• 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 or 160mg of the active substance. Propranolol 10mg, 40mg, 80mg Very rare (may affect up to 1 in 10,000 • the other ingredients are lactose, magnesium people) stearate, maize starch, stearic acid, hypromellose and 160mg tablets • severe muscle weakness (myasthenia gravis) (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 • Keep 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, • If 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 • This 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, Propranolol tablets 40mg and 80mg are pink film- harm them, even if their signs of illness are • bleeding in the oesophagus or stomach caused by high blood pressure in the liver. patients on artificial kidneys (haemodialysis) or coated tablets. the same as yours. patients on medication for diabetes. It may also Propranolol tablets 160mg are pink, circular, • If you get any side effects, talk to your 2 What you need to know before you occur in patients who are fasting or have been 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. leaflet. See section 4. • Seizure linked to low levels of sugar in the blood. Pack sizes are 28 and 56 tablets. Do not take Propranolol tablets and tell your 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 1 If you get any side effects, talk to your doctor, Marketing Authorisation Holder and What Propranolol tablets are and ingredients of this medicine (listed in section 6) 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 problems (second or third-degree heart This leaflet was last revised in March 2021 3 How to take Propranolol tablets search for MHRA Yellow Card in the Google Play block or sick sinus syndrome) 4 Possible side effects or Apple App Store. • 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 measures will help protect the environment. the kidney). 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. Pharmacode: Proof Round 7433 Technical Date sent: N/A 6. 8 Approval Date received: N/A Date Sent: 26/10/20 Technologist: T. Hull [email protected] Technically Approved Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 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. • have 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 • suffer 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 • have 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 4 • have kidney or liver problems (including cirrhosis of Propranolol tablets are not recommended during heart rhythm) 30 mg to 160 mg Possible side effects the liver) pregnancy or breast-feeding. If you are pregnant Protection of the heart • have 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. • have 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.
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