Artwork No. - Colours Used Customer Accord Pantone Black Description Atenolol Market UK Language English Size 170 x 550 mm PIL Min. Font Size 9.5 Version No. 13 (Page 1 of 2) (06-16-Atenolol SPC) Date 07_05_16 (Atenolol (ACC-UK)06-16-SPC-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

You must consult your doctor if you are If you forget to take Atenolol Tablets 6. Contents of the pack and other planning to combine Atenolol tablets with the If you forget to take a dose of the Atenolol information medicines listed below: Tablet, take it as soon as you remember, PACKAGE LEAFLET: INFORMATION FOR • Clonidine (for high blood pressure or unless it is time for your next dose. What Atenolol Tablet contains THE USER migraine). If you are taking clonidine and Do not take a double dose to make up for a • The active ingredient is Atenolol. Atenolol 25 mg Tablets Atenolol tablets together, do not stop taking forgotten dose. • The other ingredients are Heavy clonidine unless your doctor tells you to do Magnesium Carbonate, Maize Starch, Atenolol 50 mg Tablets so. If you have to stop taking clonidine, your If you stop taking Atenolol Tablets Sodium Lauryl Sulphate, Gelatin, doctor will give you careful instructions Do not stop taking Atenolol Tablets without Magnesium Stearate, Microcrystalline Atenolol 100 mg Tablets about how to do it. talking to your doctor. In some cases, you may Cellulose and Purified Talc. (Atenolol) • Verapamil, diltiazem and nifedipine (for high need to stop taking it gradually over 7-14 days blood pressure or chest pain). and you will be monitored during this time. What Atenolol Tablets looks like and Read all of this leaflet carefully before you • Disopyramide, quinidine or amiodarone (for content of the pack start taking this medicine because it an uneven heart beat). If you have any further questions about the • Atenolol 25 mg Tablets are white, circular, contains important information for you. • Digoxin (for heart problems). use of this product, then ask your doctor or flat faced, beveled edge, uncoated tablets • Keep this leaflet. You may need to read it • Adrenaline, also known as epinephrine (a pharmacist. with inscription ‘AA’ on one side and again. medicine that stimulates the heart). scoreline on the other side. • If you have any further questions, ask your • Ibuprofen or indometacin (for pain and 4. Possible side effects • Atenolol 50 mg Tablets are white, circular, doctor or your pharmacist. inflammation). flat faced, beveled edge, uncoated tablets • This medicine has been prescribed for you • Insulin or medicines that you take by mouth Like all medicines Atenolol Tablet can cause with inscription ‘AB’ on one side and only. Do not pass it on to others. It may for diabetes. side effects, although not everybody gets scoreline on the other side. harm them, even if their symptoms are the • Medicines to treat nose or sinus congestion them. • Atenolol 100 mg Tablets are white, circular, same as yours. or other cold remedies (including those you flat faced, beveled edge, uncoated tablets • If you get any side effects, talk to your can buy in the pharmacy). Stop taking Atenolol tablets and see a with inscription ‘AC’ on one side and doctor or pharmacist. This includes any doctor or go to hospital straight away if scoreline on the other side. possible side effects not listed in this leaflet. Operations you notice any of the following serious side See section 4. If you go into hospital to have an operation, tell effects contact your doctor immediately: Atenolol Tablets are available either in blister the anaesthetist or medical staff that you are • Allergic reactions: If you have an allergic strips or in Amber glass bottle with LDPE What is in this leaflet: taking Atenolol Tablets. This is because you reaction, see a doctor straight away. The closure or in securitainers. 1. What Atenolol Tablets are and what they are can get low blood pressure (hypotension) if signs may include raised lumps on your skin used for you are given certain anaesthetics while you (weals), or swelling of your face, lips, mouth, Atenolol Tablets are available in packs of 2. What you need to know before you take are taking Atenolol Tablets. tongue or throat. 28,100 and 250 tablets. Atenolol Tablets • An abnormal heart beat, feeling dizzy, tired 3. How to take Atenolol Tablets If you are in any doubt, always consult your or fainting. This could be signs of heart Not all the pack sizes are marketed. 4. Possible side effects doctor or pharmacist. block. 