MONOCINQUE 40 mg Coated Tablet

Зміст інструкції

1. MONOCINQUE 20 mg tablets, 40 mg tablets, 50 mg prolonged-release hard capsules, 80 mg prolonged-release hard capsules
   1. What MONOCINQUE is and what it is used for
   2. What you need to know before taking MONOCINQUE
   3. How to take MONOCINQUE
   4. Possible side effects
   5. How to store MONOCINQUE
   6. Contents of the pack and other information

MONOCINQUE 20 mg tablets, 40 mg tablets, 50 mg prolonged-release hard capsules, 80 mg prolonged-release hard capsules

Isosorbide-5-mononitrate

Read this leaflet carefully before you start using 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 if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MONOCINQUE is and what it is used for

MONOCINQUE based on isosorbide-5-mononitrate is an antianginal medicine belonging to the class
of nitrates which exerts its activity through a relaxing action on the vessel walls, in
particular of the veins. The dilation of the veins allows to reduce the amount of blood that from the veins goes to the
heart, with a consequent decrease in the work of the heart itself and therefore in oxygen consumption.
MONOCINQUE tablets and capsules is indicated:

• In the maintenance therapy of coronary insufficiency (condition in which the oxygen supply is insufficient to the heart's needs).
• In the prevention of angina pectoris attacks (chest pain caused by insufficient oxygen supply to the heart).
• In the treatment following myocardial infarction (heart attack).

MONOCINQUE 20 mg tablets, MONOCINQUE 40 mg tablets, MONOCINQUE 50 mg hard capsules
with prolonged release and MONOCINQUE 80 mg hard capsules with prolonged release are indicated in the
maintenance therapy of chronic myocardial insufficiency (long-lasting) also in association with
cardiotonic drugs (drugs capable of increasing heart performance) and diuretics (drugs that
increase urine production).
MONOCINQUE 20 mg and 40 mg tablets and MONOCINQUE 50 mg and 80 mg hard capsules with prolonged
release are not indicated for the control of acute stenocardic episodes (characterized by intense
retrosternal pain due to poor blood circulation).
MONOCINQUE 80 mg hard capsules with prolonged release is suitable for patients who require, for an
adequate control of the symptoms of the aforementioned conditions, high concentrations of the active ingredient in the
blood.

2. What you need to know before taking MONOCINQUE

Do not take MONOCINQUE

• If you are allergic to the active ingredient (isosorbide-5-mononitrate), to nitrates and similar substances (isosorbide dinitrate) or to any of the other components of this medicine (listed in section 6).
• In case of acute myocardial infarction (acute heart attack).
• In the presence of cardiocirculatory collapse (severe drop in blood pressure).
• If you suffer from severe hypotension (very low blood pressure).
• If you are taking sildenafil (medicine used for the treatment of male impotence), as the latter increases the hypotensive effects (reduction of blood pressure) of nitrates such as MONOCINQUE (see “Other medicines and MONOCINQUE”).

Warnings and precautions
Talk to your doctor or pharmacist before taking MONOCINQUE.
You must take MONOCINQUE with caution if you suffer from glaucoma (disease due to an increase in
pressure inside the eye).
If you suffer from low blood pressure, take MONOCINQUE only under strict medical supervision.

Other medicines and MONOCINQUE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The medicine may counteract the action of norepinephrine, acetylcholine, histamine and other substances.
The appearance of tolerance (decrease or cancellation of efficacy) to MONOCINQUE and
also to other nitrates is possible.
MONOCINQUE at high doses can intensify the action of any other hypotensive medicines (which
reduce blood pressure) administered at the same time.
The concomitant administration of sildenafil potentiates the hypotensive effect of nitrates. Therefore, its
administration with nitrates is contraindicated (see “Do not take MONOCINQUE”).

MONOCINQUE with alcohol
The simultaneous consumption of alcohol can increase the hypotensive effects of nitrates and reduce reflexes, for
example when driving vehicles or operating machinery (see “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
In pregnant women and during breastfeeding, the product should only be administered in cases of
actual need, under the direct control of the doctor.

Driving and using machines
The simultaneous consumption of alcohol can increase the hypotensive effects of nitrates and reduce reflexes, for
example, when driving vehicles or operating machinery.

MONOCINQUE 20 and 40 mg tablets contain lactose.If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking these medicines.

MONOCINQUE 50 mg and 80 mg prolonged-release hard capsules contain sucrose.If
your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking these
medicines.

MONOCINQUE 50 mg prolonged-release hard capsules contains cochineal red A (E 124)which
may cause allergic reactions.

3. How to take MONOCINQUE

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

MONOCINQUE 20 mg tablets
The recommended dose is 1 tablet 2-3 times a day.

