Monoket 20 Tablets

OPERATING INSTRUCTIONS

MONOKET® 20 mg Tablets

are taken orally.

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

Keep these instructions for use. You can need to read again.

If you have other questions, please talk your doctor or pharmacist.

This drug has been prescribed for you personally, please do not give to others.

When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

Follow exactly what is written in this instruction. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is MONOKET and what is it used for?

MONOKET is used in heart disease, vasodilator drug group (organic nitrates) are included.

Tablets are white and round shaped and the upper face is smooth notched and the lower face is curved. The tablet can be divided into two equal parts. One box contains 20 tablets.

MONOKET is the prevention of sudden chest pains (angina pectoris) due to heart failure and lack of adequate oxygen due to heart disease (coronary disease) of the heart. It is used in the treatment.

2. monoketone the need to be considered before using

monoketone Do NOT use in the following cases

Isosorbide mononitrate is, if you are hypersensitive to other nitrate compounds or the help that contain substances,

if you spend shock due to heart disease,

obstructing your heart muscle disease (hypertrophic obstructive cardiomyopathy), if any,

heart membrane you inflammation (pericarditis), if any,

if the formation of liquid between your heart muscle, your heart skinning (cardiac tamponade),

if you have sudden circulatory disorders (shock, collapse),

the blood pressure is too low (to be greater blood pressure of 90 mmHg)

severe anemia, a serious blood volume (hypovolemia) or increased intraocular pressure (narrow angle glaucoma) If you

have bleeding (cerebral hemorrhage)

Head trauma (head impact)

During the nitrate treatment, products containing phosphodiesterase inhibitors that can be used in men's hardening problem (sild Do not use enafil, tadalafil, vardenafil) (see section on use with other drugs).

USE MONOKET CAREFULLY If you

have a heart attack, if you have a low heart filling pressure in the form of impaired left heart function (left ventricular failure), if you

have aortic valve and / or mitral valve disease with heart valves, If you have

elevated intracranial pressure-related diseases ( increased intracranial pressure, only high-dose nitroglycerin was observed by vascular access.)

Standing up your blood pressure is falling If you have

severe liver and kidneys

due to the lack of thyroid hormones due to the low work (hypothyroidism), body temperature falls (hypothermia), nutritional deficiency ( malnutrition If you have a disease,

especially in patients with circulatory circulation, the symptoms of circulatory collapse may be increased after the first tablet.

Low blood pressure due to nitrate may be accompanied by slow heart attack (paradoxical bradycardia) and heart attack attack (angina).

The onset of effect of MONOKET is not fast enough to use for the treatment of sudden cardiac pain (angina) attacks.

Tolerance development (decreased effect over time) and cross-tolerance development against other nitrate components (decreased efficacy if another nitrate drug was used in previous therapy) was defined. Continuous use of high doses should be avoided to prevent the loss or loss of the drug.

Patients treated with MONOKET should be told that they should not use products containing phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil).

MONOKET treatment should not be interrupted to take products containing phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil), as this may increase the risk of sudden onset of heart attacks (see section on co-administration with other drugs).

MONOKET may cause low blood pressure (postural hypotension) and fainting in some patients. Low blood pressure (postural hypotension) was frequently observed when he was standing up with dizziness and dizziness.

Treatment with MONOKET should not be stopped suddenly, as in other nitrates. Both dosage and dosage frequency should be reduced gradually.

Since the drug contains lactose, it should not be taken by patients with rare hereditary diseases such as galactose intolerance, Lapp-lactase deficiency and glucose-galactose malabsorption.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using MONOKET with food and drink

MONOKET has no interaction with food and beverages.

Do not use with alcohol.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Since there is not enough experience in the use of MONOKET in pregnant women, use only when necessary and in the control of your doctor.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

There is no sufficient or conclusive evidence to show the risk on the newborn during breastfeeding. There is evidence that nitrates lead to milk and cause methemoglobinemia in the newborn. The proportion of isosorbide-5-mononitrate to human milk has not been determined yet. Therefore, if you are breastfeeding, use MONOKET only when necessary and under the control of your doctor.

Use

of tools and machinery MONOKET may affect your response and impair your ability to drive and use machines. This effect increases when used with alcohol.

Important information about some of the ingredients of

MONOKET contains MONOKET lactose. If you have been told by your doctor that you are sensitive to some sugars, consult your doctor before using this medicine.

Concomitant use with other drugs

Simultaneous use of some drugs with reduced blood pressure (beta blockers, calcium channel blockers, vasodilators) and / or alcohol may strengthen MONOKET's blood pressure (hypotensive) effect. This situation can be seen with drugs used in the treatment of depression (mental depression).

The combination of products containing phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil) increases the blood pressure lowering effect of MONOKET (see sections that should not be used and should be used with caution). This may cause life-threatening heart problems. Therefore, patients using MONOKET should not use products containing phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil).

