VERAPAMIL 120 mg Modified-Release Tablet

Зміст інструкції

1. VERAPAMIL EG 120 mg modified-release tablets
   1. What is VERAPAMIL EG and what is it used for
   2. What you need to know before taking VERAPAMIL EG
   3. How to take VERAPAMIL EG
   4. Possible side effects
   5. How to store VERAPAMIL EG
   6. Contents of the pack and other information
2. Verapamil EG 240 mg modified-release tablets
   1. What is VERAPAMIL EG and what is it used for?
   2. What you need to know before you take VERAPAMIL EG
   3. How to take VERAPAMIL EG
   4. Possible side effects
   5. How to store VERAPAMIL EG
   6. Contents of the pack and other information

VERAPAMIL EG 120 mg modified-release tablets

Verapamil hydrochloride

Generic Medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What VERAPAMIL EG is and what it is used for
• 2. What you need to know before you take VERAPAMIL EG
• 3. How to take VERAPAMIL EG
• 4. Possible side effects
• 5. How to store VERAPAMIL EG
• 6. Contents of the pack and other information

1. What is VERAPAMIL EG and what is it used for

VERAPAMIL EG contains the active ingredient verapamil hydrochloride which belongs to a group of
medicines called calcium channel blockers (calcium antagonists), which promote the relaxation
of the heart and blood vessels.
VERAPAMIL EG is indicated for the treatment of:

• heart problems due to reduced blood supply (acute and chronic coronary insufficiency);
• abnormal alterations of the heartbeat (hyperkinetic supraventricular arrhythmias such as paroxysmal supraventricular tachycardia, atrial fibrillation and flutter with rapid ventricular response, extrasystoles);
• high blood pressure (arterial hypertension).

This medicine is also indicated as treatment after a heart attack (myocardial infarction) and
to prevent a new heart attack if there are no signs of heart failure and when it is not possible
to use other medicines (beta-blockers).

2. What you need to know before taking VERAPAMIL EG

Do not take VERAPAMIL EG

• if you are allergic to verapamil or any of the other ingredients of this medicine (listed in section 6);
• if you have a serious heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout your body;
• if you have recently had a heart attack and have experienced complications such as a severe reduction in your heart rate (complicated myocardial infarction with marked bradycardia);
• if the function of your heart is reduced compared to normal (contractile dysfunction of the left ventricle, decompensated congestive heart failure);
• heart failure with a reduced ejection fraction of less than 35% and/or pulmonary pressure greater than 20 mm Hg (unless due to supraventricular tachycardia sensitive to verapamil therapy);
• if you have severe conduction disturbances and an irregular heartbeat (total AV block, partial AV block; incomplete bundle branch block, sinus node disease, except in patients with a ventricular pacemaker; II-III degree AV block, except in patients with a functioning ventricular pacemaker, wide complex ventricular tachycardia, atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome, short PR syndromes);
• if you have a very slow heartbeat (pronounced bradycardia with less than 50 beats/minute);
• if you have low blood pressure (hypotension with systolic pressure less than 90 mm Hg) (see section “Warnings and precautions”);
• if you are taking medicines used to treat depression (MAO inhibitors), or to treat heart problems (quinidine treatments) or to treat high blood pressure (beta-blockers) (see section “Other medicines and VERAPAMIL EG”);
• if you are taking a medicine containing ivabradine used to treat some heart problems (see section “Other medicines and VERAPAMIL EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking VERAPAMIL EG.
Do not take VERAPAMIL EG if the function of your heart is severely reduced compared to
normal (severe left ventricular dysfunction). If you develop a mild form of this disorder, your
doctor may prescribe other medicines (digitalis and/or diuretics) before starting treatment with
this medicine.
During treatment with this medicine, you may experience:

• a decrease in blood pressure below normal levels, which can cause a feeling of dizziness or other symptoms related to low blood pressure (symptomatic hypotension);
• a transient increase in liver enzymes (transaminases) associated or not with an increase in other substances in the blood (alkaline phosphatase, bilirubin). Undergo periodic liver function tests during treatment with this medicine;
• a negative inotropic effect (decrease in the force of heart contraction): if you have heart failure, your doctor will need to decide on compensation and treat you with appropriate therapy before starting verapamil.

