•
worsening of your blood circulation, if you 6 Contents of the pack and other
already suffer from poor circulation information
• worsening of breathing difficulties, if you have or What Propranolol tablets contain
have had asthma • the active substance (the ingredient that makes
• hair loss, skin rash, including worsening of the tablets work) is propranolol hydrochloride. Package leaflet: Information for the patient
psoriasis, purple spots on the skin (purpura) Each tablet contains either 10mg, 40mg, 80mg
Very rare (may affect up to 1 in 10,000
or 160mg of the active substance.
• the other ingredients are lactose, magnesium
Propranolol 10mg, 40mg, 80mg
people)
• severe muscle weakness (myasthenia gravis)
stearate, maize starch, stearic acid, hypromellose and 160mg tablets
(E464).
• there may be changes to some of the cells or • the coating contains polysorbate, carmoisine
other parts of your blood. It is possible that your (E122), titanium dioxide (E171), iron oxide red Read all of this leaflet carefully before • prevention of migraine
doctor may occasionally take blood samples to (E172), hypromellose (E464). you start taking this medicine because it • essential tremor, anxiety
check whether propranolol has had any effect contains important information for you. • certain thyroid conditions (such as
on your blood. What Propranolol tablets look like and • K eep this leaflet. You may need to read it thyrotoxicosis, which is caused by an
contents of the pack again. overactive thyroid gland)
Not known (frequency cannot be Propranolol tablets 10mg are pink, circular, • I f you have any further questions, ask your • hypertrophic cardiomyopathy (thickened
estimated from the available data): biconvex film-coated tablets impressed “C” on doctor or pharmacist. heart muscle)
• Low levels of blood sugar may occur in diabetic one face and the identifying letters “P” and “A” on • T his medicine has been prescribed for you • phaeochromocytoma (high blood pressure
and non diabetic patients including the either side of a central division line on the reverse. only. Do not pass it on to others. It may due to a tumour usually near the kidney)
newborn, toddlers and children, elderly patients, • bleeding in the oesophagus or stomach
Propranolol tablets 40mg and 80mg are pink film- harm them, even if their signs of illness are
patients on artificial kidneys (haemodialysis) or coated tablets. caused by high blood pressure in the liver.
the same as yours.
patients on medication for diabetes. It may also Propranolol tablets 160mg are pink, circular, • I f you get any side effects, talk to your
occur in patients who are fasting or have been 2 What you need to know before you
biconvex film-coated tablets impressed “C” on doctor or pharmacist. This includes any
fasting recently or who have a long-term liver one face and the identifying letters “P” and “D” on possible side effects not listed in this take Propranolol tablets
disease. either side of a central division line on the reverse.
• Seizure linked to low levels of sugar in the blood.
leaflet. See section 4. Do not take Propranolol tablets and tell your
Pack sizes are 28 and 56 tablets.
Not all pack sizes may be available. doctor if you:
Reporting of side effects What is in this leaflet • are allergic to Propranolol or any of the other
If you get any side effects, talk to your doctor, 1 What Propranolol tablets are and ingredients of this medicine (listed in section 6)
Marketing Authorisation Holder and
pharmacist or nurse. This includes any possible Manufacturer what they are used for • have untreated/uncontrolled heart failure
side effects not listed in this leaflet. You can also Accord, Barnstaple, EX32 8NS, UK 2 What you need to know before you or are in shock caused by heart problems
report side effects directly via the Yellow Card take Propranolol tablets • suffer with heart conduction or rhythm
Scheme at: www.mhra.gov.uk/yellowcard or This leaflet was last revised in March 2021 3 How to take Propranolol tablets problems (second or third-degree heart
search for MHRA Yellow Card in the Google Play block or sick sinus syndrome)
or Apple App Store.
4 Possible side effects • have a slow heart rate
5 How to store Propranolol tablets • have low blood pressure
By reporting side effects, you can help provide 6 Contents of the pack and other • suffer from severe blood circulation
more information on the safety of this medicine. information problems (which may cause your fingers and
toes to tingle or turn pale or blue)
5 How to store Propranolol tablets 1 What Propranolol tablets are and • suffer from diabetes mellitus (low blood
what they are used for sugar levels may be hidden by this medicine)
Keep Propranolol tablets out of the sight and or increased acidity of the blood (metabolic
reach of children. Propranolol is one of a group of medicines acidosis)
Do not store the tablets above 25°C. called beta-blockers. It has effects on the heart • are on a strict fasting diet
Do not take the tablets after the expiry date and circulation and also on other parts of • suffer from a tight, painful feeling in the chest
which is stated on the carton. The expiry date is the body. Propranolol can be used for many in periods of rest (Prinzmetal’s angina)
also stated on the back of the strip after ‘Exp’. Do conditions including: • suffer from asthma or any other breathing
not throw away any medicines via wastewater • hypertension (high blood pressure) difficulties
or household waste. Ask your pharmacist how to • angina pectoris (chest pain) • suffer from untreated phaeochromocytoma
throw away medicines you no longer use. These • some arrhythmias (disorders of heart rhythm) (high blood pressure due to a tumour near
• protection of the heart after a myocardial the kidney).
measures will help protect the environment.
