Delaprìde

PACKAGE LEAFLET: INFORMATION FOR THE USER

DELAPRIDE 30 mg + 1.25 mg tablets

(delapril hydrochloride and indapamide)
Please 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, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor. See section 4.

1. WHAT DELAPRIDE IS AND WHAT IT IS USED FOR

What DELAPRIDE is
DELAPRIDE is a combination of two active substances: delapril hydrochloride and indapamide.
Delapril hydrochloride belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors). Angiotensin II is a substance produced in the body that causes narrowing of the blood vessels, thereby increasing blood pressure. Delapril prevents the formation of Angiotensin II, thus reducing blood pressure.
Indapamide is a diuretic that lowers blood pressure in two ways: by reducing circulating fluid volume through its diuretic effect, which occurs by blocking renal reabsorption of sodium, and by inducing relaxation of the peripheral small arteries.

What DELAPRIDE is used for
DELAPRIDE is used to treat high blood pressure (hypertension) in patients whose blood pressure is not adequately controlled by delapril or indapamide alone.

2. WHAT YOU SHOULD KNOW BEFORE TAKING DELAPRIDE

Do not take DELAPRIDE:

• if you are allergic (hypersensitive) to delapril or other ACE inhibitors, to indapamide or other sulfonamide derivatives, or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver impairment,
• if you have severe renal impairment,
• if you have renal artery stenosis (narrowing of the renal arteries),
• if you suffer from cerebrovascular disorders (cerebral vascular problems),
• if you have pheochromocytoma (a tumor producing catecholamines, stimulant substances),
• if you have Conn’s syndrome (overactivity of the adrenal glands which may lead to low potassium levels in the blood),
• if you are more than three months pregnant (DELAPRIDE should also be avoided during early pregnancy – see section Pregnancy),
• if you have previously experienced allergic reactions such as swelling of the face, eyes, lips, tongue, throat and/or breathing difficulties during prior treatment with ACE inhibitors, or if you or a family member has had these symptoms under other circumstances,
• if you have low levels of potassium or sodium that have not responded to treatment,
• if you suffer from anuria (absence of urine production),
• if you have hereditary/idiopathic angioedema (a disease characterized by edema),
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat). The risk of angioedema may also be increased if you are taking any of the following medicines:
  • 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.

Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking DELAPRIDE.
Be especially cautious with Delapride if:

• you have kidney problems or have had a kidney transplant,

• you have certain heart conditions (valvular stenosis, i.e. narrowing of the aortic valve, or heart failure, or heart problems caused by narrowing of the coronary arteries supplying blood to the heart muscle, such as chest pain known as angina, or an abnormality on the electrocardiogram called prolonged QT),

• you are undergoing dialysis (artificial kidney treatment),

• you have a condition associated with abnormal blood potassium levels,

• you have abnormal changes in blood components,

• you have liver problems,

• you are scheduled for surgery or need to take anesthetics,

• you are scheduled for an imaging procedure requiring administration of an iodinated contrast agent,

• you have diabetes,

• you are undergoing LDL apheresis (removal of cholesterol from the blood using a machine),

• you are undergoing desensitization treatment for allergic reactions to bee or wasp stings,

• you are aged 65 years or older,

• you suffer from gout and/or have high levels of uric acid in the blood,

• you have respiratory problems,

• you experience rapid heartbeat, dizziness, or general weakness, which may indicate low blood pressure,

• you think you may be pregnant (or if there is a possibility of becoming pregnant). DELAPRIDE is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy),

• you are breastfeeding,

• you are taking any of the following medicines used to treat high blood pressure:

  • an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
  • aliskiren.

• you are taking any of the following medicines, which may increase the risk of angioedema (rapid subcutaneous swelling, e.g. in the throat):

  • sirolimus, everolimus, and other drugs belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

• If you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after starting Delapride. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take DELAPRIDE”.
Stop taking DELAPRIDE and contact a doctor immediately if you experience one or more of the following symptoms due to drug hypersensitivity: swelling of the face, eyes, lips, tongue, throat and/or difficulty breathing. (see section "Possible Side Effects")
If you are an athlete, please note that this medicine contains an active substance that may lead to a positive result in doping tests.

Children and adolescents
Delapride must not be administered to children and adolescents.

