Patient Information Leaflet: Information for the User

Ismo 20 mg tablets

Isosorbide-5-mononitrate
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ismo is and what it is used for

Ismo contains the active substance isosorbide mononitrate, which belongs to a group of medicines called organic nitrates. These medicines work by dilating blood vessels and improving blood circulation, thereby enhancing heart function.

This medicine is indicated for:

the acute and maintenance therapy of coronary insufficiency (impaired blood flow to the heart);
prevention of chest pain due to heart problems (angina pectoris);
treatment following a heart attack (myocardial infarction);
maintenance therapy for chronic conditions in which the heart fails to pump an adequate amount of blood (chronic myocardial insufficiency), also 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 heart-related chest pain behind the sternum caused by poor blood circulation (acute angina).

2. What you should know before taking Ismo

Do not take Ismo

if you are allergic to the active substance, isosorbide mononitrate, to nitrate derivatives, or to any of the other ingredients of this medicine (listed in section 6);
if you are experiencing an acute heart attack (acute myocardial infarction);
if you suffer from circulatory problems (acute circulatory failure, shock, circulatory collapse);
if your heart suddenly fails to pump an adequate amount of blood (cardiogenic shock), unless sufficient blood pressure is maintained;
if you have very low blood pressure (severe arterial hypotension);
if you have thickening of the heart walls (hypertrophic obstructive cardiomyopathy);
if you suffer from inflammation of the pericardium, the sac surrounding the heart (constrictive pericarditis);
in case of severe anaemia (blood deficiency);
if you have a significantly reduced blood volume (severe hypovolemia);
if you have fluid accumulation around the heart (cardiac tamponade);
if you are taking medicines such as sildenafil, vardenafil, or tadalafil, used to treat male impotence (see section "Other medicines and Ismo");
if you are taking medicines containing riociguat, a medicine used to treat pulmonary hypertension (see section "Other medicines and Ismo").

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

if you have a condition characterised by high pressure inside the eye (glaucoma);
in case of head injury (cranial trauma);
in case of bleeding in the brain due to rupture of a blood vessel (cerebral haemorrhage);
if you have narrowing of the aorta (aortic stenosis) or reduced function of a heart valve (mitral stenosis);
if you are prone to a sudden drop in blood pressure after quickly moving from a sitting or lying position to standing (orthostatic hypotension);
if you have high pressure around the brain (increased intracranial pressure), which may increase further if nitroglycerin is administered intravenously;
if you suffer from severe kidney problems (renal failure);
if you suffer from severe liver problems (hepatic failure);
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 Ismo (hypotension);
if you suffer from headaches (cephalalgia); Ismo may cause headaches, especially at the beginning of treatment, which can be severe in sensitive individuals. Use lower doses of the medicine to help prevent their occurrence;
if your thyroid gland produces excessive amounts of hormones (hyperthyroidism);
if you suffer from reduced activity of the thyroid gland (hypothyroidism);
in case of malnutrition;
if you recently had a heart attack (myocardial infarction);
if you are taking medicines used to treat high blood pressure (antihypertensives);
if you suffer from inadequate oxygenation of arterial blood (hypoxaemia);
if your blood oxygen levels are insufficient (hypoxaemia) due to lung disease or reduced blood supply to the heart (ischaemic heart failure). Avoid increasing the dose and avoid using this medicine at high doses or for prolonged treatment, as this may lead to a decrease or loss of effectiveness over time (tolerance).

Other medicines and Ismo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking the following medicines together with Ismo may enhance the hypotensive effect of Ismo:

other vasodilator medicines (vasodilators);
antihypertensive medicines (e.g., ACE inhibitors, beta-blockers, calcium antagonists, diuretics);
medicines for psychological disorders such as depression (tricyclic antidepressants);
medicines for psychiatric disorders (neuroleptics);
medicines for erectile dysfunction, such as sildenafil (e.g., Viagra), vardenafil, and tadalafil (see section "Do not take Ismo");
sapropterin (used to lower blood phenylalanine levels in patients with phenylketonuria);
alcoholic beverages;
medicines containing riociguat (used, for example, to treat pulmonary hypertension).

If co-administered with dihydroergotamine, Ismo may increase dihydroergotamine (DHE) levels, thereby enhancing its hypertensive effect.
The medicine may act as a physiological antagonist of noradrenaline, acetylcholine, and histamine.

Ismo with food, drink, and alcohol
Do not drink alcohol while taking Ismo, as alcohol may enhance the hypotensive effect of Ismo.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
There is insufficient information available on the use of the active substance during pregnancy. Ismo should be used during pregnancy only if strictly necessary and under strict medical supervision.

