MANIDON 2.5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Manidón 2.5 mg/ml Solution for Injection

Verapamil Hydrochloride

Read all of this leaflet carefully before you start using 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, pharmacist, or nurse.

• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. Contents of the pack and other information.

1. What is Manidón and what is it used for

Manidón belongs to a group of medicines called calcium channel blockers, with a preferential cardiac action. These medicines are used to treat chest pain, high blood pressure, or irregular heart rhythm.

Manidón injection is used in the treatment of supraventricular tachycardias, including:

-Paroxysmal supraventricular tachycardia, even when associated with accessory conduction pathways (Wolf-Parkinson-White syndrome, Lown-Ganong-Levine syndrome). When clinically justified, maneuvers to stimulate vagal tone will be performed as a first measure.

-Atrial flutter or fibrillation, except when associated with accessory conduction pathways (Wolf-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).

2. What you need to know before you use Manidón

Do not use Manidón

• If you are allergic to verapamil hydrochloride or any of the other ingredients of this medicine (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).
• Severe hypotension.
• Atrioventricular block of second or third degree (disorder in the electrical conduction between the atria and ventricles), except if a pacemaker is implanted.
• Sinus node disease (heart rhythm problems), except if a pacemaker is implanted.
• Severe congestive heart failure, except if it is secondary to a supraventricular tachycardia that can be treated with verapamil.
• Atrial flutter or fibrillation (abnormal heart rhythms).
• Ventricular tachycardia.

• If you are receiving intravenous beta-adrenergic blockers.

• If you are taking a medicine that contains ivabradine for the treatment of certain heart diseases.

Warnings and Precautions

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

The intravenous injection of Manidón should be administered very slowly, over a period of not less than two minutes, monitoring blood pressure and electrocardiogram.

A small proportion of patients who received Manidón presented with life-threatening adverse reactions.

Your doctor will have to be particularly careful when administering this medicine:

• 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, first-degree atrioventricular block, bradycardia, or asystole.
• If you are taking a beta-blocker medicine for heart arrhythmias.
• If you are taking digoxin along with Manidón.
• If you have heart failure.
• If you have hypotension.
• If you have any of the following diseases that cause muscle weakness: myasthenia gravis, Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• If you are taking digitalis medicines at the same time.
• If you are taking quinidine.
• If you are taking flecainide.
• If you are taking disopyramide, as it should not be administered 48 hours before or 24 hours after Manidón.
• If you have kidney disease.
• If you have severe liver disease.

Other Medicines and Manidón

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines, if taken together with Manidón, can change its effect. If you use or have used any of the following medicines, consult your doctor:

• Prazosin, terazosin (to treat high blood pressure).
• Flecainide, quinidine, disopyramide (for heart arrhythmias).
• Theophylline (for bronchial asthma).
• Carbamazepine (for seizures), phenytoin (antiepileptic).
• Imipramine (to treat 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 (to treat hypertension and heart disorders).
• Digitoxin, digoxin (for heart disorders).
• Cimetidine (for stomach ulcer treatment).
• Cyclosporin, everolimus, sirolimus, tacrolimus (immunosuppressive medicines to reduce the body's defenses).
• Atorvastatin, lovastatin, simvastatin (medicines to lower high cholesterol levels).
• Almotriptan (for migraine symptoms).
• Sulfinpyrazone (for gouty arthritis).
• Grapefruit juice.
• St. John's Wort (a medicine to treat depression).
• AIDS medicines, such as ritonavir.
• Lithium (for bipolar disorders).
• Muscle relaxants (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).
• Inhalation anesthetics.
• Dabigatran (a medicine to prevent blood clot formation)
• Other direct oral anticoagulants (medicines to prevent blood clot formation)

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is no experience with the use of Manidón during pregnancy, especially. Consult your doctor if you become pregnant while using 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 the possible serious adverse reactions in breastfed infants.

Driving and Using Machines

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

Manidón2.5 mg/ml Solution for Injectioncontains Sodium Chloride

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

3. How to Use Manidón

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

Remember that your medicine will be administered to you.

Your doctor will indicate the duration of your treatment with Manidón. Do not stop treatment before.

Manidón is administered by intravenous injection. Your doctor will decide what dose of Manidón is most suitable for you.

Adults:

The recommended dose in adults is as follows:

Initial dose: 5-10 mg (0.075-0.15 mg/kg) in slow injection over no less than two minutes.

If the previous dose is not sufficient, 10 mg (0.15 mg/kg) will be administered 30 minutes after the first.

Elderly Patients:

The dose should be administered over at least three minutes to minimize the adverse effects of the medicine.

Use in Children and Adolescents

The recommended dose in children is as follows:

Children under 1 year: Initial dose: 0.1-0.2 mg/kg (0.75-2 mg) as a single dose. If necessary, the same dose will be repeated after 30 minutes. Administration will be performed under electrocardiographic monitoring.

Children from 1 to 15 years: Initial dose: 0.1-0.3 mg/kg (2-5 mg) in a single dose over at least two minutes. Do not exceed 5 mg. If necessary, the same dose will be repeated after 30 minutes.

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

If You Use More Manidón Than You Should

In case of an overdose of Manidón, 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 you use more Manidón than you should, the doctor will interrupt the administration and apply the necessary measures, as in case of severe poisoning, it can cause death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

4. Possible Side Effects

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

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

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

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

Common Side Effects(may affect up to 1 in 10 patients):

• Constipation
• Nausea
• Bradycardia
• Low Blood Pressure
• Flushing
• Dizziness
• Headache
• Peripheral Edema

Uncommon Side Effects(may affect up to 1 in 100 patients):

• Abdominal Pain
• Tachycardia
• Palpitations
• Fatigue

Rare Side Effects(may affect up to 1 in 1,000 patients):

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

Frequency Not Known(frequency cannot be estimated from the available data):

• Intestinal Obstruction
• Gingival Hyperplasia (gum overgrowth)
• Abdominal Discomfort
• Bronchospasm
• Extrapyramidal Disorder (involuntary movements)
• Tetraparesis (partial paralysis)*
• Seizures
• Gynecomastia (abnormal enlargement of breast tissue)
• Impotence
• Galactorrhea (spontaneous flow of milk from the breast)
• Vertigo
• Allergic Reactions
• Muscle Weakness
• Muscle Pain
• Joint Pain
• Angioedema
• Erythema Multiforme (skin rash)
• Stevens-Johnson Syndrome (severe skin and mucous membrane disorder)
• Maculopapular Rash (skin rash with spots and bumps)
• Hair Loss
• Urticaria (hives)
• Purpura (purple spots on the skin and mucous membranes)
• Pruritus (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 (difficulty breathing)
• Renal Failure

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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.

Do not store above 30°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after CAD or EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Manidón

The active substance is verapamil (as hydrochloride). Each ampoule contains 5 mg of active substance.

The other ingredients (excipients) are: sodium chloride, 10% hydrochloric acid, and water for injection.

Appearance of the Product and Contents of the Pack

Manidón is presented in transparent colorless glass ampoules. Each pack contains 5 ampoules of 2 ml of aqueous and transparent solution for injection.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62.

28923 Alcorcón-Madrid.

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of Last Revision of this Leaflet:January 2021

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