DELAMAN 30 мг/10 мг Таблетки

Содержание инструкции

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

DELAMAN 30 mg / 10 mg tablets

(Delapril hydrochloride + manidipine hydrochloride)

Read this leaflet carefully before taking this medicine because 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 DELAMAN IS AND WHAT IT IS USED FOR

What is DELAMAN
DELAMAN 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 DELAMAN contribute to lowering blood pressure in a more
efficient way than their use alone.

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

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

2. WHAT YOU NEED TO KNOW BEFORE TAKING DELAMAN

Do not take DELAMAN:

• if you are allergic to delapril or other ACE inhibitors, 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 severe 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 leaving 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 DELAMAN 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.

DELAMAN 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 DELAMAN.

• 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 of 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 elevated 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 take anesthetics
• if you have a rapid 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). DELAMAN is not recommended in early pregnancy, and must 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" (AIIRA) (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 DELAMAN”.

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

Other medicines and DELAMAN
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 DELAMAN
• heparin (used to prevent blood clotting)
• medicines containing lithium (generally used in the treatment of manic-depressive disorders). These medicines must be taken with DELAMAN 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
• medicines 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 irregular heartbeat), corticosteroids, immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection, drugs used to treat cancer
• 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 DELAMAN”)
• antacids
• medicines that affect the metabolism of one of the active ingredients contained in DELAMAN, such as cimetidine (used to treat stomach ulcers) or some antibiotics or antifungals (used to treat 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 (AIIRA) or aliskiren (see also what is reported in the paragraphs: “Do not take DELAMAN” 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 DELAMAN”)
• Racecadotril, a medicine used to treat diarrhea (see also what is reported in the paragraph: “Do not take DELAMAN”). Tell your doctor even 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 could increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots).

DELAMAN with food and drink
DELAMAN should be taken after breakfast.
Do not take the medicine with grapefruit juice, as blood pressure may decrease
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 DELAMAN 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 DELAMAN before
starting
pregnancy or as soon as you find out you are pregnant and will advise you to
take another medicine instead of DELAMAN.
DELAMAN is not recommended in early pregnancy, and must 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
DELAMAN 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 newly born or was
born
prematurely.

Driving and using machines
It is unlikely that DELAMAN 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 these activities.

DELAMAN contains lactose and coloring agent
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.

DELAMANThe coloring agent E110 may cause allergic reactions.

3. HOW TO TAKE DELAMAN

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 DELAMAN 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
DELAMAN 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 DELAMAN 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 DELAMAN to children and adolescents under 18 years of age (see
section 2, “Do not take DELAMAN”).

If you take more DELAMAN 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 DELAMAN
If you accidentally forget to take a dose of the medicine, continue with therapy as normal.
Do not take a double dose to compensate for the forgotten single tablet.

If you stop taking DELAMAN
It is important to continue taking DELAMAN 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, DELAMAN can cause side effects, although not everybody gets them.
If side effects occur, they are usually mild and temporary. However,
some of these may 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 increases the likelihood of infections, 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, altered
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 obtaining 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 may include: swelling of the face,
eyes, lips, tongue, or throat, or difficulty breathing.
If you notice any of these reactions during treatment, stop taking DELAMAN 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
causing 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, even those not listed in this leaflet, tell 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 DELAMAN

• 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.
• DELAMAN must be used within two months of first opening the bottle (packs of 14 and 28 tablets).
• DELAMAN 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 DELAMAN contains
The active ingredients are: delapril hydrochloride and manidipine hydrochloride.
Each DELAMAN 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 DELAMAN and package contents
DELAMAN is supplied in amber glass bottles, equipped with a child-resistant closure, which
includes a desiccant.
Each pack of DELAMAN contains 14, 28, 50, 100 (50x2) divisible, round tablets, of
salmon pink colour.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Promedica S.r.l. Via Palermo 26/A, 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 under the
following denominations:

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