VERAPAMIL 120 mg Hard Capsules, Prolonged Release

Зміст інструкції

1. VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules, 240 mg prolonged-release hard capsules
   1. What is VERAPAMIL DOC Generici and what is it used for
   2. What you need to know before taking VERAPAMIL DOC Generici
   3. How to take VERAPAMIL DOC Generici
   4. Possible side effects
   5. How to store VERAPAMIL DOC generics
   6. Package contents and other information

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

Equivalent Medicine
Read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

VERAPAMIL DOC Generici 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 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 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 you have no symptoms and when other medicines cannot be used
(beta-blockers).
VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules is indicated for the treatment
of:

• high blood pressure (mild and moderate grade arterial hypertension).

2. What you need to know before taking VERAPAMIL DOC Generici

Do not take VERAPAMIL DOC Generici

• if you are allergic to verapamil or any of the other ingredients of this medicine (listed in section 6);
• if you have a severe 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 heartbeat (myocardial infarction complicated by marked bradycardia);
• if the function of your heart is reduced compared to normal (contractile dysfunction of the left ventricle (see also section “Warnings and precautions”), decompensated congestive heart failure);
• if you have severe conduction disorders 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 your heartbeat is very slow (pronounced 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 to treat heart problems (quinidine treatments) or to treat 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 the function of your heart is severely reduced
compared to normal (severe left ventricular dysfunction). If you experience a mild form of this
disorder, your doctor may prescribe you 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;
• heart problems (asymptomatic first-degree atrioventricular block, transient bradycardia, sometimes accompanied by nodal escape rhythms). If you experience heart problems, consult your doctor as it may be necessary to reduce the dose or stop treatment with verapamil or start appropriate therapy (see section “Possible side effects”).

Take VERAPAMIL DOC Generici 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 have liver problems. In this case, your doctor will periodically check the function of your heart and may decide to change the dose (generally patients with severe liver problems are given a lower dose, 30% of the usual dose);
• you have kidney problems, as this could affect your heart. Your doctor will check you periodically to verify the function of your heart;
• you have a very slow heartbeat (bradycardia) or low blood pressure (hypotension) (see section “Do not take VERAPAMIL DOC Generici”);
• you have severe 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 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
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 affected by 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, 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 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, propanolol), 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 problems with the stomach and intestines 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 HIV (anti-HIV agents, such as ritonavir);
• 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 afteradministration of VERAPAMIL DOC Generici;
• lithium, a medicine used to treat some 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 inflammation of the joints (gouty arthritis);
• ivabradine, used for the treatment of some heart problems (angina pectoris, chronic heart failure);
• dantrolene (infusion), a medicine used to treat a muscle problem called malignant hyperthermia.

VERAPAMIL DOC Generici 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, as the safety of this medicine during pregnancy has not been
established.
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 use machines, especially
at the beginning of treatment, when the dose is increased, if your doctor changes your therapy (switching
from other medicines to VERAPAMIL DOC Generici) or if you are taking alcohol.

VERAPAMIL DOC Generici contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with
an intolerance to some sugars, contact him before taking this medicine.

3. How to take VERAPAMIL DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Treatment of heart circulation disorders (moderate severity coronary insufficiency) and
for the prevention of heart rhythm disorders (tachycardic disorders)

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 2 times a day (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
adjusted by the doctor to the individual patient, by gradual increase. The effects of lowering
blood pressure with this medicine are evident within the first week of treatment.
The recommended daily dose is 1 capsule (240 mg) in the morning with food.
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 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
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 fatigue 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 DOC Generici
immediately inform your doctor 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 forgotten capsule.
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;
• heart problems (heart failure/pulmonary edema);
• slow heartbeat (bradycardia);
• heart conduction disturbances (atrioventricular block);
• low blood pressure (hypotension);
• constipation;
• nausea;
• swelling due to fluid retention (edema);
• fatigue. Uncommon(may affect up to 1 in 100 people)
• severe heart conduction disturbances (complete atrioventricular block);
• feeling of warmth (hot flushes).

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

• bruising (ecchymosis);
• allergic reactions (hypersensitivity);
• mental disorders;
• headache, dizziness;
• tingling sensation in the arms and legs (paresthesia);
• tremor;
• movement disorders (extrapyramidal disorders);
• blood circulation disorders in the brain (cerebrovascular accidents),
• confusion;
• balance disorders;
• insomnia, drowsiness;
• vision 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 the legs and arms due to fluid retention (peripheral edema);
• increased heart rate (tachycardia);
• increased awareness of heartbeats (palpitations);
• temporary loss of consciousness (syncope);
• low blood pressure (hypotension);
• feeling of warmth (hot flushes);
• difficulty walking (intermittent claudication);
• serious skin problems (purpura);
• difficulty breathing (dyspnea);
• nausea, vomiting, constipation;
• blockage of the intestine (a condition called ileus);
• swelling of the gums (gingival hyperplasia);
• abdominal pain;
• diarrhea;
• dry mouth;
• stomach and intestinal disorders;
• swelling of the face, extremities, lips, tongue, mouth and/or throat (angioedema);
• serious skin disorders (Stevens-Johnson syndrome, erythema multiforme, maculopapular rash);
• hair loss (alopecia);
• skin rashes (urticaria, rash, exanthem), itching;
• thickening of the skin (hyperkeratosis);
• skin spots (patches), spontaneous bruising (without injury);
• increased sweating (hyperhidrosis);
• muscle weakness, muscle pain (myalgia), joint pain (arthralgia), involuntary muscle contractions (spasms);
• frequent urination (pollakiuria);
• sexual dysfunction (erectile dysfunction);
• breast enlargement in men (gynecomastia);
• milk secretion (galactorrhea);
• heavy menstrual bleeding (metrorrhagia);
• fatigue;
• alteration of certain blood tests performed to check liver function (increased liver enzymes), increased levels of a hormone (prolactin);
• alteration of blood sugar levels (impaired glucose tolerance);
• paralysis (tetraparesis) when verapamil has been taken simultaneously with colchicine (see section “Other medicines and VERAPAMIL DOC Generici”).

In case of serious side effects such as a severe reduction in blood pressure (severe hypotension) and serious heart conduction problems (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 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 generics

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 at a temperature below 25°C.
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. Package contents and other information

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

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

VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules

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

Description of the appearance of VERAPAMIL DOC Generici and package contents
VERAPAMIL DOC Generici 120 mg prolonged-release hard capsules
Pack of 30 prolonged-release hard capsules in PVC/Al blisters.

VERAPAMIL DOC Generici 240 mg prolonged-release hard capsules
Pack of 30 prolonged-release hard capsules in PVC/Al blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan.

Manufacturer
Ethypharm SA - Zone Industrielle de Saint-Arnoult - 28170 Châteauneuf-en-Thymerais - France.
Francia Farmaceutici S.r.l. - Via dei Pestagalli 7 - 20138 Milan.
Lamp San Prospero S.p.A. – Via della Pace 25/A – 41030 San Prospero S.S. (MO).