Bimade 30 mg/10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

BIMADE 30 mg/10 mg tablets

delapril hydrochloride + manidipine hydrochloride

Package leaflet contents:

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

1. What Bimade is and what it is used for

Bimade is

Bimade is a combination of two active substances: delapril hydrochloride and manidipine hydrochloride.

Delapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Angiotensin II is a substance produced in the body that causes narrowing of blood vessels, leading to increased blood pressure. Delapril hydrochloride prevents the formation of angiotensin II, resulting in a decrease in blood pressure.

Manidipine belongs to a group of medicines called calcium channel antagonists, which block the influx of calcium into smooth muscle cells of blood vessels, causing blood vessels to relax and thereby reducing blood pressure.

The two active substances in Bimade work together to lower blood pressure more effectively than when either is used alone.

Bimade is used for

the treatment of high blood pressure (hypertension) in patients whose blood pressure is not adequately controlled with delapril or manidipine alone.

2. What you need to know before taking Bimade

Do not take Bimade:

• if you are allergic to delapril or any other ACE inhibitor, to manidipine or any other calcium channel blocker, or to any of the other components of this medicine (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 prior treatment with ACE inhibitors, or if you or a family member has had these symptoms under any other circumstances
• if you have severe liver disease
• if you have severe kidney problems (for example, severe kidney disease, are undergoing hemodialysis (treatment with an artificial kidney), have had a kidney transplant, or have renal artery stenosis (narrowing of the arteries to the kidneys) in case you only have one kidney)
• if you have certain heart conditions (for example, recent myocardial infarction or angina pectoris (chest pain due to insufficient oxygen supply to the heart) or heart failure)
• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease)
• if you have adrenal hyperactivity that may cause low potassium levels in the blood
• if you are more than 3 months pregnant (it is also advisable to avoid taking Bimade early in pregnancy – see Pregnancy section)
• if you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high
  • if you are taking any of the following medicines, your risk of developing angioedema may increase:
    • Racecadotril, a medicine used to treat diarrhoea
    • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus)
    • Vildagliptin, a medicine used to treat diabetes

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking Bimade:

• if you have kidney problems
• if you have liver problems
• if you suffer from certain heart conditions (e.g., ischaemic heart disease)
• if you have cerebrovascular disease (cerebrovascular problems)
• if you are undergoing LDL apheresis (a procedure that removes cholesterol from your blood using a machine)
• if you are receiving desensitisation treatment to reduce the effects of 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 condition associated with persistently high potassium levels in the blood
• if you experience symptoms such as swelling of the face, eyes, lips, tongue, throat or difficulty breathing (see section 4, “Rare adverse effects”)
• if you have abnormal changes in your blood components
• if you are undergoing anaesthesia or surgery
• if you have rapid heartbeat, dizziness, general weakness, which may indicate low blood pressure
• You should consult your doctor if you think you are (or might be) pregnant. Bimade is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section)
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (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 swelling beneath the skin, for example in the throat) is increased:

Sirolimus, everolimus and other medicines belonging to the mTOR inhibitor family (used to prevent rejection of transplanted organs).

• 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 Bimade”.

Children and adolescents

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

Taking Bimade with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines, 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 medicines:

• diuretics (used to remove water from the body by increasing urine output) and other medicines to lower blood pressure. These medicines may enhance the hypotensive effect of Bimade
• heparin (used to prevent blood clots)
• medicines containing lithium (usually used to treat manic-depressive disorders). These may only be taken with Bimade under close medical supervision
• painkillers (e.g., non-steroidal anti-inflammatory drugs such as aspirin)
• antidepressants, antipsychotics (used to treat schizophrenia and other mental illnesses) and anaesthetics
• medicines that stimulate the sympathetic nervous system (e.g., those used for colds)
• potassium-containing salts or potassium-sparing diuretics. In this case, special precautions should be taken (e.g., blood tests)
• digoxin (used to treat heart disorders)
• medicines that affect blood composition (e.g., allopurinol, used to treat gout), procainamide (for treatment of irregular heartbeat), corticosteroids, immunosuppressants (used to treat autoimmune disorders or to prevent transplant rejection), medicines for cancer treatment
• medicines for diabetes (oral medicines or insulin)
• vildagliptin, a medicine used to treat diabetes (see also information in section “Do not take Bimade”)
• antacids
• medicines that alter the metabolism of any of the active substances in Bimade, for example cimetidine (used to treat stomach ulcers), certain antibiotics or antifungals (used to treat fungal infections), phenytoin, carbamazepine, phenobarbital, rifampicin, terfenadine and astemizole, class III antiarrhythmics used to normalise heart rate (e.g., amiodarone, quinidine)
• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Bimade” and “Warnings and precautions”)
• medicines used to treat a type of chronic heart failure in adults (e.g., sacubitril/valsartan) (see also information in section “Do not take Bimade”)
• racecadotril, a medicine used to treat diarrhoea (see also information in section “Do not take Bimade”)

Tell your doctor if you are also taking:

• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the mTOR inhibitor family). See section “Warnings and precautions”
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)

Taking Bimade with food and drinks

Bimade should be taken after breakfast.

