Leaflet: information for the user

Manidipino Combix 10 mg tablets EFG

Manidipine dihydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Manidipino Combix contains manidipine dihydrochloride as the active ingredient. Manidipine dihydrochloride belongs to a group of medicines called calcium channel blockers that block the flow of calcium in the smooth muscle cells of blood vessels, causing vasodilation and the corresponding reduction in blood pressure.

Manidipino Combix is indicated for the treatment of mild to moderate essential hypertension (high blood pressure).

Do not take Manidipino Combix

• if you are allergic to manidipine, other calcium channel blockers, or any of the other components of this medication (listed in section 6).
• if you have severe kidney disease.
• if you have heart problems, for example if you have had a myocardial infarction in the last 4 weeks or if you have unstable angina (chest pain due to inadequate oxygen supply to the heart) or if you have heart failure and are not following a specific treatment.
• if you have moderate or severe liver disease.

Manidipino Combix should not be administered to children or adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Manidipino Combix:

• if you have some heart problems (for example, left ventricular dysfunction, obstruction of the outflow tract of the left ventricle, right-sided heart failure in patients with untreated sick sinus syndrome not treated with a pacemaker);
• if you have heart rhythm disorders;
• if you are an elderly patient or have any mild liver problems (see "How to take Manidipino Combix");
• if you are undergoing peritoneal dialysis.

You should also inform your doctor:

• if you are pregnant, or think you may be pregnant, if you are trying to become pregnant, or if you are breastfeeding (see "Pregnancy, lactation and fertility").

Taking Manidipino Combix with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

• diuretics (used to eliminate water from the body by increasing urine production) and other medications that reduce blood pressure, such as beta-blockers or other antihypertensive medications. These medications, in fact, can increase the blood pressure-lowering effect of Manidipino Combix;
• medications that can affect the metabolism of Manidipino Combix's active substance, such as protease inhibitors, cimetidine (used to treat stomach ulcers), or certain antibiotics (used to treat bacterial diseases, such as clarithromycin, erythromycin, and rifampicin), or some antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole, or class III antiarrhythmics used in heart rhythm disorders (such as amiodarone and quinidine);
• medications that contain digoxin, used in the treatment of heart rhythm disorders.

If you are taking any of the medications mentioned above, your doctor may prescribe another medication or adjust the dose of Manidipino Combix or another medication.

Taking Manidipino Combix with food, drinks, and alcohol

Do not take Manidipino Combix with grapefruit juice, as blood pressure may drop too low. Consuming alcohol may enhance the blood pressure-lowering effect of Manidipino Combix.

Pregnancy, lactation, and fertility

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

Pregnancy

Since Manidipino Combix should not be taken during pregnancy, your doctor will recommend that you stop treatment before becoming pregnant or as soon as you know you are pregnant, and will advise on the appropriate treatment.

Lactation

Consult your doctor if you are breastfeeding or before starting breastfeeding. Manidipino Combix should be avoided in women who are breastfeeding, if the Manidipino Combix treatment cannot be discontinued, your doctor will advise you to stop breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Occasionally, in some patients during treatment for high blood pressure, this medication may cause dizziness. In these cases, you should inform your doctor before engaging in activities such as driving or operating machinery.

Manidipino Combix contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

At the beginning, the usual dose of Manidipino Combix is 10 mg per day. After 2-4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once a day (usual maintenance dose).

If you are elderly, or if you have any kidney or liver disease, your doctor may prescribe a reduced dose.

Use in children and adolescents

Children and adolescents should not take Manidipino Combix (see section “Do not take Manidipino Combix”).

Administration

Manidipino Combix should be taken in the morning after breakfast. The tablet should be swallowed, without chewing, with an adequate amount of water. Try to take your daily dose at the same time each day.

Treatment duration

It is essential that you continue taking Manidipino Combix until your doctor tells you otherwise. Take exactly the prescribed dose and do not modify it without speaking with your doctor first.

If you take more Manidipino Combix than you should

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

If you forgot to take Manidipino Combix

If you forgot to take a dose of Manidipino Combix, take the next dose as prescribed. Do not take a double dose to compensate for the missed doses.

It is essential that you continue taking Manidipino Combix until your doctor tells you otherwise.

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

Like all medicines, Manidipino Combix may cause side effects, although not everyone will experience them.

If side effects occur, they will mainly be mild and temporary. However, some side effects can be serious and require medical attention.

Frequent side effects(may affect between 1 and 10 in every 100 patients):

Fluid accumulation in tissues causing inflammation (edema), hot flushes, dizziness, vertigo, headaches, palpitations.

Less frequent side effects(may affect between 1 and 10 in every 1,000 patients):

Prickling or painful numbness (paresthesia), increased heart rate (tachycardia), reduced blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal discomfort, skin rash, skin inflammation with redness and itching (eczema), transient alterations in laboratory tests for some enzymes (ALT, AST, LDH, GammaGT, ALP, blood urea nitrogen, and blood creatinine).

Rare side effects(may affect between 1 and 10 in every 10,000 patients):

Irritability, skin redness, itching, stomach pain (gastralgia), abdominal pain, drowsiness, chest pain, chest pain due to inadequate blood supply to the heart (angina pectoris), diarrhea, decreased appetite (anorexia), abnormal results in blood tests (e.g., increased bilirubin in the blood), jaundice.

Very rare side effects(may affect fewer than 1 in every 10,000 patients):

Myocardial infarction, in patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks, inflammation or alteration of the gums, which require careful dental attention but usually resolve with suspension of treatment.

Side effects of unknown frequency(frequency cannot be estimated with available data):

Muscle pain.

Swelling of the breast with or without pain in men (gynecomastia)

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scales (dermatitis exfoliativa)

Cloudy liquid (when undergoing dialysis through a tube in the abdomen).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Manidipino Combix 10 mg tablets

• The active ingredient is manidipino. Each tablet contains 10 mg of manidipino dihydrochloride.
• The other components (excipients) are: lactose monohydrate, cornstarch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose (E463), magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Round, biconvex tablets, yellow in color, scored on one face and smooth on the other.

OPA/AL/PVC/Al blisters.

Packaging of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: September 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) athttp://www.aemps.gob.es/