40 mg & 80 mg TABLETS
PROPRANOLOL HYDROCHLORIDE
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4.
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THIS LEAFLET CONTAINS
1. What Propranolol is for
2. Before you take Propranolol
3. How to take Propranolol
4. Possible side effects
5. How to store Propranolol
6. Further information
1. WHAT PROPRANOLOL IS FOR
Propranolol belongs to a group of medicines called
beta-blockers. It can be used to treat many conditions
including:
• symptoms of chest pain (angina pectoris)
• high blood pressure (hypertension)
• shaking (tremors)
• stress (anxiety)
• problems affecting the beat of your heart (arrhythmias, tachycardia)
• thickened heart muscle - also called 'hypertrophic cardiomyopathy'
• high blood pressure caused by a tumour on the adrenal gland. This is called 'phaeochromocytoma'
• an overactive thyroid gland - also called 'thyrotoxicosis'
• protection against further heart attacks - if you have already had one
• severe headaches (migraine)
• bleeding in the food pipe (oesophagus). This happens when the blood pressure is high in your liver
If you are not sure why you have been prescribed this
medicine then please ask your doctor.
2. BEFORE YOU TAKE PROPRANOLOL
Do not take Propranolol and tell your doctor if you:
• are allergic (hypersensitive) to Propranolol or any of the other ingredients in the tablets (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath
• have a history of asthma, wheezing or any other breathing difficulties
• have any of the following heart problems:
- have heart failure which is not under control (signs include breathlessness and swollen ankles)
- second or third degree heart block (a condition which may be treated with a pacemaker)
- very slow or very uneven heart beats
- low blood pressure (hypotension) which can make you feel dizzy or light-headed
- severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)
- chest pain that happens when you are resting rather than during exercise (Prinzmetal's angina)
- have a sudden and rapid fall in blood pressure (cardiogenic shock)
- a problem (common in the elderly) related to poor control of the working of the heart (sick sinus syndrome)
• have not been eating (fasting) for a long period of time or if your blood has become too acidic (metabolic acidosis)
• have high blood pressure caused by a tumour of the adrenal gland which has not been treated, this is called phaeochromocytoma
• have or sometimes get low blood sugar ('hypoglycaemia'). This can happen if you are not eating well, have long-term liver disease or have diabetes
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Propranolol.
Warnings and precautions
Talk to your doctor before taking Propranolol if you:
• have or have had heart problems (including heart failure, first degree heart block, heart attack, uneven heart beats or angina), as your doctor may do some tests on your heart before giving you this medicine
• suffer from blood circulation problems (such as Raynaud's disease)
• have a skin problem called psoriasis
• have a history of allergic reactions or need anti-allergic treatment e.g. following a wasp or bee sting
• have a thyroid problem, as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by this medicine
• have liver problems (such as cirrhosis) or kidney problems as you may be given a lower dose of this medicine
• have diabetes, as symptoms of low blood sugar levels (hypoglycaemia) may be hidden by this medicine
• smoke tobacco-containing products
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Propranolol.
Operations and tests
Tell your doctor, dentist or nurse you are taking Propranolol if you:
• are going to have an operation or an anaesthetic
• are going to have any blood or urine tests
Other medicines and Propranolol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines bought without a prescription. This is because Propranolol can affect the way some medicines work. Also some medicines can affect the way Propranolol works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• medicines to treat irregular or uneven heart beat, such as amiodarone, flecainide, lidocaine and propafenone
• medicines to treat high blood pressure or chest pain, such as diltiazem, nifedipine, verapamil, and nitrates such as glyceryl trinitrate
• medicines to treat high blood pressure, such as captopril and lisinopril (ACE inhibitors), doxazosin and prazosin (alpha-blockers), candersatan and irbesartan, diazoxide, hydralazine, guanethidine, methyldopa, minoxidil, moxonidine, sodium nitroprusside
• medicines to increase urine production, (diuretics), such as amiloride, furosemide or spironolactone
• digoxin to treat heart failure
• clonidine, used to treat high blood pressure or migraine.
Do not stop taking clonidine unless your doctor tells you to. If you have to stop taking clonidine, your doctor will tell you how to do it.
• medicines for stimulating the heart, such as adrenaline, noradrenaline or dobutamine
• medicines to treat diabetes, such as gliclazide, metformin or insulin
• medicines for pain and swelling, such as ibuprofen or indometacin
• medicines to treat anxiety, depression or mental health problems, such as diazepam, temazepam, fluvoxamine, imipramine, phenelzine, moclobemide, chlorpromazine and trifluoperazine
• barbiturates, to help you sleep or to treat epilepsy, such as phenobarbital
• medicines to thin the blood and prevent clotting, such as warfarin
• levodopa to treat Parkinson's disease
• cimetidine, used for too much stomach acid
• rifampicin, used for tuberculosis
• theophylline, used for asthma
• ergotamine or rizatriptan, used to treat migraines
AVOID ALCOHOL whilst taking Propranolol. This is because alcohol can change the way Propranolol works.
Pregnancy and breast-feeding
The effect of propranolol in pregnancy is not known but some beta-blockers can affect the growth of the unborn baby. Propranolol can pass into your breast milk.
If you are planning to have a baby, think you may be pregnant, are pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this or any medicine.
Driving and using machines
Propranolol may cause visual disturbances, hallucinations, fatigue, confusion, dizziness or tiredness. If you are affected, do not drive or use any tools or machines and tell your doctor.
