Isosorbe 40 mg. 30 tablets

What is Isosorb and what is it used for?

Isosorb contains isosorbide mononitrate, which belongs to the group of medicines called organic nitrates. They act on the cardiovascular system (heart and blood vessels). The drug is used to reduce the frequency of angina attacks (chest pain). Extended-release capsules are designed to allow isosorbide mononitrate to be released and absorbed slowly into the body over a period of several hours.

In angina pectoris, isosorbide mononitrate works by widening the arteries that supply blood and oxygen to the heart muscle and reduces the risk of angina pectoris (chest pain) that occurs when the heart is strained.

2. What should you know before taking Isosorb?

Do not take Isosorb if:

you are allergic to isosorbide mononitrate, other nitrates (glyceryl trinitrate or isosorbide dinitrate) or any of the other ingredients of Isosorb listed in section 6.

you are taking sildenafil, vardenafil or tadalafil to treat erectile dysfunction in men;

you suffer from low blood pressure (systolic pressure lower than 90 mm Hg);

you have a sharp and sudden drop in blood pressure (circulatory collapse, cardiogenic shock).

Warnings and precautions

Talk to your doctor before taking Isosorb if:

you have narrowed heart valves;

you feel dizzy or faint when you stand up (orthostatic hypotension);

you have a disease of the brain associated with increased pressure in the cranial cavity;

you have an acute attack of chest pain (acute angina pectoris), acute heart attack or weakness of the heart muscle (left ventricular heart failure);

you have disease and enlargement of the heart muscle, thickening of the lining of the heart (hypertrophic obstructive cardiomyopathy, constrictive pericarditis) or the lining of the heart is filled with fluid (pericardial tamponade).

Taking Isosorb can lead to a transient decrease in the flow of oxygen to the heart muscle and increase the strength of chest pain. If your symptoms worsen during treatment with Isosorb, inform your doctor immediately.

Other drugs and Isosorb

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, such as:

drugs for high blood pressure (eg, drugs from the group of beta-blockers, calcium antagonists);

drugs from the group of tricyclic antidepressants for the treatment of depression;

medicines from the neuroleptic group to treat certain mental illnesses.

Taking these medicines with Isosorb may increase the risk of low blood pressure.

Do not take sildenafil, vardenafil and tadalafil for the treatment of erectile dysfunction together with Isosorb. This can lead to a severe drop in blood pressure.

Tell your doctor if you are taking medicines containing dihydroergotamine (used to treat migraines) at the same time as Isosorb, as this may cause your blood pressure to rise excessively.

Taking Isosorb with food, drinks and alcohol

Do not take alcohol at the same time as Isosorb, as there is a risk of an excessive drop in blood pressure, dizziness, drowsiness or fatigue.

Fertility, pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

There are no clinical data on the use of Isosorb during pregnancy. Isosorb can be administered to pregnant women only at the discretion of the physician if the potential benefit to the pregnant woman outweighs the risk to the fetus.

Driving and using machines

During treatment with Isosorb, dizziness, drowsiness or fatigue may occur, especially at the beginning of treatment, when increasing the dose, switching to other drugs or taking alcohol. This should be taken into account when driving or operating machinery.

Isosorb contains lactose

Isosorb contains lactose. If you know that you have an intolerance to some sugars, ask your doctor before taking Isosorb.

3. How to take Isosorb?

Always take Isosorb exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

The capsules should be swallowed whole without chewing with a sufficient amount of water (eg with a glass of water).

Your doctor will decide what initial dose you should take and whether it needs to be increased depending on your condition and whether you are taking any other medicines. Do not change the dose you are taking unless directed to do so by your doctor.

Children:

In children, the safety and effectiveness of the product has not been proven.

If you have taken more than the required dose of Isosorb

If you have taken more than the required dose of Isosorb than prescribed (a situation known as an overdose), contact your doctor immediately or go immediately to the nearest medical facility, taking the medicine package with you.

If you forget to take Isosorb

You should take Isosorb as it is for you

If you have stopped taking Isosorb

Do not stop taking your medicine suddenly. Your doctor will explain how to reduce the dose and subsequently stop taking Isosorb.

If you have any further questions related to the use of this medicinal product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Isosorb can cause side effects, although not everybody gets them.

The most commonly reported adverse reaction is headache. Headache may affect between 1 and 10 patients in every 10 treated and decreases gradually with time and duration of use.

Other side effects are:

Common (may affect between 1 and 10 patients in every 100 treated):

Dizziness;

Fatigue.

Uncommon (may affect between 1 and 10 patients in every 1,000 treated):

Drowsiness;

Worsening chest pain, slow and irregular heartbeat (bradyarrhythmia), drop in blood pressure when standing up that causes dizziness, lightheadedness or fainting (orthostatic hypotension), fast heartbeat (reflex tachycardia);

Short-term fainting or fainting (syncope), excessive drop in blood pressure and deterioration of blood circulation (circulatory collapse);

Nausea, vomiting;

Skin rashes (exfoliative dermatitis, allergic skin reactions);

5. How to store Isosorb?

Keep out of the reach of children.

To be stored at a temperature below 25 °C. Store in the original package to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Isosorb contains:

The active substance is: isosorbide mononitrate.

The other ingredients are: hypromellose, carnauba wax, stearic acid, lactose monohydrate, magnesium stearate; for the shell: talc, hypromellose, titanium dioxide, magnesium stearate, silicon dioxide colloidal anhydrous, macrogol 400, yellow iron oxide (E 172).

What does Isosorb look like and what does the package contain?

Isosorb 40 mg extended-release tablets

Round, biconvex, cream-colored tablets marked “IM40” on one side.

10 pieces in a PVC/PVDC aluminum foil blister. 3 blisters in one package and a leaflet for the patient.

Isosorb 60 mg extended-release tablets

Elliptical tablets of cream color, with a dividing line on both sides and marking "60" from

one side.

10 pieces in a PVC/PVDC aluminum foil blister. 3 blisters in one package and a leaflet for the patient.