5. How to store Atenolol Tablets • Shortness of breath or having swollen Marketing Authorization Holder and 6. Contents of the pack and other information Taking Atenolol tablets with food & drink ankles. These could be signs of heart failure Manufacturer Alcohol may cause your blood pressure to or your heart failure getting worse. Accord Healthcare Limited, 1. What Atenolol Tablets are and what drop too low. You should avoid or limit how Sage House, 319 Pinner Road, they are used for much alcohol you drink whilst taking this Other possible side effects: North Harrow, Middlesex, medicine. Discuss this with your doctor if you Common: may affect up to 1 in 10 people) HA1 4HF, United Kingdom. Atenolol tablets contain the active ingredient have any concerns. • You may notice that your pulse rate atenolol. Atenolol is one of a group of becomes slower while you are taking the This leaflet was last revised on 12/2020 medicines called beta blockers. Pregnancy, breast-feeding and fertility tablets. This is normal, but if you are Atenolol Tablets are used If you are pregnant, trying to become pregnant concerned, please tell your doctor about it. • Treat high blood pressure (hypertension). or are planning to have a baby, or are • Cold hands and feet. • Treat uneven heart beats (arrhythmias). breast-feeding, talk to your doctor before • Diarrhoea. • Help prevent chest pain characterised by a taking this medicine. Always talk to your doctor • Feeling sick (nausea). painful feeling of tightness in the chest before taking any medicine. • Feeling tired or aching and tired muscles. (angina pectoris); • Protect the heart in the early treatment after Driving and using machines Uncommon: may affect up to 1 in 100 a heart attack (myocardial infarction). • Your medicine is not likely to affect you people) being able to drive or use any tools or • Disturbed sleep. It works by making your heart beat more machines. However, it is best to wait to see slowly and with less force. how your medicine affects you before trying Rare:may affect up to 1 in 1,000 people) these activities. • Heart block (which can cause dizziness, 2. What you need to know before you • If you feel dizzy or tired when taking this abnormal heart beat, tiredness or fainting). take Atenolol Tablets medicine, do not drive or use any tools or • Numbness and spasm in your fingers which machines. is followed by warmth and pain (Raynaud’s Do not take Atenolol Tablets: disease). • If you are allergic (hypersensitive) to 3. How to take Atenolol Tablets • Mood changes. Atenolol or any of the other ingredients of • Depression. this medicine (listed in section 6). Always take Atenolol Tablets exactly as your • Nightmares. • If you have ever had any of the following doctor has instructed you. You should check with • Feeling confused, anxious or scared. heart problems: your doctor or pharmacist if you are unsure. • Changes in personality (psychoses) or -heart failure which is not under control (this hallucinations. usually makes you breathless and causes The general dose is for guidance only, and is • Headache. your ankles to swell) as follows: • Dizziness (particularly when standing up). -second- or third-degree heart block Generally, treatment is initiated at a low • Tingling of your hands. (a condition which may be treated by a quantity, e.g. 25 mg. In accordance with the • Being unable to get an erection (impotence). pacemaker) instructions of the doctor who is treating you, • Dry mouth. -very slow or very uneven heart beats, very the dosage is then built up to the following • Dry eyes. low blood pressure or very poor circulation. quantities over the course of a few days. • Disturbances of vision. • If you have a tumour called • Thinning of your hair. phaeochromocytoma that is not being Adults • Skin rash. treated. This is usually near your kidney and • High blood pressure (hypertension) • Reduced numbers of platelets in your blood can cause high blood pressure. If you are The usual quantity for adults is 100 mg once (this may make you bruise more easily). being treated for phaeochromocytoma, your a day, or whatever quantity your doctor • Purplish marks on your skin. doctor will give you another medicine, called advises. In some cases, e.g. in the case of • Jaundice (causing yellowing of your skin or an alphablocker, to take as well as Atenolol older people or patients with kidney the whites of your eyes). Tablets. conditions, 50 mg may be enough. • If you have been told that you have higher Very rare: may affect up to 1 in 10,000 than normal levels of acid in your blood • Certain types of chest pain (angina people) (metabolic