Continued top of next column infarction (heart attack)
50995392 BBBA9693 Continued top of next column continue over page
350x210 Leaflet Reel Fed Profile Landscape (BST) page 4 page 1
Propranolol All strengths Tablets PIL - UK
Propranolol BP Tablets
approved for print/date
10, 40, 80, 160mg x 28 56 (UK) Item number: BBBA9693 Colours Non Printing Colours
1. Black 1. Profile
Originator: R.Paul Dimensions: 350x210 (Reel Fed)
JDE No.: 50995392 2. 2.
Origination Date: 18.11.2020 Min Body Text Size: 9.5, 10.5pt & 11.5pt
Dimensions: 350x210 (Reel Fed) Revision Date: 11.03.2021 Supplier: Accord Barnstaple 3. 3.
Component: Leaflet for Blisters Revised By: R.Paul 4.
5.
Proof Round
Pharmacode: 7433
Date Sent: 26/10/20
8 Technical
Approval
Date sent: N/A
Date received: N/A
6.
Technologist: T. Hull EU-Artwork-Support@accord-healthcare.com
Technically Approved Cartons and label leaflets only
German GTIN 14 (incorporating PZN):
(labels only when specified)
* Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7
12.02.2020
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.
Warnings and precautions • ibuprofen and indometacin (for pain and Your doctor will have decided how many propranolol If you forget to take Propranolol tablets
Talk to your doctor or pharmacist before taking inflammation) tablets you need to take each day depending on your If you forget to take a dose, take it as soon as you
Propranolol tablets if you: • chlorpromazine and thioridazine (for psychiatric condition. Follow your doctor’s instructions about remember, unless it is nearly time for your next dose.
•h ave heart failure (please also see “Do not take” illness) when and how to take your tablets. Please read the Take your next dose at the usual time. Don’t take two
section above) • anaesthetics label on the carton. This will also tell you how many doses at the same time. If you are worried, ask your
• s uffer from blood circulation problems (which may • warfarin (to thin the blood) tablets to take and when you should take them. Ask doctor or pharmacist for advice.
cause your fingers and toes to tingle or turn pale or • rifampicin (to treat infection) your doctor or pharmacist if you are not sure.
blue) • theophylline (treating asthma) The following table shows the recommended total If you stop taking Propranolol tablets
• have a heart weakness or first-degree heart block daily dosages for an adult: Do not stop taking your medicine without talking to
•h ave diabetes. Propranolol may change your normal Propranolol tablets with alcohol your doctor first. In some cases, it may be
response to low blood sugar, which usually involves You are advised to avoid alcohol whilst taking this Hypertension necessary to stop taking the medicine gradually. If
an increase in heart rate. Propranolol may cause medicine. (high blood pressure) 160 mg to 320 mg you have any further questions on the use of this
low blood sugar levels even in patients who are not Angina (chest pains) 120 mg to 240 mg medicine, ask your doctor or pharmacist.
diabetic (please see section 4 “Possible side effects”) Pregnancy, breast-feeding and fertility Arrythmias (disorders of
•h ave kidney or liver problems (including cirrhosis of Propranolol tablets are not recommended during heart rhythm) 30 mg to 160 mg 4 Possible side effects
the liver) pregnancy or breast-feeding. If you are pregnant Protection of the heart
•h ave thyrotoxicosis. Propranolol may hide the or breast-feeding, think you may be pregnant or after a heart attack 160 mg Like all medicines, this medicine can cause side
symptoms of thyrotoxicosis. are planning to have a baby, ask your doctor or Prevention of migraine 80 mg to 160 mg effects, although not everybody gets them.
•h ave a phaeochromocytoma (a tumour near the pharmacist for advice before taking this medicine. Essential tremor 80 mg to 160 mg
kidney) (please also see “Do not take” section above) Anxiety 40 mg to 120 mg Stop treatment and contact a doctor at once
• have a history of allergic reactions. Driving and using machines Certain thyroid conditions if you have the following symptoms of an:
Your medicine is unlikely to affect your ability to drive (such as thyrotoxicosis) 30 mg to 160 mg • intolerance to Propranolol tablets such as slow
Other medicines and Propranolol tablets or to operate machinery. However, some people Hypertrophic cardiomyopathy heart rate and low blood pressure causing dizziness,
Tell your doctor or pharmacist if you are taking, may occasionally feel dizzy or tired when taking (thickened heart muscle) 30 mg to 160 mg light-headedness, fainting or blurred vision
have recently taken or might take any other propranolol tablets. If this happens to you, ask your • allergic reaction such as itching, difficulty
Phaeochromocytoma 30 mg to 60 mg
medicines. Propranolol can interfere with the action breathing or swelling of the face, lips, throat or
doctor for advice. Bleeding in the oesophagus
of some other medicines and some medicines can tongue
caused by high blood pressure
have an effect on propranolol tablets. The medicines Anaesthetics or tests in the liver 80 mg to 160 mg
which can cause some problems when taken Tell your doctor if you notice any of the
If you are going to have an anaesthetic or any blood following side effects or notice any other
together with propranolol tablets are: or urine tests, please tell your doctor or dentist that Elderly people may be started on a lower dose.
