Verapamil Doc Generici: detailed information

Package leaflet: Information for the patient

VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules, 240 mg prolonged-release hard capsules

Generic Medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What VERAPAMIL DOC Generici is and what it is used for
What you need to know before taking VERAPAMIL DOC Generici
How to take VERAPAMIL DOC Generici
Possible side effects
How to store VERAPAMIL DOC Generici
Contents of the pack and other information

1. What VERAPAMIL DOC Generici is and what it is used for

VERAPAMIL DOC Generici contains the active substance verapamil hydrochloride, which belongs to a
group of medicines called calcium channel blockers (calcium antagonists), which help relax the
heart and blood vessels.
VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules is indicated for the treatment of:

heart problems due to reduced blood supply (chronic coronary insufficiency);
abnormal heart rhythm disorders (supraventricular tachyarrhythmias 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 a treatment following a heart attack (myocardial infarction) and
for the prevention of a further heart attack when no symptoms are present and when other medicines
(beta-blockers) cannot be used.
VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules is indicated for the treatment of:

high blood pressure (mild to moderate arterial hypertension).

2. What you should know before taking VERAPAMIL DOC Generici

Do not take VERAPAMIL DOC Generici

if you are allergic to verapamil or to any of the other ingredients of this medicine (listed in section 6);
if you have a serious heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body;
if you recently had a heart attack and developed complications such as a markedly reduced heart rate (myocardial infarction complicated by marked bradycardia);
if your heart function is reduced below normal (left ventricular contractile dysfunction (see also section “Warnings and precautions”), decompensated congestive heart failure);
if you have severe conduction disorders and an irregular heartbeat (complete AV block, partial AV block; incomplete bundle branch block, sinoatrial node disease, except in patients with a functioning artificial ventricular pacemaker; second- or third-degree AV block, except in patients with a functioning artificial ventricular pacemaker, wide-complex ventricular tachycardia, atrial fibrillation/flutter with concomitant Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome, or short PR syndromes);
if you have a very slow heartbeat (marked bradycardia with less than 50 beats/minute);
if you have low blood pressure (hypotension with systolic pressure below 90 mm Hg) (see section “Warnings and precautions”);
if you are taking medicines used to treat depression (MAO inhibitors), or for heart conditions (quinidine-type treatments), or for high blood pressure (beta-blockers) (see section “Other medicines and VERAPAMIL DOC Generici”);
if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions.

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

a drop in blood pressure below normal levels, which may cause dizziness or other symptoms related to low blood pressure (symptomatic hypotension);
a temporary increase in liver enzymes (transaminases), with or without an increase in levels of other substances in the blood (alkaline phosphatase, bilirubin). You should undergo periodic liver function tests during treatment with this medicine;
heart problems (asymptomatic first-degree atrioventricular block, transient bradycardia, sometimes accompanied by nodal escape rhythms). If you experience heart-related symptoms, consult your doctor, as it may be necessary to reduce the dose or discontinue verapamil treatment, or initiate appropriate therapy (see section “Possible side effects”).

Take VERAPAMIL DOC Generici with caution and inform your doctor if:

you have a specific heart condition called Wolff-Parkinson-White syndrome or Lown-Ganong-Levine syndrome. In these cases, your condition may worsen (very rapid ventricular response or ventricular fibrillation);
you have liver problems. In this case, your doctor will periodically monitor your heart function and may decide to adjust the dose (generally, patients with severe liver problems receive a lower dose, about 30% of the usual dose);
you have kidney problems, as this may affect your heart. Your doctor will monitor you periodically to assess your heart function;
you have a very slow heartbeat (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL DOC Generici”);
you have severe muscle disorders (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

