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)
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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
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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.
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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. trimethoprim and co-trimoxazole, also known as Formatiert: Schriftart: Times New Roman trimethoprim/sulfamethoxazole, for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)
Adaptus/Delaman with food and drink Adaptus/Delaman should be taken after breakfast. Do not take Adaptus/Delaman together with grapefruit juice as the blood pressure may be decreased too much. Drinking alcohol can lead to a fall in blood pressure when you stand up. Avoid salt-rich foods (containing a large amount of sodium chloride) as the effect of Adaptus/Delaman of lowering blood pressure can be reduced.
Pregnancy and breast-feeding 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. Pregnancy Your doctor will normally advise you to stop taking Adaptus/Delaman before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Adaptus/Delaman. Adaptus/Delaman is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding Adaptus/Delaman is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
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Adaptus/Delaman is unlikely to affect your ability to drive or use machines. However, dizziness may occur occasionally during treatment of high blood pressure. If you experience this, you should consult your doctor before attempting such activities.
Adaptus/Delaman contains lactose and colouring agent If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The colouring agent E110 may cause allergic reactions.
3. HOW TO TAKE ADAPTUS/DELAMAN
Always take Adaptus/Delaman exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recomended dose of Adaptus/Delaman is one tablet taken once a day.
Dosage reduction If you are over the age of 65 or if you suffer from kidney or liver disease, your doctor may prescribe an appropriately reduced dose.
Administration Adaptus/Delaman should be taken in the morning after breakfast. The tablet should be swallowed whole with sufficient water. You should try to take your daily dose at about the same time each day. The tablet can be divided into equal doses.
Duration of treatment It is important that you continue to take Adaptus/Delaman until your doctor tells you otherwise. Please take the exact prescribed dose and do not change it without talking to your doctor first.
HOW TO OPEN AND CLOSE THE BOTTLE The bottle has a child-resistant closure in order to prevent children opening it. Follow these instructions to open and close the bottle: - To open: A) press and turn at the same time - To close: B) press and screw at the same time
Use in children and adolescents Do not give Adaptus/Delaman to children and adolescents under the age of 18 (see section 2, “What you need to know before you take Adaptus/Delamando not take Adaptus/Delaman”).
If you take more Adaptus/Delaman than you should
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If you accidentally take too many tablets, contact your doctor immediately because this can cause your blood pressure to become abnormally low.
If you forget to take Adaptus/Delaman If you accidentally miss a dose, take the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Adaptus/Delaman It is important that you continue to take Adaptus/Delaman until your doctor tells you otherwise. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Adaptus/Delaman can cause side effects, although not everybody gets them. If any side effects occur, they are likely to be mild and temporary. However some effects may be serious and require medical attention.
The frequency of side effects is classified into the following categories: Very common in more than 1 in 10 patients Common in more than 1 in 100 patients, but less than 1 in 10 patients Uncommon in more than 1 in 1,000 patients, but less than 1 in 100 patients Rare in more than 1 in 10,000 patients, but less than 1 in 1,000 patients Very rare in less than 1 in 10,000 patients, including isolated reports Not known Frequency can not be estimated from the available data
Common side effects: Most common side effects: Cough, accumulation of fluid into the tissues causing swelling, headache.
Other common side effects: Reduction in the number of white blood cells, feeling of indifference, balance disorder, feeling of abnormal motion, feeling of dizziness, feeling of increased heart rate, very low blood pressure (especially when standing up), hot flushes, bronchitis, nausea, belly ache, digestive disorders, tiredness, abnormal blood tests (i.e. changes pointing to an abnormal liver function, increase in potassium levels).
