Package leaflet

ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets

Generic medicine
COMPOSITION
Each tablet contains:
Active substance: isosorbide-5-mononitrate 60 mg;
Excipients: purified stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, purified silica, talc, titanium dioxide, polyethylene glycol 4000, iron oxide.
PHARMACEUTICAL FORM AND CONTENT
Prolonged-release oral tablets.
Pack sizes
Box containing 30 tablets.
THERAPEUTIC CATEGORY
Organic nitrate with vasodilating action, indicated in cardiac conditions.
MARKETING AUTHORISATION HOLDER
DOC Generici Srl
Via Turati 40
20121 MILAN
MANUFACTURED BY:

VALPHARMA S.p.A. - Via Ranco, 112 - 47899 Serravalle - REPUBLIC OF SAN MARINO
VALPHARMA INTERNATIONAL S.p.A. - Via G. Morgagni, 2 - PENNABILLI (PU)

PACKAGED AND CONTROLLED BY:
LAMP S. PROSPERO S.p.A. – Via della Pace, 25/A - S. Prospero S/Secchia (Modena)
THERAPEUTIC INDICATIONS
Maintenance therapy of coronary insufficiency, prevention of angina pectoris attacks.
Post-myocardial infarction treatment and maintenance therapy of chronic myocardial insufficiency, also in combination with cardiotonics and diuretics. Due to its pharmacological profile, ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets is not suitable for the management of acute angina episodes.
CONTRAINDICATIONS
Proven hypersensitivity to the components or to substances closely related thereto from a chemical standpoint. Sildenafil enhances the hypotensive effects of nitrates; therefore, its co-administration with organic nitrates is contraindicated (see section "Interactions").
PRECAUTIONS FOR USE
Tolerance to the drug and cross-tolerance with other nitroderivatives may occur.
Use with caution in patients with glaucoma.
Pregnancy and Lactation
For precautionary reasons, the use of ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets during pregnancy and breastfeeding should be undertaken only when clearly needed and under direct medical supervision.
INTERACTIONS
Concomitant alcohol intake may enhance the hypotensive effect or affect the patient's reaction capacity, particularly in drivers of vehicles and operators of machinery requiring special attention.
When antihypertensive agents are administered concomitantly with high doses of ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets, an enhanced hypotensive effect may be observed.
Co-administration of sildenafil enhances the hypotensive effect of organic nitrates (see section "Contraindications").
SPECIAL WARNINGS
The product must not be used in cases of: acute myocardial infarction, acute circulatory failure (shock, circulatory collapse), severe arterial hypotension.
This medicine is not contraindicated in patients with celiac disease.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Unless otherwise prescribed by the physician, the following dosage is recommended for prolonged therapy: one tablet in the morning.
The tablets should be taken after meals, without chewing, with some liquid.
The tablet may be divided into three parts. In patients with particular sensitivity, the occurrence of headache or arterial hypotension may be avoided by initiating treatment with ⅓ of a tablet (20 mg) or ⅔ of a tablet (40 mg), progressively increasing the dose.
Patients whose anginal symptoms are predominantly present during the morning hours may take ⅔ of a tablet (40 mg) in the morning and ⅓ (20 mg) in the evening.
UNDESIRABLE EFFECTS
With the recommended dosage, no particularly severe adverse effects have been reported so far.
As with all nitroderivatives, cutaneous vasodilation may occur during treatment with ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets, resulting in flushing, headache of variable intensity and duration, transient episodes of dizziness and asthenia, hypotension, nausea and vomiting.
In patients with vascular lability, symptoms of circulatory collapse may appear upon first administration of ISOSORBIDE MONONITRATE DOC Generics 60 mg prolonged-release tablets. These manifestations, as well as headache, may be eliminated or reduced by initiating treatment with ⅓ of a tablet (20 mg) or ⅔ of a tablet (40 mg).
If other adverse effects occur during treatment (e.g. erythematous eruptions and/or exfoliative dermatitis), the physician should be consulted.
Following the instructions contained in this leaflet reduces the risk of adverse effects.
It is important to inform your doctor or pharmacist of any adverse effect occurring, even if not described in this leaflet.
EXPIRY DATE AND STORAGE
See the expiry date stated on the packaging.
WARNING: do not use the medicine after the expiry date stated on the packaging. This date refers to the product stored in its original, undamaged packaging under appropriate storage conditions.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
December 2012