Other medicines and DELAPRIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking any of the following medicines:

• potassium-containing salts or potassium-sparing diuretics. In such cases, special precautionary measures are recommended (e.g. blood tests),
• diuretics (used to eliminate water from the body by increasing urine production) and other medicines that lower your blood pressure. These may enhance the blood pressure-lowering effect of DELAPRIDE,
• lithium-containing preparations (usually used to treat manic-depressive disorders). These should be taken together with DELAPRIDE only under strict medical supervision,
• digitalis-containing preparations (for treating heart problems),
• anesthetics, narcotics,
• medicines used in cancer treatment,
• medicines used to protect against side effects of anticancer therapies,
• other blood pressure-lowering medicines,
• corticosteroids,
• immunosuppressive medicines (which reduce the body's defense mechanisms) used to treat autoimmune diseases or in transplant surgery,
• allopurinol (for treating gout),
• certain painkillers (e.g. non-steroidal anti-inflammatory drugs such as aspirin),
• medicines that stimulate the sympathetic nervous system (e.g. cold remedies),
• antacids,
• diabetes medicines (oral antidiabetics, especially metformin, or insulin),
• medicines for treating arrhythmias (irregular heartbeat). In such cases, special precautionary measures are recommended (e.g. blood tests),
• antipsychotics, antidepressants. In such cases, special precautionary measures are recommended (e.g. blood tests),
• certain anti-infectives (erythromycin, halofantrine, pentamidine, sparfloxacin, moxifloxacin), vincamine. In such cases, special precautionary measures are recommended (e.g. blood tests),
• calcium supplements, an angiotensin II receptor antagonist (AIIRA), or aliskiren (see also sections “Do not take DELAPRIDE” and “Warnings and Precautions”).

This is particularly important if you are also taking:

• medicines used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and Precautions”.
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation).

DELAPRIDE with food, drinks, and alcohol
DELAPRIDE may be taken with or without food, as food intake has negligible effect and does not influence the blood pressure-lowering effect. Be cautious with alcohol consumption, as it may enhance the antihypertensive effect of DELAPRIDE.

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking DELAPRIDE before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead.
DELAPRIDE is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
DELAPRIDE is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Consult your doctor before taking any medicine.

Driving and using machines
It is unlikely that DELAPRIDE will affect your ability to drive or operate machinery. However, dizziness, fatigue, or other reactions related to low blood pressure may occasionally occur, which could impair your ability to drive or use machines (see section "Possible Side Effects"). If you experience such effects, consult your doctor before engaging in these activities.

DELAPRIDE contains lactose and a colouring agent
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The colouring agent E110 may cause allergic reactions.

3. HOW TO TAKE DELAPRIDE

Dosage
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The usual initial dose is one tablet of DELAPRIDE 30 mg + 1.25 mg once daily. After 2–4 weeks of treatment, depending on your response, your doctor may decide to maintain the same dose or increase it to one tablet of 30 mg + 2.5 mg once daily.
However, in certain cases, your doctor may prescribe DELAPRIDE 30 mg + 2.5 mg immediately.
If you are over 65 years of age, have renal impairment, slightly elevated blood pressure levels, or are already taking a diuretic, your doctor may prescribe an appropriately reduced dose.

Method of administration
Delapride should preferably be taken in the morning.
Swallow the tablet with a sufficient amount of water.
Try to take your daily dose at the same time each day.

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

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

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

Use in children and adolescents
Do not administer Delapride to children and adolescents (see section 2, "Do not take Delapride").

If you take more DELAPRIDE than you should
If you accidentally take too many tablets, contact your doctor immediately, as this could excessively lower your blood pressure.

If you forget to take DELAPRIDE
If you accidentally miss a dose, continue your treatment as usual.
Do not take a double dose to make up for the missed tablet.

If you stop taking DELAPRIDE
It is important to continue taking DELAPRIDE unless otherwise instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If adverse reactions do occur, they are likely to be mild and temporary. However, some of these effects could be serious and require medical attention.

Very common adverse reactions (occur in more than 1 patient out of 10):
Cough, dizziness, vertigo (see "Driving and use of machines"), headache, weakness, stomach ache, vomiting, skin rash, itching.

