VIVACE 30 mg/10 mg TABLETS

2. What you need to know before taking Vivace

Do not takeVivace:

• if you are allergic to delapril or any other ACE inhibitor, manidipine or any other calcium channel blocker, or any of the other components of this medication (listed in section 6)
• if you have previously experienced severe allergic reactions such as swelling of the face, lips, tongue, and/or throat with difficulty breathing during previous treatments with ACE inhibitors, or if you or a family member have had these symptoms in any other circumstances
• if you have severe liver disease
• if you have severe kidney problems (e.g., severe kidney disease, are undergoing hemodialysis, have had a kidney transplant, or have renal artery stenosis in the case of having only one kidney)
• if you have certain heart problems (e.g., have recently had a heart attack or angina pectoris, or have heart failure)
• if you have aortic stenosis (narrowing of the main blood vessel that leaves the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle)
• if you have adrenal hyperactivity that may cause low potassium levels in the blood
• if you are pregnant for more than 3 months (it is also best to avoid taking Vivace at the start of pregnancy – see section Pregnancy)
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high
• if you are taking any of the following medications, the risk of angioedema may increase:
• • Racecadotril, a medication used to treat diarrhea
  • Medications used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus)
  • Vildagliptin, a medication used to treat diabetes

Do not give Vivace to children or adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vivace

• if you have kidney problems
• if you have liver problems
• if you have certain heart problems (e.g., ischemic heart disease)
• if you have blood vessel damage in the brain (cerebrovascular problems)
• if you are going to undergo LDL apheresis (a procedure that removes cholesterol from your blood using a machine)
• if you are going to receive desensitization treatment to reduce the effects of an allergy to bee or wasp stings
• if you have a connective tissue disease such as systemic lupus erythematosus or scleroderma
• if you are diabetic
• if you have a disease associated with constantly elevated potassium levels in the blood
• if you have signs such as swelling of the face, eyes, lips, tongue, or throat, or difficulty breathing (see section 4, "Rare side effects")
• if you have abnormal changes in your blood components
• if you are going to undergo anesthesia or surgery
• if you have a rapid heart rate, dizziness, general weakness that may indicate low blood pressure
• You should consult your doctor if you think you are (or may be) pregnant. Vivace is not recommended at the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period (see section Pregnancy)
• If you are taking any of the following medications used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems
  • Aliskiren
• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:

Sirolimus, everolimus, and other medications belonging to the mTOR inhibitor family (used to prevent organ rejection)

• If you are undergoing peritoneal dialysis

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Vivace".

Children and adolescents

Do not give Vivace to children or adolescents under 18 years of age.

Taking Vivace with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

Your doctor may need to adjust your dose and/or take other precautions if you are taking any of the following medications:

• diuretic medications (used to remove water from the body by increasing urine production) and other medications to lower blood pressure. These medications may enhance the blood pressure-lowering effect of Vivace
• heparin (used to prevent blood clots)
• medications containing lithium (usually used to treat manic-depressive disorders). These can only be taken with Vivace under close medical supervision
• medications for pain (e.g., non-steroidal anti-inflammatory drugs, such as aspirin)
• antidepressants, antipsychotics (used to treat schizophrenia and other mental illnesses), and anesthetics
• medications that stimulate the sympathetic nervous system (e.g., used for colds)
• potassium-containing salts, potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medication used to thin the blood to prevent clots)
• digoxin (used to treat heart disorders)
• medications that alter blood composition (e.g., allopurinol, used to treat gout; procainamide, used to treat irregular heartbeats; corticosteroids; immunosuppressants used to treat autoimmune disorders or prevent organ rejection; and medications used to treat cancer)
• medications for diabetes (oral or insulin)
• vildagliptin, a medication used to treat diabetes (see also information in the section "Do not take Vivace")
• antacids
• medications that alter the metabolism of any of the active substances in Vivace, such as cimetidine (used to treat stomach ulcers) or certain antibiotics or antifungals (used to treat fungal infections), phenytoin, carbamazepine, phenobarbital, rifampicin, terfenadine, and astemizole, antiarrhythmic medications of class III used to normalize heart rate (e.g., amiodarone, quinidine)
• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Vivace" and "Warnings and precautions")
• medications used to treat a type of long-term (chronic) heart failure in adults (e.g., sacubitril/valsartan) (see also information in the section "Do not take Vivace")
• racecadotril, a medication used to treat diarrhea (see also information in the section "Do not take Vivace")

Tell your doctor if you are also taking:

• Medications commonly used to prevent organ rejection (sirolimus, everolimus, and other medications belonging to the mTOR inhibitor family). See section "Warnings and precautions"
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medication used to thin the blood to prevent clots)

Taking Vivace with food and drinks

Vivace should be taken after breakfast.

Do not drink grapefruit juice while taking this medication, as your blood pressure may drop too low. Drinking alcohol may cause a drop in blood pressure when standing up.

Avoid salty foods (containing high amounts of sodium chloride), as they may reduce the blood pressure-lowering effect of Vivace.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will usually advise you to stop taking Vivace before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medication instead of Vivace. Vivace is not recommended at the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Vivace is not recommended for breastfeeding mothers, and your doctor should choose an alternative treatment if you wish to continue breastfeeding, especially if your baby is newborn or premature.

Driving and using machines

It is unlikely that Vivace will affect your ability to drive or use machines. However, it may occasionally cause dizziness due to a decrease in blood pressure. If this happens, you should consult your doctor before attempting these activities.

