ArteDil 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ARTEDIL 10 mg tablets

Manidipine hydrochloride

Read the entire 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.
• This medicine has been prescribed for you only, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Artedil is and what it is used for
2. What you need to know before taking Artedil
3. How to take Artedil
4. Possible side effects
5. How to store Artedil

Pack contents and additional information

1. What Artedil is and what it is used for

Artedil contains manidipino hydrochloride as the active substance. Manidipino hydrochloride belongs to a group of medicines called calcium channel blockers, which block the flow of calcium into smooth muscle cells of blood vessels, causing vasodilation and the resulting reduction in blood pressure.

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

2. What you need to know before taking Artedil

Do not take Artedil

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

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

Warnings and precautions

Consult your doctor before taking Artedil

• if you have certain heart problems (for example, left ventricular dysfunction, obstruction of the left ventricular outflow tract, right-sided heart failure in patients with untreated sick sinus syndrome);
• if you have heart rhythm disorders;
• if you are elderly or have mild liver impairment (see section “How to take Artedil”);
• if you are undergoing peritoneal dialysis.

You should also inform your doctor:

• if you are pregnant, think you may be pregnant, are trying to become pregnant, or are breastfeeding (see section “Pregnancy and Breast-feeding”).

Other medicines and Artedil

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

• Diuretics (used to remove water from the body by increasing urine production) and other medicines that lower blood pressure, such as beta-blockers or other antihypertensive drugs. These medicines may increase the blood pressure-lowering effect of Artedil;
• Medicines that may affect the metabolism of the active substance in Artedil, such as antiprotease drugs, cimetidine (used to treat gastric ulcers), or certain antibiotics (used to treat bacterial infections, such as clarithromycin, erythromycin, and rifampicin), or certain antifungals (used to treat fungal infections, such as ketoconazole and itraconazole), or phenytoin, carbamazepine, phenobarbital, terfenadine, astemizole, or class III antiarrhythmics used for heart rhythm disorders (such as amiodarone and quinidine);
• Medicines containing digoxin, used in the treatment of heart disorders.

If you are taking any of the medicines listed above, your doctor may prescribe a different medicine or adjust the dose of Artedil or of the other medicine.

Taking Artedil with food, drinks, and alcohol

Do not take Artedil with grapefruit juice, as blood pressure may drop too much. Alcohol consumption may enhance the blood pressure-lowering effect of Artedil.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Pregnancy

Consult your doctor if you are pregnant, think you may be pregnant, or are trying to become pregnant. Since Artedil should not be taken during pregnancy, your doctor will advise you to stop treatment before becoming pregnant or as soon as you know you are pregnant, and will recommend appropriate alternative treatment.

Breastfeeding

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

Driving and use of machinery

Occasionally, in some patients during treatment for high blood pressure, this medicine may cause dizziness. In such cases, you should discuss this with your doctor before performing activities such as driving or operating machinery.

Artedil contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Artedil

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Dosage

Initially, the usual dose of Artedil is 10 mg once daily. After 2–4 weeks, if the reduction in blood pressure is considered insufficient, your doctor may increase this dose to 20 mg once daily (usual maintenance dose).

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

Dose reduction

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 whole, without chewing, with an adequate amount of water.

Try to take your daily dose at the same time each day.

Duration of treatment

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

Take exactly the prescribed dose and do not change it without first talking to your doctor.

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 become abnormally low, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 make up for forgotten doses.

If you stop taking Artedil

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent adverse effects (may affect up to 1 in 10 people):

Fluid accumulation in tissues causing swelling (edema), hot flushes, dizziness, vertigo, headache, palpitations.

Uncommon adverse effects (may affect up to 1 in 100 people):

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

Rare adverse effects (may affect up to 1 in 1,000 people):

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

Very rare adverse 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, gum inflammation or changes requiring careful dental care, which usually resolve upon discontinuation of treatment.

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scaling (exfoliative dermatitis), muscle pain, breast swelling with or without pain in men (gynecomastia), 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System of Pharmacovigilance of Human Medicines: https://notificaram.es.

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

5. Storage of Artedil

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

Do not use Artedil after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Additional Information

Composition of Artedil

• The active substance is Manidipine hydrochloride.

Each Artedil 10 mg tablet contains: 10 mg of Manidipine hydrochloride.

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

Appearance of the product and contents of the container

Each pack of Artedil 10 mg tablets contains 14, 28, 30, 56, 84, 90, 98 or 112 pale yellow, round, scored tablets, packaged in blisters.

Only certain pack sizes may be marketed.

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

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

Batch release responsible

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 medicinal product is authorized in the European Economic Area member states under the following names:

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

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