Common adverse reactions (occur in more than 1 patient out of 100 but less than 1 patient out of 10):
Very low blood pressure with dizziness, weakness, visual disturbances. Abnormal blood tests indicating changes in kidney or liver function, changes in potassium levels, low potassium levels in the blood, increased levels of uric acid and glucose in the blood, skin allergic reactions.

Uncommon adverse reactions (occur in more than 1 patient out of 1,000 but less than 1 patient out of 100):
Kidney function disorders, including acute kidney failure, worsening of pre-existing kidney failure. Laboratory test abnormalities: increase in a compound produced by muscle activity called creatine phosphokinase (CPK) and in an enzyme called lactate dehydrogenase (LDH) in the blood, low sodium levels in the blood which may lead to dehydration and reduced blood pressure, impotence (inability to achieve or maintain an erection).

Rare adverse reactions (occur in more than 1 patient out of 10,000 but less than 1 patient out of 1,000):
Very low blood pressure with loss of consciousness (syncope), breathing difficulties, sinusitis, cold-like symptoms, inflammation of the tongue, bronchitis and spasmodic narrowing of the bronchi, nausea, abdominal pain, indigestion, diarrhoea, constipation and dry mouth, skin manifestations with scaly whitish lesions (psoriasis) and hair loss, depression, sleep disorders, abnormal sensations of tingling and/or burning, impotence, balance disorders, confusion, tinnitus, blurred vision and taste disturbances. Laboratory test abnormalities: reduction in the amount of blood pigment (haemoglobin) and in the volume percentage of red blood cells (haematocrit), increase in bile pigments and liver enzymes, low chloride levels in the blood and low magnesium levels in the blood.
Rare cases of reactions that may be caused by similar medicines include swelling of the face, eyes, lips, tongue, throat or difficulty in breathing (hypersensitivity/angioneurotic oedema).
If you notice any of these reactions during treatment, stop taking DELAPRIDE and seek immediate medical attention.

Very rare adverse reactions (occur in less than 1 patient out of 10,000, including isolated reports):
Very low blood pressure with rapid heartbeat, palpitations, irregular heartbeat, chest pain, transient episode of insufficient blood supply to the brain, cerebral haemorrhage. Oedema of the respiratory tract with fatal respiratory obstruction. Obstructive jaundice due to bile duct obstruction, hepatitis, inflammation of the pancreas and intestinal obstruction. Skin allergic reactions associated with inflammation and necrosis of the epidermis with exfoliation giving the appearance of burned skin (toxic epidermal necrolysis), blistering rash of the skin, mouth, eyes and genitals with fever and muscle and joint pain (Stevens-Johnson syndrome), acute skin eruption with polymorphic appearance (erythema multiforme). Blood-related abnormalities: anaemia due to deficiency or insufficient number of new blood cells produced by the bone marrow, severe reduction in the number of white blood cells making infections more likely, reduction in the number of platelets increasing the risk of bleeding or bruising, reduction in the number of specific white blood cells making infections more likely, anaemia due to excessive breakdown of red blood cells. Impairment of liver function; in case of pre-existing liver failure, impairment of brain function. Worsening of pre-existing systemic lupus erythematosus. Increased levels of calcium in the blood.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• High potassium levels in the blood (hyperkalaemia)
• Swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema)
• Kidney problems: significantly reduced urine production (acute kidney injury)
• Alteration of taste sensation (dysgeusia)
• Inability to perceive tastes (ageusia)
• Loss of consciousness/fainting
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion))

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DELAPRIDE

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and label following the word EXP. The expiry date refers to the last day of that month.
• Delapride must be used within two months of first opening the bottle.
• Keep the bottle tightly closed.
• This medicine does not require any special storage conditions.

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What DELAPRIDE contains
The active substances are: delapril hydrochloride and indapamide.
Each DELAPRIDE 30 mg + 1.25 mg tablet contains 30 mg of delapril and 1.25 mg of indapamide.
The other components are: monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose,
magnesium stearate and E110 aluminium lake.

Description of the appearance of DELAPRIDE and contents of the pack
DELAPRIDE is supplied in yellow glass bottles with a child-resistant closure including a desiccant.
Each DELAPRIDE pack contains 28 pinkish tablets with a break line.

