Package Insert: Information for the User

ARTEDIL 20 mg Tablets

Manidipino Hydrochloride

Read this package insert carefully before starting to take the medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

Artedilcontains manidipino hydrochloride as the active ingredient. Manidipino hydrochloride belongs to a group of medications called calcium channel blockers that block the flow of calcium in smooth muscle cells of blood vessels, causing vasodilation and the corresponding reduction in blood pressure.

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

Do not take Artedil

-if you are allergic (hypersensitive) to manidipino, 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.

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

Warnings and precautions

Consult your doctor before starting to take Artedil

-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 treated with a pacemaker);

-if you have heart rhythm disorders;

-if you are elderly or have mild liver problems (see "How to take Artedil");

-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 and Breastfeeding").

Other medications and Artedil

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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 lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medications, in fact, can increase the blood pressure-lowering effect of Artedil;

-Medications that can influence the metabolism of Artedil's active substance, such as protease inhibitors, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial infections, 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 Artedil or another medication.

Artedil and food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Consult your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant. As Artedil 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. Artedil should be avoided in women who are breastfeeding, if the Artedil treatment cannot be discontinued, your doctor will advise you to stop breastfeeding.

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.

Artedil contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, 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.

Dose

At the beginning, the usual dose of Artedil 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).

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

Reduction of dose

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

Administration

Artedil 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 Artedil 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 Artedil than you should

If you have accidentally taken more tablets than you should, consult your doctor immediately as your blood pressure level may be abnormally low, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Artedil

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

If you interrupt the treatment with Artedil

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

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

Like all medicines, this medicine 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 up to 1 in 10 people):

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

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

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, skin inflammation 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 people):

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 up to 1 in 10,000 people):

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 scales (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 national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Usehttps://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 Artedil after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store Artedil in its original packaging to protect it from light.

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. By doing so, you will help protect the environment.environment.

Composition of Artedil

- The active principle is Manidipino hydrochloride.

Cada comprimido de Artedil 20 mg contiene: 20 mg de Manidipino hidrocloruro.

- The other components are lactose monohydrate, cornstarch, low-substituted hydroxypropylcellulose (L-HPC-31), hydroxypropylcellulose (HPC-L), magnesium stearate, and riboflavin (E-101).

Appearance of the product and content of the container

Cada envase de Artedil 20 mg comprimidos contiene 14, 28, 30, 56, 84, 90, 98, 112 comprimidos de color amarillo anaranjado, ovalados, ranurados, envasados en blister.

It may only be marketed in some container sizes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L’Hospitalet de Llobregat

Barcelona

Responsible for manufacturing

CHIESI FARMACEUTICI S.p.A.

Via San Leonardo, 96

43122 Parma (Italia)

or

FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.

Via Grignano, 43

24041 Brembate (BG) – Italia

Responsible for batch release

CHIESI FARMACEUTICI S.p.A.

Via San Leonardo, 96

43122 Parma (Italia)

or

FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.

Via Grignano, 43

24041 Brembate (BG) – Italia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2024

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

With license from Takeda Pharmaceutical Company, Ltd – Japan