PROPRANOLOL HYDROCHLORIDE 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Propranolol Hydrochloride 10mg film-coated tablets

Your medicine is available using the name Propranolol Hydrochloride 10mg film-coated tablets but will be referred to as Propranolol throughout this leaflet.

Other strengths 40mg and 80mg are also available.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• ■ Keep this leaflet. You may need to read it again.

• ■ If you have any further questions, ask your doctor or pharmacist or nurse.

• ■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• ■ If you get any of the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Propranolol is and what it is used for

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

• 3. How to take Propranolol

• 4. Possible side effects

• 5. How to store Propranolol

• 6. Contents of the pack and other information

1. what propranolol is and what it is used for

Propranolol contains propranolol hydrochloride which belongs to a group of medicines called beta-blockers. It has effects on the heart and circulation and also on other parts of the body.

Propranolol can be used for:

• ■ Hypertension (high blood pressure)

• ■ Angina (chest pain)

• ■ Some arrhythmias (disorders of heart rhythm)

• ■ Protection of the heart after a myocardial infarction (heart attack)

• ■ Migraine

• ■ Essential tremor (involuntary and rhythmic shaking)

• ■ Certain thyroid conditions (thyrotoxicosis and hyperthyroidism, which are 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

Do not take Propranolol tablets if you:

• ■ are allergic (hypersensitive) to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6)

• ■ have untreated/uncon­trolled heart failure

• ■ have had a shock caused by heart problems

• ■ have severe heart defects (second or third degree heart blocks) a condition which may be treated by a pacemaker

• ■ suffer with heart conduction or rhythm problems

• ■ have a very slow or very uneven heart rate

• ■ have an increased acidity of the blood (metabolic acidosis)

• ■ are on a strict fasting diet

• ■ suffer from asthma, wheezing or any other breathing difficulties

• ■ suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney)

• ■ suffer from severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

• ■ suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal’s an­gina)

• ■ have very low blood pressure

If you think that one of these situations applies to you, or if you are in any doubt, talk to your doctor before you start using Propranolol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Propranolol 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.

• ■ 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 heart problems.

• ■ Suffer from muscle weakness (myasthenia gravis)

• ■ Have conditions like chronic obstructive pulmonary disease and bronchospasm because the use of Propranolol can aggravate these conditions.

• ■ Use channel blockers with negative inotropic effects like verapamil and diltiazem (please refer to ‘Other medicines and Propranolol’).

Other medicines and Propranolol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Propranolol can interfere with the action of some other medicines and some medicines can have an effect on Propranolol.

Propranolol should not be used in combination with calcium channel blockers with negative inotropic effects (e.g. verapamil, diltiazem), as it can lead to an exaggeration of these effects. This may result in severe hypotension and bradycardia.

Other medicines which can cause problems when taken together with your medicine:

• ■ Nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat hypertension or angina)

• ■ Lidocaine (local anaesthetic)

• ■ Disopyramide, quinidine, amiodarone, propafenone and glycosides (to treat heart problems)

• ■ 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)

• ■ Fingolimod (for treating multiple sclerosis)

• ■ Fluvoxamine and barbiturates (to treat anxiety and insomnia)

• ■ MAO inhibitors (to treat depression)

If you are taking clonidine (for hypertension or migraine) and Propranolol 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 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.

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. If this happens to you, ask your doctor for advice.

Pregnancy, breastfeeding 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.

Pregnancy:

The use of this medicine is not recommended during pregnancy, unless your doctor considers it essential.

Breastfeeding:

Breastfeeding is not recommended when taking this medicine.

Important information about some of the ingredients of Propranolol:

Propranolol contains lactose monohydrate. 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

Always take this medicine exactly as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

Swallow your propranolol tablets with a drink of water before meals. Swallow whole. Do not chew.

Do not stop taking this medicine unless your doctor tells you to stop.

Adults

The following table shows the recommended dosages for an adult:

	Recommended dose	Total daily dosage (Maximum)
Hypertension (high blood pressure)	Initially 40mg two or three times daily, which may be increased by 80mg per day at weekly intervals.	160mg to 320mg
Angina (chest pains) and tremor	Initially 40mg two to three times daily, which may be increased by 40mg per day at weekly intervals.	120mg to 240mg
Protection of the heart after a heart attack	Initially 40mg four time a day and after a few days changes to 80mg twice a day	160mg
Migraine	Initially 40mg two to three times daily, which may be increased by 40mg per day at weekly intervals.	80mg to 160mg
Arrhythmias (disorders of heart rhythm), hyperthyroidism and thyrotoxicosis (certain thyroid conditions) and hypertrophic cardiomyopathy (thickened heart muscle)	10mg to 40mg three or four times daily	120mg to 160mg
Phaeochromocytoma	Before an operation: 60mg daily Non-operable treatment dose: 30mg daily	30mg to 60mg
Liver disease due to high blood pressure	Initially 40mg twice daily, increasing to 80mg twice daily	160mg to 320mg

Paediatric population

Propranolol can also be used to treat children with migraine and arrhythmias:

• ■ For migraine the dose under the age of 12 is 20mg two or three times daily and the adult dose for children 12 years or older.