INSTRUCTIONS FOR USE

ISOSORBIDE MONONITRATE DOC Generici 50 mg modified-release hard capsules

modified release
Equivalent medicinal product
COMPOSITION
Each capsule contains:
Active substance:
isosorbide-5-mononitrate 50 mg
Excipients:
neutral starch and sucrose microgranules, sucrose, maize starch, shellac, ethylcellulose,
talc, povidone.
Capsule shell components:
gelatin, titanium dioxide (E 171), erythrosine (E 127), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).
PHARMACEUTICAL FORM AND CONTENT
Modified-release hard oral capsules, pack containing 30 capsules.
PHARMACOTHERAPEUTIC CATEGORY
Vasodilators used in cardiac diseases.
MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40 - 20121 Milan
MANUFACTURED BY:
Aptalis Pharma S.r.l. - Via Marche, 9 - S. Giuliano Milanese (MI)
Aptalis Pharma S.r.l. - Via Martin Luther King, 13 - Pessano con Bornago (MI)
PACKAGED AND CONTROLLED BY:
MIPHARM S.p.A. - Via B. Quaranta, 12 - Milan
THERAPEUTIC INDICATIONS
Maintenance therapy of coronary insufficiency, prevention of angina pectoris attacks.
Post-myocardial infarction treatment and maintenance therapy of chronic myocardial insufficiency,
also in combination with cardiotonics and diuretics. Due to its pharmacological profile, ISOSORBIDE
MONONITRATE DOC Generici is not suitable for the control of acute angina episodes.
CONTRAINDICATIONS
Proven individual hypersensitivity to isosorbide, either mononitrate or dinitrate, or to any of the other
components of the medicine and substances closely related from a chemical standpoint. The product
must not be administered in cases of acute myocardial infarction, acute circulatory failure (shock, circulatory collapse), or severe arterial hypotension.
Sildenafil potentiates the hypotensive effects of nitrates; therefore, its concomitant administration with organic nitrates is contraindicated (see section “Interactions”).
Generally contraindicated during pregnancy and breastfeeding (see “Special warnings”).
PRECAUTIONS FOR USE
Use with caution in patients with glaucoma. In cases of arterial hypotension, the product should be
administered only under medical prescription.
INTERACTIONS
Concomitant alcohol intake may enhance the hypotensive effect, as may concomitant administration of antihypertensive agents with high doses of ISOSORBIDE
MONONITRATE DOC Generici. The drug may act as an antagonist of noradrenaline,
acetylcholine, histamine and other substances.
Concomitant administration of sildenafil enhances the hypotensive effect of organic nitrates (see section “Contraindications”).
SPECIAL WARNINGS
Tolerance to this product and to other nitro-derivatives may develop.
Keep the medicine out of the reach and sight of children.
Pregnancy and breastfeeding
This product should be administered to pregnant women and during breastfeeding only when clearly needed and under direct medical supervision.
Effects on ability to drive and use machines
Concomitant alcohol intake may enhance the hypotensive effect or reduce reaction capacity in drivers and machine operators requiring particular attention.
The medicine is not contraindicated for patients with celiac disease.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
Unless otherwise prescribed by a physician, the following dosage is recommended:
1 capsule of ISOSORBIDE MONONITRATE DOC Generici once daily in the morning, taken with a little liquid, without chewing.
In case of particular patient sensitivity, the onset of headache or arterial hypotension may be avoided by initiating treatment with half a tablet of ISOSORBIDE MONONITRATE DOC
Generici 20 mg in the morning and evening.
OVERDOSE
Cases of overdose are not known. If overdose occurs, induce vomiting and/or perform gastric lavage. Check whether the patient has ingested other drugs simultaneously and monitor hemodynamic parameters.
UNDESIRABLE EFFECTS
With the recommended dosage, no serious adverse effects have been reported so far.
As with all nitro-derivatives, treatment with ISOSORBIDE MONONITRATE DOC Generici may cause cutaneous vasodilation with flushing, headache of variable intensity and duration, transient episodes of dizziness and asthenia, hypotension, nausea, vomiting, agitation, pallor, sweating and collapse.
If one or more of the described adverse effects or others (e.g. erythematous eruptions and/or exfoliative dermatitis) occur during treatment, consult the physician. In patients with circulatory instability, symptoms of collapse may appear after the first dose.
Following the instructions in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of any adverse effect, even if not described in the package leaflet.
EXPIRY DATE AND STORAGE
WARNING: do not use the medicine after the expiry date stated on the packaging.
KEEP MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN
December 2012

PACKAGE LEAFLET

ISOSORBIDE MONONITRATE DOC Generici, 20 mg Tablets, 40 mg Tablets

Generic Medicinal Product
COMPOSITION
ISOSORBIDE MONONITRATE DOC Generici 20 mg tablets
Each tablet contains:
Active substance: isosorbide-5-mononitrate 20 mg
Excipients: lactose, talc, precipitated silica, maize starch, microcrystalline cellulose, aluminium stearate.

ISOSORBIDE MONONITRATE DOC Generici 40 mg tablets
Each tablet contains:
Active substance: isosorbide-5-mononitrate 40 mg
Excipients: lactose, talc, precipitated silica, maize starch, microcrystalline cellulose, aluminium stearate, colouring agent E 110.

PHARMACEUTICAL FORM AND CONTENT
Tablets – for oral use.
Box of 50 tablets 20 mg.
Box of 30 tablets 40 mg.

