ISOSORBIDE 20 mg Tabletka

Treść ulotki

1. ISOSORBIDE MONONITRATE DOC Generici 60 mg prolonged-release tablets
2. ISOSORBIDE MONONITRATE DOC Generici 50 mg hard capsules with
3. ISOSORBIDE MONONITRATE DOC Generici, 20 mg Tablets, 40 mg Tablets

ISOSORBIDE MONONITRATE DOC Generici 60 mg prolonged-release tablets

Generic medicine

COMPOSITION
Each tablet contains:

Active ingredient: isosorbide-5-mononitrate 60 mg;

Excipients:purified stearic acid, carnauba wax, hydroxypropylmethylcellulose, lactose, magnesium
stearate, purified silicon dioxide, talc, titanium dioxide, polyethylene glycol 4000, iron oxide.

PHARMACEUTICAL FORM AND CONTENT
Prolonged-release tablets, for oral use.

PACKAGING
Pack of 30 tablets.

PHARMACOTHERAPEUTIC CATEGORY
Organic nitrate with vasodilating action, indicated in cardiac conditions.

MARKETING AUTHORISATION HOLDER
DOC Generici Srl
Via Turati 40
20121 MILAN

PRODUCED 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 for coronary insufficiency, prevention of angina pectoris attacks.
Post-myocardial infarction treatment and maintenance therapy for chronic myocardial insufficiency
even in association with cardiotonics and diuretics. Due to its pharmacological profile, ISOSORBIDE

MONONITRATE DOC Generici 60 mg prolonged-release tabletsis not suitable for
controlling acute stenocardic episodes.

CONTRAINDICATIONS
Known individual hypersensitivity to the components or substances closely related from a
chemical point of view. Sildenafil potentiates the hypotensive effects of nitrates and, therefore, its co-
administration with organic nitrates is contraindicated (see paragraph “Interactions”).

PRECAUTIONS FOR USE
The development of tolerance to the drug and cross-tolerance with other
nitroderivatives is possible.
Use with caution in patients with glaucoma.

Pregnancy and Breastfeeding
As a precautionary measure, the use of ISOSORBIDE MONONITRATE DOC Generici 60 mg

prolonged-release tabletsduring pregnancy and breastfeeding should only be carried out in cases of
actual necessity and under the direct control of the doctor.

INTERACTIONS
The simultaneous intake of alcohol can potentiate the hypotensive effect or affect the ability to
react of patients, particularly drivers of vehicles and operators of machinery that
require particular attention.
In the case of concomitant administration of antihypertensives with high doses of ISOSORBIDE

MONONITRATE DOC Generici 60 mg prolonged-release tablets, a
potentiation of the hypotensive effect can be observed.
The co-administration of sildenafil potentiates the hypotensive effect of organic nitrates (see paragraph
“Contraindications”).

SPECIAL WARNINGS
The preparation must not be used in case of: acute myocardial infarction, acute circulatory insufficiency (shock, circulatory collapse), severe arterial hypotension.
The medicine is not contraindicated for subjects affected by celiac disease.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Unless otherwise prescribed by a doctor, the following dosage is recommended for prolonged therapies: one
tablet in the morning.
The tablets should be taken after meals, without chewing, with some liquid.
The tablet can be divided into three parts. In case of particular sensitivity of patients, it is
possible to avoid the appearance of headache or arterial hypotension, starting treatment with ⅓ of
tablet (20 mg) or ⅔ (40 mg) and gradually increasing the dosage.
Subjects in whom anginal symptoms are prevalent during the morning hours can
take one tablet (40 mg) in the morning and one tablet (20 mg) in the evening.

UNDESIRABLE EFFECTS
When adopting the recommended dosage, no side effects of particular severity have been known so far.
As with all nitroderivatives, cutaneous vasodilation can occur during treatment with ISOSORBIDE

MONONITRATE DOC Generici 60 mg prolonged-release tablets
with redness, headache of varying intensity and duration, transient episodes of dizziness and asthenia,
hypotension, nausea and vomiting.
In patients with vascular lability at the first intake of ISOSORBIDE MONONITRATE DOC

Generici 60 mg prolonged-release tablets, symptoms of circulatory collapse can occur.
These manifestations, as well as headache, can be eliminated or reduced by starting treatment with ⅓ of
tablet (20 mg) or ⅔ of tablet (40 mg).
If side effects of another kind occur during treatment (e.g. erythematous rashes
and/or exfoliative dermatitis), the treating doctor must be consulted.

undesirable.