• ■ For arrhythmias the dosage will be adjusted by the doctor according to the child's age or weight.

Older people

Older people should be started with the lowest dose. The optimum dose will be individually determined by the doctor.

Liver or kidney failure

The optimum dose will be individually determined by the doctor.

If you take more Propranolol than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Overdose causes an excessively slow heart rate, too low blood pressure, heart failure and breathing difficulty with symptoms such as fatigue, hallucinations, fine tremor, confusion, nausea, vomiting, body spasms, fainting or coma, low blood sugar. 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

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Propranolol

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, pharmacist or nurse.

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.

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 syn­drome)

• ■ Disturbed sleep/nightmares

• ■ Fatigue

• ■ Breathlessness

Uncommon (may affect up to 1 in 100 people):

• ■ Nausea, vomiting and diarrhoea

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

• ■ Worsening of breathing difficulties, sometimes with fatal outcome, if you have or have had asthma or asthmatic complaints

• ■ Heart failure, worsening of heart problems

• ■ Swelling of the skin which may occur in the face, tongue, larynx, abdomen, or arms and legs (angioedema)

• ■ Dizziness, particularly on standing up

• ■ Worsening of your blood circulation, if you already suffer from poor circulation

• ■ Hair loss (Alopecia)

• ■ Mood changes

• ■ Confusion

• ■ Memory loss

• ■ Psychosis or hallucinations (disturbances of the mind)

• ■ Paraesthesia (an abnormal sensation, typically tingling or pricking (‚pins and needles‘)

• ■ Disturbances of vision

• ■ Dry eyes

• ■ Skin rash, including worsening of psoriasis

• ■ Your medicine may alter the number and types of your blood cells such as reduce the number of platelets (thrombocytopenia) in your blood which may make you bruise and bleed more easily.

• ■ Purple spots on the skin (purpura)

Very rare (may affect up to 1 in 10,000 people):

• ■ Severe muscle weakness (myasthenia gravis)

• ■ Low levels of blood sugar may occur in diabetic and nondiabetic 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

• ■ Excessive sweating

Not known (frequency cannot be estimated from the available data):

• ■ Headache or seizure linked to low levels of sugar in the blood

• ■ Inability in a man to achieve an erection (impotence)

• ■ Decrease in renal blood flow

• ■ Joint pain(arthralgia)

• ■ Constipation

• ■ Dry mouth

• ■ Shortness of breath or breathlessness (dyspnoea)

• ■ Conjunctivitis (inflammation of the eye also called ‘pink eye’)

• ■ Depression

• ■ Severe and dangerous lowered white blood cell count (agranulocytosis)

• ■ Worsening of angina pectoris (chest pains)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

You can also report side effects directly via Yellow Card Scheme ator search for MHRA Yellow Card in the Google Play or Apple App Store.

5. how to store propranolol

• ■ Keep out of the sight and reach of children.

• ■ This medicinal product does not require any special storage conditions.

• ■ Do not use this medicine after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.

• ■ If your doctor decides to stop the treatment, return any leftover medicine to the pharmacist. Only keep it if your doctor tells you to.

• ■ If your medicine appears to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you further.

• ■ 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 to protect the environment.

6. contents of the pack and other information

What Propranolol contains

The active ingredient is propranolol hydrochloride.

Each film-coated tablet contains 10mg of propranolol hydrochloride.

The other ingredients are: maize starch, lactose monohydrate, magnesium stearate, hypromellose E464, microcrystalline cellulose E460, acetylated monoglycerides and diglycerides and titanium dioxide E171.

What Propranolol looks like and contents of the pack

The tablets are white to off-white, round, biconvex film-coated tablets imprinted with ‘AI’ on one side and a score-line on the other side.

The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Your medicine is available in blister packs of 28, 30 and 50 tablets.

Manufacturer

Manufactured by: Accord Healthcare Limited. Sage House, 319 Pinner road, North Harrow, HA1 4HF, United Kingdom. Or

Accord Healthcare Polska Sp.z.o.o, Ul Lutomierska 50, 95–200, Pabianice, Poland.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder:

Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0636 | POM |

Leaflet issue and revision date (Ref): 08.07.21

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Call +44 (0) 1302 365000 (Regulatory)

Please be ready to give the following information: Product name: Propranolol Hydrochloride

10mg film-coated tablets

Reference No: 21828/0636

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