Children and adolescents
There are no data available on the safety and efficacy of verapamil prolonged-release hard capsules in children and adolescents; therefore, the use of this medicine is not recommended in children and adolescents.
Other medicines and VERAPAMIL DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Specific monitoring may be required if you are taking other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

alpha-blockers, medicines used to treat high blood pressure and to help urination in patients with an enlarged prostate (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 clots (thrombi);
carbamazepine, a medicine used to treat epilepsy (anticonvulsant);
imipramine, a medicine used to treat depression;
gliburide, a medicine used to treat diabetes;
medicines used to treat bacterial infections (clarithromycin, erythromycin, rifampicin, telithromycin);
doxorubicin, a medicine used to treat certain types of cancer;
phenobarbital, a medicine used to induce anesthesia and to treat epilepsy;
medicines used to treat anxiety and promote sleep (buspirone, midazolam);
beta-blockers (metoprolol, propranolol), medicines used to treat high blood pressure and certain heart conditions;
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 ulcers;
medicines used after organ transplantation (cyclosporine, everolimus, sirolimus, tacrolimus);
medicines used to lower high blood lipid levels (atorvastatin, lovastatin, simvastatin);
almotriptan, a medicine used to treat migraine;
St. John’s wort (hypericum), used to treat depression;
medicines used to treat HIV (anti-HIV agents, such as ritonavir);
medicines used for anesthesia (neuromuscular blockers and inhaled anesthetics);
acetylsalicylic acid, a medicine used to treat pain, fever, and inflammation or to prevent 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 certain heart rhythm disorders. Do not take disopyramide within 48 hours before or 24 hours after administration of VERAPAMIL DOC Generici;
lithium, a medicine used to treat certain mental disorders;
aliskiren, a medicine used to treat high blood pressure.

Verapamil may reduce the hypoglycemic effect of metformin.

Avoid taking VERAPAMIL DOC Generici if you are taking:

colchicine, a medicine used to prevent and treat joint inflammation (gouty arthritis);
ivabradine, used to treat certain heart conditions (angina pectoris, chronic heart failure);
dantrolene (infusion), a medicine used to treat a muscle disorder called malignant hyperthermia.

VERAPAMIL DOC Generici with grapefruit juice and alcohol
Avoid consuming grapefruit juice and alcoholic beverages during treatment with this
medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under direct medical supervision,
as the safety of this medicine during pregnancy has not been established.
Do not take this medicine while breastfeeding, as verapamil passes into breast milk.
If you need to take this medicine, breastfeeding must be discontinued, as serious adverse effects may occur in the infant.
Driving and using machines
This medicine may impair your ability to drive or operate machinery, especially
at the beginning of treatment, when the dose is increased, when your doctor changes your therapy (switching
from other medicines to VERAPAMIL DOC Generici), or if you consume alcohol.
VERAPAMIL DOC Generici contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take VERAPAMIL DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Treatment of heart circulation disorders (moderate severity coronary insufficiency) and
prevention of heart rhythm disorders (tachyarrhythmias)
VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules
The recommended dose is 1 capsule in the morning and 1 capsule in the evening (240 mg/day).
If necessary, this dose may be increased to 2 capsules twice daily (480 mg/day).
VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules
The dose of VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules must be
individually adjusted by the doctor through gradual increases. The blood pressure-lowering effects of
this medicine become evident within the first week of treatment.
The recommended daily dose is 1 capsule (240 mg) in the morning with food.
Your doctor may reduce the initial dose to 120 mg daily, taken in the morning, for example if you are
elderly or of small body size.
Your doctor may subsequently increase the dose as follows:

one capsule (240 mg) every morning, plus one capsule of VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules (120 mg) every evening;
one capsule (240 mg) every 12 hours.

If you take more VERAPAMIL DOC Generici than you should
Symptoms of overdose may include low blood pressure (hypotension),
reduced heart rate (bradycardia) up to complete heart block (high-grade AV block and sinus arrest),
elevated blood sugar levels (hyperglycaemia), feeling of fatigue and loss of interest (apathy), increased
blood acidity (metabolic acidosis). Death has occurred following ingestion of very high doses (overdose).
In case of accidental ingestion of an excessive dose of VERAPAMIL DOC Generici,
contact your doctor immediately or go to the nearest hospital.
If you forget to take VERAPAMIL DOC Generici
Do not take a double dose to make up for the missed capsule.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

dizziness, headache;
heart problems (heart failure/pulmonary edema);
slow heart rate (bradycardia);
disturbances in the heart's electrical conduction (atrioventricular block);
low blood pressure (hypotension);
constipation;
nausea;
swelling due to fluid accumulation (edema);
fatigue. Uncommon (may affect up to 1 in 100 people)
severe disturbances in the heart's electrical conduction (complete atrioventricular block);
sensation of warmth (hot flushes).

