MANIDON 80 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the User

Manidón 80 mg film-coated tablets

verapamil hydrochloride

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

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

Contents of the Prospectus:

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

1. Package contents and additional information.

1. What is Manidón and what is it used for

Manidón belongs to the group of medications called calcium channel blockers, with a preferentially cardiac action. These medications are used to treat chest angina, high blood pressure, or irregular heart rhythm.

Manidón is taken in:

• Prevention and treatment of chest angina. Treatment of high blood pressure.
• Prevention of paroxysmal supraventricular tachycardia, after intravenous treatment.

• Control of patients with chronic atrial flutter and/or fibrillation, except when associated with the existence 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 taking Manidón

Do not take Manidón

• If you are allergic to verapamil hydrochloride or any of the other components of this medication (listed in section 6).
• • If you have any of the following heart diseases: cardiogenic shock (the heart is unable to pump enough blood that the body needs).
  • Atrioventricular block of second or third degree (disorder in the electrical conduction between the atria and ventricles), except if a pacemaker is implanted.
  • Sick sinus syndrome (heart rhythm problems), except if a pacemaker is implanted.
  • Left heart failure.
  • Atrial flutter or fibrillation (abnormal heart rhythms).
• If you are taking a medication that contains ivabradine for the treatment of certain heart diseases.

Warnings and precautions

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

Your doctor will need to take special care when administering this medication:

• If you have any of the following heart problems: acute phase of myocardial infarction complicated with bradycardia, marked hypotension, or left ventricular dysfunction; cardiac block, atrioventricular block of first degree, bradycardia, or asystole.
• If you are taking a beta-blocker medication for heart arrhythmias.
• If you are taking digoxin along with Manidón.

• If you have heart failure.

• If you have any of the following diseases that cause muscle weakness: myasthenia gravis, Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• If you have kidney disease.
• If you have severe liver disease.

Other medications and Manidón

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Some medications, if taken together with Manidón, may alter their effect. If you use or have used any of the following medications, 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 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 hypertension and heart disorders).
• Digitoxin, digoxin (for heart disorders).
• Cimetidine (for stomach ulcer treatment).
• Cyclosporine, everolimus, sirolimus, tacrolimus (immunosuppressive medications to reduce the body's defenses).
• Atorvastatin, lovastatin, simvastatin (medications to lower high cholesterol levels).
• Almotriptan (for migraine symptoms).
• Sulfinpyrazone (for gouty arthritis).
• Grapefruit juice.
• St. John's Wort (medication for depression).
• AIDS medications such as ritonavir.
• Lithium (for mood problems).
• Muscle relaxants (used as adjuncts in anesthesia).
• Acetylsalicylic acid (aspirin).
• Alcohol.
• Antihypertensives (to lower high blood pressure), diuretics (medications to urinate), vasodilators (medications for circulatory disorders).
• Inhalation anesthetics.
• Dabigatran (medication to prevent blood clot formation).
• Other direct oral anticoagulants (medications to prevent blood clot formation)

Taking Manidón with food, drinks, and alcohol

It has been observed that grapefruit juice increases the plasma levels of verapamil, so Manidón should not be taken together with grapefruit juice.

Taking alcohol together with Manidón may potentiate the hypotensive effect.

Pregnancy, breastfeeding, and fertility

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

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. Manidón will only be administered during breastfeeding if it is essential for the mother's health due to possible serious adverse reactions in breastfed infants.

Driving and using machines

Be careful when driving or using any tool or machinery, as Manidón may reduce your reaction capacity, especially at the beginning of treatment, when the dose is increased, when changing from another medication, and with alcohol consumption.

Manidón 80 mg film-coated tablets contain sodium croscarmellose

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Manidón

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

The suitable dose of this medication may be different for each patient.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Manidón.

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

Adults

Chest angina and secondary prevention post-myocardial infarction:

360 mg per day. The optimal daily dose ranges from 240 to 480 mg.

Hypertension:

240 mg per day. If necessary, it can 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:

From 240 to 480 mg per day for non-digitalized patients and from 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 doses.

It is essential that you continue taking this medication until your doctor tells you to stop.

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

If you take more Manidón than you should

You may notice some of the following symptoms: feeling of tiredness, shortness of breath, dizziness, weakness, chest pain, feeling of fainting, difficulty thinking, intense thirst, dry and pasty mouth, urge to urinate, somnolence, blurred vision, difficulty speaking or moving, nausea, vomiting, diarrhea, disorientation. If a severe overdose has occurred, the doctor will take the necessary measures.

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, as in the case of a severe overdose, it can cause death.

If you forget to take Manidón

It is essential that you take your Manidón tablets regularly. If you forgot to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the missed dose and take the next dose at its usual time. Do not take a double dose to make up for the missed doses. Please consult your doctor before continuing your treatment.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

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

The most frequently reported adverse effects are headache, dizziness, gastrointestinal disorders: nausea, constipation, and abdominal pain, as well as bradycardia (decreased 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 patients)

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

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

• Abdominal pain
• Tachycardia
• Palpitations
• Fatigue

Rare adverse effects: (may affect up to 1 in 1000 patients):

• Vomiting
• Somnolence
• Burning sensation
• Paresthesia (tingling or numbness)
• Tremor
• Tinnitus (ringing in the ears)
• Excessive sweating

Unknown frequency(the frequency cannot be estimated from the available data):

• Intestinal obstruction
• Gingival hyperplasia (gum overgrowth)
• 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
• Redness of the skin (erythema multiforme)
• Stevens-Johnson syndrome (more severe erythema)
• Maculopapular rash (rash with spots and papules)
• Hair loss
• Hives
• Purpura (purple spots on skin and mucous membranes)
• Itching
• Increased liver enzymes
• Increased prolactin in blood (a hormone that stimulates breast development and milk production)
• Atrioventricular block of first, second, and third degree (obstruction in the heart)
• Heart failure
• Sinus pause
• Sinus bradycardia
• Asystole
• Hyperkalemia
• Dyspnea (breathing difficulty)
• Renal failure

*There has been a report of paralysis when verapamil was taken with colchicine, so their combined use is not recommended.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Manidón

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Manidón

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

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

Appearance of the product and package contents

Manidón is packaged in PVC/Aluminum blisters and comes in packages containing 30 or 60 film-coated tablets, which are round, biconvex, and white.

Marketing authorization holder and manufacturer

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this prospectus:January 2021

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