Leaflet: information for the user

Manidón retard 180 mg prolonged-release tablets

verapamil hydrochloride

Read this 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, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. 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.

Manidón is taken for:

• Prevention and treatment of chest pain.
• 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 presence of accessory conduction pathways.

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

Do not take Manidón

• If you are allergic to hydrochloride of verapamil or to 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).
• Second- or third-degree atrioventricular block (conduction disorder between the atria and ventricles of the heart), except if there is an implanted pacemaker.
• Sick sinus syndrome (heart rhythm problems), except if there is an implanted pacemaker.
• Left ventricular heart failure.
• Atrial fibrillation or flutter (abnormal heart rhythms).
• If you are taking a medication that contains ivabradine for the treatment of certain heart conditions.

Warnings and precautions

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

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

Other medications and Manidón

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

Some medications, if taken together with Manidón, may alter its 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 asthma).
• Carbamazepine (for seizures), phenytoin (antiepileptic).
• Imipramine (for depression).
• Glibenclamide (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 high blood pressure and heart disorders).
• Digoxin, digitoxin (for heart disorders).
• Cimetidine (for stomach ulcer treatment).
• Ciclosporin, 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).
• Orange juice.
• St. John's Wort (medication for depression).
• Medications for HIV such as ritonavir.
• Lithium (for mood disorders).
• Neuromuscular blocking agents (used as adjuncts in anesthesia).
• Aspirin.
• Alcohol.
• Antihypertensive medications (to lower high blood pressure), diuretics (medications for urination), 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 orange juice increases the plasma levels of verapamil, therefore Manidón should not be taken together with orange juice.

The consumption of 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 intend 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 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 switching from another medication, and with alcohol consumption.

Manidón retard 180 mg prolonged-release tablets contain sodium alginate

This medication contains 25.55 mg of sodium (main component of table salt/for cooking)in each tablet. This is equivalent to 1.27% of the recommended daily maximum sodium intake for an adult.

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

The appropriate 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 him or your pharmacist:

Adults

Angina pectoris 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 a week to 360 mg per day and subsequently up to a maximum of 480 mg per day.

Prevention 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 of body weight per day in several doses.

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

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

If you take more Manidónthan you should

You may notice 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 sticky mouth, frequent urination, drowsiness, 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 a severe overdose can cause death.

If you forgot to take Manidón

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

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
• Hot flashes
• Dizziness
• Headache
• Peripheral edema
• Hypotension (low blood pressure)

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 1000 patients):

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

Unknown frequency(the frequency cannot be estimated from the 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 its use in combination 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.

Keepthis medication out of sight and reach of children.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the 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 prolonged-release tablet contains 180 mg of active ingredient.

The other components (excipients) are:

Core ingredients: microcrystalline cellulose, sodium alginate, povidone, magnesium stearate, and purified water.

Coating ingredients: hypromellose, macrogol 400, macrogol 6000, talc, titanium dioxide (E-171), iron oxide and hydroxides (E-172) (iron oxide red), and montanglicol wax.

Appearance of the product and contents of the packaging

Manidón is packaged in PVC/PVDC/Aluminum blisters and is presented in containers containing 60 prolonged-release tablets, oblong, biconvex, pink, scored, marked with KNOLL on one face and 180SR on the other. The score is solely for breaking and facilitating swallowing, but not for dividing into equal doses.

Holder of the marketing authorization and responsible manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

AbbVie Deutschland GmbH & Co. KG.

Knollstrasse, 50.

67061 Ludwigshafen

Germany.

or

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

Last review date of this leaflet:January 2021

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