Patient Information Leaflet

Isosorbide mononitrato Sandoz 20 mg tablets, 40 mg tablets, 60 mg prolonged-release tablets

Generic medicine
Please read all of this leaflet carefully before you start taking 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:

What Isosorbide mononitrato Sandoz is and what it is used for
What you need to know before taking Isosorbide mononitrato Sandoz
How to take Isosorbide mononitrato Sandoz
Possible side effects
How to store Isosorbide mononitrato Sandoz
Contents of the pack and other information

1. What Isosorbide mononitrato Sandoz is and what it is used for

Isosorbide mononitrato Sandoz contains the active substance isosorbide 5-mononitrate, which
belongs to a group of medicines called organic nitrates. These medicines work
by dilating blood vessels and improving blood flow to the heart.
This medicine is indicated for:

maintenance therapy of coronary insufficiency (heart disease characterized by obstruction of the coronary arteries, the blood vessels supplying blood to the heart);
prevention of angina pectoris attacks (heart disease characterized by chest pain);
recovery treatment to restore heart function after a heart attack, even in combination with other medicines that improve heart rhythm and lower blood pressure (cardiotonics and diuretics);
treatment of chronic heart failure (a disease characterized by the heart's inability to supply adequate blood to the body), even in combination with medicines that improve heart rhythm and lower blood pressure (cardiotonics and diuretics).

This medicine is not suitable for controlling acute episodes of chest pain behind the sternum caused by poor blood circulation (acute angina).

2. What you need to know before taking Isosorbide mononitrato Sandoz

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Do not take Isosorbide mononitrato Sandoz:

if you are allergic to isosorbide-5-mononitrate, organic nitrates, or any of the other ingredients of this medicine (listed in section 6);
if you are currently having a heart attack;
if you suffer from severe circulatory problems (acute circulatory failure, shock, circulatory collapse);
in case of cardiogenic shock (a serious problem with blood circulation to the heart), unless adequate blood pressure is maintained;
if you have very low blood pressure (severe arterial hypotension);
if you have thickening of the heart walls causing obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
if you suffer from inflammation of the pericardium, the sac surrounding the heart (constrictive pericarditis);
if you have a lower than normal volume of circulating blood (severe hypovolemia);
if you have fluid accumulation in the pericardial sac (cardiac tamponade);
if you have high blood pressure in the pulmonary blood vessels (primary pulmonary hypertension);
if you are taking medicines such as sildenafil, vardenafil, tadalafil, used to treat male impotence (see section “Other medicines and Isosorbide mononitrato Sandoz”);
if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and Isosorbide mononitrato Sandoz”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Isosorbide mononitrato Sandoz.
Use this medicine with caution and inform your doctor:

if you have a condition characterized by high pressure inside the eye (glaucoma);
if you have a severe decrease in red blood cell levels (marked anemia);
if your thyroid gland produces excessive amounts of hormones (hyperthyroidism);
if you have sustained a head injury (cranial trauma);
if you have bleeding within the brain (cerebral hemorrhage);
if you have narrowing of the aorta (aortic stenosis) or reduced function of a heart valve (mitral stenosis);
if you suffer from a rapid drop in blood pressure when standing up suddenly (orthostatic hypotension);
if you have increased pressure in the brain (intracranial hypertension);
if you suffer from kidney problems (renal failure);
if you suffer from heart circulation disorders (coronary artery disease), as this may lead to a condition where the heart receives insufficient oxygen (myocardial hypoxia);
if you have taken other similar medicines (nitrate derivatives), as this may reduce the effectiveness of this medicine (cross-tolerance);
if you are taking medicines used to treat high blood pressure (calcium antagonists), as they may enhance the blood pressure-lowering effect of this medicine (decrease in blood pressure);
if you suffer from reduced intestinal motility, when taking Isosorbide mononitrato Sandoz prolonged-release tablets, as this may lead to reduced release of the medicine.