It is important to inform the doctor or pharmacist of the appearance of any effect
EXPIRY DATE AND STORAGE
See the expiry date indicated on the packaging.

ATTENTION:do not use the medicine after the expiry date indicated on the packaging. This
date refers to the product in intact packaging, correctly stored.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN
December 2012

ISOSORBIDE MONONITRATE DOC Generici 50 mg hard capsules with

modified release
Generic medicine

COMPOSITION
Each capsule contains:

Active ingredient:
isosorbide-5-mononitrate 50 mg

Excipients:
neutral starch and sucrose microgranules, sucrose, corn starch, shellac, ethylcellulose,
talc, povidone.

Constituents of the shell:
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
Hard capsules with modified release, for oral use in packs of 30 capsules.

THERAPEUTIC CATEGORY
Vasodilators used in heart disease.

MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40 - 20121 Milan

PRODUCED 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 for coronary insufficiency, prevention of angina pectoris attacks.
Post-myocardial infarction treatment and maintenance therapy for chronic myocardial insufficiency
also in association with cardiotonics and diuretics. Due to its pharmacological profile, ISOSORBIDE
MONONITRATE DOC Generici is not suitable for controlling acute stenocardic episodes.

CONTRAINDICATIONS
Known individual hypersensitivity to isosorbide mono or dinitrate or to any other
components of the drug and chemically related substances. The preparation
should not be administered in cases of acute myocardial infarction, acute circulatory
insufficiency (shock, circulatory collapse), severe arterial hypotension.
Sildenafil potentiates the hypotensive effects of nitrates and, therefore, its co-administration with organic nitrates
is contraindicated (see paragraph “Interactions”).
Generally contraindicated in pregnancy and breastfeeding (see “Special warnings”).

PRECAUTIONS FOR USE
Use with caution in patients with glaucoma. In case of arterial hypotension, the preparation must
be administered only on a doctor's prescription.

INTERACTIONS
The simultaneous intake of alcohol can potentiate the hypotensive effect as well as in the case of
simultaneous administration of antihypertensives with high doses of ISOSORBIDE
MONONITRATE DOC Generici. The drug can act as an antagonist of norepinephrine,
acetylcholine, histamine and other substances.
The co-administration of sildenafil potentiates the hypotensive effect of organic nitrates (see paragraph
“Contraindications”).

SPECIAL WARNINGS
Tolerance to the preparation and cross-tolerance with other nitroderivatives may occur.
Keep the medicine out of the reach and sight of children.
Pregnancy and breastfeeding
In pregnant women and during breastfeeding, the product should only be administered in cases
of actual necessity, under the direct control of a doctor.
Effects on ability to drive and operate machinery
The simultaneous intake of alcohol can potentiate the hypotensive effect or decrease the ability to
react in drivers of vehicles and operators of machinery requiring particular attention.
The medicine is not contraindicated for subjects with celiac disease.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Unless otherwise prescribed by a doctor, the following dosage is recommended:
1 capsule of ISOSORBIDE MONONITRATE DOC Generici once a day, in the morning, to
be swallowed with some liquid, without chewing.
In case of particular sensitivity of patients, it is possible to avoid the onset of headaches or arterial hypotension
by starting 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 this should happen, it is advisable to induce
vomiting and/or perform gastric lavage. Check if the patient has simultaneously ingested
other drugs and in any case monitor haemodynamic parameters.

UNDESIRABLE EFFECTS
When using the recommended dosage, no side effects of particular severity have been known so far.
As with all nitroderivatives, cutaneous vasodilation with redness, headache of varying intensity and
duration, transient episodes of dizziness and asthenia, hypotension, nausea, vomiting,
agitation, pallor, sweating and collapse may occur during treatment with ISOSORBIDE
MONONITRATE DOC Generici.
If one or more of the described side effects or of another kind (e.g.
erythematous eruptions and/or exfoliative dermatitis) occur during treatment, the treating doctor should be consulted. Symptoms of collapse may occur with the first
administration in patients with circulatory lability.

undesirable.
It is important to inform your doctor or pharmacist of the occurrence of any effect
EXPIRY AND STORAGE
WARNING:do not use the medicine after the expiry date indicated on the packaging.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN
December 2012

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

Equivalent Medicinal Product

COMPOSITION

ISOSORBIDE MONONITRATE DOC Generici 20 mg tablets
Each tablet contains:

Active ingredient:isosorbide-5-mononitrate 20 mg

Excipients:lactose, talc, precipitated silica, corn starch, microcrystalline cellulose, aluminium
stearate.