acidosis). pectoris) • Changes to some of the cells or other parts The usual quantity for adults is 50–100 mg of your blood. Your doctor may take blood This medicine is not suitable for use in once a day (possibly split into 50 mg twice a samples every so often to check whether children. day), or whatever quantity your doctor Atenolol Tablets has had any effect on your advises. blood. Do not take Atenolol Tablets if any of the above apply to you. If you are not sure, talk to • Certain heart rhythm disorders Not known (frequency cannot be estimated your doctor or pharmacist before taking (arrhythmias) from the available data) Atenolol Tablets. The usual quantity for adults is 50–100 mg • Lupus-like syndrome (a disease where the once a day, or whatever quantity your doctor immune system produces antibodies that Warnings and precautions advises. attacks mainly skin and joints). Atenolol is best taken at the same time Talk to your doctor before taking Atenolol every day, with water, milk, or another fluid, Conditions that may get worse tablets if: preferably in the mornings. If you have any of the following conditions, • You have asthma, wheezing or any other they may get worse when you start to take similar breathing problems, or you get • After a heart attack your medicine. This happens rarely affecting allergic reactions, for example to insect Initial treatment will be by intravenous less than 1 in 1,000 people. stings. If you have ever had asthma or injection. After 15 minutes this will usually be • Psoriasis (a skin condition). wheezing, do not take this medicine followed by a 50mg dose of atenolol given • Being short of breath or having swollen without first checking with your doctor. orally (by mouth). 12hr after the intravenous ankles (if you have heart failure). • you have a type of chest pain (angina) dose, a further 50 mg oral dose will be • Asthma or breathing problems. called Prinzmetal's angina. given. A 100mg oral dose will be given after • Poor circulation. • You have poor blood circulation or controlled a further 12hrs. Treatment will then continue heart failure. as a once daily 100mg dose. Reporting of side effects • You have first-degree heart block. If you get any side effects, talk to your doctor • You have diabetes. Your medicine may Elderly people or pharmacist. This includes any possible side change how you respond to having low If you are an elderly person, your doctor may effects not listed in this leaflet. You can also blood sugar. You may feel your heart decide to give you a lower dose, particularly if report side effects directly via the Yellow Card beating faster. you have problems with your kidneys. Scheme. Website: • You have thyrotoxicosis (a condition caused www.mhra.gov.uk/yellowcard. By reporting by an overactive thyroid gland). Your People with severe kidney problems side effects you can help provide more medicine may hide the symptoms of If you have severe kidney problems your information on the safety of this medicine. thyrotoxicosis. doctor may decide to give you a lower dose. • You have problems with your kidneys. You 5. How to store Atenolol Tablets may need to have some check-ups during Children your treatment. This medicine must not be given to children. • Keep this medicine out of the sight and reach of children. If you are not sure if any of the above apply to If you take more Atenolol Tablets than you • Do not store above 25°C. Store in a dry you, talk to your doctor or pharmacist before should place. taking Atenolol tablets. If you take more Atenolol Tablets than • Do not use your tablets after the expiry date Other medicines and Atenolol Tablets prescribed by your doctor, talk to a doctor or stated on the label or carton. The expiry Tell your doctor or pharmacist if you are taking, go to a hospital straight away. Take the date refers to the last day of that month. have recently taken or might take any other medicine pack with you so that the tablets can • Do not throw away any medicines via medicines. This includes medicines that you buy be identified. wastewater or household waste. Ask your without a prescription and herbal medicines. This pharmacist how to throw away medicines is because Atenolol Tablets can affect the way Symptoms of overdose include reduced heart you no longer use. These measures will some other medicines work and some medicines rate, blood pressure, a feeling of tightness in help protect the environment. can have an effect on Atenolol Tablets. chest due to cramps in the muscles surrounding the airways or sometimes loss of consciousness.