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 San Leonardo, 96, 43122 Parma, Italy

This instruction leaflet was last updated in: October 2022

PATIENT LEAFLET: INFORMATION FOR THE USER

DELAPRIDE 30 mg + 2.5 mg tablets

(delapril hydrochloride and indapamide)
Please 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.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor. See section 4.

What DELAPRIDE is and what it is used for

2. What you need to know before taking DELAPRIDE
3. How to take DELAPRIDE
4. Possible side effects
5. How to store DELAPRIDE
6. Contents of the pack and other information

1. WHAT DELAPRIDE IS AND WHAT IT IS USED FOR

What DELAPRIDE is
DELAPRIDE is a combination of two active substances: delapril hydrochloride and indapamide.
Delapril hydrochloride belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. Angiotensin II is a substance produced in the body that causes narrowing of blood vessels, thereby increasing blood pressure. Delapril prevents the production of Angiotensin II, thus reducing blood pressure.
Indapamide is a diuretic that lowers blood pressure in two ways: by reducing circulating fluids through its diuretic effect, which works by blocking renal reabsorption of sodium, and by inducing relaxation of the peripheral small arteries.

What DELAPRIDE is used for
DELAPRIDE is used for the treatment of high blood pressure (hypertension) in patients whose condition is not adequately controlled by delapril or indapamide alone.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DELAPRIDE

Do not take DELAPRIDE:

• if you are allergic (hypersensitive) to delapril or other ACE inhibitors, to indapamide or other sulfonamide-derived drugs, or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver failure;
• if you have severe renal failure;
• if you have renal artery stenosis (narrowing of the renal arteries);
• if you have cerebrovascular disorders (cerebrovascular problems);
• if you have phaeochromocytoma (a tumor producing catecholamines, stimulant substances);
• if you have Conn's syndrome (overactivity of the adrenal glands which may lead to low potassium levels in the blood);
• if you are more than three months pregnant. (DELAPRIDE should also be avoided during early pregnancy - see section Pregnancy);
• if you have previously experienced allergic reactions such as swelling of the face, eyes, lips, tongue, throat, and/or breathing difficulties during prior treatment with ACE inhibitors, or if you or a family member has had these symptoms under other circumstances;
• if you have low levels of potassium or sodium that have not responded to treatment;
• if you have anuria (absence of urine production);
• if you have hereditary/idiopathic angioedema (a disease characterized by edema);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g., in 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 organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus);
  • Vildagliptin, a medicine used to treat diabetes.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking DELAPRIDE.
Be especially cautious with Delapride if you:

• have kidney problems or have had a kidney transplant;
• have certain heart conditions (valvular stenosis, i.e., narrowing of the aortic valve, or heart failure, or heart problems caused by narrowing of the coronary arteries supplying blood to the heart muscle, such as chest pain known as angina, or an abnormal electrocardiogram known as long QT);
• are undergoing dialysis (treatment with artificial kidney);
• have a condition associated with altered blood potassium levels;
• have abnormal changes in blood components;
• have liver problems;
• are about to undergo surgery or receive anesthetics;
• are scheduled for an imaging procedure requiring administration of iodinated contrast media;
• have diabetes;
• are undergoing LDL apheresis (removal of cholesterol from the blood using a machine);
• are undergoing desensitization treatment for allergic reactions to bee or wasp stings;
• are aged 65 years or older;
• have gout and/or high levels of uric acid in the blood;
• have respiratory problems;
• experience rapid heartbeat, dizziness, or general weakness, which may indicate low blood pressure;
• think you may be pregnant (or if there is a possibility of becoming pregnant). DELAPRIDE is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child if taken during this period (see section Pregnancy);
• are breastfeeding;
• are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren;
  • if you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, e.g., in the throat) is higher:
• sirolimus, everolimus, and other drugs belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection).
  • If you experience visual disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Delapride. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

Your doctor may periodically monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.
See also the section “Do not take DELAPRIDE”.
Stop taking DELAPRIDE and seek immediate medical attention if you experience one or more of the following symptoms due to hypersensitivity reactions: swelling of the face, eyes, lips, tongue, throat, and/or difficulty breathing. (See “Possible Side Effects”)
If you are an athlete, please note that this medicine contains an active substance that may lead to a positive result in anti-doping tests.