ISOSORBIDE MONONITRATE DOC Generici 40 mg tablets
Each tablet contains:

Active ingredient:isosorbide-5-mononitrate 40 mg

Excipients:lactose, talc, precipitated silica, corn starch, microcrystalline cellulose, aluminium
stearate, colourant E 110.

PHARMACEUTICAL FORM AND CONTENT
Tablets - oral use.
Pack of 50 tablets 20 mg.
Pack of 30 tablets 40 mg.

PHARMACOTHERAPEUTIC CATEGORY
C01DA14 - Vasodilators used in heart disease.
Isosorbide mononitrate exerts a vasodilating action capable of increasing coronary blood flow
resulting in improved myocardial collateral circulation.

MARKETING AUTHORISATION HOLDER
DOC Generici Srl - Via Turati 40 - 20121 Milan

PRODUCED 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, also in association with
cardiotonic and diuretic drugs. Due to its pharmacological profile, the drug is not suitable for controlling
acute stenocardic episodes.

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

PRECAUTIONS FOR USE
The development of habituation to the preparation and cross-habituation with other nitroderivatives is possible.
An interval of 10-12 hours between one administration and the next can minimize this phenomenon.
In case of arterial hypotension, it should be administered only under medical supervision.
The preparation should be used with caution in patients with hypothyroidism, hypothermia, gastric hypermotility
or malabsorption syndrome, malnutrition, liver and kidney diseases.
Use with caution in the elderly because postural hypotension may occur.
Symptoms of hypotension may indicate overdose; in these cases, the dosage should be
promptly adjusted.
Do not use the drug beyond the expiry date indicated on the packaging.
In pregnant and breastfeeding women, the product should only be administered in cases of
real necessity, under the direct control of the doctor.

INTERACTIONS
The simultaneous intake of alcohol can potentiate the hypotensive effect or affect the ability to
react of patients, particularly drivers of vehicles and operators of machinery that
require particular attention.
In the case of concomitant administration of antihypertensives with high doses of the substance, a
potentiation of the hypotensive effect may be observed.
The co-administration of sildenafil potentiates the hypotensive effect of organic nitrates (see paragraph
“Contraindications”).

SPECIAL WARNINGS
Use with caution in patients with glaucoma. In case of arterial hypotension, it should be
administered only under medical supervision.
The simultaneous intake of alcohol can potentiate the hypotensive effect or affect the ability to
react of patients, particularly drivers of vehicles and operators of machinery that
require particular attention.
The medicine is not contraindicated for subjects affected by celiac disease.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Unless otherwise prescribed by a doctor, the following dosage is recommended for prolonged therapies:

ISOSORBIDE MONONITRATE DOC Generici 20 mg tablets
1 tablet 3 times a day.
Due to the good tolerability of the drug, the dose can be increased without any risk to 2
tablets 3 times a day.

ISOSORBIDE MONONITRATO DOC Generici 40 mg tablets
1 tablet 2-3 times a day.
The dosage can be adjusted by the attending physician to the individual case.
In case of particular sensitivity of patients, it is possible to avoid the appearance of headache or hypotension
starting treatment with half a 20 mg tablet in the morning and evening.
To divide the tablet, place it on a rigid surface with the median notch facing
down. With light pressure from the thumb, the tablet breaks into two equal parts.
The tablets should be taken after meals, without chewing, with some liquid.

OVERDOSE
No cases of overdose with ISOSORBIDE MONONITRATE DOC Generici are known.
If this should happen, it is advisable to induce vomiting and/or perform gastric lavage.
Check if the patient has ingested other drugs at the same time and monitor haemodynamic parameters in any case.

UNDESIRABLE EFFECTS
When adopting the recommended dosage, no side effects of particular severity have been known so far.
As with all nitroderivatives, cutaneous vasodilation with redness, headache of varying intensity and
duration, transient episodes of dizziness and asthenia, hypotension, nausea, vomiting may occur during treatment with ISOSORBIDE
MONONITRATE DOC Generici.
In patients with vascular lability, the first intake of ISOSORBIDE MONONITRATE DOC
Generici may manifest 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.

undesirable.
These side effects are generally transient. When they occur, however,
it is advisable to consult a doctor.
It is important to inform the doctor of the appearance of side effects not described in the
EXPIRY DATE AND STORAGE
See the expiry date indicated on the packaging.
The period of validity refers to the product in intact packaging, correctly stored.

Caution: do not use the medicine after the expiry date indicated on the packaging.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN
December 2012