(667783) Date: 20-05-16, R-22~01~21, 27~01~21 Note: PIL is required centrally folded in bible paper Artwork No. - Colours Used Customer Accord Pantone Black Description Atenolol Market UK Language English Size 170 x 550 mm PIL Min. Font Size 9.5 Version No. 13 (Page 2 of 2) (06-16-Atenolol SPC) Date 07_05_16 (Atenolol (ACC-UK)06-16-SPC-PIL) Prepared By Checked By Approved By Regulatory Affairs Regulatory Affairs Quality Assurance

You must consult your doctor if you are If you forget to take Atenolol Tablets 6. Contents of the pack and other planning to combine Atenolol tablets with the If you forget to take a dose of the Atenolol information medicines listed below: Tablet, take it as soon as you remember, PACKAGE LEAFLET: INFORMATION FOR • Clonidine (for high blood pressure or unless it is time for your next dose. What Atenolol Tablet contains THE USER migraine). If you are taking clonidine and Do not take a double dose to make up for a • The active ingredient is Atenolol. Atenolol 25 mg Tablets Atenolol tablets together, do not stop taking forgotten dose. • The other ingredients are Heavy clonidine unless your doctor tells you to do Magnesium Carbonate, Maize Starch, Atenolol 50 mg Tablets so. If you have to stop taking clonidine, your If you stop taking Atenolol Tablets Sodium Lauryl Sulphate, Gelatin, doctor will give you careful instructions Do not stop taking Atenolol Tablets without Magnesium Stearate, Microcrystalline Atenolol 100 mg Tablets about how to do it. talking to your doctor. In some cases, you may Cellulose and Purified Talc. (Atenolol) • Verapamil, diltiazem and nifedipine (for high need to stop taking it gradually over 7-14 days blood pressure or chest pain). and you will be monitored during this time. What Atenolol Tablets looks like and Read all of this leaflet carefully before you • Disopyramide, quinidine or amiodarone (for content of the pack start taking this medicine because it an uneven heart beat). If you have any further questions about the • Atenolol 25 mg Tablets are white, circular, contains important information for you. • Digoxin (for heart problems). use of this product, then ask your doctor or flat faced, beveled edge, uncoated tablets • Keep this leaflet. You may need to read it • Adrenaline, also known as epinephrine (a pharmacist. with inscription ‘AA’ on one side and again. medicine that stimulates the heart). scoreline on the other side. • If you have any further questions, ask your • Ibuprofen or indometacin (for pain and 4. Possible side effects • Atenolol 50 mg Tablets are white, circular, doctor or your pharmacist. inflammation). flat faced, beveled edge, uncoated tablets • This medicine has been prescribed for you • Insulin or medicines that you take by mouth Like all medicines Atenolol Tablet can cause with inscription ‘AB’ on one side and only. Do not pass it on to others. It may for diabetes. side effects, although not everybody gets scoreline on the other side. harm them, even if their symptoms are the • Medicines to treat nose or sinus congestion them. • Atenolol 100 mg Tablets are white, circular, same as yours. or other cold remedies (including those you flat faced, beveled edge, uncoated tablets • If you get any side effects, talk to your can buy in the pharmacy). Stop taking Atenolol tablets and see a with inscription ‘AC’ on one side and doctor or pharmacist. This includes any doctor or go to hospital straight away if scoreline on the other side. possible side effects not listed in this leaflet. Operations you notice any of the following serious side See section 4. If you go into hospital to have an operation, tell effects contact your doctor immediately: Atenolol Tablets are available either in blister the anaesthetist or medical staff that you are • Allergic reactions: If you have an allergic strips or in Amber glass bottle with LDPE What is in this leaflet: taking Atenolol Tablets. This is because you reaction, see a doctor straight away. The closure or in securitainers. 1. What Atenolol Tablets are and what they are can get low blood pressure (hypotension) if signs may include raised lumps on your skin used for you are given certain anaesthetics while you (weals), or swelling of your face, lips, mouth, Atenolol Tablets are available in packs of 2. What you need to know before you take are taking Atenolol Tablets. tongue or throat. 28,100 and 250 tablets. Atenolol Tablets • An abnormal heart beat, feeling dizzy, tired 3. How to take Atenolol Tablets If you are in any doubt, always consult your or fainting. This could be signs of heart Not all the pack sizes are marketed. 4. Possible side effects doctor or pharmacist. block. 