Reports suggest that with MONOKET, when dihydroergotamine is used, the effect of dihydroergotamine on blood levels and blood pressure may increase.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How is MONOKET used?

Instructions for appropriate use and dose / frequency of administration:

Your doctor will adjust the required MONOKET dose and duration of treatment according to the condition of your disease.

If your MONOKET doctor does not recommend otherwise, take 1 tablet (equivalent to 40 mg isosorbide mononitrate) twice a day, the second dose is taken 8 hours after the first dose. In patients in need of higher nitrate, the dose can be increased to 1 tablet (equivalent to 60 mg isosorbide mononitrate) 3 times a day. In this case, a tablet is taken every 6 hours.

Method and method of:

administrationRemove the tablets as a whole with a glass of water without chewing.

Different age groups:

Use: The in children safety and efficacy of MONOKET on children has not yet been determined.

Use in the elderly:

There is no evidence that dose adjustment is required in elderly patients.

It should be used as recommended by the doctor.

Special Use Conditions:

Renal failure / liver failure

If you have a different degree of kidney and liver disease, no dose adjustment is required. However, severe liver, kidney diseases should be used carefully and under medical supervision.

Unless your doctor recommends otherwise follow these instructions.

Do not forget to take your medication in time.

Your doctor will tell you how long your treatment will take with MONOKET. Do not cut the treatment early because you cannot get the desired result.

If you have an impression that the effect of MONOKET is too strong or too weak, talk to your doctor or pharmacist.

If you have used more MONOKET than you should use,use from

talk to a doctor or pharmacist if you have used more than you shouldMONOKET.

In case of overdose, increased heart rate (tachycardia), serious decrease in blood pressure (hypotension), pallor, sweating, weak heartbeat, dizziness, headache, power loss, dizziness, nausea, vomiting and diarrhea may occur.

A type of poisoning (methemoglobinemia) has been reported in patients receiving other organic nitrates, but this does not indicate that the isosorbide mononitrate will also occur in overdose. This condition, called methemoglobinemia, may include bruising (cyanosis), rapid breathing, unconsciousness and cardiac arrest on the fingers and lips.

Again, high doses may lead to increased intracranial pressure and some other symptoms related to the brain.

If you forget to use MONOKET,bypass the missed

your doctor will decide when todose.

It is important that you follow the instructions of your doctor for the new administration time of the following dose.

Do not take double doses to compensate for forgotten doses.

Effects when treatment with MONOKET is terminated Treatment with MONOKET should not be

stopped suddenly, as in other nitrates. Both dosage and dosage frequency should be reduced gradually. Doing so may cause withdrawal (withdrawal) symptoms.

4. What are the possible side effects?

Like all medicines, there may be side effects in individuals who are sensitive to the substances contained in MONOKET.

Very common (1/10); common (1/100 - <1/10); uncommon (1 / 1.000 - <1/100), infrequent (1 / 10.000 - <1 / 1.000), very rare (<1 / 10.000), unknown (unpredictable from available data).

Nervous system disorders

Very common: Headache

Common: Dizziness (including dizziness while standing) Drowsiness

Heart disorders

Common: Increase in heart rate

Uncommon: Increased complaints of heart spasm (angina pectoris)

Vascular disorders

Common: Falling blood pressure while getting up (orthostatic hypotension)

Uncommon: the bankruptcy of one of Circulation (collapse) (slowing of heart rate (bradycardia), and fainting (syncope) as related)

Unknown: Low blood pressure (hypotension)

Gastrointestinal system

disorders: Uncommon:Nausea, vomiting

Very rare: Heartburn

Skin and subcutaneous tissue disorders

Uncommon: allergic skin reactions (eg rash), flushing

Very sparse: face and throat swelling (angioedema) as a result of allergies, called Stevens Johnson syndrome, is a rare disease caused by drug allergy.

Unknown: Skin inflammation with redness and crusting in some cases

General disorders and diseases of the application area

Common: Exhaustion

Symptoms of severe hypotension (nausea), including nausea, vomiting, restlessness, pallor and frequent breathing, have been reported for organic nitrates.

During treatment with MONOKET, temporary oxygen may be seen due to the relative redistribution of blood flow due to low ventilation in the lung. In patients with coronary artery disease, this may lead to less oxygenation of the heart muscle (myocardial hypoxia).

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

5. Storage of

MONOKET Keep MONOKET out of the reach of children and in its packaging.

Store at room temperature below 25 ° C.

Use in accordance with the expiry date

Do not use MONOKET after the expiration date in the packaging / carton / bottle.

The first two digits of the expiration date are the month, the last four digits indicate the year.

Do not use MONOKET if you notice any defects in the product and / or its packaging.