ARTEDIL 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

ARTEDIL 10 mg Tablets

Manidipine Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and other information

1. What is Artedil and what is it used for

Artedil contains manidipine hydrochloride as the active substance. Manidipine hydrochloride 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.

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

2. What you need to know before you take 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 heart attack in the last 4 weeks or if you suffer from unstable angina (chest pain due to inadequate oxygen supply to the heart) or if you suffer from heart failure and are not receiving 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 certain heart problems (for example, left ventricular dysfunction, left ventricular outflow tract obstruction, right-sided heart failure in patients with untreated sick sinus syndrome);
• if you have heart rhythm disturbances;
• if you are elderly or have mild liver problems (see section “How to take Artedil”);
• if you are undergoing peritoneal dialysis.

You should also tell your doctor:

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

Other medicines and Artedil

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

It is especially important that you tell 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 can increase the blood pressure-lowering effect of Artedil;
• Medicines that can affect the metabolism of the active substance of Artedil, such as protease inhibitors, cimetidine (used to treat stomach 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 antiarrhythmic agents used in heart rate problems (such as amiodarone and quinidine);
• Medicines containing digoxin, used in the treatment of heart rhythm disturbances.

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

Taking Artedil with food, drinks, and alcohol

Do not take Artedil with grapefruit juice, as blood pressure may drop too low. Consumption of alcohol can 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 taking this medicine.

Pregnancy

Consult your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. As 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 treatment.

Breast-feeding

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

Driving and using machines

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

Artedil contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Artedil

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dose

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

Dose reduction

If you are elderly or have 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 a sufficient 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 dose prescribed by your doctor and do not change it without talking to 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 may be abnormally low, or call the Toxicology Information Service, telephone 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Common side effects(may affect up to 1 in 10 people):

Fluid accumulation in tissues causing swelling (edema), flushing, dizziness, lightheadedness, headache, palpitations.

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

Painful tingling or numbness (paresthesia), increased heart rate (tachycardia), low blood pressure (hypotension), difficulty breathing (dyspnea), weakness, dry mouth, nausea, vomiting, constipation, gastrointestinal disorders, skin rash, skin inflammation with redness and itching (eczema), transient changes in laboratory tests of some enzymes (ALT, AST, LDH, GammaGT, ALP, Urea in blood 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 blood test results (for example, increased bilirubin in blood), jaundice.

Very rare side effects(may affect up to 1 in 10,000 people):

Heart attack, in patients with pre-existing angina, they may experience an increase in frequency, duration, or severity of these attacks, gum inflammation or changes, which require careful dental attention but usually resolve with discontinuation of treatment.

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

Abnormal skin redness (erythema multiforme), skin disease with abnormal redness and scales (exfoliative dermatitis), muscle pain, breast swelling with or without pain in men (gynecomastia), cloudy fluid (during dialysis through a tube in the abdomen).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system included in the Spanish Medicines Agency's Pharmacovigilance System for Human Use https://notificaram.es.

By reporting side 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 which is stated on the carton. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Artedil

• The active substance is Manidipine Hydrochloride.

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

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

Appearance and packaging of the product

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 manager

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 medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: July 2024

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.

Under licence from Takeda Pharmaceutical Company, Ltd – Japan