Propranolol contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE PROPRANOLOL
Always take Propranolol Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure. Take this medicine by mouth with water, perferably before meals.
Do not stop taking this medicine unless your doctor tells you to stop.
The recommended doses are;
Adults and children over 12 years of age:
Angina, migraine and tremors. Initially 40 mg two or three times daily, increasing to 80-160 mg daily for migraine and tremors and 120-240 mg daily for angina.
Hypertension. Initially 80 mg twice daily, increasing to 160-320 mg/daily.
Irregular or fast heartbeat, thickened heart muscle and over-active thyroid gland. 10-40 mg three or four times daily. Anxiety. 40 mg daily for short-term anxious situations. For long-term anxiety 40 mg two or three times daily. Treatment should be reviewed after six to twelve months.
Heart attack Start between 5-21 days after an attack with 40 mg four times daily for two or three days, then 80 mg twice a day.
Phaeochromocytoma-. Before an operation; 60 mg daily for three days, otherwise 30 mg daily.
Increased blood pressure in the liver. Initially 40 mg twice daily, increasing to 80 mg twice daily or, if necessary, a maximum of 160 mg twice daily.
Children under 12 years of age:
Your doctor will decide on the amount of Propranolol to give to your child based on their weight and what condition they are taking the medicine for.
Elderly:
Your doctor will decide how much Propranolol to give you.
Patients with kidney or liver problems:
A reduced initial dose may be given.
If you take more Propranolol than you should
Contact your doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you so the doctor knows what you have taken.
The symptoms of overdose can include an excessively slowed heart beat, fainting, dizziness, breathlessness on exertion, confusion, hallucinations, body spasms, coma and heart attack.
If you forget to take Propranolol
Take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you suddenly stop taking Propranolol
Keep taking this medicine until your doctor tells you to stop. You may have to stop taking this medicine gradually. Your doctor will help you do this.
Stopping this medicine suddenly can cause symptoms such as a faster heart beat, sweating, shaking, palpitations, worsening of angina, heart attack or death.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Propranolol can cause side effects, although not everybody gets them.
If you get any of the following side effects, see your doctor or go to the nearest hospital emergency department straight away:
• any kind of skin rash, flaking skin, boils, swelling of the face, lips, tongue or throat, sudden wheezing, fluttering or tightness of the chest or collapse. This may mean you are having an allergic reaction to propranolol
• difficulty in breathing, especially if you have a history of asthma, wheezing or other lung diseases.
If you get any of the following side effects, stop taking Propranolol and tell your doctor as soon as possible:
• slowing of the heart beat or worsening of heart failure (signs include breathlessness and swollen ankles)
• low blood pressure (hypotension) which can make you feel dizzy or light-headed when standing quickly
• feelinq dizzy or faint, and worsening of breathinq (called 'heart block1)
• poor blood circulation making the fingers and toes cold, numb and pale (Raynaud's phenomenon), this can lead to cramp-like pains in the lower leg
• bleeding or bruising more easily or purplish marks on the skin, sore throat, fever, frequent infections. These symptoms may indicate changes in the levels of your blood cells.
• low blood sugar (hypoglycaemia) in children or elderly who do not have diabetes (signs include weakness, headache, feeling hungry, visual disturbances, mood changes and fits (seizures))
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (affects less than 1 in 10 people)
• nightmares or difficulty sleeping
• feeling tired or weak
Uncommon (affects less than 1 in 100 people)
• feeling sick (nausea), being sick (vomiting) or diarrhoea
Rare (affects less than 1 in 1,000 people)
• strange sounds and visions (hallucinations), loss of touch with reality (psychoses), mood changes, feeling confused, memory loss, feeling dizzy, tingling or numbness in the hands and feet
• dry eyes, changes in eyesight
• hair loss, skin rashes or worsening of the skin problem 'psoriasis1
Very rare (affects less than 1 in 10,000 people, including isolated reports)
• muscle weakness and a disease of the muscles (called 'myasthenia gravis') getting worse
Side effects with an unknown frequency occurrence
• signs of excessive thyroid hormone levels (hyperthroidism) masked
• changes in blood fat levels
• depression, headache
• conjunctivitis
• worsening of angina attacks
• constipation, dry mouth
• joint pain
• changes in kidney function
• sexual dysfunction
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PROPRANOLOL
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container, and keep the container tightly closed.
Do not use the tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
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. FURTHER INFORMATION
What Propranolol tablets contain
The active substance (the ingredient that makes the tablets work) is propranolol hydrochloride. Each tablet contains either 10 mg, 40 mg or 80 mg of the active substance.
The other ingredients are; lactose monohydrate, gelatine, stearic acid, magnesium stearate, ethylcellulose, hypromellose, diethyl phthalate, Opaspray K-1-5506 (titanium dioxide, hypromellose and carmine E120), beeswax yellow.
What Propranolol Tablets look like and contents of the pack
The 10 mg tablets are pink, round film-coated tablets, engraved MP64 on one side.
The 40 mg tablets are pink, round film-coated tablets engraved MP65 on one side.
The 80 mg tablets are pink, round film-coated tablets, engraved MP66 on one side.
All three strengths of Propranolol Tablets come in containers of 50,100, 250, 500 and 1000 tablets and blister packs of 28 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited
41-43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brampton Road, London, SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 08/2016
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