Isoptin 40

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Isoptin 40(Isoptin)

40 mg, coated tablets

Verapamil hydrochloride
Isoptin 40 and Isoptin are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Isoptin 40 and what is it used for
• 2. Important information before taking Isoptin 40
• 3. How to take Isoptin 40
• 4. Possible side effects
• 5. How to store Isoptin 40
• 6. Contents of the packaging and other information

1. What is Isoptin 40 and what is it used for

Isoptin 40 is available in the form of coated tablets containing 40 mg of the active substance

• verapamil hydrochloride. Verapamil hydrochloride is a selective calcium antagonist that acts directly on the heart muscle.

The action of the medicine is based on the inhibition of calcium ions passing through the cell membrane to the heart muscle cells and vascular smooth muscle cells.
The medicine has antihypertensive and antiarrhythmic effects.
The antihypertensive effect of the medicine is the result of a decrease in peripheral resistance without a simultaneous increase in heart rate. In the case of normal arterial 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 40 is indicated for use in adults, children, and adolescents 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 40

When not to take Isoptin 40

Warnings and precautions

Before starting treatment with Isoptin 40, the patient should discuss it with their doctor.
Particular caution should be exercised in patients:
˗
with acute myocardial infarction complicated by bradycardia, significant hypotension, or left ventricular dysfunction
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with heart block, atrioventricular block I˚, bradycardia, asystole
˗
taking antiarrhythmic drugs, beta-blockers
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taking digoxin
˗
with heart failure with ejection fraction above 35%
˗
with hypotension
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taking statins
˗
with neuromuscular transmission disorders [myasthenia gravis, Lambert-Eaton syndrome, late stages of Duchenne muscular dystrophy]
˗
with renal dysfunction
˗
with severe liver dysfunction

Isoptin 40 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those they plan to take.
Interactions with verapamil are possible with the following medicines:

• alpha-blockers (e.g., prazosin, terazosin)
• antiarrhythmic drugs (e.g., flecainide, quinidine)
• bronchodilators (e.g., theophylline)
• antiepileptic and anticonvulsant drugs (e.g., carbamazepine, phenytoin)
• antidepressants (e.g., imipramine)
• antidiabetic drugs (e.g., gliburide)
• 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 that increase uric acid excretion (e.g., sulfinpyrazone)
• dabigatran (anticoagulant) and direct-acting oral anticoagulants
• ivabradine (used in the treatment of heart diseases), see section "When not to take Isoptin 40"
• metformin (used in the treatment of diabetes). Verapamil may reduce the effect of metformin on glucose levels.

Isoptin 40 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 40 and lithium without changes or with increased lithium serum levels. However, the addition of Isoptin 40 has also been shown to decrease lithium serum levels in patients chronically receiving oral fixed doses of lithium. The condition of patients receiving both drugs should be closely monitored.
Drugs that block neuromuscular transmission
The medicine may enhance the effect of drugs that block neuromuscular transmission (curare-like and depolarizing drugs). It may be necessary to reduce the dose of Isoptin 40 and/or the dose of the drug that blocks neuromuscular transmission when these drugs are used together.
Acetylsalicylic acid
Increased tendency to bleeding.
Ethyl alcohol
Increased ethanol plasma levels.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor 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 in pregnancy if it is absolutely necessary.
The medicine passes into breast milk in small amounts. 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

In some patients, Isoptin 40 may affect their ability to react to such an extent that it impairs their ability to drive vehicles, operate machinery, or work in hazardous conditions. This is especially true during the initial treatment period, when increasing the dose, when switching from another medicine, and when consuming alcohol. The medicine may increase ethanol plasma levels and delay its elimination. Therefore, the effect of alcohol may be enhanced.

