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Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET DMA Isosorbidemononitrate 20 mg / 40 mg tablets 1.3.1.3 Package Leaflet NL/H/0179/001-002 Property of Sandoz GmbH Confidential May not be used, divulged or otherwise disclosed without the consent of Sandoz GmbH Page 1 of 9 20161116 551-024A.00 551-024B.00 Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 2 of 9 20161116 551-024A.00 551-024B.00 Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 3 of 9 20161116 551-024A.00 551-024B.00 Package leaflet: Information for the user [nationally completed name] 20 mg tablets [nationally completed name] 40 mg tablets Isosorbidemononitrate Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet What is in this leaflet: 1. What [nationally completed name] is and what it is used for 2. What you need to know before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. What [nationally completed name] is and what it is used for [nationally completed name] belongs to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood. [nationally completed name] may be used to prevent an attack of angina pectoris (heart cramp). [nationally completed name] is not suitable for the treatment of acute attacks of angina pectoris. 2. What you need to know before you before you take [nationally completed name] Do not take [nationally completed name] if you: are allergic (hypersensitive) to - isosorbide mononitrate or, - any of the other ingredients (listed in section 6) or, - other nitrates (the group of medicines that isosorbide mononitrate belongs to) have any condition where your blood pressure is very low or your blood is not circulating properly (such as shock) Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 4 of 9 20161116 551-024A.00 551-024B.00 have suffered from a head injury or bleeding in the brain are dehydrated due to illness such as diarrhea or being sick have heart problems such as severe narrowing (stenosis) of the heart valves (mitral or aortic valve) or an inflammation of the heart surface or progressive heart failure due to long term lung disease have had a recent heart attack have raised pressure in your head have severe anaemia (low level of red blood cells) take medicines used to treat male erection dysfunction (such as sildenafil, tadalafil or vardenafil. See also section 2 “Taking other medicines”). Do not take [nationally completed name] if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk to your doctor or pharmacist before using [nationally completed name] if you: suffer from a severe brain disease (cerebral sclerosis or cerebral ischaemia) suffer from an enlarged heart muscle (hypertrophic cardiomyopathy) have certain heart problems such as an acute attack of angina pectoris, obstruction of the blood vessels of the heart (coronary heart disease), damage to the heart muscle (hypertrophic obstructive cardiomyopathy), narrowing of the heart valves (aortic of mitral stenosis) have severe liver problems. Other medicines and [nationally completed name] Talk to your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , including medicines obtained without a prescription. It may be necessary to change your dose or, in some cases, to stop one of the medicines. It is especially important for your doctor to know if you are taking: medicines used to control blood pressure or heart function, medicines used to treat migraine (dihydroergotamine) and, DO NOT TAKE [nationally completed name] with medicines to treat male erection dysfunction (inhibitors of an enzyme called phosphodiesterase type 5, including amongst others sildenafil, tadalafil or vardenafil). If you take these medicines together with [nationally completed name], a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. [nationally completed name] with and alcohol You are advised not to drink alcohol with this medicine. Pregnancy and breastfeeding Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 5 of 9 20161116 551-024A.00 551-024B.00 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. Driving and using machines Be careful if you drive or operate machinery if you take this medicine. [nationally completed name] may not directly affect your ability to drive or operate machinery. However, side effects such as dizziness may interfere with this ability, particularly together with alcohol. You should not drive a vehicle or operate a machine or perform tasks that require alertness if you experience these symptoms. [nationally completed name] 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 [nationally completed name] Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets with water, you can take them with or without food. You should take the last daily dose at the end of the afternoon. The recommended doses are: Starting dose: 10 mg 2 to 3 times daily. Maintenance dose: 40-80 mg daily divided in 2 to 3 doses. Maximum dose: 40 mg 2 to 3 times daily. Considerations for treatment and treatment discontinuation Treatment should be started in a gradual manner, especially in patients under treatment with diuretics or other antihypertensive drugs. It is advised to take the dose in