Patient leaflet - Propranolol Hydrochloride 80 mg film-coated tablets
1. What Propranolol hydrochloride Tablets is and what it is used for
The full name of your medicine is Propranolol hydrochloride 10mg, 40mg and 80mg film-coated Tablets, but within the leaflet it will be referred to as Propranolol hydrochloride Tablets. Propranolol is one of a group of drugs called beta-blockers. It has effects on the heart and circulation and also on other parts of the body. Propranolol hydrochloride Tablets can be used for many conditions including:
- Hypertension (high blood pressure)
- Angina (chest pain)
- Some arrhythmias (disorders of heart rhythm)
- Protection of the heart after a myocardial infarction (heart attack)
- Prevention of migraine
- Essential tremor, anxiety
- Certain thyroid conditions (such as thyrotoxicosis, which is caused by an overactive thyroid gland)
- Hypertrophic cardiomyopathy (thickened heart muscle)
- Phaeochromocytoma (high blood pressure 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 hydrochloride Tablets If you have ever had asthma or wheezing, do not take your Propranolol hydrochloride Tablets. Go back to your doctor or pharmacist. Do not take Propranolol hydrochloride Tablets:
- If you are allergic to propranolol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Propranolol hydrochloride Tablets.
Propranolol hydrochloride 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 hydrochloride Tablets. Talk to your doctor or pharmacist before taking Propranolol hydrochloride Tablets if you:
- Get allergic reactions to such things as insect stings.
- Have diabetes as Propranolol may change your normal response to low blood sugar, which usually involves an increase in heart rate. Propranolol may cause low blood sugar levels even in patients who are not diabetic.
Suffer from unstable angina (non
exercise-induced sharp chest pain).
- Have thyrotoxicosis. Propranolol may hide the symptoms of thyrotoxicosis.
- Have kidney or liver problems (including cirrhosis of the liver). If so, talk to your doctor because you may need to have some check-ups during your treatment.
- Have any other health problems such as circulation disorders, heart problems, breathlessness or swollen ankles.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Propranolol hydrochloride Tablets. Other medicines and Propranolol
hydrochloride Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Propranolol hydrochloride Tablets can interfere with the action of some other drugs and some drugs can have an effect on your medicine. The drugs which can cause some problems when taken together with your medicine are:
- Verapamil
- Diltiazem
- Nifedipine
Nisoldipine
- Nicardipine
- Isradipine
- Lacidipine (which are used to treat hypertension or angina)
- Disopyramide
- Lidocaine
- Quinidine
- Amiodarone or propafenone (for irregular heartbeats)
- Digoxin (for heart failure)
- Adrenaline (a heart stimulant)
- Ibuprofen and indometacin (for pain and inflammation)
- Ergotamine, dihydroergotamine or rizatriptan (for migraine)
- Chlorpromazine and thioridazine (for certain psychiatric disorders)
- Cimetidine (for stomach problems)
- Rifampicin (for the treatment of tuberculosis)
- Theophylline (for asthma)
- Warfarin (to thin the blood) and hydralazine (for hypertension).
If you are taking clonidine (for hypertension or migraine) and Propranolol hydrochloride 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.
Propranolol hydrochloride Tablets with food, drink and alcohol
Alcohol may affect how this medicine works. Operations
If you go into hospital to have an operation, tell the anaesthetist or the medical staff that you are taking Propranolol hydrochloride Tablets.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate machinery.
However, some people may occasionally feel dizzy or tired when taking Propranolol hydrochloride Tablets. If this happens to you, ask your doctor for advice.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Propranolol hydrochloride Tablets contains lactose
Propranolol contains 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.