• insulin (to treat diabetes) effects not listed:
you are taking Propranolol tablets. If you see another
•e rgotamine, dihydroergotamine or rizatriptan (for doctor or go into hospital, let them know what Children and Adolescents: Common (may affect up to 1 in 10 people):
migraine) medicines you are taking. Under some circumstances, propranolol tablets • disturbed sleep/nightmares
•d isopyramide, quinidine, amiodarone, propafenone can be used to treat children with the following • the heart beating more slowly
(to treat irregular heartbeat (arrhythmia)) Propranolol tablets contain Lactose conditions: • cold fingers and toes, numbness and spasm in
•d igitalis glycosides (digoxin) (to treat heart If you have been told by your doctor that you have irregular heartbeats, phaeochromocytoma, the fingers which is followed by warmth and pain
conditions) an intolerance to some sugars, contact your doctor thyrotoxicosis, Fallot’s tetralogy, migraine. (Raynaud’s phenomenon)
• v erapamil, diltiazem, nifedipine, nisoldipine, before taking this medicinal product. The dosage will be adjusted by the doctor according • fatigue
nicardipine, isradipine, lacidipine and to the child’s age or weight.
dihydropyridine (to treat heart diseases) Propranolol tablets contain Carmoisine Uncommon (may affect up to 1 in 100 people):
• a drenaline (used in anaphylactic shock) (E122) If you take more Propranolol tablets than you • feeling or being sick, diarrhoea
• lidocaine (to treat irregular heartbeat or as a local Propranolol tablets contain carmoisine (E122) which should
anaesthetic) may cause allergic reactions. Propranolol is severely toxic if used in overdose. If Rare (may affect up to1 in 1,000 people):
• c imetidine (to treat stomach ulcers) you have accidently taken more than the prescribed • bruising more easily (thrombocytopaenia)
•h ydralazine (to treat high blood pressure) 3 • mood changes, confusion, memory loss, psychosis
How to take Propranolol tablets dose or are experiencing symptoms of overdose, you
or hallucinations (disturbances of the mind)
• c lonidine (for hypertension or migraine). If you are should urgently seek medical attention. Overdose
taking clonidine and propranolol together, you must • tingling sensation (pins and needles)
Always take this medicine exactly as your doctor or causes difficulty breathing, low blood pressure, • disturbances of vision, dry eyes
not stop taking clonidine unless your doctor tells pharmacist has told you. Check with your doctor or drowsiness, fits, dilated pupils, an excessively
you to do so. If it becomes necessary for you to stop • breathlessness and/or swollen ankles, if you also
pharmacist if you are not sure. slowed heart beat with symptoms such as dizziness, have heart failure
taking clonidine, your doctor will give you careful Propranolol tablets should be swallowed with a drink sickness, confusion, hallucinations, body spasms,
instructions on how to do it. • heart block which may cause an abnormal heart
of water, before meals. breathlessness on exertion, fainting or coma. beat, dizziness, tiredness or fainting
Overdose could result in heart attack. • dizziness, particularly on standing up
Continued top of next column continue over page Continued top of next column continue over page
350x210 Leaflet Reel Fed Profile Landscape (BST) page 2 page 3
Propranolol All strengths Tablets PIL - UK
Propranolol BP Tablets
approved for print/date
10, 40, 80, 160mg x 28 56 (UK) Item number: BBBA9693 Colours Non Printing Colours
1. Black 1. Profile
Originator: R.Paul Dimensions: 350x210 (Reel Fed)
JDE No.: 50995392 2. 2.
Origination Date: 18.11.2020 Min Body Text Size: 9.5, 10.5pt & 11.5pt
Dimensions: 350x210 (Reel Fed) Revision Date: 11.03.2021 Supplier: Accord Barnstaple 3. 3.
Component: Leaflet for Blisters Revised By: R.Paul 4.
5.
Proof Round
Pharmacode: 7433
Date Sent: 26/10/20
8 Technical
Approval
Date sent: N/A
Date received: N/A
6.
Technologist: T. Hull EU-Artwork-Support@accord-healthcare.com
Technically Approved Cartons and label leaflets only
German GTIN 14 (incorporating PZN):
(labels only when specified)
* Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7
12.02.2020
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.