a sitting position when one or more of the following situations are applicable: at the start of the treatment, in case of elderly patients or when higher doses than the maintenance dose are given. Long maintenance treatment should be withdrawn in a gradual manner to prevent a rebound phenomenon and overlapping treatment should be started to avoid the risk of angina pectoris (chest pain with or without radiation, nausea and sweating) e.g. on-demand nitrates. [Nationally completed name] and older people Older patients (aged 65 years or above) generally need lower starting doses than other adult patients. Your doctor will advise you about this. If you take more [nationally completed name] than you should Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 6 of 9 20161116 551-024A.00 551-024B.00 If you take more [nationally completed name] than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the doctor knows what you have taken. You may develop slower or higher heart beat low blood pressure, paleness, transpiration, weak pulse, higher heart rate, light-headedness when rising up, headache, weakness, dizziness, sickness, vomiting, diarrhea, difficulty breathing, shock or coma.. If you forget to take [nationally completed name] Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. If you stop taking [nationally completed name] Do not suddenly stop taking [nationally completed name] without talking to your doctor. The doctor may need to slowly lower the dose. 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. Stop taking [nationally completed name] and see a doctor or go to hospital straight away, if you notice any of the following serious side effects: Common (may affect up to 1 in 10 people) fast heart beat Uncommon (may affect up to 1 in 100 people)) slow heart beat severe fall in blood pressure, collapse or fainting. Other side effects include: Very common (may affect more than 1 in 10 people) headache (especially when you first start taking [nationally completed name]). Common (may affect up to 1 in 10 people) a decrease in blood pressure, dizziness or faintness when standing up due to low blood pressure, a racing heart beat, drowsiness, dizziness and weakness may also occur (especially when [nationally completed name] is used for the first time or when your dose is increased). Uncommon (may affect up to 1 in 100 people) Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 7 of 9 20161116 551-024A.00 551-024B.00 worsening of angina due to very low blood pressure feeling or being sick skin rash, itching flushing (e.g. in the face). Very rare (may affect up to 1 in 10,000 people) skin rash with flaking or peeling. 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store [nationally completed name] Keep this medicine out of the sight and reach of children. Do not use [nationally completed name] after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month. Store below 25ºC in the original packaging in order to protect from moisture. 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 protect the environment. 6. Contents of the pack and other information What [nationally completed name] contains [nationally completed name] 20 mg tablets: The active substance is isosorbidemononitrate. Each tablet contains 20 mg isosorbidemononitrate. [nationally completed name] 40 mg tablets: The active substance is isosorbidemononitrate. Each tablet contains 40 mg isosorbidemononitrate. The other ingredients are: Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 8 of 9 20161116 551-024A.00 551-024B.00 Lactose, talc, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycollate, magnesium stearate. What [nationally completed name] looks like and contents of the pack [nationally completed name] 20 mg tablet is a white, biplanar round tablet with bevelled edges, scored on one side, inscription on reverse side ‘20’ The tablets can be divided into equal halves. [nationally completed name] 40 mg tablet is a white, biplanar round tablet with bevelled edges, scored on one side, inscription on reverse side ‘40’ The tablets can be divided into equal halves. Packsizes: 20 mg tablets PVC/Aluminium blister containing 30,40,50,80 or 500 tablets. Polypropylene tablet container containing 30 tablets. 40 mg tablets PVC/Aluminium blister containing 20, 30, 40, or 500 tablets. Polypropylene tablet container containing 30 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [To be completed nationally] Manufacturer: Lek Pharmaceuticals d.d. Verovškova 57 SI-1526 Ljubljana Slovenia Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany Salutas Pharma GmbH Dieselstraße 5 70839 Gerlingen Germany Business use only Sandoz 1.3.1 spc-label-pl - common-pl – 7,834 (NL/H/0179/001-002/IA/034) ISOSORBIDE MONONITRATE 20 MG; 40 MG TABLET Page 9 of 9 20161116 551-024A.00 551-024B.00 This medicinal product is authorised in the Member States of the EEA under the following names: The Netherlands: Isosorbidemononitraat Sandoz 20 Isosorbidemononitraat Sandoz 40 Spain: Mononitrato de Isosorbida Sandoz 20 mg comp. EFG Mononitrato de Isosorbida Sandoz 40 mg comp. EFG This leaflet was last approved in {MM/YYYY} [To be completed nationally]