Package Leaflet: Information for the user ADAPTUS/DELAMAN 30 mg / 10 mg tablets Delapril hydrochloride / manidipine hydrochloride 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. - 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. See section 4. What is in this leaflet 1. What Adaptus/Delaman is and what it is used for 2. What you need to know before you take Adaptus/Delaman 3. How to take Adaptus/Delaman 4. Possible side effects 5. How to store Adaptus/Delaman 6. Contents of the pack and other information 1. WHAT ADAPTUS/DELAMAN IS AND WHAT IT IS USED FOR Adaptus/Delaman is Adaptus/Delaman is a combination of two active substances, delapril hydrochloride and manidipine hydrochloride. Delapril hydrochloride belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitor medicines). Angiotensin II is a substance produced in the body that causes the narrowing of blood vessels. This results in an increase in blood pressure. Delapril hydrochloride prevents the production of Angiotensin II and so causes a lowering of blood pressure. Manidipine hydrochloride is one of a group of medicines called calcium-channel blockers that blocks calcium flow into smooth muscle cells of the blood vessels causing the blood vessels to relax and a corresponding reduction in the blood pressure. The two active substances in Adaptus/Delaman work together to lower blood pressure more effectively than if either was given alone. Adaptus/Delaman is used for the treatment of high blood pressure (hypertension) in patients whose blood pressure is not adequately controlled on delapril or manidipine (the two active substances) alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADAPTUS/DELAMAN Do not take Adaptus/Delaman: if you are allergic to delapril or other ACE inhibitor medicines, manidipine or other similar calcium-channel blockers or any of the other ingredients of this medicine (listed in section 6) PIL V (7.10) 2019-053 if you have ever suffered from allergic reactions such as swelling of the face, eyes, lips, tongue, throat or difficulty in breathing with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances if you have severe liver impairment if you have severe kidney problems (i.e. severe kidney impairment, are on haemodialysis (an artificial kidney treatment), have had a kidney transplantation or suffer from renal artery stenosis (narrowing of the renal artery) in case you have only one kidney) if you have certain heart problems (e.g. recently had a heart attack or an angina pectoris attack (chest pain due to an inadequate supply of oxygen to the heart), heart failure) if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (cardiac muscle disease) if you have overactive adrenal glands which can lead to low blood levels of potassium if you are more than 3 months pregnant. (It is also better to avoid Adaptus/Delaman in early pregnancy – see pregnancy section.) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased if you are taking any of the following medicines, the risk of angioedema may be increased: - Racecadotril, a medicine used to treat diarrhoea; - Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) - Vildagliptin, a medicine used to treat diabetes Do not give Adaptus/Delaman to children and adolescents under the age of 18. Warnings and precautions Talk to your doctor or pharmacist before taking Adaptus/Delaman PIL V (7.16.1) 20198-0510 2 if you suffer from kidney problems if you suffer from liver problems if you suffer from certain heart problems (e.g. coronary heart disease) if you suffer from damage to the blood vessels in the brain (cerebrovascular problems) if you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine), if you are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings, if you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma if you have diabetes if you have a condition which is associated with persistently high potassium levels in your blood if you have signs such as swelling of the face, eyes, lips, tongue, throat or difficulty in breathing (see section 4, “Rare side effects”) if you have abnormal changes in your blood components if you are to undergo any surgery or receive anaesthetics if you have rapid heart beat, dizziness, general weakness which may indicate low blood pressure You must tell your doctor if you think you are (or might become) pregnant. Adaptus/Delaman is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). if you are taking any of the following medicines used to treat high blood pressure: - an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. - aliskiren” If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) is increased: sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the headings “Do not take Adaptus/Delaman” Children and adolescent Do not give Adaptus/Delaman to children and adolescents under the age of 18. Other medicines and Adaptus/Delaman Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor may need to change your dose and/or take other precautions if you are taking any of the following medicines: diuretic medicines (used to remove water from the body by increasing urine production) and other medicines which reduce your blood pressure. These may intensify the blood pressure-lowering effect of Adaptus/Delaman. heparin (used to prevent blood from clotting) medicines containing lithium (generally used to treat manic-depressive disorders). These should only be taken with Adaptus/Delaman under the close supervision of your doctor. certain pain killers (i.e. non steroidal anti-inflammatory drugs, e.g. aspirin) antidepressants, antipsychotics (used to treat schizophrenia and other mental diseases) and anaesthetics medicines stimulating the sympathetic nervous system (e.g. used as cold medicines) salts containing potassium or potassium-sparing diuretics. In this case special precautionary measures (e.g. blood tests) may be appropriate. PIL V (7.16.1) 20198-0510 3 digoxin (used to treat heart disorders) medicines changing the blood picture (e.g. allopurinol, which is used to treat gout), procainamide (for the treatment of an irregular heart beat), corticosteroids, immunosuppressants used for the treatment of auto- immune disorders or following transplant surgery to prevent rejection medicines for the treatment of cancer) medicines for diabetes (medicines for oral use or insulin) vildagliptin, a medicine used for diabetes diarrhoea (see also information under the headingssection “Do Formatiert: Schriftart: Times New Roman not take Adaptus/Delaman”) Formatiert: AN, Links, Einzug: Links: 0 cm, Hängend: 0,63 antacids cm, Vom nächsten Absatz trennen, Diesen Absatz nicht zusammenhalten, Tabstopps: 0,63 cm, Listentabstopp + medicines influencing the metabolism of one active substance contained in Adaptus/Delaman, e.g. Nicht an 0,75 cm cimetidine (used to treat stomach ulcers) or certain antibiotics or antimycotics (used to treat fungal Formatiert: Schriftart: Times New Roman infections), phenytoin, carbamazepine, phenobarbital, rifampicine, terfenadine and astemizole, class III antiarrythmics which are used for heart rhythm problems (e.g. amiodarone, quinidine). an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Adaptus/Delaman” and "Warnings and precautions”") medicines used to treat a type of long-term (chronic) heart failure in adults (e.g. sacubitril/valsartan) (see Formatiert: Schriftart: Times New Roman also information under the headingssection “Do not take Adaptus/Delaman”) Formatiert Racecadotril, a medicine used to treat diarrhoea (see also information under the headingssection “Do not Formatiert: Schriftart: Times New Roman take Adaptus/Delaman”) Formatiert: Schriftart: Times New Roman, Nicht Fett, Vildagliptin, a medicine used to treat diabetes Schriftfarbe: Automatisch Kommentiert [FraM1]: information on concomitant use Tell your doctor if you are also taking: with racecadotril were missing in this section of the PIL Medicines which are most often used to avoid rejection of transplanted organs (sirolimus, everolimus and Formatiert: Schriftart: Times New Roman other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions” Kommentiert [FraM2]: moved to the above section Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that regarding medicines for diabetes can increase the amount of potassium in your blood (e.g.