Isoptin 80

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Isoptin 80 (Isoptin), 80 mg, coated tablets

Verapamil hydrochloride
Isoptin 80 and Isoptin are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of 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 the symptoms of their illness are the same.
• 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 80 and what is it used for
• 2. Important information before using Isoptin 80
• 3. How to use Isoptin 80
• 4. Possible side effects
• 5. How to store Isoptin 80
• 6. Contents of the packaging and other information

1. What is Isoptin 80 and what is it used for

Isoptin 80 is available in the form of coated tablets containing 80 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 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 of the medicine is the result of a decrease in peripheral resistance without a simultaneous 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 disorders, is based on the slowing of conduction in the atrioventricular node. As a result, depending on the type of rhythm disorder, 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 80 is indicated for use in adults, children, and adolescents 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 pectoris 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 using Isoptin 80

When not to use Isoptin 80:

• if the patient is 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 patients treated with the medicine, there is a risk of ventricular tachyarrhythmia, including ventricular fibrillation
• if the patient is taking ivabradine.

Warnings and precautions

Before starting treatment with Isoptin 80, you should discuss it with your doctor.
Particular 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-adrenergic 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 80 and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those you plan to take.
Interactions with verapamil are possible with the following medicines:

• alpha-adrenergic 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-adrenergic 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 in urine (e.g., sulfinpyrazone)
• dabigatran (anticoagulant) and direct-acting oral anticoagulants
• ivabradine (used in the treatment of heart diseases), see section "When not to use Isoptin 80"
• metformin (used in the treatment of diabetes). Verapamil may reduce the glucose-lowering effect of metformin.

Isoptin 80 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 80 and lithium without changes or with increased lithium serum levels. However, the addition of Isoptin 80 also resulted in decreased lithium serum levels in patients receiving chronic oral lithium therapy. Patients receiving both drugs should be closely monitored.
Drugs blocking neuromuscular transmission
The medicine may enhance the effect of drugs blocking neuromuscular transmission (curare-like and depolarizing drugs). It may be necessary to reduce the dose of Isoptin 80 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 80, 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 readjusting it based on serum cholesterol levels. The likelihood of an 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 medicine in pregnant women, and therefore, the medicine can be used during pregnancy only 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 serious side effects in breastfed infants, the medicine can be used during breastfeeding only if it is essential for the mother's health.

Driving and using machines

In some patients, Isoptin 80 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 occurs especially during the initial treatment period, during dose increase, 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 80 contains sodium

Isoptin 80 contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Isoptin 80

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Isoptin 40 (40 mg) and Isoptin 80 (80 mg) are available on the market.
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 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 medicine should not be stopped abruptly. A gradual dose reduction is recommended.
Isoptin 80 should be used in patients who are expected to respond well to small doses (e.g., patients with liver impairment or the elderly). In patients requiring 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 sucked or chewed), with a sufficient amount of liquid, preferably during or immediately after a meal.
Adults and adolescents over 50 kg in 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 impairment, the metabolism of the medicine is impaired to varying degrees depending on the degree of liver impairment, which makes the medicine more potent and longer-acting. Therefore, particular caution should be exercised when determining the dose in patients with liver impairment, and small doses should be administered during the initial treatment period (see section Warnings and precautions).

Using a higher than recommended dose of Isoptin 80

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. Overdose has led to deaths.
Treatment
In the case of an overdose, supportive treatment should be used, individually tailored. In the treatment of intentional overdose of the medicine taken orally, beta-adrenergic stimulation and/or parenteral calcium (calcium chloride) have been used effectively. 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. Verapamil hydrochloride cannot be removed from the body by hemodialysis.

Missing a dose of Isoptin 80

You should not take a double dose to make up for a missed dose.

Stopping treatment with Isoptin 80

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

4. Possible side effects

Like all medicines, this medicine 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:

• central dizziness, headache
• bradycardia
• flushing, hypotension
• constipation, nausea
• peripheral edema

Frequent(in 1 to 10 patients out of 100):

• palpitations, tachycardia
• abdominal pain
• fatigue

Infrequent(in 1 to 10 patients out of 1000):

• 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, arrest of the sinoatrial node, 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, exanthema
• arthralgia, muscle weakness, myalgia
• renal failure
• sexual dysfunction, galactorrhea, gynecomastia
• increased prolactin levels in blood, increased liver enzyme activity

After the medicine was placed on the market, one case of paralysis (quadriparesis) was reported after concomitant use of verapamil and colchicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Isoptin 80

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 in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Isoptin 80 contains

The active substance of the medicine is verapamil hydrochloride. One coated tablet contains 80 mg of verapamil hydrochloride.
The excipients are: calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate, and the tablet coating: hypromellose 2910, sodium lauryl sulfate, macrogol 6000, talc, titanium dioxide (E 171).

What Isoptin 80 looks like and contents of the packaging

Isoptin 80 is available in packages containing: 40 tablets, 50 tablets.
Blisters of PVC/Aluminum in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:16447/26-02-2013
8571/06-02-2007

Parallel import authorization number: 92/25

Date of leaflet approval: 11.03.2025

[Information about the trademark]