ADAPTUS 30 mg/10 mg Coated Tablet

Зміст інструкції

1. ADAPTUS 30 mg / 10 mg tablets
   1. WHAT IS ADAPTUS AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING ADAPTUS
   3. HOW TO TAKE ADAPTUS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ADAPTUS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

ADAPTUS 30 mg / 10 mg tablets

(Delapril hydrochloride + manidipine hydrochloride)

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

1. WHAT IS ADAPTUS AND WHAT IS IT USED FOR

What is Adaptus
Adaptus is a combination of two active ingredients: delapril hydrochloride and manidipine hydrochloride.
Delapril hydrochloride belongs to a group of drugs known as angiotensin converting enzyme (ACE) inhibitors. Angiotensin II is a substance produced
in the body that causes narrowing of the blood vessels, thus causing an increase in
blood pressure. Delapril hydrochloride prevents the production of angiotensin II, thereby causing a reduction in pressure.
Manidipine hydrochloride belongs to a group of drugs called Calcium antagonists, which
prevent the entry of calcium into the smooth muscle cells present in the blood vessels, thereby causing vasodilation with a consequent reduction in blood pressure.
The two active ingredients present in Adaptus contribute to lowering blood pressure more
effectively than their use alone.

What is Adaptus used for
For the treatment of high blood pressure (hypertension) in patients in whom this is not
adequately controlled by the use of delapril or manidipine (the two active ingredients) alone.
See your doctor if you do not feel better or if you feel worse.

• 1. What is Adaptus and what is it used for
• 2. What you need to know before taking Adaptus
• 3. How to take Adaptus
• 4. Possible side effects
• 5. How to store Adaptus
• 6. Contents of the pack and other information

2. WHAT YOU NEED TO KNOW BEFORE TAKING ADAPTUS

Do not take Adaptus:

• if you are allergic to delapril or other ACE inhibitor drugs, manidipine or other Calcium channel blockers, or to any of the other ingredients of this medicine (listed in section 6)
• if you have suffered from allergic reactions, such as swelling of the face, eyes, lips, tongue,
• of the throat or difficulty breathing with previous treatments of ACE inhibitors or if you or a member of your family has had these symptoms in other circumstances
• if you suffer from severe liver failure
• if you suffer from serious kidney problems (for example severe kidney failure, if you are on dialysis (an artificial kidney treatment), if you have had a kidney transplant or if you suffer from renal artery stenosis (narrowing of the renal artery) if you have only one kidney)
• if you suffer from heart problems (for example if you have recently had a heart attack or angina pectoris (chest pain due to inadequate oxygen supply to the heart), heart failure)
• if you have problems with aortic stenosis (narrowing of the main blood vessel exiting the heart) or if you have hypertrophic cardiomyopathy (heart muscle disease)
• if you have hyperactivity of the adrenal glands which may lead to a lowering of potassium levels in the blood
• if you are pregnant for more than three months. (It is best to avoid Adaptus even in the early stages of pregnancy - see the Pregnancy section).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• if you are taking any of the following medicines, the risk of angioedema may be increased.
• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Adaptus should not be administered to children and adolescents under the age of 18 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking Adaptus

• if you suffer from kidney problems
• if you suffer from liver problems
• if you suffer from certain heart problems (for example coronary artery disease)
• if you suffer from disorders due to damage to the blood vessels in the brain (cerebrovascular problems)
• if you are undergoing LDL apheresis (removal of cholesterol from the blood with a machine)
• if you intend to undergo desensitization treatment to reduce the effects of allergy to bee or wasp stings
• if you suffer from a collagen-vascular disease such as systemic lupus erythematosus or scleroderma
• if you have diabetes
• if you have a condition associated with a persistently high level of potassium in the blood
• if you experience swelling of the face, eyes, lips, tongue, throat or difficulty breathing (see section 4, “rare side effects”)
• if you experience abnormal changes in blood components
• if you are to undergo surgery or receive anesthetics
• if you have a fast heartbeat, dizziness, or a general feeling of weakness that may indicate low blood pressure
• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Adaptus is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see the Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren.
• If you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs)

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported under the heading “Do not take Adaptus”.

Children and adolescents
Adaptus should not be administered to children and adolescents under the age of 18 years.