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if you suffer from headaches. Isosorbide mononitrate Sandoz may cause headaches, especially at the beginning of treatment, which may be severe in sensitive individuals. Use lower doses of the medicine to prevent their occurrence.
if you have circulatory disorders (ischemia), heart damage (myocardial damage), or impaired heart function (advanced congestive heart failure), as these conditions may worsen with the use of Isosorbide mononitrate Sandoz.
if you notice a bluish discoloration of the skin and mucous membranes (cyanosis) in the absence of lung disease (pneumopathy). In such cases, a specific test should be performed (monitoring of methemoglobin levels), especially during high-dose treatments. (See section “If you take more Isosorbide mononitrate Sandoz than you should”)

Avoid increasing the dose and avoid using this medicine at high doses or for prolonged treatments, as this may lead to a gradual reduction or loss of effectiveness over time (tolerance).
Other medicines and Isosorbide mononitrato Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking:

phosphodiesterase inhibitors used to treat impotence such as sildenafil, vardenafil, and tadalafil,
riociguat, a medicine used to treat pulmonary hypertension (see section “Do not take Isosorbide mononitrato Sandoz”);

Be especially careful if you are taking:

medicines used to treat high blood pressure (e.g. beta-blockers, vasodilators, diuretics, calcium antagonists, ACE inhibitors);
medicines used to treat mental disorders, known as antipsychotics (neuroleptics);
medicines used to treat depression (tricyclic antidepressants);
dihydroergotamine, a medicine used to treat headache (cephalalgia);
norepinephrine, used to treat low blood pressure;
acetylcholine, a medicine used during certain surgical procedures;
histamine, a medicine used for diagnostic purposes (allergy testing).

Isosorbide mononitrato Sandoz and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may cause a drop in blood pressure and reduce reflexes, for example when driving or operating machinery requiring particular attention.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine is not recommended during pregnancy or breastfeeding, except in cases of absolute necessity and always under direct medical supervision.
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Driving and using machines
This medicine may impair your ability to drive or operate machinery.
This effect may be increased if you consume alcohol at the same time.
Isosorbide mononitrato Sandoz 20 mg tablets contain lactose:
This medicine contains 151.7 mg of lactose, a sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Isosorbide mononitrato Sandoz 40 mg tablets contain lactose, sunset yellow FCF (E110), and sodium
This medicine contains 131.5 mg of lactose, a sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 0.2 mg of sunset yellow FCF (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
Isosorbide mononitrato Sandoz 60 mg prolonged-release tablets contain lactose:
This medicine contains 215 mg of lactose, a sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Isosorbide mononitrato Sandoz

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose for long-term treatment is
as follows:
Isosorbide mononitrato Sandoz 20 mg tablets
The recommended dose is 1 tablet three times a day. The dose may be increased to 2
tablets three times a day.
Do not chew the tablets; take them with half a glass of water after meals.
Isosorbide mononitrato Sandoz 40 mg tablets
The recommended dose is 1 tablet 2-3 times a day. Your doctor may consider it
necessary to adjust the dosage.
If you are prone to developing headaches and/or low blood pressure, start
treatment with half a 40 mg tablet in the morning and half in the evening.
Do not chew the tablets; take them with half a glass of water after meals.
Isosorbide mononitrato Sandoz 60 mg prolonged-release tablets
The recommended dose is 1 prolonged-release tablet per day, taken in the morning,
unless otherwise prescribed by your doctor. If you are prone to developing headaches and/or
low blood pressure, start treatment with 1 tablet of 20 mg or 1
tablet of 40 mg, progressively increasing the dose.
If you need to divide the tablet, place it on a hard surface with the scored side facing
upwards. Apply slight pressure with your thumb to break the tablet into two equal parts.
If you take more Isosorbide mononitrato Sandoz than you should
If you have taken or ingested too much of this medicine, contact your doctor immediately or go
to the nearest hospital emergency department.
Stop treatment immediately and go to hospital if you experience the following
symptoms of overdose:
decrease in blood pressure;
pale face;
sweating;
weak pulse;
increased heart rate (tachycardia);
dizziness when standing upright (postural vertigo);
headache (cephalalgia);
muscle weakness (asthenia) and drowsiness;
dizziness;
nausea, vomiting and diarrhoea;
feeling of warmth (flushing);
increased intracranial pressure (with very high doses).
In addition, in case of overdose, a blood disorder
(methaemoglobinaemia) may occur, along with bluish discoloration of the skin (cyanosis),
accompanied by increased respiratory rate, anxiety, loss of consciousness and cardiac arrest.
If you forget to take Isosorbide mononitrato Sandoz
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Isosorbide mononitrato Sandoz
Stop treatment with this medicine gradually to avoid the occurrence of
unwanted effects.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most side effects depend on the dose of medicine used.
Possible side effects are:
Very common (may affect more than 1 in 10 people):
headache (cephalalgia), especially at the beginning of treatment, which usually disappears during continued therapy.
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Common (may affect up to 1 in 10 people):
nausea.
At the beginning of treatment or when the dose is increased, the following may occur:
dizziness (including postural dizziness, which worsens with position);
drowsiness and feeling of fatigue (asthenia);
drop in blood pressure when suddenly changing from a sitting to an upright position (orthostatic hypotension);
increased heart rate (reflex tachycardia),
which generally disappear during continued treatment.
Uncommon (may affect up to 1 in 100 people):
worsening of chest pain (angina pectoris);
circulatory collapse, sometimes accompanied by slow and irregular heartbeat (bradyarrhythmia) and fainting (syncope);
vomiting and diarrhoea;
allergic skin reactions (allergic dermatitis), skin redness.
Very rare (may affect up to 1 in 10,000 people):
burning sensation in the stomach (pyrosis);
muscle pain (myalgia).
Not known (frequency cannot be estimated from the available data):
decrease in blood pressure (hypotension);
inflammation of the skin with skin peeling (exfoliative dermatitis);
loss of effectiveness (tolerance), also due to the use of similar medicines (cross-tolerance);
swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in breathing and swallowing (angioedema).
In addition, the following side effects may occur, for which the frequency is unknown:

condition in which blood is inadequately oxygenated (temporary hypoxaemia);
worsening of heart condition (myocardial hypoxia);
severe drop in blood pressure (symptoms include nausea, vomiting, restlessness, pallor and excessive sweating).

Isosorbide mononitrate Sandoz 20 mg and 40 mg tablets
Side effects such as flushing and headache (cephalalgia) may be reduced or eliminated by starting treatment with half a 20 mg tablet in the morning and evening.
Isosorbide mononitrate Sandoz 60 mg prolonged-release tablets
Side effects such as flushing and headache (cephalalgia) may be reduced or eliminated by starting treatment with one 20 mg or 40 mg tablet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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.
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5. How to store Isosorbide mononitrato Sandoz

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 below 25°C.
Do not dispose of medicines 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 Isosorbide mononitrate Sandoz 20 mg tablets contain

The active substance is isosorbide-5-mononitrate. Each tablet contains 20 mg of isosorbide-5-mononitrate.
The other components are: microcrystalline cellulose, lactose, precipitated silica, maize starch, talc, magnesium stearate.

What Isosorbide mononitrate Sandoz 40 mg tablets contain

The active substance is isosorbide-5-mononitrate. Each tablet contains 40 mg of isosorbide-5-mononitrate.
The other components are: microcrystalline cellulose, lactose, precipitated silica, maize starch, talc, magnesium stearate, sunset yellow FCF (E 110).

What Isosorbide mononitrate Sandoz 60 mg prolonged-release tablets contain

The active substance is isosorbide-5-mononitrate. Each tablet contains 60 mg of isosorbide-5-mononitrate.
The other components are: monohydrate lactose, hypromellose, maize starch, glyceryl palmitostearate, magnesium stearate.

Description of the appearance of Isosorbide mononitrate Sandoz and pack contents
Isosorbide mononitrate Sandoz 20 mg tablets
PVC/Aluminum blister containing 50 tablets for oral use.
Isosorbide mononitrate Sandoz 40 mg tablets
PVC/Aluminum blister containing 30 tablets for oral use.
Isosorbide mononitrate Sandoz 60 mg prolonged-release tablets
PVC/Aluminum blister containing 30 prolonged-release tablets for oral use.
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturer
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Edmond Pharma S.r.l – Strada Statale dei Giovi, 131 - 20037 Paderno Dugnano (Mi)
Laboratorio Farmacologico Milanese S.r.l. - Via Monterosso, 273 – 21042 Caronno Pertusella (Va)
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