Vivace contains lactose and a coloring agent

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

The coloring agent E-110 may cause allergic reactions.

3. How to take Vivace

Follow the administration instructions for Vivace exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended doseof Vivace is one tablet per day.

Dose reduction

If you are over 65 years old or have kidney or liver problems, your doctor may prescribe a lower dose.

Administration

Vivace 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 approximately the same time each day.

The tablet can be divided into equal doses.

Duration of treatment

It is important that you continue taking Vivace until your doctor tells you to stop.

Please take the exact dose prescribed by your doctor and do not change it without consulting them first.

Use in children and adolescents

Do not give Vivace to children or adolescents under 18 years of age (see section 2, "What you need to know before taking Vivace - Do not take Vivace").

If you take more Vivace than you should

If you have taken more tablets than you should, consult your doctor immediately, as this may cause your blood pressure to drop too low.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Vivace

If you forget to take a dose, take the next dose as you normally would. Do not take a double dose to make up for forgotten doses.

If you stop taking Vivace

It is important that you continue taking Vivace until your doctor tells you to stop.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Vivace can cause adverse effects, although not all people suffer from them.

If adverse effects appear, they are usually mild and transient. However, some adverse effects can be serious and require medical attention.

The frequency of adverse effects is classified into the following categories:

Frequent Adverse Effects:

Most frequent adverse effects:

Cough, fluid accumulation in tissues causing edema, headache

Other frequent adverse effects:

Decrease in the number of white blood cells, feeling of apathy, balance disorder, sensation of abnormal movement, sensation of vertigo, dizziness, palpitations, hypotension (especially when standing), hot flashes, bronchitis, nausea, abdominal pain, digestive disorders, fatigue, alteration of analytical parameters (e.g., changes indicating abnormal liver function, increased potassium levels).

Infrequent Adverse Effects:

Anemia due to a lack or insufficient number of new blood cells produced by the bone marrow, significant decrease in the number of white blood cells, which increases the likelihood of infection, decrease in the number of blood platelets, which increases the risk of bleeding or bruising, decrease in the number of certain white blood cells, which increases the likelihood of infection, decrease in blood plasma and red blood cell volume ratio, loss of appetite, confusion, insomnia, mood changes, nervousness, anxiety, irritability, altered taste, blurred vision, increased heart rate, fainting (syncope), breathing difficulties, inflammation of the sinuses and nasal mucosa (e.g., constant nasal secretion), sore throat, vomiting, diarrhea, constipation, dry mouth, formation of stones in the bile ducts (especially if there is inflammation of the gallbladder), redness, itching, skin inflammation with redness and itching (eczema), excessive sweating, muscle and joint stiffness, pain in the arms and legs, kidney failure, high protein levels in the urine, inability to achieve or maintain an erection (impotence), feeling of weakness, general malaise, alteration of analytical parameters (e.g., changes indicating abnormal liver function).

Rare Adverse Effects:

Allergic reactions, decreased libido, somnolence, myocardial infarction, cardiac rhythm disorders, chest pain due to lack of oxygen to the heart (angina pectoris), chest pain, stroke, stomach pain, urticaria, abnormal skin redness, muscle cramps, acute kidney failure, accumulation of urea (a waste product excreted in the urine) in the blood, irritability, alteration of analytical parameters (e.g., increased bilirubin, changes indicating abnormal heart or muscle function).

Rare reactions that may be caused by these types of medications include inflammation of the face, lips, tongue, throat, or difficulty breathing. If you notice any of these reactions during treatment, stop taking Vivace and inform your doctor immediately.

Very Rare Adverse Effects (including isolated cases):

Anemia due to rapid destruction of red blood cells, in patients with pre-existing angina pectoris (chest pain due to lack of oxygen to the heart), the frequency, duration, and severity of angina attacks and the occurrence of heart attacks may increase, poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's disease), breathing difficulties, pancreatitis, intestinal obstruction, tongue inflammation, appearance of blisters on the face, mouth, eyes, and genitals along with fever (Stevens-Johnson syndrome), hair loss, psoriasis.

Adverse Effects of Unknown Frequency:

• High potassium levels in the blood (hyperkalemia)
• Swelling of the skin, lips, tongue, or throat with difficulty swallowing or breathing (angioedema)
• Kidney problems: severely decreased urine production (acute kidney injury)
• Muscle pain
• Swelling of the breast with or without pain in men (gynecomastia)
• Cloudy fluid (when performing dialysis through a tube in the abdomen)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vivace

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date indicated on the packaging after "Cad.: "

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Additional Information

Composition of Vivace

Vivace is a combination of two active substances, delapril hydrochloride and manidipine hydrochloride.

Each Vivace 30 mg/10 mg tablet contains 30 mg of delapril hydrochloride and 10 mg of manidipine hydrochloride, respectively.

The other components are lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin, and aluminum lake E-110 (orange-yellow).

Appearance of the Product and Packaging Content

Vivace is presented in Alu-Alu blisters.

Each Vivace packaging contains 28 scored, round, salmon-colored tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Manufacturer:

Chiesi Farmaceutici, S.p.A.

Via San Leonardo 96

43122 Parma (Italy)

Or

Fine Foods & Pharmaceuticals N.T.M. S.p.A.

Via Grignano, 43

24041 Brembate (BG)

Italy

This medication is authorized in the following EEA Member States under the following names:

Date of the Last Revision of this Prospectus: July 2024

Delapril and manidipine are licensed from Takeda Pharmaceutical Company Ltd.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.