Package Insert: Information for the User

Manidón 2.5 mg/ml Injectable Solution

Verapamil Hydrochloride

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information.

Manidón belongs to a group of medications known as calcium channel blockers, with a predominantly cardiac action. These medications are used to treat chest pain, high blood pressure, or irregular heart rhythm.

Injectable Manidón 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, vagal tone-stimulating maneuvers will be performed as the first measure.

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

No use Manidón

• If you are allergic to hydrochloride verapamil or any of the other components of this medication (listed in section 6).
• If you have any of the following heart conditions:

• Cardiogenic shock (the heart is unable to pump enough blood that the body needs).
• Severe hypotension.
• Second- or third-degree atrioventricular block (conduction disorder between the atria and ventricles of the heart), except if there is an implanted pacemaker.
• Heart block (problems with the heart rhythm), except if there is an implanted pacemaker.
• 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 medication that contains ivabradina for the treatment of certain heart conditions.

Warnings and precautions

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

Manidón injection should be administered very slowly, over a time not less than two minutes, while monitoring blood pressure and electrocardiogram.

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

Your doctor will have to take special care in the administration of 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 arrest, first-degree atrioventricular block, 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 hypotension.
• If you have any of the following muscle weakness diseases: myasthenia gravis, Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• If you are taking digitalis medications simultaneously.
• If you are taking quinidina.
• If you are taking flecainida.
• If you are taking disopiramida, as it should not be administered 48 hours before or 24 hours after Manidón.
• If you have any kidney disease.
• If you have severe liver disease.

Other medications and Manidón

Inform your doctor or pharmacist if you are using, have used recently, 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:

• Prazosina, terazosina (for high blood pressure).
• Flecainida, quinidina, disopiramida (for heart arrhythmias).
• Theophylline (for asthma).
• Carbamazepine (for seizures), phenytoin (antiepileptic).
• Imipramine (for depression).
• Gliburida (for diabetes).
• Metformin: Verapamil may reduce the hypoglycemic effect of metformin.
• Colchicine (for gout).
• Claritromicina, eritromicina, rifampicina, telitromicina (antibiotics).
• Doxorubicina (for cancer).
• Phenobarbital (for seizures and sedation).
• Buspirona, midazolam (sedatives used for insomnia and anxiety).
• Metoprolol, propranolol (for high blood pressure and heart conditions).
• Digitoxina, digoxina (for heart conditions).
• Cimetidina (for stomach ulcer treatment).
• Ciclosporina, everolimus, sirolimus, tacrolimus (immunosuppressive medications to reduce the body's defenses).
• Atorvastatina, lovastatina, simvastatina (medications to reduce elevated cholesterol levels).
• Almotriptán (for migraine symptoms).
• Sulfinpirazona (for gouty arthritis).
• Orange juice.
• St. John's Wort (medication for depression).
• Medications for HIV, such as ritonavir.
• Lithium (for bipolar disorders).
• Neuromuscular blocking agents (used as adjuncts in anesthesia).
• Acetylsalicylic acid (aspirin).
• Alcohol.
• Antihypertensives (for high blood pressure), diuretics (medications for urination), vasodilators (medications for circulatory disorders).
• Inhalation anesthetics.
• Dabigatrán (medication to prevent blood clot formation)
• Other direct oral anticoagulants (medications to prevent blood clot formation)

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, especially. Consult your doctor if you become pregnant while using Manidón.

Verapamil is excreted in breast milk in small amounts.Limited 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 severe adverse reactions in infants.

Driving and operating machinery

Be careful when driving or using any hazardous tools or machinery, as Manidón may reduce your reaction time, especially at the beginning of treatment, when increasing the dose, when changing from another medication, and with alcohol consumption.

Manidón 2.5 mg/ml injectable solutioncontains sodium chloride

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to have your medication administered.

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

Manidón is administered via intravenous injection. Your doctor will decide on the most suitable dose of Manidón for you.

Adults:

The recommended dose in adults is as follows:

Initial dose: 5-10 mg (0.075-0.15 mg/kg) via slow injection in 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.

Geriatric patients:

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

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 at 30 minutes. Administration should be performed under electrocardiographic monitoring.

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

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

If you use more Manidón than you should

In case of a Manidón overdose, you may experience some of the following symptoms: feeling tired, shortness of breath, dizziness, weakness, chest pain, feeling like you are going to faint, difficulty thinking, intense thirst, dry and pasty mouth, frequent urination, drowsiness, blurred vision, difficulty speaking or moving, nausea, vomiting, diarrhea, disorientation.

If you use more Manidón than you should, your doctor will interrupt the administration and apply the necessary measures, as a severe overdose 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 medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

The side effects that have been reported most frequently are headache, dizziness, gastrointestinal disturbances: nausea, constipation, and abdominal pain, as well as bradycardia (decreased heart rate), tachycardia (increased heart rate), palpitations, hypotension (decreased blood pressure), hot flashes, peripheral edema (swelling in feet, legs, and ankles) and fatigue.

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

Frequent side effects(may affect up to 1 in 10 patients):

• Constipation
• Nausea
• Bradycardia
• Low blood pressure
• Hot flashes
• Dizziness
• Headache
• Peripheral edema

Infrequent 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
• Drowsiness
• Burning sensation
• Prickling or pins and needles (paresthesia)
• Tremor
• Tinnitus
• Excessive sweating

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

• Intestinal obstruction
• Increased gum size (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)
• Itching
• Increased liver enzymes
• Increased prolactin in blood (a hormone that stimulates breast development and milk production)
• First, second, and third-degree atrioventricular block (heart obstruction)
• Heart failure
• Sinus pause
• Bradycardia
• Asystole
• Hyperkalemia
• Dyspnea (breathing difficulty)
• Renal insufficiency

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

Reporting side effects

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

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

Do not store at a temperature above 86°F (30°C).

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Manidón

The active ingredient is verapamil (as hydrochloride). Each ampule contains 5 mg of active ingredient.

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

Appearance of the product and content of the container

Manidónis presented in colourless transparent glass ampules. Each container contains 5 ampules of 2 ml of transparent aqueous injectable solution.

Holder of the marketing authorization and manufacturer responsible

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer responsible:

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

Avda. de Leganés, 62.

28923 Alcorcón-Madrid.

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet:January 2021

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/