Other medicines and Adaptus
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
The doctor may need to adjust the dose and/or take other precautions if you are
taking any of the following medicines:

• diuretics (used to eliminate water from the body by increasing urine production) and other medicines that lower your blood pressure. These medicines can intensify the lowering of blood pressure achieved with Adaptus
• heparin (used to prevent blood clotting)
• medicines containing lithium (usually used in the treatment of manic-depressive disorders). These medicines must be taken with Adaptus only under strict medical supervision
• some painkillers (for example non-steroidal anti-inflammatory drugs such as aspirin)
• antidepressants, antipsychotics (used in the treatment of schizophrenia and other mental disorders) and anesthetics
• drugs that stimulate the sympathetic nervous system (e.g. cold medicines)
• salts containing potassium or potassium-sparing diuretics. In this case, special precautions are recommended (e.g. blood tests)
• digoxin (used to treat heart disorders)
• medicines that modify blood components (for example allopurinol, used to treat gout), procainamide (for the treatment of irregular heartbeat), corticosteroids, immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection, drugs used to treat tumors
• medicines for diabetes (both oral and insulin)
• vildagliptin, a medicine used to treat diabetes (see also what is reported in the paragraph: “Do not take Adaptus”)
• antacids
• medicines that affect the metabolism of one of the active ingredients contained in Adaptus, such as cimetidine (used in the treatment of gastric ulcers) or some antibiotics or antifungals (used in the treatment of fungal infections), phenytoin, carbamazepine, phenobarbital, rifampicin, terfenadine and astemizole, class III antiarrhythmics used for heart rhythm problems (such as amiodarone, quinidine).
• an angiotensin II receptor blocker (ARB) or aliskiren (see also what is reported in the paragraph: “Do not take Adaptus” and “Warnings and Precautions”).
• medicines used to treat a type of long-term (chronic) heart failure in adults (e.g. sacubitril/valsartan) (see also what is reported in the paragraph: “Do not take Adaptus”)
• Racecadotril, a medicine used to treat diarrhea (see also what is reported in the paragraph: “Do not take Adaptus”). Also tell your doctor if you are taking:
• Drugs commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See paragraph “Warnings and precautions”.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant drug used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots).

Adaptus with food and drink
Adaptus should be taken after breakfast.
Do not take the medicine with grapefruit juice, as blood pressure may drop
too much.
Drinking alcohol may cause a sudden drop in your blood pressure when
you stand up.
Avoid foods high in salt (containing a high amount of sodium chloride) as they may reduce
the effectiveness of Adaptus in lowering blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
As a rule, your doctor will advise you to stop taking Adaptus before starting
pregnancy or as soon as you find out you are pregnant and will advise you to
take another medicine instead of Adaptus.
Adaptus is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third
month of pregnancy.

Breastfeeding
Adaptus is not recommended for mothers who are breastfeeding and the doctor may choose another
treatment if you wish to breastfeed, especially if your baby is newborn or was
born prematurely.

Driving and operating machinery
It is unlikely that Adaptus will affect your ability to drive vehicles or operate machinery.
However, dizziness may occasionally occur during treatment for high blood pressure. If this
happens to you, consult your doctor before engaging in such activities.

Adaptus contains lactose and coloring agent
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
The coloring agent E110 may cause allergic reactions.

3. HOW TO TAKE ADAPTUS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose of Adaptus is one tablet, once a day.

Dose reduction
If you are over 65 years of age, or if you suffer from kidney or liver disorders, your doctor may
prescribe you a suitably reduced dose.

Method of administration
Adaptus should be taken in the morning, after breakfast.
Swallow the tablet whole, with a sufficient amount of water.
You should try to take your daily dose every day at the same time.
The tablet can be divided into equal parts.

Duration of treatment
It is important to continue taking Adaptus unless otherwise indicated by your doctor.
Take exactly the prescribed dose and do not change it without first consulting your doctor.

C
To avoid misuse by children, the bottle is equipped with a child-resistant closure.
To open and close the bottle, follow these instructions for use:

• To open: A) press and turn simultaneously
• To close: B) press and screw simultaneously

Use in children and adolescents
Do not administer Adaptus to children and adolescents under the age of 18 (see section
2, “Do not take Adaptus”).

If you take more Adaptus than you should
If you accidentally take too many tablets, contact your doctor immediately
as this may excessively reduce your blood pressure.

If you forget to take Adaptus
If you accidentally forget to take a dose of the medicine, continue with therapy as normal.
Do not take a double dose to make up for forgetting a single tablet.

