Manidon 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidón 80 mg film-coated tablets

verapamil 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Manidón is and what it is used for.

2. What you need to know before taking Manidón.

3. How to take Manidón.

4. Possible adverse effects.

5. How to store Manidón.

6. Contents of the pack and other information.

1. What Manidón is and what it is used for

Manidón belongs to the group of medicines known as calcium channel blockers, with predominantly cardiac action. These medicines are used to treat angina pectoris, high blood pressure, or irregular heart rhythm.

Manidón is used for:

• Prevention and treatment of angina pectoris. Treatment of high blood pressure.

• Prevention of paroxysmal supraventricular tachycardia, after intravenous treatment.

• Management of patients with chronic atrial flutter and/or atrial fibrillation, except when associated with the presence of accessory conduction pathways.

Secondary prevention post-myocardial infarction in patients without heart failure during the acute phase.

2. What you need to know before starting to take Manidón

Do not take Manidón

• If you are allergic to verapamil hydrochloride or to any of the other components of this medicine (listed in section 6).
• If you have any of the following heart conditions:
  • Cardiogenic shock (the heart is unable to pump enough blood to meet the body's needs).
  • Second- or third-degree atrioventricular block (a disorder in the electrical conduction between the heart's atria and ventricles), unless you have an implanted pacemaker.
  • Sick sinus syndrome (heart rhythm problems), unless you have an implanted pacemaker.
  • Left ventricular failure.
  • Atrial flutter or atrial fibrillation (abnormal heart rhythms).
• If you are taking a medicine containing ivabradine for the treatment of certain heart conditions.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Manidón.

Your doctor must exercise special care when administering this medicine:

• If you have any of the following heart problems: acute phase of myocardial infarction complicated by bradycardia, marked hypotension, or left ventricular dysfunction; cardiac block, first-degree atrioventricular block, bradycardia, or asystole.
• If you are taking a beta-blocker medicine for heart arrhythmias.
• If you are taking digoxin together with Manidón.
• If you have heart failure.
• If you have any of the following conditions causing muscle weakness: myasthenia gravis, Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• If you have any kidney disease.
• If you have severe liver disease.

Other medicines and Manidón

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may alter their effect when taken together with Manidón. If you are taking or have taken any of the following medicines, consult your doctor:

• Prazosin, terazosin (for high blood pressure).
• Flecainide, quinidine, disopyramide (for heart arrhythmias).
• Theophylline (for bronchial asthma).
• Carbamazepine (for seizures), phenytoin (antiepileptic).
• Imipramine (for treating depression).
• Gliburide (for diabetes).
• Metformin: Verapamil may reduce the hypoglycemic effect of metformin.
• Colchicine (for gout).
• Clarithromycin, erythromycin, rifampicin, telithromycin (antibiotics).
• Doxorubicin (for cancer).
• Phenobarbital (for seizures and as a sedative).
• Buspirone, midazolam (sedatives used for insomnia and anxiety).
• Metoprolol, propranolol (for treating hypertension and heart disorders).
• Digitoxin, digoxin (for heart disorders).
• Cimetidine (for treating stomach ulcers).
• Cyclosporine, everolimus, sirolimus, tacrolimus (immunosuppressive drugs to reduce the body's immune defenses).
• Atorvastatin, lovastatin, simvastatin (medicines to lower elevated cholesterol levels).
• Almotriptan (for migraine symptoms).
• Sulfinpyrazone (for gouty arthritis).
• Grapefruit juice.
• St. John’s wort (herbal medicine for treating depression).
• Medicines for HIV/AIDS such as ritonavir.
• Lithium (for mood disorders).
• Neuromuscular blocking agents (used as adjuvants in anesthesia).
• Acetylsalicylic acid (aspirin).
• Alcohol.
• Antihypertensives (to lower high blood pressure), diuretics (medicines to increase urine production), vasodilators (medicines for circulatory disorders).
• Inhalational anesthetics.
• Dabigatran (medicine to prevent blood clot formation).
• Other direct oral anticoagulants (medicines to prevent blood clot formation).

Taking Manidón with food, drinks, and alcohol

Grapefruit juice has been shown to increase plasma levels of verapamil; therefore, Manidón should not be taken together with grapefruit juice.

Consumption of alcohol together with Manidón may enhance the hypotensive effect.

Pregnancy, breastfeeding, and fertility

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

There is no experience with the use of Manidón during pregnancy. Consult your doctor if you become pregnant while taking Manidón.

Verapamil is excreted in breast milk in small amounts. Limited data from human studies suggest that the use of verapamil may be compatible with breastfeeding. However, Manidón will only be administered during breastfeeding if essential for the mother’s health due to the potential for serious adverse reactions in breastfed infants.

Driving and use of machinery

Exercise caution when driving or operating tools or machinery, as Manidón may reduce reaction capacity, especially at the beginning of treatment, when the dose is increased, when switching from another medicine, and when consuming alcohol.

Manidón 80 mg film-coated tablets contain croscarmellose sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free.”

3. How to take Manidón

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The appropriate dose of this medicine may be different for each patient.

Remember to take your medicine.

Your doctor will tell you how long to take Manidón.

The most frequently recommended doses are those listed below, but if your doctor has prescribed a different dose, do not change it without consulting your doctor or pharmacist:

Adults

Angina pectoris and secondary prevention after myocardial infarction:

360 mg per day. The optimal daily dose ranges between 240 and 480 mg.

Arterial hypertension:

240 mg per day. If necessary, this may be increased after one week to 360 mg per day and subsequently up to a maximum of 480 mg per day.

Prophylaxis of supraventricular tachycardias:

240 to 480 mg per day for non-digitalized patients and 120 to 360 mg per day for digitalized patients.

Use in children and adolescents

Children: maximum 10 mg/kg body weight per day in several divided doses.

It is important that you continue taking this medicine until your doctor tells you to stop.

If you think that the effect of Manidón is too strong or too weak, tell your doctor or pharmacist.

If you take more Manidón than you should

You may experience one or more of the following symptoms: feeling of fatigue, shortness of breath, dizziness, weakness, chest pain, feeling faint, difficulty thinking, intense thirst, dry and sticky mouth, increased urination, drowsiness, blurred vision, difficulty speaking or moving, nausea, vomiting, diarrhea, disorientation. In case of severe poisoning, the doctor will take the necessary measures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested, as severe poisoning may potentially lead to death.

If you forget to take Manidón

It is important that you take your Manidón tablets regularly. If you forget to take your dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next one at your usual time. Do not take a double dose to make up for a missed dose. Please consult your doctor before continuing your treatment.

4. Possible adverse effects

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

The following adverse effects come from clinical studies with verapamil or from post-marketing surveillance.

The adverse effects most frequently reported are headache, dizziness, gastrointestinal disorders: nausea, constipation, and abdominal pain, as well as bradycardia (reduced heart rate), tachycardia (increased heart rate), palpitations, hypotension (low blood pressure), flushing, peripheral edema (swelling in feet, legs, and ankles), and fatigue.

The following adverse effects have been observed with the following frequencies:

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

• Constipation
• Nausea
• Bradycardia
• Flushing
• Dizziness
• Headache
• Peripheral edema
• Hypotension (low blood pressure)

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

• Abdominal pain
• Tachycardia
• Palpitations
• Fatigue

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

• Vomiting
• Somnolence
• Burning sensation
• Tingling or pricking (paresthesia)
• Tremor
• Tinnitus
• Excessive sweating

Frequency not known (frequency cannot be estimated from available data):

• Intestinal obstruction
• Gum overgrowth (gingival hyperplasia)
• Abdominal discomfort
• Bronchospasm
• Involuntary movements (extrapyramidal disorder)
• Paralysis (tetraparesis)*,
• Seizures
• Abnormal breast enlargement
• Impotence
• Milk secretion
• Dizziness
• Allergic reactions
• Muscle weakness
• Muscle pain
• Joint pain
• Angioedema
• Skin redness (erythema multiforme)
• Stevens-Johnson syndrome (more severe erythema)
• Maculopapular skin rash (skin rash with spots and papules)
• Hair loss
• Urticaria
• Purpura (purple spots on skin and mucous membranes)
• Pruritus (itching)
• Increased liver enzymes
• Increased blood prolactin levels (a hormone that stimulates breast development and milk production)
• First-, second-, and third-degree atrioventricular block (heart block)
• Heart failure
• Sinus pause
• Sinus bradycardia
• Asystole
• Hyperkalemia
• Dyspnea (difficulty breathing)
• Renal failure

*There has been one report of paralysis when verapamil was taken with colchicine; therefore, concomitant use is not recommended.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Manidón

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

No special storage conditions are required.

Do not use Manidón after the expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Manidón

The active substance is verapamil (as hydrochloride). Each film-coated tablet contains 80 mg of active substance.

The other components (excipients) are: monobasic calcium phosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, talc, macrogol 6000, hypromellose, titanium dioxide (E-171), sodium lauryl sulfate and purified water.

Appearance of the medicinal product and contents of the pack

Manidón is packaged in PVC/aluminum blisters and is available in packs containing 30 or 60 film-coated tablets, round, biconvex and white in colour.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Famar A.V.E., Anthoussa Plant
Anthoussa Avenue 7
Anthoussa - Attiki
15349, Greece

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of latest revision of this leaflet: January 2021

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