Children and adolescents
Delapride must not be administered to children and adolescents.

Other medicines and DELAPRIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Your doctor may consider it necessary to adjust your dose and/or take other precautions if you are taking any of the following medicines:

• potassium-containing salts or potassium-sparing diuretics. In such cases, special precautions are recommended (e.g., blood tests);
• diuretics (used to eliminate water from the body by increasing urine production) and other medicines that lower your blood pressure. These medicines may enhance the blood pressure-lowering effect of DELAPRIDE;
• lithium-containing preparations (usually used to treat manic-depressive disorders). These should be taken together with DELAPRIDE only under strict medical supervision;
• digitalis-containing preparations (for treating heart problems);
• anesthetics, narcotics;
• medicines used in cancer treatment;
• medicines used to protect against side effects of anticancer therapies;
• other medicines to lower blood pressure;
• corticosteroids;
• immunosuppressive medicines (which reduce the body's defense mechanisms) used to treat autoimmune diseases or in transplant surgery;
• allopurinol (for treating gout);
• certain painkillers (e.g., non-steroidal anti-inflammatory drugs such as aspirin);
• medicines that stimulate the sympathetic nervous system (e.g., cold remedies);
• antacids;
• diabetes medicines (oral antidiabetics, especially metformin, or insulin);
• medicines for treating arrhythmias (irregular heartbeat). In such cases, special precautions are recommended (e.g., blood tests);
• antipsychotics, antidepressants. In such cases, special precautions are recommended (e.g., blood tests);
• certain anti-infectives (erythromycin, halofantrine, pentamidine, sparfloxacin, moxifloxacin), vincamine. In such cases, special precautions are recommended (e.g., blood tests);
• calcium supplements;
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take DELAPRIDE” and “Warnings and precautions”). This is particularly important if you are also taking:
• medicines used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

DELAPRIDE with food, drinks, and alcohol
DELAPRIDE can be taken with or without food, as food intake has negligible effect and does not influence the blood pressure-lowering effect. Be cautious when consuming alcohol, as it may enhance the antihypertensive effect of DELAPRIDE.

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking DELAPRIDE before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
DELAPRIDE is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
DELAPRIDE is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Consult your doctor before taking any medicine.

Driving and using machines
It is unlikely that DELAPRIDE will affect your ability to drive or operate machinery. However, dizziness, fatigue, or other reactions due to lowered blood pressure may occasionally occur, which could impair your ability to drive or use machines (see “Possible Side Effects”). If this happens, consult your doctor before engaging in such activities.

DELAPRIDE contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE DELAPRIDE

Dosage
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The usual starting dose is one tablet of DELAPRIDE 30 mg + 1.25 mg once daily. After 2–4
weeks of treatment, depending on the response, your doctor may decide to maintain the same dose or
increase it to one tablet of 30 mg + 2.5 mg once daily.
However, in certain cases, your doctor may prescribe DELAPRIDE 30 mg + 2.5 mg immediately.
If you are over 65 years of age, have renal impairment, slightly elevated blood pressure levels,
or are already taking a diuretic, your doctor may prescribe an appropriately reduced dose.

Method of administration
Delapride should preferably be taken in the morning.
Swallow the tablet with a sufficient amount of water.
Try to take your daily dose at the same time each day.

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

Use in children and adolescents
Do not administer Delapride to children and adolescents (see section 2, "Do not take Delapride").

If you take more DELAPRIDE than you should
If you accidentally take too many tablets, contact your doctor immediately,
as this could excessively lower your blood pressure.

If you forget to take DELAPRIDE
If you accidentally miss a dose, continue your treatment as usual.
Do not take a double dose to make up for the missed tablet.

If you stop taking DELAPRIDE
It is important to continue taking DELAPRIDE unless otherwise instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If adverse reactions occur, they are likely to be mild and temporary. However, some of these effects could be serious and require medical attention.

Very common adverse reactions (occur in more than 1 patient out of 10):
Cough, dizziness, vertigo (see "Driving and use of machines"), headache, weakness, stomach ache, vomiting, skin rashes, itching.