THERAPEUTIC CATEGORY
C01DA14 - Vasodilators used in cardiac diseases.
Isosorbide mononitrate exerts a vasodilating action capable of increasing coronary blood flow, thereby improving myocardial collateral circulation.

MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40 - 20121 Milan
MANUFACTURED AND CONTROLLED BY:
MIPHARM S.p.A. – Via B. Quaranta, 12 – 20141 Milan

THERAPEUTIC INDICATIONS
Maintenance therapy for coronary insufficiency, prevention of angina pectoris attacks.
Post-myocardial infarction treatment and chronic myocardial insufficiency, even in combination with cardiotonics and diuretics. Due to its pharmacological profile, the drug is not suitable for controlling acute angina episodes.

CONTRAINDICATIONS
Hypersensitivity to the components or substances closely related from a chemical standpoint.
The product must not be used in cases of hypertrophic cardiomyopathy, acute phase of myocardial infarction, acute circulatory failure (shock, circulatory collapse), severe arterial hypotension, marked anaemia, head trauma, cerebral haemorrhage, increased intraocular pressure (glaucoma), hyperthyroidism.
Sildenafil potentiates the hypotensive effects of nitrates; therefore, its co-administration with organic nitrates is contraindicated (see section “Interactions”).
Generally contraindicated during pregnancy and breastfeeding.

PRECAUTIONS FOR USE
Tolerance to the product and cross-tolerance with other nitroderivatives may occur.
An interval of 10–12 hours between doses may minimize this phenomenon.
In case of arterial hypotension, the drug should be administered only under medical supervision.
The product should be used with caution in patients with hypothyroidism, hypothermia, gastric hypermotility or malabsorption syndrome, malnutrition, and hepatic or renal disease.
Use with caution in elderly patients, as postural hypotension may occur.
Symptoms of hypotension may indicate overdose; in such cases, dosage should be promptly adjusted.
Do not use the medicine after the expiry date stated on the packaging.
In pregnant women and during breastfeeding, the product should be administered only when strictly necessary and under direct medical supervision.

INTERACTIONS
Concomitant intake of alcohol may enhance the hypotensive effect or affect patients' reaction capacity, particularly in drivers and operators of machinery requiring high attention.
When anti-hypertensive agents are administered concomitantly with high doses of this substance, an enhanced hypotensive effect may be observed.
Co-administration of sildenafil enhances the hypotensive effect of organic nitrates (see section “Contraindications”).

SPECIAL WARNINGS
Use with caution in patients affected by glaucoma. In case of arterial hypotension, administration should occur only under medical supervision.
Concomitant intake of alcohol may enhance the hypotensive effect or affect patients' reaction capacity, particularly in drivers and operators of machinery requiring high attention.
The medicine is not contraindicated for patients with celiac disease.

DOSAGE, METHOD AND TIME OF ADMINISTRATION
Unless otherwise prescribed by a physician, the following dosage is recommended for prolonged therapy:
ISOSORBIDE MONONITRATE DOC Generici 20 mg tablets
1 tablet three times daily.
Due to the good tolerability of the drug, the dose may be increased without risk to 2 tablets three times daily.

ISOSORBIDE MONONITRATE DOC Generici 40 mg tablets
1 tablet two to three times daily.
Dosage may be adjusted by the attending physician according to individual needs.
In patients with particular sensitivity, the occurrence of headache or arterial hypotension may be avoided by initiating treatment with half a 20 mg tablet in the morning and evening.
To divide the tablet, place it on a hard surface with the central groove facing downwards. Apply slight thumb pressure to break the tablet into two equal parts.
The tablets should be taken after meals, without chewing, with a small amount of liquid.

OVERDOSE
No cases of overdose with ISOSORBIDE MONONITRATE DOC Generici are known.
In the event of overdose, induction of vomiting and/or gastric lavage is recommended.
Check whether the patient has ingested other drugs simultaneously and monitor haemodynamic parameters in any case.

UNDESIRABLE EFFECTS
When the recommended dosage is followed, no serious adverse effects have been reported so far.
As with all nitroderivatives, during treatment with ISOSORBIDE MONONITRATE DOC Generici, cutaneous vasodilation may occur, causing flushing, headache of variable intensity and duration, transient episodes of dizziness and asthenia, hypotension, nausea, vomiting.
In patients with vascular lability, the first dose of ISOSORBIDE MONONITRATE DOC Generici may cause symptoms of cardiocirculatory collapse. These manifestations, as well as headache, can be eliminated or reduced by starting treatment with half a 20 mg tablet in the morning and evening.

Following the instructions contained in the package leaflet reduces the risk of
undesirable effects.
These adverse effects are generally transient. However, it is advisable to consult the
physician if they occur.
It is important to inform the physician of any adverse effects not described in the
package leaflet.

EXPIRY DATE AND STORAGE
See expiry date on the packaging.
The shelf life refers to the product kept in unopened original packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the packaging.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
December 2012