Isoptin Sr

Package Leaflet: Information for the Patient

Isoptin SR, 120 mg, Prolonged-Release Tablets

Verapamil Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this 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.

Table of Contents of the Leaflet:

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

1. What is Isoptin SR and what is it used for

Isoptin SR is available in the form of prolonged-release tablets containing 120 mg of the active substance - verapamil hydrochloride. Verapamil hydrochloride is a selective calcium antagonist acting directly on the heart muscle.
The action of the drug is based on the inhibition of calcium ions passing through the cell membrane to the heart muscle cells and vascular smooth muscle cells.
The drug has antihypertensive and antiarrhythmic effects.
The antihypertensive effect of the drug is the result of a decrease in peripheral resistance without a simultaneous increase in heart rate. In the case of normal arterial pressure, the drug 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 arrhythmia, there is a restoration of sinus rhythm and/or normalization of ventricular contractions. The drug does not change the normal heart rate or only slightly reduces it.
Isoptin SR is indicated for use in adults for the treatment of:

• hypertension
• coronary heart disease (states 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-adrenergic 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

When not to take Isoptin SR

Warnings and precautions

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

Isoptin SR and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those you plan to take.
Interactions with the following medicines are possible:

Isoptin SR 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
Increased sensitivity to lithium (neurotoxicity) has been reported during concomitant treatment with Isoptin SR and lithium without changes or with increased lithium serum levels. However, the addition of Isoptin SR also resulted in decreased lithium serum levels in patients chronically receiving oral fixed doses of lithium. The condition of patients receiving both drugs should be closely monitored.
Drugs blocking neuromuscular transmission
The drug may enhance the effect of drugs blocking neuromuscular transmission (curare-like and depolarizing drugs). It may be necessary to reduce the dose of Isoptin SR and/or the dose of the drug blocking neuromuscular transmission when these drugs are used together.
Acetylsalicylic acid
Increased tendency to bleeding.
Ethyl alcohol
Increased ethanol plasma levels.
HMG-CoA reductase inhibitors (statins)
In patients taking Isoptin SR, 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 drug is started in patients already taking an HMG-CoA reductase inhibitor (e.g. simvastatin, atorvastatin, or lovastatin), it is recommended to consider reducing the statin dose and then re-adjust it based on serum cholesterol levels.
The likelihood of interaction with fluvastatin, pravastatin, or rosuvastatin is lower.
Hypotensive, diuretic, and vasodilating drugs
Enhancement of the 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 drug in pregnant women, and therefore, the drug can be used in pregnancy only if it is absolutely necessary.
The drug 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 drug can be used during breastfeeding only if it is essential for the mother's health.

Driving and using machines

Isoptin SR may affect your ability to react to such an extent that it impairs your ability to drive vehicles, operate machinery, or work in hazardous conditions. This is especially true at the beginning of treatment, during dose increase, when switching from another drug, and when consuming alcohol. The drug may increase blood alcohol levels and delay its elimination. For this reason, the effect of alcohol may be enhanced.

Isoptin SR contains sodium

Isoptin SR contains less than 1 mmol (23 mg) of sodium per tablet, which means the drug is considered "sodium-free".

3. How to take Isoptin SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose of the drug should be selected 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 use, the daily dose should not exceed 480 mg, while during short-term use, a higher dose can be used. The duration of treatment is unlimited. After long-term use, the drug should not be stopped abruptly. It is recommended to gradually reduce the dose.
Oral administration. The tablet should be swallowed whole (not sucked or chewed), with a sufficient amount of liquid, preferably during or immediately after a meal.
Adults and adolescents over 50 kg of body weight
Hypertension: 120 mg to 480 mg per day in one or two divided doses.
Coronary heart disease, paroxysmal supraventricular tachycardia, atrial fibrillation, and atrial flutter: 120 mg to 480 mg per day in one or two divided doses.
In all the above-mentioned indications, unless the doctor has prescribed otherwise, the usual dose is: 1 or 2 Isoptin SR tablets once or twice a day.
For patients who may show a satisfactory response to small doses (e.g. patients with liver failure or the elderly), it is recommended to use Isoptin 40 mg or Isoptin 80 mg film-coated tablets.
Special populations
Children and adolescents
Isoptin SR should not be used in children. In children, drugs with unmodified release should be used.
Renal impairment
When using the drug in patients with renal impairment, caution should be exercised and the patient's condition should be closely monitored.
Hepatic impairment
In patients with liver failure, the drug's metabolism is impaired to a varying degree, depending on the degree of liver failure, which makes the drug act stronger and longer. Therefore, special caution should be exercised when determining the dose in patients with liver failure, and small doses should be administered during the initial treatment period (see "Warnings and precautions").

Overdose of Isoptin SR

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

Missed dose of Isoptin SR

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

Stopping treatment with Isoptin SR

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

4. Possible side effects

Like all medicines, Isoptin SR 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:
Common(in 1 to 10 patients out of 100):
˗
central dizziness, headache
˗
bradycardia
˗
flushing, hypotension
˗
constipation, nausea
˗
peripheral edema
Uncommon(in 1 to 10 patients out of 1,000):
˗
palpitations, tachycardia
˗
abdominal pain
˗
fatigue
Rare(in 1 to 10 patients out of 10,000):
˗
paresthesia, muscle tremors
˗
drowsiness
˗
tinnitus
˗
vomiting
˗
excessive sweating
Side effects with unknownfrequency (frequency cannot be estimated from available data):
˗
hypersensitivity reactions
˗
extrapyramidal disorders, seizures
˗
hyperkalemia
˗
peripheral dizziness
˗
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, erythema
˗
arthralgia, muscle weakness, myalgia
˗
renal failure
˗
sexual dysfunction, galactorrhea, gynecomastia
˗
increased prolactin levels in blood, increased liver enzyme activity
One case of paralysis (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. You can also report side effects directly to the Department of Drug 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
You can also report side effects 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

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 contains

The active substance is verapamil hydrochloride 120 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), glycerol wax.

What Isoptin SR looks like and contents of the pack

White, round, biconvex tablet.
Isoptin SR is available in packs containing:
40 tablets
100 tablets
Blister pack (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
Phone: (22) 546 64 00
Date of last revision of the leaflet:02/2024