Monocinque

Package leaflet: Information for the user

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

Isosorbide-5-mononitrate
Please read all of this leaflet carefully before you start using 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, as it may be harmful.
• If you experience any side effect, including those 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 taking 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 medication belonging to the class of nitrates. It exerts its effect through relaxation of the blood vessel walls, particularly the veins. Venous dilation reduces the amount of blood returning from the veins to the heart, thereby decreasing the heart's workload and consequently its oxygen demand.

MONOCINQUE tablets and capsules are indicated:

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

MONOCINQUE 20 mg tablets, MONOCINQUE 40 mg tablets, MONOCINQUE 50 mg prolonged-release hard capsules, and MONOCINQUE 80 mg prolonged-release hard capsules are indicated for maintenance therapy of chronic myocardial insufficiency (long-lasting), either alone or in combination with cardiotonic drugs (medications that enhance heart performance) and diuretics (medications that increase urine production).

MONOCINQUE 20 mg and 40 mg tablets, as well as MONOCINQUE 50 mg and 80 mg prolonged-release hard capsules, are not indicated for the management of acute angina episodes (characterized by severe retrosternal pain due to poor blood circulation in the heart).

MONOCINQUE 80 mg prolonged-release hard capsules are suitable for patients who require high blood concentrations of the active substance to adequately control symptoms of the above-mentioned conditions.

2. What you need to know before taking MONOCINQUE

Do not take MONOCINQUE

• If you are allergic to the active substance (isosorbide-5-mononitrate), to nitro derivatives and similar substances (isosorbide dinitrate), or to any of the other ingredients of this medicine (listed in section 6).
• In case of acute myocardial infarction (heart attack in the acute phase).
• 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 (a medicine used to treat male impotence), as it 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 should take MONOCINQUE with caution if you have glaucoma (a disease caused by increased pressure inside the eye).
If you suffer from low blood pressure, take MONOCINQUE only under strict medical supervision.

Other medicines and MONOCINQUE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine may interfere with the action of noradrenaline, acetylcholine, histamine, and other substances.
Tolerance (reduced or nullified effectiveness) to MONOCINQUE and other nitrates may develop.
High doses of MONOCINQUE may enhance the effect of other concomitantly administered antihypertensive medicines (those that lower blood pressure).
Concomitant administration of sildenafil enhances the hypotensive effect of nitrates. Therefore, its use together with nitrates is contraindicated (see "Do not take MONOCINQUE").

MONOCINQUE and alcohol
Drinking alcohol at the same time may 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 may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This product should be administered during pregnancy and breastfeeding only if clearly needed and under direct medical supervision.

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

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

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

3. How to take MONOCINQUE

Take this medicine exactly as directed by 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 daily.

MONOCINQUE 40 mg tablets
The recommended dose is 1 tablet 2–3 times daily.

The dosage may be adjusted by the doctor according to the individual patient's needs.

If you suffer from circulatory instability (unstable blood pressure values), symptoms of collapse may occur after the first dose (see section 4 "Possible side effects"). These symptoms, as well as headache caused by nitrates, can largely be avoided by starting treatment with half a 20 mg tablet in the morning and evening.

Take the tablets after meals, without chewing, with a little liquid.

MONOCINQUE 50 mg prolonged-release hard capsules
The recommended dose is one capsule once daily in the morning, to be taken with some liquid, without chewing.

MONOCINQUE 80 mg prolonged-release hard capsules
The recommended dose is one capsule once daily in the morning, to be taken with some liquid, without chewing.

If you take more MONOCINQUE than you should
There are no known cases of overdose due to the low toxicity of the medicine; however, in such cases, induction of vomiting and/or gastric lavage is recommended.
Check whether the patient has ingested other medicines at the same time and monitor haemodynamic (cardiovascular) parameters in any case.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
No significant side effects have been observed at the prescribed doses.
As with all nitrate derivatives, possible side effects may include:

• Headache of variable intensity and duration.
• Dilation of skin blood vessels causing flushing.
• Transient episodes of dizziness and asthenia (reduced muscle strength).
• Orthostatic hypotension (sudden drop in blood pressure following abrupt change from sitting or lying position to standing).
• Skin reactions (skin rashes), exfoliative dermatitis (inflammatory skin disease with skin peeling).

In individuals with marked sensitivity to the hypotensive effects of nitrates, pronounced symptoms may occur such as: nausea, vomiting, weakness (asthenia), restlessness, pallor, sweating and circulatory collapse.
Upon first administration, in patients with unstable circulation, collapse symptoms may occur (see section 3 "How to take MONOCINQUE").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps 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 stated on the packaging. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging stored correctly.
No special storage precautions are required.
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 MONOCINQUE contains
MONOCINQUE 20 mg tablets
Each tablet contains:
Active substance: isosorbide-5-mononitrate 20 mg.
Other components: lactose, maize starch, microcrystalline cellulose, talc, magnesium stearate.

MONOCINQUE 40 mg tablets
Each tablet contains:
Active substance: isosorbide-5-mononitrate 40 mg.
Other components: lactose, maize starch, microcrystalline cellulose, talc, magnesium stearate.

MONOCINQUE 50 mg prolonged-release hard capsules
Each capsule contains:
Active substance: isosorbide-5-mononitrate 50 mg.
Other components: sucrose, maize starch, talc, stearic acid, ethylcellulose.
Each capsule shell contains: carmine red A (E124), quinoline yellow (E104), titanium dioxide (E171), gelatin.

MONOCINQUE 80 mg prolonged-release hard capsules
Each capsule contains:
Active substance: isosorbide-5-mononitrate 80 mg.
Other components: sucrose, maize starch, talc, stearic acid, ethylcellulose.
Each capsule shell contains: iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), gelatin.

Description of the appearance of MONOCINQUE and contents of the pack
MONOCINQUE 20 mg tablets
Box containing 50 white, 20 mg, scored tablets.

MONOCINQUE 40 mg tablets
Box containing 30 white, 40 mg, scored tablets.

MONOCINQUE 50 mg prolonged-release hard capsules
Carton box containing 30 prolonged-release orange-coloured hard capsules of 50 mg for oral use.

MONOCINQUE 80 mg prolonged-release hard capsules
Carton box containing 30 prolonged-release orange-coloured hard capsules of 80 mg for oral use.

Marketing Authorization Holder
Istituto Luso Farmaco d'Italia S.p.A. - Milanofiori – Strada 6 – Edificio L – Rozzano (MI), Italy.

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, Italy.
A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi 3 – Florence, Italy.
Laboratorios Menarini S.A. - C/Alfonso XII, 587 - 08918 Badalona (Barcelona), Spain.