Uncommon side effects: Anaemia due to a lack or insufficient number of new blood cells produced by the bone marrow, severe reduction in the number of white blood cells which makes infections more likely, reduction in the number of blood platelets which increases risk of bleeding or bruising, reduction in the number of certain white blood cells which makes infections more likely, anaemia, reduction in the amount of blood pigment and in the proportion of volume of red blood cells, loss of appetite, confusion, sleeplessness, mood swings, nervousness, anxiety, altered sensation, distortion of taste, blurred vision, rapid heart beat, fainting, shortness of breath, inflammation of the sinuses and mucosa of the nose (e.g. “runny nose”), sore throat, vomiting, diarrhoea, constipation, mouth dryness, gallstone disease (especially with existing inflammation of the gallbladder), rash, itching, inflammation of the skin with redness and itching (eczema), abnormally increased sweating, muscle and joint stiffness, leg and arm pain, impaired kidney function, presence of an excess of proteins in the urine, being unable to achieve or maintain an erection (impotence), feeling weak, feeling of discomfort, abnormal blood tests (i.e. changes pointing to an abnormal kidney function).
Rare side effects:
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Allergic reactions, reduced libido, feeling very drowsy, heart attack, irregular heart beat, chest pain due to an inadequate supply of oxygen to the heart (angina pectoris), chest pain, stroke, stomach ache, hives, abnormal redness of the skin, muscle cramps, acute kidney failure, occurrence of urea (a waste product normally excreted in the urine) in the blood, irritability, abnormal blood tests (i.e. increase in bile pigment, changes pointing to an abnormal change in function e.g. of the heart or muscles).
Rare reactions which can be caused by these kinds of medicines include swelling of the face, eyes, lips, tongue, throat or difficulty in breathing. If during treatment you notice any of these reactions, stop taking Adaptus/Delaman and seek immediate medical attention.
Very rare side effects (including isolated reports): Anaemia due to a too extensive breakdown of the red blood cells, in patients with pre-existing angina pectoris (chest pain due to an inadequate supply of oxygen to the heart) increased frequency, duration and severity of angina pectoris attacks and occurrence of heart attacks, poor blood circulation which makes the toes and fingers numb and pale (Raynaud’s phenomenon), difficulty in breathing, inflammation of the pancreas, bowel obstruction, inflammation of the tongue, blistering of the skin, mouth, eyes and genitals with fever (Stevens- Johnson syndrome), hair loss, psoriasis.
Not known: High level of potassium in the blood (hyperkalaemia); Swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema); Kidney problems: severely decreased urine output (acute renal impairment), m.uscle pain, breast swelling with Formatiert: Schriftart: (Standard) Times New Roman, 11 Pt., or without tenderness in males (gynaecomastia). Nicht Fett, Nicht Kursiv, Nicht unterstrichen, Englisch (Großbritannien), Nicht Durchgestrichen
Formatiert: Englisch (Großbritannien) Formatiert: Schriftart: (Standard) Times New Roman, 11 Pt., Reporting of side effects Nicht unterstrichen, Englisch (Großbritannien), Nicht If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed Durchgestrichen 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 ADAPTUS/DELAMAN
Keep this medicine out of the sight and reach of children. Do not use Adaptus/Delaman after the expiry date which is stated on the carton and on the label. Adaptus/Delaman should be used within two months after the first opening of the bottle (box of 14, 28 tablets) Adaptus/Delaman should be used within 3.5 months after the first opening of the bottle (box of 50, 100 tablets) Keep the bottle tightly closed. (Only for 100 tablets pack sizes) Use completely the medicinal product contained in one bottle before opening the other bottle.
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 Adaptus/Delaman contains Adaptus/Delaman is a combination of two active substances, delapril hydrochloride and manidipine hydrochloride.
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Each tablet of Adaptus/Delaman 30 mg/10 mg contains 30 mg delapril hydrochloride and 10 mg manidipine hydrochloride respectively. The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, riboflavin, E 110 aluminium lake.
What Adaptus/Delaman looks like and contents of the pack Adaptus/Delaman is supplied in amber-glass bottles, closed with a child-resistant closure including a drying agent. Each box of Adaptus/Delaman contains 14, 28, 50, 100 (50x2) salmon-pink, round, scored tablets.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [To be completed nationally]
Manufacturer Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
Italy: Adaptus/Delaman Greece: Vivace Germany: Vivace Spain: Vivace/Bimade
This leaflet was last revised in MM/YYYY
Delapril and manidipine licensed by Takeda Pharmaceutical Company , Ltd - Japan
Detailed information on this medicine is available on the web site of: „name of MS/Agency“
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