Take VERAPAMIL EG with caution and tell your doctor if:

• you suffer from a particular heart disease called Wolff-Parkinson-White syndrome or if you have Lown-Ganong-Levine syndrome. In these cases, your condition may worsen (very rapid ventricular response or ventricular fibrillation);
• if you suffer from heart diseases related to conduction problems as verapamil acts on the AV and SA nodes and prolongs AV conduction time: the development of a second or third degree AV block requires discontinuation of treatment and, if necessary, initiation of appropriate therapy;
• you have liver problems. In this case, the doctor will periodically check your heart function and may decide to change the dose (usually patients with severe liver problems are given a lower dose, 30% of the usual dose);
• you have kidney problems as this may affect your heart. The doctor will check you periodically to verify your heart function;
• you have a very slow heartbeat (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL EG”);
• you have serious muscle problems (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

Children and adolescents
There is no data available to establish the safety and efficacy of modified-release verapamil tablets in
children and adolescents, therefore the use of this medicine is not recommended
in children and adolescents.

Other medicines and VERAPAMIL EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. If you are taking other medicines, specific checks may be necessary.
Take this medicine with caution and tell your doctor if you are taking the following medicines:

• alpha-blockers, medicines used to treat high blood pressure and to help eliminate urine in patients with an enlarged prostate gland called “benign prostatic hyperplasia” (terazosin, prazosin);
• medicines used to treat heart rhythm disorders (quinidine, flecainide, dronedarone);
• theophylline, a medicine used to treat asthma;
• dabigatran etexilate and sulfinpyrazone, medicines used to prevent the formation of blood clots (thrombi);
• carbamazepine and phenytoin, medicines used to treat epilepsy (anticonvulsants);
• imipramine, a medicine used to treat depression;
• gliburide, a medicine used to treat diabetes;
• medicines used to treat infections caused by bacteria (clarithromycin, erythromycin, rifampicin, telithromycin);
• doxorubicin, a medicine used to treat some types of cancer;
• phenobarbital, a medicine used to induce anesthesia and to treat epilepsy;
• medicines used to treat anxiety and to promote sleep (buspirone, midazolam);
• beta-blockers (metoprolol, propranolol), medicines used to treat high blood pressure and some heart problems;
• digitalis (digitoxin, digoxin), medicines used to treat heart problems (heart failure) (see section “Warnings and precautions”);
• cimetidine, a medicine used to treat stomach and intestinal problems such as acidity or the presence of lesions (ulcers);
• medicines used following an organ transplant (cyclosporine, everolimus, sirolimus, tacrolimus);
• medicines used to lower high levels of fats in the blood (atorvastatin, lovastatin, simvastatin);
• almotriptan, a medicine used to treat migraine;
• St. John's wort, used to treat depression;
• medicines used to treat AIDS (anti-HIV agents);
• medicines used for anesthesia (neuromuscular blockers and inhalation anesthetics);
• acetylsalicylic acid, a medicine used to treat pain, fever and inflammation or to prevent the formation of blood clots (thrombi);
• other medicines used to treat high blood pressure (e.g.: vasodilators, angiotensin converting enzyme inhibitors and diuretics);
• disopyramide, a medicine used to prevent and treat some heart rhythm disorders. Do not take disopyramide within 48 hours before or 24 hours after administration of VERAPAMIL EG;
• lithium, a medicine used to treat some mental disorders;
• aliskiren, a medicine used to treat high blood pressure.

Avoid taking VERAPAMIL EG if you are taking:

• colchicine, a medicine used to prevent and treat an inflammation of the joints (gouty arthritis);
• ivabradine, used to treat some heart problems (angina pectoris, chronic heart failure);
• dantrolene (infusion), a medicine used to treat a muscle problem called malignant hyperthermia.

VERAPAMIL EG with drinks and alcohol
Avoid consuming grapefruit juice and alcoholic beverages during treatment with this
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant unless absolutely necessary and under direct
medical supervision.
Do not take this medicine if you are breastfeeding as verapamil passes into breast milk.
If you have to take this medicine, you must stop breastfeeding as serious side effects may occur in the baby.

Driving and using machines
This medicine can impair your ability to drive or operate machinery, especially
at the beginning of treatment, when the dose is increased, if your doctor changes your therapy (switching
from other medicines to VERAPAMIL EG) or if you are drinking alcohol.

VERAPAMIL EG contains lactose
This medicine contains lactose, a type of sugar. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

3. How to take VERAPAMIL EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet in the morning and 1 tablet in the evening (240 mg/day) in the treatment of heart circulation disorders (moderate severity coronary insufficiency) and for the
prevention of heart rhythm disorders (tachycardic disorders).
If necessary, this dose may be increased to 2 tablets 2 times a day (480 mg/day).

If you take more VERAPAMIL EG than you should
Symptoms of overdose may include decreased blood pressure (hypotension),
decreased heart rate (bradycardia) up to blockage of heart activity (high-degree AV block and sinus arrest), high blood sugar levels (hyperglycemia), feeling of
fatigue and loss of interest (apathy), increased blood acidity (metabolic acidosis). Following the intake of very high doses (overdose), death has occurred.
In case of accidental ingestion/intake of an excessive dose of VERAPAMIL EG, immediately inform your doctor or go to the nearest hospital.

If you forget to take VERAPAMIL EG
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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 following side effects may occur:

Common(may affect up to 1 in 10 people)

• dizziness, headache;
• slow heartbeat (bradycardia);
• low blood pressure (hypotension);
• feeling of warmth (hot flushes);
• constipation;
• nausea;
• swelling of the legs and arms due to fluid retention (peripheral edema);

Uncommon(may affect up to 1 in 100 people)

• increased awareness of heartbeats (palpitations);
• increased heart rate (tachycardia);
• abdominal pain;
• fatigue. Rare(may affect up to 1 in 1,000)
• feeling of pins and needles in the arms and legs (paresthesia);
• tremor;
• drowsiness;
• perception of ringing in the ear (tinnitus);
• vomiting;
• increased sweating (hyperhidrosis).

Frequency not known(the frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity);
• convulsions;
• increased potassium in the blood (hyperkalemia);
• movement disorders (extrapyramidal disorders);
• paralysis (tetraparesis) when verapamil has been taken at the same time as colchicine (see section “Other medicines and VERAPAMIL EG”);
• vertigo;
• serious heart problems (atrioventricular block, sinus bradycardia, sinus arrest, heart failure, asystole);
• difficulty breathing (bronchospasm and dyspnea);
• serious problems with the intestine (ileus);
• swelling of the gums (gingival hyperplasia);
• discomfort in the abdomen;
• swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
• serious skin disorders (purpura, Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
• hair loss (alopecia);
• skin rashes (urticaria, rash), itching;
• muscle weakness, muscle pain (myalgia), joint pain (arthralgia);
• kidney problems (renal failure);
• sexual dysfunction (erectile dysfunction);
• growth of breast tissue in men (gynecomastia);
• milk secretion (galactorrhea);
• alteration of some blood tests performed to check liver function (increased liver enzymes), increased levels of a hormone (prolactin);
• alteration of blood sugar levels (impaired glucose tolerance);

In case of serious side effects such as a severe drop in blood pressure (severe hypotension) and serious problems with heart conduction (complete AV block), seek immediate medical attention, who will indicate appropriate therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store VERAPAMIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VERAPAMIL EG contains

• The active ingredient is verapamil hydrochloride. Each modified-release tablet contains 120 mg of verapamil hydrochloride.
• The other ingredients are: sodium alginate, povidone, lactose, magnesium stearate, Opadry Orange (talc, titanium dioxide, polyvinyl alcohol, Peg 3350, Iron oxides and lakes).

Description of the appearance of VERAPAMIL EG and contents of the pack
Pack of 30 tablets.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano

Manufacturer
Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero (MO)

Verapamil EG 240 mg modified-release tablets

Verapamil hydrochloride

Generic Medicine
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What VERAPAMIL EG is and what it is used for
• 2. What you need to know before you take VERAPAMIL EG
• 3. How to take VERAPAMIL EG
• 4. Possible side effects
• 5. How to store VERAPAMIL EG
• 6. Contents of the pack and other information

1. What is VERAPAMIL EG and what is it used for?

VERAPAMIL EG contains the active ingredient verapamil hydrochloride, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists), which promote the relaxation
of the heart and blood vessels.
VERAPAMIL EG is indicated for the treatment of high blood pressure (mild to moderate arterial hypertension).

2. What you need to know before you take VERAPAMIL EG

Do not take VERAPAMIL EG

• if you are allergic to verapamil or any of the other ingredients of this medicine (listed in section 6);
• if you have a serious heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout your body;
• if you have recently had a heart attack and have experienced complications such as a severe slowing of the heartbeat (complicated myocardial infarction with marked bradycardia);
• if the function of your heart is reduced compared to normal (contractile dysfunction of the left ventricle, decompensated congestive heart failure);
• heart failure with a reduced ejection fraction of less than 35% and/or pulmonary pressure greater than 20 mm Hg (unless due to supraventricular tachycardia sensitive to verapamil therapy);
• if you have severe conduction disturbances and an irregular heartbeat (total AV block, partial AV block; incomplete bundle branch block, sinus node disease, except in patients with a ventricular pacemaker; II-III degree AV block, except in patients with a functioning ventricular pacemaker, wide complex ventricular tachycardia, atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome, short PR syndromes);

ventricular artificial pacemaker, wide complex ventricular tachycardia, atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine
syndrome, short PR syndromes);

• if you have a very slow heartbeat (pronounced bradycardia with less than 50 beats/minute);
• if you have low blood pressure (hypotension with systolic pressure less than 90 mm Hg) (see section “Warnings and precautions”);
• if you are taking medicines used to treat depression (MAO inhibitors), or to treat heart problems (quinidine treatments) or to treat high blood pressure (beta-blockers) (see section “Other medicines and VERAPAMIL EG”);
• if you are taking a medicine containing ivabradine used to treat some heart problems. (see section “Other medicines and VERAPAMIL EG”);

Warnings and precautions
Talk to your doctor or pharmacist before taking VERAPAMIL EG.
Do not take VERAPAMIL EG if the function of your heart is severely reduced compared to
normal (severe left ventricular dysfunction). If you develop a mild form of this disorder, your
doctor may prescribe other medicines (digitalis and/or diuretics) before starting treatment with
this medicine.
During treatment with this medicine, you may experience:

• a decrease in blood pressure below normal levels, which can cause a feeling of dizziness or other symptoms related to low blood pressure (symptomatic hypotension);
• a transient increase in liver enzymes (transaminases) associated or not with an increase in other substances in the blood (alkaline phosphatase, bilirubin). Undergo periodic liver function tests during treatment with this medicine;
• a negative inotropic effect (decrease in the force of heart contraction): if you have heart failure, your doctor will need to decide on compensation and treat it with adequate therapy before starting verapamil.

Take VERAPAMIL EG with caution and tell your doctor if:

• you suffer from a particular heart disease called Wolff-Parkinson-White syndrome or if you have Lown-Ganong-Levine syndrome. In these cases, your condition may worsen (very rapid ventricular response or ventricular fibrillation);
• you suffer from heart diseases related to conduction problems as verapamil acts on the AV and SA nodes and prolongs AV conduction time: the development of a second or third degree AV block requires discontinuation of treatment and, if necessary, initiation of appropriate therapy;
• you have liver problems. In this case, your doctor will periodically check your heart function and may decide to change the dose (usually patients with severe liver problems are given a lower dose, 30% of the usual dose);
• you have kidney problems as this may affect your heart. Your doctor will check you periodically to verify your heart function;
• you have a very slow heartbeat (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL EG”);
• you have serious muscle problems (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

Children and adolescents
There are no data available to establish the safety and efficacy of modified-release verapamil tablets in children and adolescents, therefore the use of this medicine is not recommended
in children and adolescents.

Other medicines and VERAPAMIL EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. If you are taking other medicines, specific checks may be necessary.
Take this medicine with caution and tell your doctor if you are taking the following medicines:

• alpha-blockers, medicines used to treat high blood pressure and to help eliminate urine in patients with an enlarged prostate called “benign prostatic hyperplasia” (terazosin, prazosin);
• medicines used to treat heart rhythm disorders (quinidine, flecainide, dronedarone);
• theophylline, a medicine used to treat asthma;
• dabigatran etexilate and sulfinpyrazone, medicines used to prevent blood clot formation (thrombi);
• carbamazepine and phenytoin, medicines used to treat epilepsy (anticonvulsants);
• imipramine, a medicine used to treat depression;
• gliburide, a medicine used to treat diabetes;
• medicines used to treat infections caused by bacteria (clarithromycin, erythromycin, rifampicin, telithromycin);
• doxorubicin, a medicine used to treat some types of cancer;
• phenobarbital, a medicine used to induce anesthesia and to treat epilepsy;
• medicines used to treat anxiety and to promote sleep (buspirone, midazolam);
• beta-blockers (metoprolol, propranolol), medicines used to treat high blood pressure and some heart problems;
• digitalis (digitoxin, digoxin), medicines used to treat heart problems (heart failure) (see section “Warnings and precautions”);
• cimetidine, a medicine used to treat stomach and intestinal problems such as acidity or the presence of lesions (ulcers);
• medicines used following organ transplantation (cyclosporine, everolimus, sirolimus, tacrolimus);
• medicines used to lower high levels of fats in the blood (atorvastatin, lovastatin, simvastatin);
• almotriptan, a medicine used to treat migraine;
• St. John's wort, used to treat depression;
• medicines used to treat AIDS (anti-HIV agents);
• medicines used for anesthesia (neuromuscular blockers and inhalation anesthetics);
• acetylsalicylic acid, a medicine used to treat pain, fever and inflammation or to prevent blood clot formation (thrombi);
• other medicines used to treat high blood pressure (e.g. vasodilators, angiotensin converting enzyme inhibitors and diuretics);
• disopyramide, a medicine used to prevent and treat some heart rhythm disorders. Do not take disopyramide within the 48 hours before or 24 hours after administration of VERAPAMIL EG;
• lithium, a medicine used to treat some mental disorders;
• aliskiren, a medicine used to treat high blood pressure.

Avoid taking VERAPAMIL EG if you are taking:

• colchicine, a medicine used to prevent and treat inflammation of the joints (gouty arthritis);
• ivabradine, used to treat some heart problems (angina pectoris, chronic heart failure);
• dantrolene (infusion), a medicine used to treat a muscle problem called malignant hyperthermia.

VERAPAMIL EG with drinks and alcohol
Avoid consuming grapefruit juice and alcoholic beverages during treatment with this
medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant unless absolutely necessary and under direct
medical supervision.
Do not take this medicine if you are breastfeeding as verapamil passes into breast milk.
If you have to take this medicine, you must stop breastfeeding as serious side effects may occur in the baby.

Driving and using machines
This medicine can impair your ability to drive vehicles or operate machinery, especially
at the beginning of treatment, when the dose is increased, if your doctor changes your therapy (switching
from other medicines to VERAPAMIL EG) or if you are drinking alcohol.

VERAPAMIL EG contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with
lactose intolerance, contact him before taking this medicine.

3. How to take VERAPAMIL EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose of VERAPAMIL EG 240 mg tablets must be adjusted to the individual patient. The effects
of the blood pressure lowering of this medicine are evident within the first
week of treatment.
The recommended daily dose is 1 tablet (240 mg) in the morning on a full stomach.
The doctor may reduce the initial dose to 120 mg per day, to be taken in the morning, for example if you are
an elderly person or of small stature.
The doctor may subsequently increase the dose as follows:

• one tablet (240 mg) every morning, plus one tablet of VERAPAMIL EG 120 mg tablets (120 mg) every evening;
• one tablet (240 mg) every 12 hours.

If you take more VERAPAMIL EG than you should
The symptoms of overdose may be decreased blood pressure (hypotension),
decreased heart rate (bradycardia) up to blockage of heart activity (high-degree AV block and sinus arrest), high blood sugar levels (hyperglycemia), feeling of
tiredness and loss of interest (apathy), increased blood acidity (metabolic acidosis). In
following the intake of very high doses (overdose) death has occurred.
In case of accidental ingestion/intake of an excessive dose of VERAPAMIL EG, immediately inform
your doctor or go to the nearest hospital.

If you forget to take VERAPAMIL EG
Do not take a double dose to make up for the missed tablet.
If you have any doubts 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 following side effects may occur:

Common(may affect up to 1 in 10 people)

• dizziness, headache;
• slow heartbeat (bradycardia);
• low blood pressure (hypotension);
• feeling of warmth (hot flushes);
• constipation;
• nausea;
• swelling of the legs and arms due to fluid retention (peripheral edema);

Uncommon(may affect up to 1 in 100 people)

• increased awareness of heartbeats (palpitations);
• increased heart rate (tachycardia);
• abdominal pain;
• fatigue. Rare(may affect up to 1 in 1,000)
• sensation of tingling in the arms and legs (paresthesia);
• tremor;
• drowsiness;
• perception of ringing in the ear (tinnitus);
• vomiting;
• increased sweating (hyperhidrosis).

Frequency not known(the frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity);
• convulsions;
• increased potassium in the blood (hyperkalemia);
• movement disorders (extrapyramidal disorders);
• paralysis (tetraparesis) when verapamil has been taken at the same time as colchicine (see section “Other medicines and VERAPAMIL EG”);
• vertigo;
• serious heart problems (atrioventricular block, sinus bradycardia, sinus arrest, heart failure, asystole);
• difficulty breathing (bronchospasm and dyspnea);
• serious problems with the intestines (ileus);
• swelling of the gums (gingival hyperplasia);
• discomfort in the abdomen;
• swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
• serious skin disorders (purpura, Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
• hair loss (alopecia);
• skin rashes (urticaria, rash), itching;
• muscle weakness, muscle pain (myalgia), joint pain (arthralgia);
• kidney problems (renal failure);
• sexual dysfunction (erectile dysfunction);
• growth of breast tissue in men (gynecomastia);
• milk secretion (galactorrhea);
• alteration of some blood tests performed to check liver function (increased liver enzymes), increased levels of a hormone (prolactin);
• alteration of blood sugar levels (impaired glucose tolerance);

In case of serious side effects such as a severe drop in blood pressure (severe hypotension) and serious problems with heart conduction (complete AV block), seek immediate medical attention, who will indicate appropriate therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store VERAPAMIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

VERAPAMIL EG 240 mg modified-release tablets

• The active ingredient is verapamil hydrochloride. Each modified-release tablet contains 240 mg of verapamil hydrochloride.
• The other ingredients are: sodium alginate, povidone, lactose, magnesium stearate, Opadry Green (talc, titanium dioxide, polyvinyl alcohol, Peg 3350, Iron oxides and lakes).

Description of the appearance of VERAPAMIL EG and contents of the pack
Pack of 30 tablets.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano

Manufacturer
Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero (MO)