Common adverse reactions (occur in more than 1 patient out of 100 but less than 1 patient out of 10):
Very low blood pressure with dizziness, weakness, visual disturbances. Abnormal blood tests indicating changes in kidney or liver function, changes in potassium levels, low blood potassium levels, increased levels of uric acid and glucose in blood, skin allergic reactions.

Uncommon adverse reactions (occur in more than 1 patient out of 1,000 but less than 1 patient out of 100):
Renal function disorders, including acute renal failure, worsening of pre-existing renal insufficiency. Laboratory test abnormalities: increased levels of a compound produced by muscle activity called creatine phosphokinase (CPK) and of an enzyme called lactate dehydrogenase (LDH) in blood, low blood sodium levels which may lead to dehydration and reduced blood pressure, impotence (inability to achieve or maintain an erection).

Rare adverse reactions (occur in more than 1 patient out of 10,000 but less than 1 patient out of 1,000):
Very low blood pressure with loss of consciousness (syncope), breathing difficulties, sinusitis, cold-like symptoms, inflammation of the tongue, bronchitis and spasmodic narrowing of the bronchi, nausea, abdominal pain, indigestion, diarrhea, constipation and dry mouth, skin manifestations with whitish scaly lesions (psoriasis) and hair loss, depression, sleep disorders, abnormal sensations of tingling and/or burning, impotence, balance disorders, confusion, tinnitus, blurred vision and taste disturbances. Laboratory test abnormalities: reduction in the amount of blood pigment (haemoglobin) and in the volume percentage of red blood cells (haematocrit), increased levels of bile pigments and liver enzymes, low blood chloride and low blood magnesium levels.

Rare cases of reactions that may be caused by similar medicines include swelling of the face, eyes, lips, tongue, throat or difficulty in breathing (hypersensitivity/angioneurotic edema). If you notice any of these reactions during treatment, stop taking DELAPRIDE and seek immediate medical attention.

Very rare adverse reactions (occur in less than 1 patient out of 10,000, including isolated reports):
Very low blood pressure with rapid heartbeat, palpitations, irregular heartbeat, chest pain, transient episode of insufficient blood supply to the brain, cerebral haemorrhage. Respiratory tract edema with fatal respiratory obstruction. Obstructive jaundice due to bile duct obstruction, hepatitis, inflammation of the pancreas and intestinal obstruction. Allergic skin reactions associated with inflammation and necrosis of the epidermis with exfoliation giving the appearance of burned skin (toxic epidermal necrolysis), blistering skin rash affecting mouth, eyes and genitals with fever and muscle and joint pain (Stevens-Johnson syndrome), acute widespread skin rash with various forms (erythema multiforme). Blood disorders: anaemia due to deficiency or insufficient number of new blood cells produced by the bone marrow, severe reduction in the number of white blood cells increasing the likelihood of infections, reduced platelet count increasing the risk of bleeding or bruising, reduced number of specific white blood cells increasing the risk of infections, anaemia due to excessive breakdown of red blood cells. Impaired liver function; in case of pre-existing liver failure, impairment of brain function. Worsening of pre-existing systemic lupus erythematosus. Increased levels of calcium in blood.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)

• High levels of potassium in blood (hyperkalaemia)

• Swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema)

• Kidney problems: significantly reduced urine output (acute kidney injury)

• Alteration of taste sensation (dysgeusia)

• Inability to perceive tastes (ageusia)

• Loss of consciousness/fainting

• Decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion))

• Reporting of adverse reactions
  If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting adverse reactions can help provide more information on the safety of this medicine.

5. HOW TO STORE DELAPRIDE

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What DELAPRIDE contains
The active substances are: delapril hydrochloride and indapamide.
Each DELAPRIDE 30 mg + 2.5 mg tablet contains 30 mg of delapril and 2.5 mg of indapamide.
The other components are monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, and magnesium stearate.

Description of the appearance of DELAPRIDE and contents of the package
DELAPRIDE is supplied in aluminum blisters with 14 compartments.
Each DELAPRIDE pack contains 28 white tablets with a score line.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Promedica Srl
Via Palermo 26/A, 43122 Parma, Italy

Manufacturers
Chiesi Farmaceutici S.p.A.
Via San Leonardo, 96, 43122 Parma, Italy

Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano, 43, 24041 Brembate (BG), Italy

This leaflet was last revised in: November 2022