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

bruising (ecchymoses);
allergic reactions (hypersensitivity);
mental disturbances;
headache, dizziness;
tingling sensation in arms and legs (paraesthesia);
tremor;
movement disorders (extrapyramidal disorders);
disturbances in blood circulation to the brain (cerebrovascular accidents);
confusion;
balance disorders;
insomnia, drowsiness;
visual disturbances (blurred vision);
vertigo;
perception of ringing in the ears (tinnitus);
serious heart problems (atrioventricular block, sinus bradycardia, sinus arrest, heart failure, angina pectoris, myocardial infarction, chest pain);
swelling of arms and legs due to fluid accumulation (peripheral edema);
increased heart rate (tachycardia);
increased awareness of heartbeat (palpitations);
temporary loss of consciousness (syncope);
low blood pressure (hypotension);
sensation of warmth (hot flushes);
difficulty in walking (intermittent claudication);
severe skin problems (purpura);
difficulty breathing (dyspnea);
nausea, vomiting, constipation;
intestinal obstruction (a condition called ileus);
gum swelling (gingival hyperplasia);
abdominal pain;
diarrhea;
dry mouth;
stomach and intestinal disturbances;
swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
severe skin disorders (Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
hair loss (alopecia);
skin eruptions (urticaria, rash, exanthema), itching;
thickening of the skin (hyperkeratosis);
skin spots (patches), spontaneous bruising (without bumping);
increased sweating (hyperhidrosis);
muscle weakness, muscle pain (myalgia), joint pain (arthralgia), involuntary muscle contractions (spasms);
frequent passage of small amounts of urine (pollakiuria);
sexual dysfunction (erectile dysfunction);
breast enlargement in men (gynecomastia);
milk secretion (galactorrhea);
heavy bleeding between two menstrual periods (metrorrhagia);
fatigue;
changes in certain blood tests performed to monitor liver function (increased liver enzymes), increased levels of a hormone (prolactin);
changes in blood sugar levels (impaired glucose tolerance);
paralysis (tetraparesis) when verapamil is taken concomitantly with colchicine (see section "Other medicines and VERAPAMIL DOC Generici").

If you experience serious side effects such as a severe drop in blood pressure (severe hypotension) or serious disturbances in the heart's electrical conduction (complete AV block), contact your doctor immediately. He or she will advise you on appropriate treatment.
Reporting of side effects
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 via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VERAPAMIL DOC generici

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.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VERAPAMIL DOC Generici contains
VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules

The active substance is verapamil hydrochloride. Each prolonged-release hard capsule contains 120 mg of verapamil hydrochloride.
The other components are: sucrose and maize starch microgranules, shellac, Eudragit L 100 (copolymer of methacrylic acid and methyl methacrylate), Eudragit L 30 D (copolymer of ethyl acrylate and methacrylic acid), Eudragit NE 30 D (copolymer of ethyl acrylate and methyl methacrylate), talc, diethyl phthalate. Capsule composition: gelatin, titanium dioxide.

VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules

The active substance is verapamil hydrochloride. Each prolonged-release hard capsule contains 240 mg of verapamil hydrochloride.
The other components are: sucrose and maize starch microgranules, shellac, Eudragit L 100 (copolymer of methacrylic acid and methyl methacrylate), Eudragit L 30 D (copolymer of ethyl acrylate and methacrylic acid), Eudragit NE 30 D (copolymer of ethyl acrylate and methyl methacrylate), talc, diethyl phthalate. Capsule composition: gelatin, titanium dioxide.

Description of the appearance of VERAPAMIL DOC Generici and contents of the pack
VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules
Pack containing 30 prolonged-release hard capsules in PVC/Al blisters.
VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules
Pack containing 30 prolonged-release hard capsules in PVC/Al blisters.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan, Italy.
Manufacturer
Ethypharm SA - Zone Industrielle de Saint-Arnoult - 28170 Châteauneuf-en-Thymerais - France.
Francia Farmaceutici S.r.l. - Via dei Pestagalli 7 - 20138 Milan, Italy.
Lamp San Prospero S.p.A. – Via della Pace 25/A – 41030 San Prospero S.S. (MO), Italy.