Staveran 120

Package Leaflet: Information for the Patient

STAVERAN 40, 40 mg, coated tablets

STAVERAN 80, 80 mg, coated tablets

STAVERAN 120, 120 mg, coated tablets

Verapamil hydrochloride

Read the package leaflet carefully before taking the medicine, 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. See section 4.

Table of Contents of the Leaflet

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

1. What is Staveran and what is it used for

Staveran is available in the form of coated tablets containing 40 mg, 80 mg or 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 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 reduced peripheral resistance without a significant 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 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.

Staveran is indicated for use in adults, children and adolescents for the prevention and/or 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 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 taking Staveran

When not to take Staveran

Warnings and precautions

Before starting treatment with Staveran, discuss it with your doctor.
Particular caution should be exercised in patients:

Staveran and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, as well as about medicines you plan to take.
Interactions with verapamil are possible:

• 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. glibenclamide),
• 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 (e.g. sulfinpyrazone),
• dabigatran (a drug used to prevent blood clots).

Additional information is provided below for some interactions.
Antiviral drugs against human immunodeficiency virus (HIV)
Ritonavir may increase verapamil plasma concentrations, 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 verapamil and lithium without changes or with increased lithium serum levels. However, the addition of verapamil also resulted in decreased lithium serum levels in patients chronically receiving oral fixed doses of lithium. 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 Staveran 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 concentration.
HMG-CoA reductase inhibitors (statins)
In patients taking Staveran, 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 dose of the statin and then readjusting it based on serum cholesterol levels.
The likelihood of interaction with fluvastatin, pravastatin or rosuvastatin is lower.
Hypotensive, diuretic and vasodilating drugs
Enhanced hypotensive effect.
Metformin
Verapamil may reduce the glucose-lowering effect of metformin.

Staveran with food, drink and alcohol

Interactions with grapefruit juice and products containing St. John's wort extract are also possible.

Pregnancy and breastfeeding

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 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 is excreted 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 be used during breastfeeding only if it is essential for the mother's health.

Driving and using machines

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

Staveran contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Staveran 40 contains orange yellow S (E110), Staveran 80 contains orange yellow S (E110) and Staveran 120 contains quinoline yellow (E104)

The medicine may cause allergic reactions.

3. How to take Staveran

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
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 may be used. The duration of treatment is unlimited. After long-term use, the medicine should not be stopped abruptly. It is recommended to gradually reduce the dose.
Staveran 40 should be used in patients who are expected to respond satisfactorily to small doses (e.g. patients with liver failure or the elderly). In patients requiring higher doses (e.g. 240 mg to 480 mg of verapamil hydrochloride per day), Staveran 80 or Staveran 120 should be used.
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 a varying degree depending on the degree of liver failure, which makes the medicine act stronger and longer. Therefore, particular caution should be exercised when determining the dose in patients with liver failure, and during the initial treatment period, small doses should be administered (see Warnings and precautions).
Method of administration
Oral use. The tablet should be swallowed whole (not sucked or chewed), with a sufficient amount of liquid, preferably during or immediately after a meal.

Using a higher than recommended dose of Staveran

In case of taking a higher dose than recommended, contact your doctor or go to the emergency department of the nearest hospital immediately.
Symptoms of overdose are:
Hypotension, bradycardia, slowing of conduction up to high-degree atrioventricular block and sinus arrest,
hyperglycemia, stupor, metabolic acidosis. Overdose has led to deaths.
Treatment
In case of 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 effectively used. In case of significant hypotension or high-degree atrioventricular block, vasoconstrictor drugs or cardiac pacing should be used, respectively.
In case of asystole, standard procedures should be used, including beta-adrenergic stimulation (e.g. isoprenaline hydrochloride), other vasoconstrictor drugs or cardiopulmonary resuscitation. Verapamil hydrochloride cannot be removed from the body by hemodialysis.

Missing a dose of Staveran

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

Stopping treatment with Staveran

After long-term use, do not stop taking the medicine abruptly. It is recommended to gradually reduce the dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 presented according to the frequency classification:
Common(occurring in less than 1 in 10 patients):

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

Uncommon(occurring in less than 1 in 100 patients):

• palpitations, tachycardia,
• abdominal pain, diarrhea,
• fatigue.

Rare(occurring in less than 1 in 1,000 patients):

• paresthesia, muscle tremors,
• drowsiness,
• tinnitus,
• vomiting, dry mouth,
• excessive sweating.

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

• hypersensitivity reactions,
• extrapyramidal disorders, seizures,
• hyperkalemia,
• visual disturbances,
• peripheral dizziness,
• atrioventricular block (I°, II°, III°), heart failure, sinus arrest, sinus bradycardia, asystole,
• bronchospasm, dyspnea, pulmonary edema,
• abdominal discomfort, gingival hyperplasia, intestinal obstruction,
• angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, pruritus, urticaria, rash, erythematous rash,
• arthralgia, muscle weakness, myalgia,
• renal failure, frequent urination,
• erectile dysfunction, galactorrhea, gynecomastia,
• increased prolactin levels in the blood, increased liver enzyme activity, occurrence of liver cell damage symptoms.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Staveran

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light. Do not store above 25°C.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Staveran contains:

• The active substance of the medicine is verapamil hydrochloride. Each tablet contains 40 mg, 80 mg or 120 mg of verapamil hydrochloride.
• The other ingredients are: Tablet core: gelatin, crystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate, talc, potato starch Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, orange yellow S (E110) (Staveran 40), orange yellow S (E110) (Staveran 80), quinoline yellow (E104) (Staveran 120).

What Staveran looks like and contents of the pack

Staveran 40 mg are orange, round, biconvex coated tablets.
Staveran 80 mg are orange, round, biconvex coated tablets with a score line on one side.
Staveran 120 mg are yellow, round, biconvex coated tablets with a score line on one side.
One pack contains 20 or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2
39-460 Nowa Dęba

Date of last revision of the leaflet: