ISOSORBIDE 20 mg Coated Tablet

Зміст інструкції

1. Isosorbide mononitrate Sandoz 20 mg tablets, 40 mg tablets, 60 mg prolonged-release tablets
   1. What Isosorbide mononitrato Sandoz is and what it is used for
   2. What you need to know before taking Isosorbide mononitrate Sandoz
   3. How to take Isosorbide mononitrate Sandoz
   4. Possible side effects
   5. How to store Isosorbide mononitrato Sandoz
   6. Package Contents and Other Information

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

Generic medicine
Read this leaflet carefully before taking 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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Isosorbide mononitrate Sandoz is and what it is used for
• 2. What you need to know before you take Isosorbide mononitrate Sandoz
• 3. How to take Isosorbide mononitrate Sandoz
• 4. Possible side effects
• 5. How to store Isosorbide mononitrate Sandoz
• 6. 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 ingredient isosorbide 5-mononitrate, which
belongs to a group of medicines called organic nitrates. These medicines work by
dilating blood vessels and facilitating blood flow to the heart.
This medicine is indicated for:

• the maintenance therapy of coronary insufficiency (heart disease characterized by an obstruction of the coronary arteries, the blood vessels that carry blood to the heart);
• in the prevention of angina pectoris attacks (heart disease that manifests with chest pain);
• in the recovery treatment of heart function after a heart attack, even in association with other medicines that improve heart rate and lower blood pressure (cardiotonics and diuretics);
• in the treatment of chronic heart failure (disease characterized by the heart's inability to provide the body with an adequate amount of blood), even in association with medicines that improve heart rate and lower blood pressure (cardiotonics and diuretics).

This medicine is not suitable for controlling acute painful crises at the level of the heart
and behind the sternum due to poor blood circulation (acute angina pectoris).

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

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Do not take Isosorbide mononitrate 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 having a heart attack;
• if you suffer from severe circulatory problems (acute circulatory insufficiency, shock, circulatory collapse);
• in case of cardiogenic shock (a serious problem with blood circulation to the heart) unless sufficient blood pressure is maintained;
• if you have very low blood pressure (severe arterial hypotension);
• if you have an enlargement of the heart walls with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
• if you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• if you have a reduced blood volume compared to normal values (severe hypovolemia);
• if you have a build-up of fluid around the lining of the heart (cardiac tamponade);
• if you have high blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
• if you are taking medicines such as sildenafil, vardenafil, tadalafil, used to treat erectile dysfunction in men (see section “Other medicines and Isosorbide mononitrate Sandoz”);
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and Isosorbide mononitrate Sandoz”).

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

• if you have a disease 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 high amounts of hormones (hyperthyroidism);
• if you have had a head injury (craniocerebral trauma);
• if you have bleeding inside the brain (cerebral haemorrhage);
• if you have a narrowing of the aorta (aortic stenosis) or the function of a heart valve is reduced (mitral stenosis);
• if you suffer from a rapid drop in blood pressure when you get up suddenly (orthostatic hypotension);
• if you have high pressure in the brain (increased intracranial pressure);
• if you suffer from kidney problems (renal insufficiency);
• if you suffer from heart circulation problems (coronary artery disease), as a condition may occur in which there is a lack of oxygen to the heart (myocardial hypoxia);
• if you have taken other similar medicines (nitrates) as it may decrease the effectiveness of this medicine (cross-tolerance);
• if you are taking medicines used to treat high blood pressure (calcium antagonists), as it may increase the hypotensive effect of this medicine (decrease in blood pressure);
• if you have a slowing of intestinal motility, for taking Isosorbide mononitrate Sandoz prolonged-release tablets, because it may cause a reduction in the release of the medicine.

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• if you suffer from headaches. Isosorbide Mononitrate Sandoz may cause, in the early stages of therapy, headaches that may be severe in sensitive individuals. Use lower doses of the medicine to avoid their occurrence.
• if you have blood circulation disorders (ischemia), heart damage (myocardial damage) and alteration of its activity (advanced congestive heart failure), as they 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 a lung disease (pneumopathy). In these cases, a specific analysis (control of methemoglobin levels) is necessary, especially during high-dose treatments. (See section “If you take more Isosorbide Mononitrate Sandoz than you should”)

Avoid increasing the doses and avoid the use of this medicine at high doses and for prolonged treatments, as a decrease or loss of effectiveness may occur over time (tolerance).

Other medicines and Isosorbide mononitrate Sandoz
Tell 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:

• medicines that are phosphodiesterase inhibitors, used in the treatment of erectile dysfunction such as sildenafil, vardenafil and tadalafil,
• riociguat, a medicine used to treat pulmonary hypertension (see section “Do not take Isosorbide mononitrate Sandoz”);

Be particularly 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, called antipsychotics (neuroleptics);
• medicines used to treat depression (tricyclic antidepressants);
• dihydroergotamine, a medicine used to treat headaches (migraine);
• norepinephrine, used to treat low blood pressure;
• acetylcholine, a medicine used during some operations;
• histamine, a medicine used for diagnostic purposes (allergy tests).

Isosorbide mononitrate Sandoz with alcohol
Avoid drinking 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 that requires particular attention.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medicine is not recommended if you are pregnant or breastfeeding, unless absolutely necessary and always under the direct control of a doctor.
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Driving and using machines
This medicine can impair the ability to drive and use machines.
This effect may be increased if you drink alcohol at the same time.

Isosorbide mononitrate Sandoz 20 mg tablets contains lactose:
This medicine contains 151.7 mg of lactose, a sugar. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

Isosorbide mononitrate Sandoz 40 mg tablets contains lactose, yellow sunset FCF (E110) and sodium
This medicine contains 131.5 mg of lactose, a sugar. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
This medicine contains 0.2 mg of yellow sunset 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 mononitrate Sandoz 60 mg prolonged-release tablets contains lactose:
This medicine contains 215 mg of lactose, a sugar. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Isosorbide mononitrate Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose for prolonged treatments is as
follows:

Isosorbide mononitrate Sandoz 20 mg tablets
The recommended dose is 1 tablet 3 times a day. The dose may be increased to 2
tablets 3 times a day.
Do not chew the tablets, take them with half a glass of water after meals.

Isosorbide mononitrate Sandoz 40 mg tablets
The recommended dose is 1 tablet 2-3 times a day. Your doctor may deem it
necessary to adjust the dosage.
If you are prone to developing headache and/or low blood pressure, start
treatment with half a 40 mg tablet in the morning and evening.
Do not chew the tablets, take them with half a glass of water after meals.

Isosorbide mononitrate Sandoz 60 mg prolonged-release tablets
The recommended dose is 1 prolonged-release tablet a day, taken in the morning
unless otherwise prescribed by your doctor. If you are prone to developing headache and/or
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low blood pressure, start treatment with 1 20 mg tablet or 1
40 mg tablet and gradually increasing the dosage.
If you need to divide the tablet, you must place it on a rigid surface with the
part with the notch facing up. With light pressure from your thumb, break the
tablet in two equal parts.

If you take more Isosorbide mononitrate Sandoz than you should
In case of ingestion/taking an excessive dose of this medicine, immediately notify your doctor or go to the Emergency Room of the nearest hospital.
Immediately stop treatment and go to hospital if you experience the following
overdose symptoms:
decreased blood pressure;
pale face;
sweating;
weak heartbeat;
increased heart rate (tachycardia);
dizziness when standing up (postural dizziness);
headache;
muscle fatigue (asthenia) and drowsiness;
dizziness;
nausea, vomiting and diarrhea;
feeling of warmth (hot flashes);
increased pressure inside the brain (using very high doses).
Furthermore, in case of overdose, a blood disease
(metahemoglobinemia) and bluish discoloration of the skin (cyanosis) accompanied by increased
breathing rate, anxiety, loss of consciousness and blockage of heart function may occur.

If you forget to take Isosorbide mononitrate Sandoz
Do not take a double dose to make up for the missed tablet.

If you stop taking Isosorbide mononitrate Sandoz
Stop treatment with this medicine gradually to avoid the occurrence of
undesirable effects.
If you have any further questions on 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 everybody gets them.
Most side effects depend on the dose of medicine you have used.
The 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 therapy.
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Common(may affect up to 1 in 10 people),
nausea
At the beginning of treatment or with an increase in doses, you may experience:
dizziness (including postural dizziness, which worsens depending on position);
drowsiness and feeling tired (asthenia);
lowering of blood pressure when moving suddenly from a sitting to an upright position (orthostatic hypotension);
increased heart rate (reflex tachycardia).
These generally disappear as therapy continues.

Uncommon(may affect up to 1 in 100 people)
worsening of chest pain (angina pectoris);
circulatory collapse, even accompanied by slow and irregular heartbeat (brady-arrhythmia) and fainting (syncope);
vomiting and diarrhea;
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 available data)
decrease in blood pressure (hypotension);
skin inflammation with skin scaling (exfoliative dermatitis);
loss of effectiveness (tolerance) also due to the use of other similar medicines
(cross-tolerance).
swelling of the face, lips, mouth, tongue or throat that can cause difficulty in
breathing and swallowing (angioedema).
In addition, the following side effects may occur for which the frequency is not known:

• condition in which the blood is not adequately oxygenated (temporary hypoxemia).
• worsening of heart condition (myocardial hypoxia);
• severe drop in blood pressure (symptoms include nausea, vomiting, agitation, paleness and excessive sweating)

Isosorbide mononitrate Sandoz 20 mg and 40 mg tablets
Side effects such as flushing and headache (cephalalgia) can 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) can be reduced or
eliminated by starting treatment with a 20 mg or 40 mg tablet.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
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effects you can help provide more information on the safety of this
medicine.

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 which is stated on the packaging after
“Exp”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in 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 ingredient is isosorbide-5-mononitrate. Each tablet contains 20 mg of isosorbide-5-mononitrate.
• The other ingredients are: microcrystalline cellulose, lactose, precipitated silica, corn starch, talc, magnesium stearate.

What Isosorbide mononitrate Sandoz 40 mg tablets contain

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

What Isosorbide mononitrate Sandoz 60 mg prolonged-release tablets contain

• The active ingredient is isosorbide-5-mononitrate. Each tablet contains 60 mg of isosorbide-5-mononitrate.
• The other ingredients are: lactose monohydrate, hydroxypropylmethylcellulose, corn starch, glyceryl palmitostearate, magnesium stearate.

Description of the appearance of Isosorbide mononitrate Sandoz and package 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 Authorisation 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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