Isoptin Sr-e 240

Package Leaflet: Information for the Patient

Isoptin SR-E 240, 240 mg, Prolonged-Release Tablets

Verapamil Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What Isoptin SR-E 240 is and what it is used for
• 2. Important information before taking Isoptin SR-E 240
• 3. How to take Isoptin SR-E 240
• 4. Possible side effects
• 5. How to store Isoptin SR-E 240
• 6. Contents of the pack and other information

1. What Isoptin SR-E 240 is and what it is used for

Isoptin SR-E 240 is available in the form of prolonged-release tablets containing 240 mg of the active substance - verapamil hydrochloride. Verapamil hydrochloride is a selective calcium antagonist acting directly on the heart muscle. The action of the medicine is based on the inhibition of calcium ion passage through the cell membrane to the heart muscle cells and vascular smooth muscle cells. The medicine has antihypertensive and antiarrhythmic effects. The antihypertensive effect is the result of reduced peripheral resistance without a significant increase in heart rate. In the case of normal blood pressure, the medicine does not have a significant hypotensive effect. The antiarrhythmic effect, especially in the case of supraventricular rhythm disturbances, is based on the slowing of conduction in the atrioventricular node. As a result, depending on the type of rhythm disturbance, there is a restoration of sinus rhythm and/or normalization of ventricular contractions. The medicine does not change the normal heart rate or only slightly reduces it. Isoptin SR-E 240 is indicated for use in adults for the treatment of:

• hypertension
• coronary heart disease (conditions characterized by insufficient oxygen supply to the heart muscle), including:
• chronic stable angina pectoris
• unstable angina pectoris (with increasing pain, pain at rest)
• Prinzmetal's angina
• angina after myocardial infarction without heart failure, when beta-blockers are not indicated
• arrhythmias, such as:
• paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with rapid atrioventricular conduction (except for Wolff-Parkinson-White syndrome [WPW] or Lown-Ganong-Levine syndrome [LGL])

2. Important information before taking Isoptin SR-E 240

When not to take Isoptin SR-E 240

• if you are allergic to verapamil hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in cardiogenic shock
• in atrioventricular block II˚ or III˚ (except for patients with a functioning pacemaker)
• in sick sinus syndrome (except for patients with a functioning pacemaker)
• in heart failure with reduced ejection fraction below 35% and/or pulmonary capillary wedge pressure above 20 mmHg (if not secondary to supraventricular tachycardia responding to verapamil treatment)
• in atrial fibrillation/flutter with accessory conduction pathway (e.g. Wolff-Parkinson-White syndrome [WPW], Lown-Ganong-Levine syndrome [LGL]). In these patients, there is a risk of ventricular tachyarrhythmia, including ventricular fibrillation
• if you are taking ivabradine

Warnings and precautions

Before starting treatment with Isoptin SR-E 240, discuss it with your doctor. Special caution should be exercised in patients:

• with acute myocardial infarction complicated by bradycardia, significant hypotension, or left ventricular dysfunction
• with heart block, atrioventricular block I˚, bradycardia, asystole
• taking antiarrhythmic drugs, beta-blockers
• taking digoxin
• with heart failure with ejection fraction above 35%
• with hypotension
• taking statins
• with neuromuscular transmission disorders [myasthenia gravis, Lambert-Eaton syndrome, late stages of Duchenne muscular dystrophy]
• with renal impairment
• with severe liver impairment

Isoptin SR-E 240 with other medicines

Tell your doctor about all medicines you are taking or have recently taken, including those you plan to take. Possible interactions with verapamil include:

• alpha-blockers (e.g. prazosin, terazosin)
• antiarrhythmic drugs (e.g. flecainide, quinidine)
• bronchodilators (e.g. theophylline)
• antiepileptic drugs (e.g. carbamazepine, phenytoin)
• antidepressants (e.g. imipramine)
• antidiabetic drugs (e.g. gliburyde)
• drugs for gout (e.g. colchicine)
• antibiotics (e.g. clarithromycin, erythromycin, rifampicin, telithromycin)
• anticancer drugs (e.g. doxorubicin)
• barbiturates (e.g. phenobarbital)
• benzodiazepines and other anxiolytic drugs (e.g. buspirone, midazolam)
• beta-blockers (e.g. metoprolol, propranolol)
• cardiac glycosides (e.g. digitoxin, digoxin)
• H2 receptor antagonists (e.g. cimetidine)
• immunomodulating and immunosuppressive drugs (e.g. cyclosporine, everolimus, sirolimus, tacrolimus)
• lipid-lowering drugs (e.g. atorvastatin, lovastatin, simvastatin)
• serotonin receptor agonists (e.g. almotriptan)
• drugs increasing uric acid excretion (e.g. sulfinpyrazone) - dabigatran (anticoagulant) and direct oral anticoagulants
• ivabradine (used in the treatment of heart diseases), see section "When not to take Isoptin SR-E 240"
• metformin (used in the treatment of diabetes). Verapamil may reduce the effect of metformin in reducing glucose levels.

Isoptin SR-E 240 with food and drink

Interactions with grapefruit juice and products containing St. John's wort extract are also possible. Additional information on some interactions is provided below. Antiviral drugs against human immunodeficiency virus (HIV) Ritonavir may increase verapamil plasma levels, enhancing its effect. Caution should be exercised when these drugs are used together, and if necessary, the verapamil dose should be reduced. Lithium There have been reports of increased lithium sensitivity (neurotoxicity) during concomitant treatment with Isoptin SR-E 240 and lithium without changes or with increased lithium serum levels. However, the addition of Isoptin SR-E 240 also resulted in decreased lithium serum levels in patients chronically receiving oral fixed doses of lithium. Close monitoring of patients receiving both drugs is recommended. Muscle relaxants The medicine may enhance the effect of muscle relaxants (curare-like and depolarizing drugs). It may be necessary to reduce the dose of Isoptin SR-E 240 and/or the dose of the muscle relaxant when these drugs are used together. Acetylsalicylic acid Increased risk of bleeding. Ethanol Increased ethanol plasma levels. HMG-CoA reductase inhibitors (statins) In patients taking Isoptin SR-E 240, treatment with HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, or lovastatin) should be started with the lowest possible dose, which is then adjusted by gradual increase. If the use of the medicine is started in patients already taking an HMG-CoA reductase inhibitor (e.g. simvastatin, atorvastatin, or lovastatin), consideration should be given to reducing the statin dose, and then re-adjusting it based on serum cholesterol levels. The likelihood of an interaction with fluvastatin, pravastatin, or rosuvastatin is lower. Hypotensive, diuretic, and vasodilating drugs Enhanced hypotensive effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. There are no data on the use of the medicine in pregnant women, and therefore, the medicine can only be used during pregnancy if it is absolutely necessary. The medicine passes into breast milk in a small percentage. The risk to newborns and infants cannot be excluded. However, due to the possibility of severe side effects in breastfed infants, the medicine can only be used during breastfeeding if it is essential for the mother's health.

Driving and using machines

Isoptin SR-E 240 may affect your ability to react to such an extent that it impairs your ability to drive or operate machinery. This is especially true at the beginning of treatment, when increasing the dose, when switching from another medicine, and when consuming alcohol. The medicine may increase blood ethanol levels and delay its elimination. Therefore, the effect of alcohol may be enhanced.

Isoptin SR-E 240 contains tartrazine

Isoptin SR-E 240 contains tartrazine (E104), which may cause allergic reactions in some patients.

Isoptin SR-E 240 contains sodium

Isoptin SR-E 240 contains 37.1 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Isoptin SR-E 240

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist. The dose of the medicine should be adjusted individually, depending on the severity of the disease. Long-term clinical experience confirms that in all indications, the daily dose is usually between 240 mg and 360 mg. During long-term treatment, the daily dose should not exceed 480 mg, while during short-term treatment, a higher dose can be used. The duration of treatment is unlimited. After long-term treatment, the medicine should not be stopped abruptly. It is recommended to gradually reduce the dose.