Isoptin 40 contains sodium

Isoptin 40 contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Isoptin 40

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Isoptin, coated tablets are available in the following doses: 40 mg (Isoptin 40) or 80 mg (Isoptin 80).
The dose of the medicine should be adjusted individually, depending on the severity of the disease. Long-term clinical experience has shown 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 may be used. The duration of treatment is unlimited. After long-term treatment, the medicine should not be stopped abruptly. A gradual dose reduction is recommended.
Isoptin 40, 40 mg coated tablets should be used in patients who are expected to respond satisfactorily to small doses (e.g., patients with liver failure or elderly patients). In patients who require higher doses (e.g., 240 mg to 480 mg of verapamil hydrochloride per day), Isoptin 80 or Isoptin SR or Isoptin SR-E 240 should be used.
Oral administration. The tablet should be swallowed whole (not chewed or sucked), 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 three divided doses.
Coronary heart disease, paroxysmal supraventricular tachycardia, atrial fibrillation, and atrial flutter: 120 mg to 480 mg per day in three or four divided doses.
Special populations
Children and adolescents (only in arrhythmias)
Up to 6 years of age: 80 mg to 120 mg of verapamil hydrochloride per day in two or three divided doses.
From 6 to 14 years of age: 80 mg to 360 mg of verapamil hydrochloride per day in two, three, or four divided doses.
Renal impairment
When using the medicine 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 metabolism of the medicine is impaired to varying degrees, depending on the degree of liver failure, which makes the medicine more potent and longer-acting. Therefore, particular 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 section Warnings and precautions).

Taking a higher dose of Isoptin 40 than recommended

Symptoms
Hypotension, bradycardia, slowing of conduction up to high-degree atrioventricular block and arrest of the sinoatrial node, hyperglycemia, stupor, metabolic acidosis, acute respiratory failure syndrome.
Deaths have occurred due to overdose.
Treatment
In the event of an overdose, supportive treatment should be initiated, tailored to the individual patient. In the treatment of intentional overdose, beta-adrenergic stimulation and/or parenteral calcium (calcium chloride) have been effective. In the case of significant hypotension or high-degree atrioventricular block, vasopressor agents or cardiac pacing should be used, respectively. In the case of asystole, standard procedures, including beta-adrenergic stimulation (e.g., isoproterenol hydrochloride), other vasopressor agents, or cardiopulmonary resuscitation, should be used.
Verapamil hydrochloride cannot be removed from the body by hemodialysis.

Missing a dose of Isoptin 40

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Isoptin 40

After long-term treatment, the medicine should not be stopped abruptly. A gradual dose reduction is recommended.

4. Possible side effects

Like all medicines, Isoptin 40 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 out of 100):
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central dizziness, headache
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bradycardia
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flushing, hypotension
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constipation, nausea
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peripheral edema
Uncommon(in 1 to 10 patients out of 1000):
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palpitations, tachycardia
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abdominal pain
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fatigue
Rare(in 1 to 10 patients out of 10,000):
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paresthesia, muscle tremors
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drowsiness

• tinnitus ˗ vomiting ˗ excessive sweating

Side effects with unknownfrequency (frequency cannot be estimated from available data):
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hypersensitivity reactions
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extrapyramidal disorders, seizures
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hyperkalemia
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peripheral dizziness
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atrioventricular block (I˚, II˚, III˚), heart failure, arrest of the sinoatrial node, sinus bradycardia, asystole (cardiac arrest)
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bronchospasm, dyspnea
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abdominal discomfort, gingival hyperplasia, intestinal obstruction
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angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, pruritus, urticaria, rash, erythematous rash
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arthralgia, muscle weakness, myalgia
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renal failure
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sexual dysfunction, galactorrhea, gynecomastia
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increased prolactin levels, increased liver enzyme activity
One case of paralysis (quadriparesis) has been reported after concomitant use of verapamil and colchicine.
If any side effect worsens or any side effect not listed in the leaflet occurs, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301 Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Isoptin 40

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Isoptin 40 contains

The active substance of the medicine is verapamil hydrochloride 40 mg.
The excipients are: calcium phosphate dihydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate, and the tablet coating:
hypromellose 2910, sodium lauryl sulfate, macrogol 6000, purified talc, titanium dioxide (E 171).

What Isoptin 40 looks like and contents of the packaging

Isoptin 40 is available in packaging containing 40 or 50 coated tablets, in PVC/Al blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

BGP Proionta M.E.P.E
Ag. Dimitriou 63
174 56 Alimos
Greece

Manufacturer

Vianex S.A.
15 km. Athinon Marathonos Avenue
153 44 Pallini Attiki
Greece

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Greece, the country of export: 8571/06-02-2007
Parallel import authorization number: 382/22
Date of leaflet approval: 19.10.2022
[Information about the trademark]