Bedranol Tablets 10mg
PACKAGE LEAFLET: INFORMATION FOR THE USER Propranolol hydrochloride tablets - 10mg, 40mg, 80mg and 160mg
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Propranolol Tablets are and what they are used for
2. Before you take Propranolol Tablets
3. How to take Propranolol Tablets
4. Possible side effects
5. How to store Propranolol Tablets
6. Further information
1. WHAT PROPRANOLOL TABLETS ARE AND WHAT THEY ARE USED FOR
Propranolol tablets contain a medicine called propranolol. It belongs to a group of medicines called ‘Beta-blockers’ and works by controlling blood pressure and thus reducing the demand on the heart.
Propranolol 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.
• Prevention of a further heart attack - if you have already suffered from a heart attack
• Controlling an abnormal heart beat
• Management of tremor
• Prevention of migraine
• Treatment of thyrotoxicosis - in combination with other medicines
• Management of phaeochromocytoma (a rare tumor of the adrenal gland) - in combination with other medicines.
2. BEFORE YOU TAKE PROPRANOLOL TABLETS
Do not take Propranolol Tablets if you:
• Are hypersensitive (allergic) to propranolol or any of the other ingredients.
• Have untreated/uncontrolled heart failure or are in shock caused by heart problems
• Suffer with heart conduction or rhythm problems
• Suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal’s angina)
• 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
• Have low blood sugar levels.
• Suffer from diabetes mellitus
• Suffer from increased acidity of the blood (metabolic acidosis)
• Have a slow heart beat
• Have low blood pressure
• Have problems with your circulation.
Take special care with Propranolol Tablets
Consult your doctor before taking Propranolol tablets if you:
• Have a history of allergic reactions. Propranolol may make you more sensitive to allergens which cause allergies in sensitive people.
• Have kidney disease
• Have liver disease including cirrhosis
• Have heart weakness or first degree heart block.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
In particular tell your doctor if you are taking any of the following:
• Propafenone, lignocaine used to treat abnormal heart rates
• Verapamil, Diltiazem and Nifedipine used to treat high blood pressure, angina and abnormal heart rhythms
• Xamoterol used as a heart stimulant in certain heart conditions
• Insulin and other diabetic agents used in the treatment of diabetes
• Adrenaline and other Sympathomimetics used to treat heart attacks and low blood pressure
• Clonidine - used to treat high blood pressure and migraine
• Digitoxin or digoxin used to treat heart failure
• Ergotamine, dihydroergotamine or related medicines used to treat migraine
• Non-steroidal anti-inflammatory drugs (NSAIDs) e.g ibuprofen, indomethacin used to treat pain and inflammation.
• Chlorpromazine used to treat psychiatric disorders
• Rifampicin used to treat infections
• Thyroxine used in the treatment of thyroid disorders
• Cimetidine used to treat stomach ulcers
• Fluvoxamine used to treat depression
• Aldesleukin used in the treatment of certain cancers
• Alprostadil used to treat impotence
• Corticosteroids used to treat a variety of illnesses
• Rizatriptan used to treat migraine
• Moxisylyte used to treat poor circulation
• Muscle relaxants often used in the treatment of multiple sclerosis
• Oestrogen and progesterone - used in the contraceptive pill
• Tropisetron used to treat sickness (usually after chemotherapy)
• Pyridostigmine used to treat myasthenia gravis
• ACE inhibitors- e.g. ramipril used to treat high blood pressure.
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 an anesthetic you need.
If you need to have any blood or urine tests you should tell the doctor or nurse you are taking propranolol tablets as they may interfere with the results.
Pregnancy and breastfeeding
Propranolol tablets are not recommended for use during pregnancy or breastfeeding. 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 some people to feel dizzy or tired. If you are affected do not drive or operate machinery as your alertness may be impaired.
Food and Drink
Alcohol may enhance the effect of the medicine.
Important information about some of the ingredients in Propranolol tablets
Propranolol 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 PROPRANOLOL TABLETS
Always take Propranolol 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 of water.
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, 2 or 3 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 propranolol 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.
For migraine and tremor
The initial dose is 40mg, 2 or 3 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 The initial dose is 10mg to 40mg, 3 or 4 times a day.
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
If you have liver or kidney problems a lower dose may be prescribed. You doctor will tell you what dose to take.
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 of the child’s body weight. The dose may be given 3 to 4 times a day.
For migraine
Children under 12 years of age: 40mg may be given 2 or 3 times a day
Children over 12 years of age: may be given the same dose as an adult (see the dosage prescribed by your doctor)
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
This medicine is to be taken at regular intervals, as determined 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.
If you stop taking Propranolol Tablets
Do not stop taking Propranolol tablets without consulting your doctor as your condition may worsen.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Propranolol tablets can cause side effects, although not everybody gets them.
Allergic reactions may occur rarely, with symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and dizzy when standing up. If any of these occur, STOP taking the medicine and contact a doctor immediately.
Common (less than 1 in 10)
• Sleep disturbances, nightmares
• Slowing of the heart beat
• Cold hands and feet, Raynaud’s syndrome
• Fatigue and lack of energy
Uncommon (less than 1 in 100)
• Diarrhoea, feeling sick (nausea) and being sick (vomiting)
Rare (less than 1 in 1,000)
• 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.
• Seeing and hearing things that are not there (Hallucinations)
• Psychoses, mood changes, memory loss, pins and needles.
• Visual disturbances and dry eyes.
• Worsening of heart failure, low blood pressure/fainting on standing, dizziness, precipitation of heart block.
• Worsening of muscle pains and cramps after exercise (intermittent claudication)
• Patients with asthma or a history of breathing problems may experience difficulty in breathing.
• Hair loss (Alopecia), worsening of psoriasis, skin rashes
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, changes in kidney function
• Muscle weakness, numbness
• Depression, confusion, headache
• Conjunctivitis
• Worsening of angina
• Shortness of breath
• Constipation, dry mouth, abdominal cramps
• Itchy skin
• 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.
5. STORING PROPRANOLOL 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 of via 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 reach and sight of children
6. FURTHER INFORMATION What Propranolol tablets contain:
Propranolol 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 Propranolol tablets look like and contents of the pack
Propranolol Tablets 10mg are pink, round, film-coated tablets with P1 embossed on one side and breakline on reverse.
Propranolol Tablets 40mg are pink, round, film-coated tablets with P2 embossed on one side and breakline on reverse.
Propranolol Tablets 80mg are pink, round, film-coated tablets with P3 embossed on one side and breakline on reverse.
Propranolol Tablets 160mg are pink, round, film-coated tablets with P4 embossed on one side and breakline on reverse.
Propranolol Tablets 10mg, 40mg, 80mg and 160mg are supplied in packs of 500
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK