Monodur 60 Mg 30 Tablets

BRIEF PRODUCT INFORMATION

1. NAME OF HUMAN MEDICINAL PRODUCT

MONODUR® 60 mg elongated (durules®) tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipients:

See section 6.1 for excipients.

3. PHARMACEUTICAL FORM

Extended effective tablet.

Extended tablets are light yellow, 7x13 mm sized, oval, notched, and one side A / ID marked tablets.

4. CLINICAL FEATURES

4.1. Therapeutic indications

Coronary artery disease is indicated for the prevention of angina attacks.

4.2. Posology and method

of administration/ duration and duration of administration:

Poses MONODUR® is used for prophylactic treatment. The dose is individual and should be adjusted according to the patient's clinical response. MONODUR® Extended Action Tablet is taken in the morning in a single dose per day.

In the beginning of treatment; In order to reduce the likelihood of headache, 30 mg per day can be given for 2-4 days.

Normal dose: 60 mg per day. If necessary, the dose can be increased to 120 mg per day.

There is a risk of developing tolerance for nitrate treatment. Therefore, it is important to take a single dose per day to ensure that nitrate concentrations are reduced at a certain time interval, thus reducing the risk of developing tolerance.

MONODUR®, if required; beta adrenergic receptor blockers and calcium antagonists.

Method of

administration MONODUR® tablets can be divided. The tablets or half tablet should be swallowed with half a glass of liquid without crushing and chewing.

Additional information on special populations:

Pediatric population: The safety and efficacy of MONODUR® in children has not been established.

Geriatric population: There is no evidence of routine dose adjustment in elderly patients.

Renal / hepatic failure: Renal or hepatic dysfunction has no major effect on the pharmacokinetic properties and usually does not require dose adjustment.

4.3. Contraindications

- shock, hypotension, constrictive cardiomyopathy, constrictive pericarditis, and the case of pericardial tamponade

- may cause hypotension guanylate cyclase stimulating the use with riosiguat

- hypersensitivity to any of the active substances and auxiliary agents

- phosphodiesterase type 5 inhibitors (such as sildenafil), together withuse

contraindicated in case of.

4.4. Special warnings and precautions for use In

patients with severe cerebrovascular disease, increased intracranial pressure, aortic stenosis, mitral stenosis and hypertrophic obstructive cardiomyopathy, anemia, hypoxemia and hypothyroidism should be used with caution in patients.

4.5. Interactions with other medicinal products and other forms of interaction

The following combination should be avoided:

Phosphodiesterase type 5 inhibitors (sildenafil, etc.): Patients with nitroglycerin products may also suffer from severe drop in blood pressure, which may result in permanent damage to the heart and brain, and may cause ischemia and circulatory disorders, as well as phosphodiesterase type 5 inhibitors. (sildenafil, etc.) is contraindicated.

Concomitant use of riosiguate, a stimulant of soluble guanylate cyclase, and MONODUR® may cause hypotension. Therefore, concomitant use of MONODUR® and riociguat is contraindicated (see section 4.3).

Alcohol should not be used as alcohol will increase the effect and undesirable effects of this drug.

4.6 Pregnancy and lactation

General advice

Pregnancy category: C

Women with childbearing potential / Contraception

No interaction studies have been conducted between MONODUR® tablets and oral contraceptives.

Pregnancy

There was no increase in the damage of the drug on fetus in preclinical studies with experimental animals. According to the limited clinical experience on pregnant women, MONODUR® should only be used during pregnancy if the potential benefit for the mother is determined to be greater than the potential risk for the fetus.

lactation period

There is no information about whether MONODUR® is excreted in breast milk. Therefore, it should not be used in lactation period unless it is considered necessary by the physician.

Fertility No

data available.

4.7. Effects onedrive and use machines The use of course

ability to MONODUR® may dizziness, and this should be taken into consideration when special attention is required, for example, when using vehicles and machinery.

8.4. Undesirable effects

The majority of side effects depend on the pharmacological properties and dose of the drug. At the beginning of the treatment, 25% of the patients may have headaches. This effect depends on the vasodilator effect of the drug and usually disappears within a week. Headache can be prevented by administering a dose of 30 mg for the first 2-4 days at the start of treatment.

A drop in blood pressure may cause reflex tachycardia, dizziness and fainting.

Undesirable effects are listed below according to the system organ class and incidence. Frequency classification: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1 / 1,000 to <1/100), infrequently (> 1 / 10,000 to <1 / 1,000 ), very rare (<1 / 10,000) and unknown (unpredictable).

Nervous system diseases:

Common: Headache, dizziness

Sparse: Fainting

Cardiac diseases:

Common: Tachycardia

Vascular diseases:

Common: Hypotension

Gastrointestinal diseases:

Common: Nausea

Uncommon: Vomiting, diarrhea

Skin and subcutaneous tissue disorders:

Infrequent: Rash , pruritus,

musculoskeletal disorders, connective tissue and bone disorders:

Very rare: Myalgia

the reporting of suspected adverse reactions:

the reporting of suspected adverse drug reactions post-registration is of great importance. Reporting provides a continuous monitoring of the benefit / risk balance of the drug. Any suspected adverse reactions to health professionals Turkey Pharmacovigilance Center (TÜFAM) What must inform. (www.titck.gov.tr; e-mail: [email protected]; tel: 0 800 314 00 08; fax: 0312 218 35 99)

4.9. Overdose and treatment The Overdose

experience ofis limited. No symptoms were observed with a dose of 20 mg given to children aged 2 years and 5 years.

Symptoms:

Throbbing headache, excitation, redness of the skin, cold sweating, vomiting, dizziness, syncope, tachycardia, palpitation and drop in blood pressure. Very high doses may cause methemoglobinemia (very rarely).

Treatment:

If necessary, gastric lavage is performed within the first hour and activated carbon is given. If blood pressure drops, intravenous fluid should be administered.

Symptomatic treatment: (methionine 1-2 mg / kg should be given slowly if there is cyanosis as a result of methemoglobinemia).

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Vasodilators used in heart disease, organic nitrates

ATC code: C01DA14

MONODUR® is an extended effective tablet form of isosorbide-5-mononitrate, an active metabolite of isosorbide dinitrate. Nitrate compounds provide dose-dependent relaxation in smooth muscles. The effectiveness of treatment depends on dose and individual sensitivity. Low doses lead to venous dilatation and lead to a reduction in venous return to the heart (reduced boot). In addition to venous dilatation, high doses lead to dilatation in the arteries and reduce systemic vascular resistance (decreased sequelae). Isosorbide-5-mononitrate reduces the load of the heart as a result of venous and arterial dilatation and can also provide vasodilatation in the coronary arteries by direct effect. Reduction of the end-diastolic pressure and the amount of blood returning to the heart decreases the intramural pressure and increases the subendocardial blood flow. As a result, in patients who are given isosorbide-5-mononitrate, the workload of the heart is reduced and the oxygen saturation of the myocardium is improved.

MONODUR® is used in prophylactic treatment of angina pectoris. The effect time measured by the exercise tests continues for at least 12 hours. At this point, the plasma concentration is about 1-200 hours (about 1300 nmol / L) after drug administration.

For long-term treatment with nitrates, there is a risk of development of tolerance from individual to individual. For this reason, MONODUR® should be administered as a single dose daily to provide an interval in which the nitrate concentration decreases.

MONODUR® tablets have an insoluble matrix portion, the matrix is ​​usually broken down as a result of intestinal peristalsis. While the active substance is dissolved during the passage of the tablet through the gastrointestinal tract, the tablet can be disintegrated into feces.

5.2. Pharmacokinetic Properties

General characteristics

Absorption: The

effect of MONODUR® starts within one hour after collection. Bioavailability is about 90%. Absorption is not affected by food. The active substance is released independently and independently of the pH of the medium and this process is completed in about 10 hours.

Distribution: If

a single dose of 60 mg of MONODUR® is administered orally once a day, the maximum plasma concentration (approximately 3000 nmol / L) is reached after approximately 4 hours of ingestion. The plasma concentration slowly decreases to 500 nmol / L towards the end of the dosing interval (24 hours after the drug is taken up) after administration of the drug. The dispersion volume of the isosorbide-5-mononitrate is about 0.6 L / kg.

Biotransformation:

MONODUR is not metabolized from the liver during the first pass.

Elimination:

Total clearance is 115 mL / min. Its elimination occurs mainly in the liver, where it is converted into inactive metabolites by denitration and conjugation. Metabolites are mainly excreted via the kidney. Only 2% of the administered dose is excreted unchanged from the kidneys.

Liver and renal failure has no significant effect on the clinical effect of MONODUR®.

5.3. Preclinical safety data No

data available

6. PHARMACEUTICAL PROPERTIES

6.1. List of excipients

Aluminum silicate

Paraffin wax

Hydroxypropyl cellulose

Magnesium stearate

Colloidal silicon

Hydroxypropylmethyl cellulose

Polyethylene glycol 6000

dioxide Titanium dioxide (E 171)

Yellow iron oxide (E 172)

6.2. Incompatibilities Not

applicable.

6.3. Shelf life

36 months

6.4. Special precautions for storage

should be stored at room temperature below 30ºC and protected from excessive moisture.

6.5. Nature and contents of the packaging

PVC al blister containing 30 tablets

6.6. Disposal of other residues and other special precautions have not been

The products or waste materials that used must be disposed of in accordance with the 'Regulation on Control of Medical Wastes' and 'Regulation on Control of Packaging and Packaging Wastes'.