If you stop taking Adaptus
It is important to continue taking Adaptus unless otherwise indicated by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Adaptus can cause side effects, although not everybody gets them.
If side effects do occur, they are usually mild and temporary. However,
some of these could be serious and require medical attention.
The frequency with which side effects occur is classified into the following categories:

Common side effects:
Very common side effects:
Cough, fluid retention in the tissues with swelling, headache.

Other common side effects:
Reduction in the number of white blood cells, apathy, loss of balance, impaired balance,
dizziness, fast heartbeat, very low blood pressure (especially in
upright position), hot flushes, bronchitis, nausea, abdominal pain, digestive disorders,
fatigue, altered blood tests (e.g. changes indicating impaired liver function,
increased potassium levels).

Uncommon side effects:
Anemia due to deficiency 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 platelets with an increased risk of bleeding and bruising, anemia,
reduction in the amount of hemoglobin and the ratio of red blood cell volume, loss of appetite,
confusion, drowsiness, mood changes, nervousness, anxiety, altered sensations, impaired
sense of taste, blurred vision, fast heartbeat, fainting, shortness of breath,
inflammation of the sinuses and nasal mucosa (runny nose), sore throat, vomiting, diarrhea,
constipation, dry mouth, gallstones (especially in case of pre-existing infection of the
gallbladder), erythema, itching, skin inflammation with redness and itching (eczema), excessive
sweating, stiffness of muscles and joints, pain in legs and arms, impaired
kidney function, presence of excess protein in the urine, difficulty getting or maintaining
an erection (impotence), weakness, feeling unwell, altered blood tests (e.g. changes
indicating impaired kidney function).

Rare side effects:
Allergic reactions, decreased libido, drowsiness, heart attack, irregular heartbeat,
chest pain due to insufficient oxygen supply to the heart (angina pectoris), chest pain,
stroke, stomach pain, hives, abnormal skin redness,
muscle cramps, acute kidney failure, presence of urea (a waste product normally
excreted in urine) in the blood, irritability, altered blood tests (e.g. increased bilirubin,
changes indicating impaired function for example cardiac or muscular).
Rare side effects caused by this type of drug can include: swelling of the face,
eyes, lips, tongue, or throat or difficulty breathing.
If you notice any of these reactions during treatment, stop taking Adaptus and
seek immediate medical assistance.

Very rare side effects (including isolated reports):
Anemia due to excessive breakdown of red blood cells, in patients with pre-existing angina pectoris
(chest pain due to insufficient oxygen supply to the heart) increased frequency,

duration and intensity of angina attacks and heart attack, poor blood circulation
that causes numbness and paleness of the toes and fingers (Raynaud's phenomenon),
difficulty breathing, inflammation of the pancreas, intestinal blockage, inflammation of the tongue,
appearance of blisters on the skin, mouth, eyes and genitals with fever (Stevens-Johnson syndrome),
hair loss, psoriasis.

Not known:

• High levels of potassium in the blood (hyperkalemia)
• Swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema)
• Kidney problems: significantly reduced urine production (acute kidney injury)
• Muscle pain
• Breast enlargement with or without breast tenderness in men (gynecomastia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .. By reporting side effects you can help provide more information on
the safety of this medicine.

5. HOW TO STORE ADAPTUS

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package and label after the wording EXP. The expiry date refers to the last day of that month.
• Adaptus must be used within two months of first opening the bottle (packs of 14 and 28 tablets).
• Adaptus must be used within three and a half months of first opening the bottle (packs of 50 and 100 tablets)
• Keep the bottle tightly closed.
• ( Only for the 100 tablet pack) Use all the medicine contained in the first bottle before opening the other.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Adaptus contains
The active ingredients are: delapril hydrochloride and manidipine hydrochloride.
Each Adaptus 30 mg/10 mg tablet contains 30 mg of delapril hydrochloride and 10
mg of manidipine hydrochloride, respectively.
The other ingredients are: lactose monohydrate, low substituted hydroxypropylcellulose,
hydroxypropylcellulose, magnesium stearate, riboflavin, E110 aluminium lake.

Description of Adaptus and package contents
Adaptus is supplied in amber glass bottles, equipped with a child-resistant closure, which includes
a desiccant.
Each pack of Adaptus contains 14, 28, 50, 100 (50x2) divisible, round, salmon pink
tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Master Pharma S.r.l. Via Giacomo Chiesi 1, 43122 Parma, Italy

Manufacturer
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

Delapril and Manidipine under license from Takeda Pharmaceutical Company, Ltd - Japan