5. How to store Atenolol Tablets • Shortness of breath or having swollen Marketing Authorization Holder and 6. Contents of the pack and other information Taking Atenolol tablets with food & drink ankles. These could be signs of heart failure Manufacturer Alcohol may cause your blood pressure to or your heart failure getting worse. Accord Healthcare Limited, 1. What Atenolol Tablets are and what drop too low. You should avoid or limit how Sage House, 319 Pinner Road, they are used for much alcohol you drink whilst taking this Other possible side effects: North Harrow, Middlesex, medicine. Discuss this with your doctor if you Common: may affect up to 1 in 10 people) HA1 4HF, United Kingdom. Atenolol tablets contain the active ingredient have any concerns. • You may notice that your pulse rate atenolol. Atenolol is one of a group of becomes slower while you are taking the This leaflet was last revised on 12/2020 medicines called beta blockers. Pregnancy, breast-feeding and fertility tablets. This is normal, but if you are Atenolol Tablets are used If you are pregnant, trying to become pregnant concerned, please tell your doctor about it. • Treat high blood pressure (hypertension). or are planning to have a baby, or are • Cold hands and feet. • Treat uneven heart beats (arrhythmias). breast-feeding, talk to your doctor before • Diarrhoea. • Help prevent chest pain characterised by a taking this medicine. Always talk to your doctor • Feeling sick (nausea). painful feeling of tightness in the chest before taking any medicine. • Feeling tired or aching and tired muscles. (angina pectoris); • Protect the heart in the early treatment after Driving and using machines Uncommon: may affect up to 1 in 100 a heart attack (myocardial infarction). • Your medicine is not likely to affect you people) being able to drive or use any tools or • Disturbed sleep. It works by making your heart beat more machines. However, it is best to wait to see slowly and with less force. how your medicine affects you before trying Rare:may affect up to 1 in 1,000 people) these activities. • Heart block (which can cause dizziness, 2. What you need to know before you • If you feel dizzy or tired when taking this abnormal heart beat, tiredness or fainting). take Atenolol Tablets medicine, do not drive or use any tools or • Numbness and spasm in your fingers which machines. is followed by warmth and pain (Raynaud’s Do not take Atenolol Tablets: disease). • If you are allergic (hypersensitive) to 3. How to take Atenolol Tablets • Mood changes. Atenolol or any of the other ingredients of • Depression. this medicine (listed in section 6). Always take Atenolol Tablets exactly as your • Nightmares. • If you have ever had any of the following doctor has instructed you. You should check with • Feeling confused, anxious or scared. heart problems: your doctor or pharmacist if you are unsure. • Changes in personality (psychoses) or -heart failure which is not under control (this hallucinations. usually makes you breathless and causes The general dose is for guidance only, and is • Headache. your ankles to swell) as follows: • Dizziness (particularly when standing up). -second- or third-degree heart block Generally, treatment is initiated at a low • Tingling of your hands. (a condition which may be treated by a quantity, e.g. 25 mg. In accordance with the • Being unable to get an erection (impotence). pacemaker) instructions of the doctor who is treating you, • Dry mouth. -very slow or very uneven heart beats, very the dosage is then built up to the following • Dry eyes. low blood pressure or very poor circulation. quantities over the course of a few days. • Disturbances of vision. • If you have a tumour called • Thinning of your hair. phaeochromocytoma that is not being Adults • Skin rash. treated. This is usually near your kidney and • High blood pressure (hypertension) • Reduced numbers of platelets in your blood can cause high blood pressure. If you are The usual quantity for adults is 100 mg once (this may make you bruise more easily). being treated for phaeochromocytoma, your a day, or whatever quantity your doctor • Purplish marks on your skin. doctor will give you another medicine, called advises. In some cases, e.g. in the case of • Jaundice (causing yellowing of your skin or an alphablocker, to take as well as Atenolol older people or patients with kidney the whites of your eyes). Tablets. conditions, 50 mg may be enough. • If you have been told that you have higher Very rare: may affect up to 1 in 10,000 than normal levels of acid in your blood • Certain types of chest pain (angina people) (metabolic acidosis). pectoris) • Changes to