MANIDON HTA 240 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Manidón HTA 240 mg prolonged-release tablets

Verapamil hydrochloride

Read all of this leaflet carefully before you start taking 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 pack and other information

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

1. Contents of the pack and further 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 is taken in:

• Prevention and treatment of chest pain.
• Treatment of high blood pressure.
• Prevention of supraventricular paroxysmal tachycardia, after intravenous treatment.
• Control of patients with chronic atrial flutter and/or atrial 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 you take Manidón

Do not take 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).
• Atrioventricular block of second or third degree (disorder in the electrical conduction between the atria and the ventricles of the heart), except if a pacemaker is implanted.
• Sick sinus syndrome (heart rhythm problems), except if a pacemaker is implanted.
• Left heart failure.
• Atrial flutter or atrial fibrillation (abnormal heart rhythms).
• 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 take Manidón.

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, atrioventricular block of first degree, 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 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 medicines and Manidón

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 convulsive crises 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 drugs to decrease 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 (medicine to treat depression).
• AIDS medicines such as ritonavir.
• Lithium (for mood problems).
• Neuromuscular blocking agents (used as adjuvants in anesthesia).

• Acetylsalicylic acid (aspirin).
• Alcohol.
• Antihypertensives (to lower high blood pressure), diuretics (medicines to urinate), vasodilators (medicines for circulatory disorders).
• Inhalation anesthetics.
• Dabigatran (medicine to prevent blood clot formation).
• Other direct oral anticoagulants (medicines 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 can enhance the hypotensive effect.

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 taking this medicine.

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 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.

Manidón HTA 240mg prolonged-release tablets contain sodium alginate

This medicine contains 34.07 mg of sodium (main component of table salt) in each tablet. This is equivalent to 1.70% of the maximum recommended daily intake of sodium for an adult.

3. How to take Manidón

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

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

Remember to take your Manidón medicine.

Your doctor will indicate the duration of treatment with Manidón.

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

Adults

Chest pain and secondary prevention post-myocardial infarction:

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

High blood pressure:

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.

Supraventricular tachycardia prophylaxis:

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 important that you continue taking this medicine until your doctor tells you to stop.

If you think the action of Manidón is too strong or too weak, tell 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, need to urinate, 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 medicine and the amount ingested, as in the case of a severe overdose, it can cause death.

If you forget to take Manidón

It is important 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 the 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 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), hot flashes, 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
• Hot flashes
• Dizziness
• Headache
• Peripheral edema
• Hypotension (low blood pressure)

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
• Drowsiness
• 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 (paralysis)*,
• Seizures
• Abnormal breast enlargement
• Impotence
• Milk secretion
• Vertigo
• Allergic reactions
• Muscle weakness
• Muscle pain
• Joint pain
• Angioedema
• Erythema multiforme (skin rash)
• Stevens-Johnson syndrome (severe skin rash)
• Maculopapular rash (skin rash with spots and papules)
• Hair loss
• Urticaria
• Purpura (purple spots on 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 (breathing difficulties)
• Renal failure

*There has been a report of paralysis 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. This includes any 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. Storing Manidón

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste.

Deposit the packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Manidón

The active substance is verapamil (as hydrochloride). Each prolonged-release tablet contains 240 mg of active substance.

The other ingredients (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), montanglicol wax, and quinoline yellow and carmine indigo (aluminum lacquer E-104 + E-132).

Appearance of the product and contents of the pack

Manidón is packaged in PVC/PVDC/Aluminum blisters and is presented in packs containing 30 prolonged-release tablets, oblong, pale green in color, and scored, marked with two triangle-shaped logos and separated, each, by the score line. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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 medicine 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 leaflet:January 2021

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