Propranolol 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPRANOLOL 10 mg,
40 mg & 80 mg TABLETS
PROPRANOLOL HYDROCHLORIDE
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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 any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
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)
• 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.
Take special care with Propranolol
Tell your doctor before you take this medicine 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.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken 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.
• moxisylyte to treat blood circulation problems like Raynaud's disease
• 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
• medicines to thin the blood and prevent clotting, such as warfarin
• levodopa to treat Parkinson's disease
• muscle relaxants such as baclofen or tizanidine
• mefloquine, used to treat malaria
• aldesleukin to treat cancer
• oestrogens used for contraception or hormone replacement therapy (HRT)
• steroids, such as hydrocortisone or prednisolone, to treat swelling and allergies
• pilocarpine to help produce more saliva and tears
• alprostadil for problems maintaining an erection
• cimetidine - used for too much stomach acid
• rifampicin, used for tuberculosis
• theophylline, used for asthma
• ergotamine or rizatriptan, used to treat migraines
• levothyroxine, used for thyroid problems
• pyridostigmine, used to treat muscle disorders such as myasthenia gravis
AVOID ALCOHOL whilst taking Propranolol. This is because alcohol can change the way Propranolol works.
Pregnancy and breast-feeding
If you are pregnant or plan to become pregnant speak to your doctor before taking Propranolol. Its effect in pregnancy is not known but some beta-blockers can affect the growth of the unborn baby.
Do not breast-feed your baby unless you have spoken to your doctor first as Propranolol can pass into your breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy or tired while taking Propranolol. If this happens, do not drive or use any tools or machines and tell your doctor.
Important information about some of the ingredients in Propranolol tablets
This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE PROPRANOLOL
Taking this medicine
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.
Do not stop taking this medicine unless your doctor tells you to stop.
Adults and children over 12 years of age:
The usual dose ranges from 30 mg - 320 mg daily depending on what condition you are taking the medicine for.
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
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
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. 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.
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
• feeling dizzy or faint, and worsening of breathing (called 'heart block')
• 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 and mood changes)
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 'psoriasis'
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
• depression
• headache
• conjunctivitis
• worsening of angina attacks
• constipation, dry mouth
• joint pain
• sexual dysfunction
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PROPRANOLOL
Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to 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, Gelatin, 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 (UK) Limited Boumpoulinas 11, 1st Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 11/2011
PPL0008&0009&0010/0010&0040&080T/LEA001