some of the cells or other parts The usual quantity for adults is 50–100 mg of your blood. Your doctor may take blood This medicine is not suitable for use in once a day (possibly split into 50 mg twice a samples every so often to check whether children. day), or whatever quantity your doctor Atenolol Tablets has had any effect on your advises. blood. Do not take Atenolol Tablets if any of the above apply to you. If you are not sure, talk to • Certain heart rhythm disorders Not known (frequency cannot be estimated your doctor or pharmacist before taking (arrhythmias) from the available data) Atenolol Tablets. The usual quantity for adults is 50–100 mg • Lupus-like syndrome (a disease where the once a day, or whatever quantity your doctor immune system produces antibodies that Warnings and precautions advises. attacks mainly skin and joints). Atenolol is best taken at the same time Talk to your doctor before taking Atenolol every day, with water, milk, or another fluid, Conditions that may get worse tablets if: preferably in the mornings. If you have any of the following conditions, • You have asthma, wheezing or any other they may get worse when you start to take similar breathing problems, or you get • After a heart attack your medicine. This happens rarely affecting allergic reactions, for example to insect Initial treatment will be by intravenous less than 1 in 1,000 people. stings. If you have ever had asthma or injection. After 15 minutes this will usually be • Psoriasis (a skin condition). wheezing, do not take this medicine followed by a 50mg dose of atenolol given • Being short of breath or having swollen without first checking with your doctor. orally (by mouth). 12hr after the intravenous ankles (if you have heart failure). • you have a type of chest pain (angina) dose, a further 50 mg oral dose will be • Asthma or breathing problems. called Prinzmetal's angina. given. A 100mg oral dose will be given after • Poor circulation. • You have poor blood circulation or controlled a further 12hrs. Treatment will then continue heart failure. as a once daily 100mg dose. Reporting of side effects • You have first-degree heart block. If you get any side effects, talk to your doctor • You have diabetes. Your medicine may Elderly people or pharmacist. This includes any possible side change how you respond to having low If you are an elderly person, your doctor may effects not listed in this leaflet. You can also blood sugar. You may feel your heart decide to give you a lower dose, particularly if report side effects directly via the Yellow Card beating faster. you have problems with your kidneys. Scheme. Website: • You have thyrotoxicosis (a condition caused www.mhra.gov.uk/yellowcard. By reporting by an overactive thyroid gland). Your People with severe kidney problems side effects you can help provide more medicine may hide the symptoms of If you have severe kidney problems your information on the safety of this medicine. thyrotoxicosis. doctor may decide to give you a lower dose. • You have problems with your kidneys. You 5. How to store Atenolol Tablets may need to have some check-ups during Children your treatment. This medicine must not be given to children. • Keep this medicine out of the sight and reach of children. If you are not sure if any of the above apply to If you take more Atenolol Tablets than you • Do not store above 25°C. Store in a dry you, talk to your doctor or pharmacist before should place. taking Atenolol tablets. If you take more Atenolol Tablets than • Do not use your tablets after the expiry date Other medicines and Atenolol Tablets prescribed by your doctor, talk to a doctor or stated on the label or carton. The expiry Tell your doctor or pharmacist if you are taking, go to a hospital straight away. Take the date refers to the last day of that month. have recently taken or might take any other medicine pack with you so that the tablets can • Do not throw away any medicines via medicines. This includes medicines that you buy be identified. wastewater or household waste. Ask your without a prescription and herbal medicines. This pharmacist how to throw away medicines is because Atenolol Tablets can affect the way Symptoms of overdose include reduced heart you no longer use. These measures will some other medicines work and some medicines rate, blood pressure, a feeling of tightness in help protect the environment. can have an effect on Atenolol Tablets. chest due to cramps in the muscles surrounding the airways or sometimes loss of consciousness.

INP001 10 0726 0 667783

(667783) Date: 20-05-16, R-22~01~21, 27~01~21 Note: PIL is required centrally folded in bible paper