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

Avoid high-salt meals (containing large amounts of sodium chloride), as this may reduce the antihypertensive effect of Bimade.

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 medicine.

Pregnancy

Your doctor will usually advise you to stop taking Bimade before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Bimade. Bimade is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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

Driving and using machines

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

Bimade contains lactose and a colouring agent

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

The colouring agent E-110 may cause allergic-type reactions.

3. How to take Bimade

Follow exactly the instructions for using Bimade provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Bimade is one tablet daily.

Dose reduction

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

Administration

Bimade 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 may be divided into equal doses.

Duration of treatment

It is important that you continue taking Bimade until your doctor tells you otherwise.

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

Use in children and adolescents

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

If you take more Bimade than you should

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

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

If you forget to take Bimade

If you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.

If you stop treatment with Bimade

It is important that you continue taking Bimade until your doctor tells you otherwise.

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

4. Possible adverse effects

Like all medicines, Bimade may cause adverse effects, although not everyone experiences them.

If adverse effects occur, they are usually mild and transient. However, some adverse effects may 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 oedema, headache

Other frequent adverse effects:

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

Uncommon adverse effects:

Anaemia due to lack or insufficient production of new blood cells by the bone marrow, marked decrease in the number of white blood cells in the blood leading to increased risk of infections, decrease in the number of platelets in the blood leading to increased risk of bleeding or bruising, decrease in the number of certain white blood cells in the blood leading to increased risk of infections, decrease in blood plasma volume and in the proportion of red blood cells, loss of appetite, confusion, insomnia, mood changes, nervousness, anxiety, irritability, altered taste, blurred vision, increased heart rate, fainting (syncope), breathing difficulty, swelling of sinuses and nasal mucosa (e.g. constant nasal discharge), sore throat, vomiting, diarrhoea, constipation, dry mouth, formation of gallstones in bile ducts (especially if gallbladder inflammation is present), redness, itching, skin inflammation with redness and itching (eczema), excessive sweating, muscle and joint stiffness, pain in arms and legs, renal failure, high levels of protein in urine, inability to achieve or maintain an erection (impotence), feeling of weakness, general malaise, alteration of laboratory 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 insufficient oxygen supply to the heart (angina pectoris), chest pain, stroke, stomach pain, urticaria, abnormal redness of the skin, muscle cramps, acute renal failure, accumulation of urea (a waste product excreted in urine) in the blood, irritability, alteration of laboratory parameters (e.g. increased biliary pigment, changes indicating abnormal heart or muscle function).

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

Very rare adverse effects (including isolated cases):

Anaemia due to rapid destruction of red blood cells, in patients with pre-existing angina pectoris (chest pain due to insufficient oxygen supply to the heart), frequency, duration and severity of angina attacks may increase, as well as occurrence of heart attacks, poor blood circulation causing numbness and pale colour of fingers and toes (Raynaud's disease), breathing difficulty, pancreatitis, intestinal obstruction, tongue inflammation, appearance of blisters on the face, mouth, eyes and genitals accompanied by fever (Stevens-Johnson syndrome), hair loss, psoriasis.

Adverse effects with unknown frequency:

• High potassium concentration in blood (hyperkalaemia)
• Swelling of the skin, lips, tongue or throat with difficulty swallowing or breathing (angioedema)
• Kidney problems: severely reduced urine output (acute deterioration of renal function)
• Muscle pain
• Breast swelling with or without pain in men (gynaecomastia)
• Cloudy fluid (when performing dialysis through a tube in the abdomen).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bimade

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after "Exp:".

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Bimade

Bimade is a combination of two active substances: delapril hydrochloride and manidipine hydrochloride.

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

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

Appearance of the medicinal product and contents of the container

Bimade is presented in Alu-Alu blisters.

Each Bimade pack contains 28 salmon-colored, round, scored tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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)

Or

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

Via Grignano, 43

24041 Brembate (BG)

Italy

Local representative:

Chiesi España, S.A.U.

Plaça d’Europa, 41-43, 10th Floor

08908 L’Hospitalet de Llobregat – Barcelona (Spain)

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

Date of the most recent review of this leaflet: July 2024

Delapril and manidipine are licensed by Takeda Pharmaceutical Company, Ltd.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.