Summary of Product Characteristics: Information for the User

Manidipine Cinfa 20 mg Tablets EFG

Manidipine Hydrochloride

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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 cinfa contains manidipino hydrochloride as the active ingredient. Manidipino belongs to a group of medications 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 cinfa is indicated for the treatment of high blood pressure (essential mild to moderate hypertension).

Do not take manidipino cinfa

Manidipino 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 cinfa

You should also inform your doctor:

Taking manidipino cinfa with other medications

Inform your doctor or pharmacist if 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:

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

Taking manidipino cinfa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

Consult your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant.

As manidipino 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.

Breastfeeding

Consult your doctor if you are breastfeeding or before starting breastfeeding. Manidipino should be avoided in women who are breastfeeding, if the manidipino 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 cinfa contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Dose

At the beginning, the recommended dose of manidipino 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 (recommended maintenance dose).

Manidipino should not be administered to children or adolescents (see section “Do not take manidipino cinfa”).

Dose reduction

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

Administration

Manidipino 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 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 cinfa 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 forget to take manidipino cinfa

If you forget to take a dose of manidipino, take the next dose as prescribed.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with manidipino cinfa

It is essential that you continue taking manidipino 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, this medicine can 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 up to 1 in 10 patients):

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

Less frequent side effects(may affect up to 1 in 100 patients):

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

Rare side effects(may affect up to 1 in 1,000 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 blood), jaundice.

Very rare side effects(may affect 1 in 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(cannot be estimated from available data):

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scaling (dermatitis exfoliativa), muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy liquid (when performing dialysis through a tube in the abdomen).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. 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.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of manidipino cinfa

• The active ingredient is manidipino hydrochloride, 20 mg.
• The other components are lactose monohydrate, cornstarch, low-substitution hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, and riboflavin (E-101).

Appearance of the product and contents of the packaging

Manidipino cinfa 20 mg tablets are presented in the form of oval-shaped scored tablets with a yellow color.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620-Huarte (Navarra) – Spain

Responsible for manufacturing

ABIOGEN PHARMA S.P.A

Meucci Street, 36

56121 Ospedaletto, Italy

or

DOPPEL FARMACEUTICI, S.R.L.

Volturno Street, 48 Quinto De Stampi

I-20089 Rozzano, Milan, Italy

or

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620-Huarte (Navarra) – Spain

or

VAMFARMA, S.R.L.

Kennedy Street, 5

26833 Comazzo (LO)

Italy

Last review date of this leaflet:September 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73230/P_73230.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73230/P_73230.html