Breastfeeding
It is not known whether the active substance is excreted in breast milk. Ismo should be used during breastfeeding only if strictly necessary and under strict medical supervision.

Fertility
There is no information available on the effect of the active substance on fertility.

Driving and using machines
Even when used as directed, this medicine may affect your reaction ability, potentially impairing your reflexes while driving or operating machinery. This should be particularly considered at the beginning of treatment, when increasing the dose, when switching medicines, and when alcohol is consumed concurrently.

Ismo contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Ismo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet of Ismo 20 mg, 2-3 times daily. The dosage may be
gradually increased by the doctor up to 2 tablets of Ismo 20 mg, 2-3 times daily.
In case of particular sensitivity in patients, the occurrence of headache or arterial hypotension may be avoided by starting treatment with half a tablet of Ismo 20 mg in the morning and evening.
Method and duration of use
The tablets should be taken without chewing, after meals or shortly before going to bed,
with a sufficient amount of liquid (for example, a glass of water).
Your doctor will decide the duration of treatment.
Use in children and adolescents
The safety and efficacy of Ismo in children have not been established.
Elderly patients
Dosage adjustment is not required in elderly patients. However, caution should be exercised in elderly patients with known hypersensitivity to antihypertensive drugs.
Patients with renal or hepatic impairment
Dosage adjustment is necessary in patients with renal or hepatic impairment.
If you take more Ismo than you should
If you take an excessive dose of Ismo, inform your doctor immediately or go to the nearest Emergency Department.
In case of overdose, the following symptoms may occur: severe drop in blood pressure
with reflex increase in heart rate (tachycardia), headache, weakness,
dizziness and vertigo, skin flushing, nausea, vomiting, diarrhea.
At high doses, methaemoglobinaemia (a blood disorder in which an abnormal amount of haemoglobin accumulates in the blood), bluish discoloration of the skin and mucous membranes (cyanosis), shortness of breath (dyspnoea), and increased respiratory rate (tachypnoea) may occur.
At very high doses, an increase in intracranial pressure may occur, leading to neurological symptoms.
If you forget to take Ismo
Do not take a double dose to make up for the missed dose.
If you stop taking Ismo
If you stop taking Ismo suddenly, you may experience discomfort. Inform your doctor if you stop taking Ismo.
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 gets them.
Possible side effects are:
Very common (may affect more than 1 in 10 people)

headache (cephalaea)
Common (may affect up to 1 in 10 people)
dizziness
weakness (asthenia)
increased heart rate (tachycardia)
drop in blood pressure when standing up or moving suddenly (orthostatic hypotension)

Uncommon (may affect up to 1 in 100 people)

increased chest pain (worsening of angina pectoris symptoms)
circulatory collapse (sometimes accompanied by disturbances and slowing of the heart rate, and sudden temporary loss of consciousness)
flushing
skin allergic reactions

Rare (may affect up to 1 in 1,000 people)

nausea
vomiting
Very rare (may affect up to 1 in 10,000 people)
inflammatory skin disease leading to cracking and peeling of the skin (exfoliative dermatitis)

Not known (frequency cannot be estimated from the available data)

low blood pressure (hypotension)
heartburn (pyrosis)
sudden and temporary loss of consciousness (syncope)
bluish discoloration of the skin and mucous membranes (cyanosis). This effect may be due to an increase in the blood of a substance called methaemoglobin (methaemoglobinaemia).
drowsiness

During administration of Ismo, a temporary reduction in oxygen supply in arterial blood (hypoxaemia) may occur, which, in patients with coronary circulatory disorders, may lead to insufficient oxygen supply to the heart muscle (myocardial hypoxia).
If signs of hypersensitivity reaction occur, Ismo must no longer be taken.
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.

5. How to store Ismo

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.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
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.
Do not store above 30 °C.

6. Package contents and other information

What Ismo contains

The active substance is: isosorbide-5-mononitrate. Each tablet contains 20 mg of isosorbide-5-mononitrate. The other components are: anhydrous lactose, highly dispersed anhydrous silicon dioxide, magnesium stearate.

Description of the appearance of Ismo and contents of the pack
White, round tablets, printed with "BM 3B" and a score line on each side.
Ismo 20 is available in packs containing 50 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Esteve Pharmaceuticals GmbH, Hohenzollerndamm 150-151, 14199 Berlin, Germany
Manufacturer
Kern Pharma, S.L., Polígon Industrial Colón II, Venus 72, 08228 Terrassa (Barcelona), Spain.