MONOCINQUE 40 mg tablets
The recommended dose is 1 tablet 2-3 times a day.
The dosage may be adjusted by the doctor to the needs of the individual patient.
If you suffer from circulatory lability (instability of blood pressure values), symptoms of collapse may occur at
first intake (see section 4 “Possible side effects”). These symptoms, as well as headache caused by nitrates, can be largely avoided by starting treatment with half a 20 mg tablet
in the morning and evening.
Take the tablets after meals, without chewing, with some liquid.

MONOCINQUE 50 mg prolonged-release hard capsules
The recommended dose is one capsule 1 time a day in the morning, to be swallowed with some liquid, without
chewing.

MONOCINQUE 80 mg prolonged-release hard capsules
The recommended dose is one capsule 1 time a day in the morning, to be swallowed with some liquid, without
chewing.

If you take more MONOCINQUE than you should
No cases of overdose are known due to the low toxicity of the medicine; however, in such cases
it is recommended to induce vomiting and/or subject the patient to gastric emptying.
Check if the patient has taken other medicines at the same time and monitor in any case the
hemodynamic (cardiovascular) parameters.
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 everyone will experience them.
No significant side effects have been observed at the prescribed doses.
As with all nitrates, possible side effects may include:

• Headache of varying intensity and duration.
• Dilation of skin vessels with redness.
• Transient episodes of dizziness and asthenia (reduced muscle strength).
• Orthostatic hypotension (sudden drop in blood pressure following an abrupt change from a sitting or lying position to an upright position).
• Skin manifestations (skin rashes), exfoliative dermatitis (inflammatory skin disease with scaling).

In subjects with marked sensitivity to the hypotensive effects of nitrates, more pronounced symptoms may occur such as: nausea, vomiting, weakness (asthenia), agitation, pallor, sweating and collapse
(circulatory failure).
Upon first administration, in patients with circulatory lability, symptoms of collapse may occur (see
paragraph 3 “How to take MONOCINQUE”).

Reporting of side effects
Reporting of side effects
If any side effect occurs, including those not listed in this leaflet, please inform your
doctor or pharmacist. Side effects can also be reported directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting
of side effects helps to provide more information on the safety of this medicine.

5. How to store MONOCINQUE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to
the last day of that month and the product in intact packaging, correctly stored.
No particular precautions for storage are necessary.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MONOCINQUE contains
MONOCINQUE 20 mg tablets
Each tablet contains:

Active ingredient: isosorbide-5-mononitrate 20 mg.

Other ingredients: lactose, corn starch, microcrystalline cellulose, talc, magnesium stearate.
MONOCINQUE 40 mg tablets
Each tablet contains:

Active ingredient: isosorbide-5-mononitrate 40 mg.

Other ingredients: lactose, corn starch, microcrystalline cellulose, talc, magnesium stearate.
MONOCINQUE 50 mg prolonged-release hard capsules
Each capsule contains:

Active ingredient: isosorbide-5-mononitrate 50 mg.

Other ingredients: sucrose, corn starch, talc, stearic acid, ethylcellulose.
Each capsule consists of: cochineal red A (E124), quinoline yellow (E104) titanium dioxide (E 171),
gelatin.
MONOCINQUE 80 mg prolonged-release hard capsules
Each capsule contains:

Active ingredient: isosorbide-5-mononitrate 80 mg.

Other ingredients: sucrose, corn starch, talc, stearic acid, ethylcellulose.
Each capsule consists of: iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E 171),
gelatin.

Description of the appearance of MONOCINQUE and contents of the pack
MONOCINQUE 20 mg tablets
Pack of 50 divisible white tablets containing 20 mg.
MONOCINQUE 40 mg tablets
Pack of 30 divisible white tablets containing 40 mg.
MONOCINQUE 50 mg prolonged-release hard capsules
30 prolonged-release capsules of 50 mg, orange in colour, for oral use in a cardboard pack.
MONOCINQUE 80 mg prolonged-release hard capsules
30 prolonged-release capsules of 80 mg, orange in colour, for oral use in a cardboard pack.

Marketing authorisation holder
Istituto Luso Farmaco d'Italia S.p.A.- Milanofiori – Strada 6 – Edificio L – Rozzano (MI).

Manufacturer
MONOCINQUE 20 mg tablets and MONOCINQUE 40 mg tablets
Berlin Chemie AG-Glienicker Weg, 125-Berlin (Germany).
MONOCINQUE 50 mg prolonged-release hard capsules and MONOCINQUE 80 mg prolonged-release hard capsules

• A. Menarini Manufacturing Logistics and Services S.r.l. - Via Campo di Pile - L’Aquila.
• A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi 3 – Firenze. Laboratorios Menarini S.A. - C/Alfonso XII, 587 - 08918 Badalona (Barcelona) – Spain.