Manidon 2.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Manidón 2.5 mg/ml injectable solution

verapamil hydrochloride

Read all of this leaflet carefully before you start using 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 you should not give it 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 these effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before using Manidón.

3. How to use Manidón.

4. Possible side 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 a 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.

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

• Paroxysmal supraventricular tachycardia, even when associated with accessory conduction pathways (Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome). When clinically justified, maneuvers aimed at stimulating vagal tone should be performed as a first step.

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

2. What you need to know before using Manidón

Do not use Manidón

• If you are allergic to verapamil hydrochloride or 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).

• Severe hypotension.

• Second- or third-degree atrioventricular block (a disorder in electrical conduction between the heart's atria and ventricles), unless a pacemaker is implanted.

• Sick sinus syndrome (heart rhythm problems), unless a pacemaker is implanted.

• Severe congestive heart failure, except if secondary to supraventricular tachycardia that can be treated with verapamil.

• Atrial flutter or atrial fibrillation (abnormal heart rhythms).

• Ventricular tachycardia.

• If you are receiving intravenous beta-adrenergic blocking drugs.

• If you are taking a medicine containing ivabradine for the treatment of certain heart conditions.

Warnings and precautions

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

Intravenous injection of Manidón must be administered very slowly, over no less than two minutes, while monitoring blood pressure and electrocardiogram.

A small proportion of patients receiving Manidón have experienced life-threatening adverse reactions.

Your doctor must exercise special caution 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 hypotension.
• If you have any of the following conditions causing muscle weakness: myasthenia gravis, Lambert-Eaton syndrome, or advanced Duchenne muscular dystrophy.
• If you are simultaneously taking digitalis medications.
• If you are taking quinidine.
• If you are taking flecainide.
• If you are taking disopyramide, which must not be administered within 48 hours before or 24 hours after Manidón.
• If you have 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 using or have used 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 (immunosuppressant 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 bipolar disorders).
• Neuromuscular blocking agents (used as adjuncts in anesthesia).
• Acetylsalicylic acid (aspirin).
• Alcohol.
• Antihypertensives (to lower high blood pressure), diuretics (medicines to increase urination), vasodilators (medicines for circulatory disorders).
• Inhalational anesthetics.
• Dabigatran (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 might 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, 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. However, Manidón will only be administered during breastfeeding if essential for the mother's health due to the potential for serious adverse reactions in infants.

Driving and using machines

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

Manidón 2.5 mg/ml injectable solution contains sodium chloride

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

3. How to use Manidón

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

Remember to have your medication administered.

Your doctor will determine the duration of your treatment with Manidón. Do not stop the treatment prematurely.

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

Adults:

The recommended dose in adults is as follows:

Initial dose: 5–10 mg (0.075–0.15 mg/kg) given as a slow injection over no less than two minutes.

If this initial dose is insufficient, 10 mg (0.15 mg/kg) will be administered 30 minutes after the first dose.

Elderly patients:

The dose should be administered over at least three minutes to minimize 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 may be repeated after 30 minutes. Administration must be performed under electrocardiographic monitoring.

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

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

If you use more Manidón than you should

In case of overdose of Manidón, you may experience one or more of the following symptoms: feeling of fatigue, shortness of breath, dizziness, weakness, chest pain, feeling of fainting, difficulty thinking, intense thirst, dry and sticky mouth, increased urge to urinate, drowsiness, blurred vision, difficulty speaking or moving, nausea, vomiting, diarrhea, disorientation.

If you use more Manidón than you should, your doctor will stop administration and apply the necessary measures, as severe intoxication may lead to death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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), hot flushes, 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
• Low blood pressure
• Hot flushes
• Dizziness
• Headache
• Peripheral edema

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 enlargement of the breasts
• Impotence
• Lactation (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, the combination 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 through the Spanish Pharmacovigilance System for Human Medicines: 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.

Do not store above 30°C.

Store in the original packaging to protect from light.

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

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Manidón

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

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

Appearance of the product and contents of the container

Manidón is presented in clear, colorless glass ampoules. Each pack contains 5 ampoules of 2 ml of aqueous, clear, injectable solution.

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.

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the most recent review of this summary: January 2021

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