3. How to take Propranolol hydrochloride Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Propranolol hydrochloride Tablets should be swallowed with a drink of water. Your doctor will have decided how many Propranolol hydrochloride Tablets you need to take each day depending on your condition. Follow your 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 recommended total daily dosages for an adult:
Hypertension (high blood pressure) 160 mg to
320 mg Angina (chest pains) 120 mg to
240 mg Arrythmias (disorders of heart rhythm)* 30 mg to 160 mg Protection of the heart after 160 mg a heart attack
Prevention of migraine* 80 mg to 160 mg Portal Hypertension 80 mg to 320 mg Essential tremor 80 mg to 160 mg Anxiety 40 mg to 120 mg Certain thyroid conditions 30 mg to 160 mg (such as thyrotoxicosis)*
Hypertrophic cardiomyopathy 30 mg to 160 mg (thickened heart muscle)
Phaeochromocytoma* 30 mg to 60 mg Bleeding in the oesophagus 80 mg to 160 mg caused by high blood pressure
in the liver
*Under some circumstances, Propranolol hydrochloride 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.
Elderly people may be started on a lower dose. Propranolol hydrochloride 40 mg and 80 mg film-coated Tablets have score-line. The score line is intended for breaking the tablet if you have difficulty swallowing it whole.
If you take more Propranolol hydrochloride Tablets than you should
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. Signs of an overdose may include: slow heart-rate, low blood pressure, heart failure, wheezing and shortness of breath.
If you accidentally take an overdose of your medicine, either call your doctor straight away, or go to your nearest hospital casualty department. Always take any remaining tablets, the container and the label with you, so that the medicine can be identified.
If you forget to take Propranolol hydrochloride Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Propranolol hydrochloride 10mg, 40mg and 80mg Film-coated Tablets
If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Don’t take two doses at the same time. If you are worried, ask your doctor or pharmacist for advice. If you stop taking Propranolol hydrochloride Tablets
Do not stop taking your medicine without talking to your doctor first. 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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Serious side effects
STOP treatment and contact a doctor at once if you have the following symptoms of an:
- Intolerance to Propranolol hydrochloride Tablets such as slow heart rate and low blood pressure causing dizziness, light-headedness, fainting or blurred vision
- Allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue.
Common (may affect up to 1 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 1 in 100 people)
- Diarrhoea
- Nausea
- Vomiting
Rare (may affect up to 1 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 hydrochloride 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 newborn, 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.
- Depression
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 hydrochloride 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 carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. If your doctor decides to stop treatment, return any leftover tablets to your pharmacist. Only keep them if the doctor tells you to.
6. Contents of the pack and other information
What Propranolol hydrochloride Tablets contains:
The active ingredient is propranolol
hydrochloride. Propranolol hydrochloride Tablets is produced as film-coated tablets in three different strengths. Each tablet contains 10 mg or 40 mg or 80 mg of propranolol hydrochloride. The other ingredients are:
Core: Gelatin (120 bloom), Lactose
monohydrate, Carmellose calcium, Magnesium stearate.
Coating: Instacoat A17E00146 containing HPMC 2910/Hypromellose (E464), Polyethylene Glycol (E 1521), Talc (E553b), Calcium Carbonate (E
170), Lake Erythrosine (E 127), Iron Oxide Yellow (E 172), Lake Brilliant Blue (E 133). What Propranolol hydrochloride Tablets look like and contents of the pack
Propranolol hydrochloride 10 mg, 40 mg and 80 mg film-coated tablets are produced in packs of 28, 30, 56, and 60 tablets.
Propranolol hydrochloride 10 mg film-coated tablets are pink colored, round, convex film-coated tablets plain on both sides with approximately 5.1 mm diameter.
Propranolol hydrochloride 40 mg film-coated tablets are pink colored, round, convex film-coated tablet, break line on one side and debossed “P4” on another side with approximately 8.6 mm diameter.
Propranolol hydrochloride 80 mg film-coated tablets are Pink colored, round, convex film-coated tablets, breakline on one side and plain on another side with approximately 11.2 mm diameter.
Marketing Authorisation Holder
Orbit Pharma Limited
128 City Road, London
United Kingdom, EC1V 2NX
Manufacturer
Sciom Limited
Unit 4, Martinfield Business Centre, Martinfield, Welwyn Garden City,
AL7 1HG, United Kingdom
This leaflet was last revised in OCT 2024.