ISMO 20 mg Tablet

Зміст інструкції

1. Ismo 20 mg tablets
   1. What Ismo is and what it is used for
   2. What you need to know before taking Ismo
   3. How to take Ismo
   4. Possible side effects
   5. How to store Ismo
   6. Contents of the pack and other information

Ismo 20 mg tablets

Isosorbide-5-mononitrate
Read this leaflet carefully before you start 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ismo is and what it is used for

Ismo contains the active ingredient isosorbide mononitrate, which belongs to a group of medicines
called organic nitrates. These medicines work by dilating blood vessels and improving
blood circulation and therefore the activity of the heart.
This medicine is indicated for:

• the treatment and maintenance therapy of coronary insufficiency (impaired blood flow to the heart);
• preventing chest pain due to heart problems (angina pectoris);
• the 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), even in association with medicines that improve the heartbeat and that 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 stenocardia).

2. What you need to know before taking Ismo

Do not take Ismo

• if you are allergic to the active ingredient, isosorbide mononitrate, to nitrates or to any of the other ingredients of this medicine (listed in section 6).
• if you are having a heart attack (acute myocardial infarction);
• if you suffer from circulatory problems (acute circulatory insufficiency, 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 an increase in the size of the heart walls (obstructive hypertrophic cardiomyopathy);
• if you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• in case of severe anemia (blood deficiency)
• if you have a reduced blood volume (severe hypovolemia);
• if you have a build-up of fluid around the heart (cardiac tamponade);
• if you are taking medicines such as sildenafil, vardenafil, tadalafil, used to treat impotence in men (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 disease characterized by high pressure inside the eye (glaucoma);
• in case of head injuries (traumatic brain injury);
• in case of bleeding in the brain due to rupture of a blood vessel (cerebral hemorrhage);
• if you have a narrowing of the aorta (aortic stenosis) or the function of a heart valve is reduced (mitral stenosis);
• if you are subject to a sudden drop in blood pressure after suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension);
• if you have high pressure around the brain (increased intracranial pressure) which may increase further if you take nitroglycerin intravenously;
• if you suffer from severe kidney problems (renal insufficiency);
• if you suffer from severe liver problems (hepatic insufficiency);
• if you have taken other similar medicines (nitrates) as this may decrease the effectiveness of this medicine (cross-tolerance);
• if you are taking medicines used to treat high blood pressure (calcium channel blockers), as they may enhance the effect of Ismo on lowering blood pressure (hypotension);
• if you suffer from headaches (cephalalgia). As Ismo may cause, in the early stages of therapy, headaches which may be severe in sensitive individuals. Use lower doses of the medicine to avoid their occurrence;
• if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you suffer from reduced activity of the thyroid gland (hypothyroidism);
• in case of malnutrition;
• if you have recently had a heart attack (myocardial infarction);
• if you are taking medicines used to treat high blood pressure (antihypertensives);
• if you suffer from insufficient oxygenation of arterial blood (hypoxemia);
• if the oxygenation of the blood is insufficient (hypoxemia) due to a lung condition or reduced blood supply to the heart (ischemic heart failure). Avoid increasing doses and avoid using this medicine at high doses and for prolonged treatments, as a decrease or loss of effectiveness may occur 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.
The concomitant use of the following medicines together with Ismo may enhance the hypotensive action
of Ismo:

• other vasodilating medicines (vasodilators)
• medicines for hypotension (for example, ACE inhibitors, beta-blockers, calcium channel blockers, diuretics)
• medicines for psychological illnesses such as depression (tricyclic antidepressants)
• medicines for the treatment of psychiatric disorders (neuroleptics)
• medicines for the treatment of erectile dysfunction, such as sildenafil (like 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 for the treatment of pulmonary hypertension).

If co-administered with dihydroergotamine, Ismo may increase the level of dihydroergotamine (DHE),
enhancing its hypertensive action.
The medicine may act as a physiological antagonist of norepinephrine, acetylcholine and histamine.

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

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 using this medicine.
Pregnancy
There is not enough information available on the use of the active ingredient during pregnancy. Ismo must
only be used during pregnancy if strictly necessary and exclusively under medical supervision.
Breastfeeding
It is not known whether the active ingredient is excreted in breast milk. Ismo must only be used during
breastfeeding if strictly necessary and exclusively under medical supervision.
Fertility
There is no information available on the effect of the active ingredient on fertility.

Driving and using machines
Even when used as prescribed, this medicine may alter your ability to react, in
such a way as to impair reflexes when driving vehicles or using machinery. This should be
particularly considered at the beginning of treatment, when increasing the dosage and
when changing medicine as well as when taking it with alcohol.

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

3. How to take Ismo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 1 Ismo 20 mg tablet, 2-3 times a day. The dosage may be
gradually increased by your doctor up to 2 Ismo 20 mg tablets, 2-3 times a day.
In case of particular sensitivity of patients, it is possible to avoid the appearance of headache or hypotension
by starting treatment with half an Ismo 20 mg tablet, in the morning and in the evening.

Method and duration of use
The tablets should be taken without chewing, after meals or shortly before going to sleep,
with a sufficient amount of liquid (for example, a glass of water).
The treating physician 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
No dosage adjustments are necessary in elderly patients. However, caution is advisable
in elderly patients with known hypersensitivity to antihypertensive drugs.

Patients with renal and hepatic impairment
Dosage adjustments are necessary in patients with renal or hepatic impairment.

If you take more Ismo than you should
In case of taking an excessive dose of Ismo, inform your doctor immediately or go to the
nearest Emergency Room.
In case of overdose, the following symptoms may occur: severe drop in blood pressure
with a reflex increase in heart rate (tachycardia) and headache, feeling of weakness,
dizziness and lightheadedness, skin flushing, nausea, vomiting, diarrhea.
At high doses, methemoglobinemia may occur (a blood disease in which an abnormal amount of hemoglobin accumulates in the blood), bluish discoloration of the skin and mucous membranes
(cyanosis), shortness of breath (dyspnea) and increased respiratory rate (tachypnea).
At very high doses, an increase in intracranial pressure may occur with resulting cerebral symptoms.

If you forget to take Ismo
Do not take a double dose to make up for a missed dose.

If you stop taking Ismo
If you suddenly stop taking Ismo, you may feel unwell. Inform your doctor,
if you stop taking Ismo.
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 have side effects, although not everybody gets them.
Possible side effects are:
Very common (may affect more than 1 in 10 people)

• headache (cephalalgia) Common (may affect up to 1 in 10 people)
• dizziness
• weakness (asthenia)
• increased heart rate (tachycardia)
• low 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 and temporary loss of consciousness)
• flushing
• allergic skin reactions

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

• nausea
• vomiting Very rare (may affect up to 1 in 10,000)
• inflammatory skin disease resulting in cracking and scaling (exfoliative dermatitis)

Not known (frequency cannot be estimated from 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 methemoglobin (methemoglobinemia).
• drowsiness

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

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 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 which is stated on the packaging. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
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 to protect
the environment.
Do not store at a temperature above 30 °C.

6. Contents of the pack and other information

What Ismo contains

• The active substance is: isosorbide-5-mononitrate 1 tablet contains isosorbide-5-mononitrate 20 mg. The other ingredients are: anhydrous lactose, highly dispersed anhydrous silicon dioxide, magnesium stearate.

Description of the appearance of Ismo and contents of the pack
White, round tablets, with the imprint "BM 3B" and an incision line on each side.
Ismo 20 is available in packs of 50 tablets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Esteve Pharmaceuticals GmbH, Hohenzollerndamm 150-151, 14199 Berlin, Germany
Manufacturer
Kern Pharma, SL, Polígon Industrial Colón II, Venus 72, 08228 Terrassa (Barcelona), Spain.