MANIDON RETARD 180 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Manidon

Do not take Manidon

• 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 Manidon.

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 Manidon.
• 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 Manidon

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

Some medicines, if taken together with Manidon, can change its effect. 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 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 hypertension and heart disorders).
• Digitoxin, digoxin (for heart disorders).
• Cimetidine (for stomach ulcers).
• 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 (a medicine for 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 (a medicine to prevent blood clot formation).
• Other direct oral anticoagulants (medicines to prevent blood clot formation)

Taking Manidon with food, drinks, and alcohol

It has been observed that grapefruit juice increases the plasma levels of verapamil, so Manidon should not be taken together with grapefruit juice.

Taking alcohol together with Manidon may 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 Manidon during pregnancy. Consult your doctor if you become pregnant while taking Manidon.

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. Manidon 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 Manidon may reduce your reaction ability, especially at the beginning of treatment, when the dose is increased, when changing from another medicine, and with alcohol consumption.

Manidon retard 180 mg prolonged-release tablets contain sodium alginate

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

3. How to take Manidon

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

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

Remember to take your Manidon medicine regularly.

Your doctor will indicate the duration of treatment with Manidon.

The most frequently recommended doses are those 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.

Prophylaxis 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 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 Manidon is too strong or too weak, tell your doctor or pharmacist.

If you take more Manidon 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, urge to urinate, somnolence, 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 taken, as in the case of a severe overdose, it can cause death.

If you forget to take Manidon

It is important that you take your Manidon 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 missed doses. Please consult your doctor before continuing 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
• 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 (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 Manidon

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

Do not store above 25°C.

Do not use Manidon after the expiry date stated on the packaging 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Manidon

The active substance is verapamil (as hydrochloride). Each prolonged-release tablet contains 180 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), iron oxides and hydroxides (E-172) (red iron oxide), and montan glycol wax.

Appearance of the product and pack contents

Manidon is packaged in PVC/PVDC/Aluminum blisters and comes in packs containing 60 prolonged-release tablets, which are oblong, biconvex, pink, and scored, marked with KNOLL on one side and 180SR on the other. The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing authorization holder and manufacturer

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/