Overdose of Isoptin SR-E 240

Symptoms Hypotension, bradycardia, slowing of conduction to high-degree atrioventricular block and sinus arrest, hyperglycemia, stupor, metabolic acidosis, acute respiratory failure. Overdose has led to deaths. Treatment In overdose, supportive treatment should be applied, individually tailored. In the treatment of intentional overdose of the medicine, beta-adrenergic stimulation and/or parenteral calcium (calcium chloride) have been effectively used. In the case of clinically significant hypotension or high-degree atrioventricular block, vasoconstrictor drugs or cardiac pacing should be used, respectively. In the case of asystole, standard procedures should be applied, including beta-adrenergic stimulation (e.g. isoproterenol hydrochloride), other vasoconstrictor drugs, or cardiopulmonary resuscitation. If there is an overdose of verapamil hydrochloride in a prolonged-release form, due to slower absorption of the medicine, the patient should be hospitalized and monitored for up to 48 hours. Verapamil hydrochloride cannot be removed from the body by hemodialysis.

Missing a dose of Isoptin SR-E 240

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Isoptin SR-E 240

After long-term treatment, do not stop taking the medicine abruptly. It is recommended to gradually reduce the dose.

4. Possible side effects

Like all medicines, Isoptin SR-E 240 can cause side effects, although not everybody gets them. The most common side effects were: headache, dizziness, gastrointestinal disorders: nausea, constipation, and abdominal pain, as well as bradycardia, tachycardia, palpitations, hypotension, flushing, peripheral edema, and fatigue. Side effects are listed below by system organ class and frequency:

Common(in 1 to 10 patients in 100):

˗ central dizziness, headache

˗ bradycardia

˗ flushing, hypotension

˗ constipation, nausea

˗ peripheral edema

Uncommon(in 1 to 10 patients in 1,000):

˗ palpitations, tachycardia

˗ abdominal pain

˗ fatigue

Rare(in 1 to 10 patients in 10,000):

˗ paresthesia, muscle tremors

˗ somnolence

˗ tinnitus

˗ vomiting

˗ excessive sweating

Side effects with unknown frequency(frequency cannot be estimated from available data):

˗ hypersensitivity reactions

˗ extrapyramidal disorders, seizures

˗ hyperkalemia

˗ peripheral vertigo

˗ atrioventricular block (I˚, II˚, III˚), heart failure, sinus arrest, sinus bradycardia, asystole (cardiac arrest)

˗ bronchospasm, dyspnea

˗ abdominal discomfort, gingival hyperplasia, intestinal obstruction

˗ angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, pruritus, urticaria, rash, erythematous rash

˗ arthralgia, muscle weakness, myalgia

˗ renal failure

˗ sexual dysfunction, galactorrhea, gynecomastia

˗ increased prolactin levels in the blood, increased liver enzyme activity

A case of paresis (quadriparesis) has been reported after concomitant use of verapamil and colchicine.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; Fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isoptin SR-E 240

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the blister after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Isoptin SR-E 240 contains

The active substance is verapamil hydrochloride 240 mg. The other ingredients are: microcrystalline cellulose, sodium alginate, povidone, magnesium stearate, purified water, and tablet coating: hypromellose, macrogol 400, macrogol 6000, talc, titanium dioxide (E171), tartrazine (E104), and indigo carmine (E132), glycerol wax.

What Isoptin SR-E 240 looks like and contents of the pack

The tablet is light green, prolonged-release. Isoptin SR-E 240 is available in packs containing: 20 tablets (2 blisters of 10 tablets), 40 tablets (4 blisters of 10 tablets). Blister pack of PCW/PVDC/Al in a cardboard box.

Marketing authorization holder

Viatris Healthcare Sp. z o.o., ul. Postępu 21B, 02-676 Warsaw

Manufacturer

FAMAR A.V.E. ANTHOUSSA PLANT, Anthoussa Avenue 7, Anthoussa Attiki, 15349, Greece

Importer

Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary

To obtain more detailed information, please contact the marketing authorization holder: Viatris Healthcare Sp. z o.o., ul. Postępu 21B, 02-676 Warsaw, Tel: (22) 546 64 00. Date of last revision of the leaflet:02/2024