Modet турецкие таблетки инструкция по применению на русском языке

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   MODET 1000 MG FİLM TABLET — kullanma tali̇mati, ne için kullanılır, yan etkileri, zararları, doz

MODET 1000 mg Tablet Kullanmadan önce dikkat edilmesi
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Ruhsat Sahibi

Üretici

MODET İlaçları

• MODET 500 mg 60 kapsül

Modet Film Tablet is a pharmaceutical product containing calcium dobesilate monohydrate as its active ingredient, formulated as a film-coated tablet for oral administration. This medication is primarily prescribed for treating circulation disorders in small blood vessels, with specific applications in diabetic eye disease, venous insufficiency, and hemorrhoidal conditions. Manufactured by Santa Farma İlaç Sanayi A.Ş., a Turkish pharmaceutical company, Modet has gained recognition for its vasoprotective properties and its ability to improve microcirculation in various vascular disorders.

Composition and Formulation

Each Modet film-coated tablet contains 1000 mg of calcium dobesilate monohydrate as the primary active ingredient. The chemical name for this compound is calcium 2,5-dihydroxybenzenesulfonate monohydrate, which is a synthetic product with vasoprotective properties. In addition to the active ingredient, Modet contains several excipients that contribute to its physical properties and stability, including croscarmellose sodium, magnesium stearate, and a film coating mixture containing hypromellose, titanium dioxide (E171), macrogol, quinoline yellow aluminum lake, talc, and indigo carmine aluminum lake. The tablets are green-colored, oblong-shaped, and feature a score line that allows for easier splitting if necessary.

Pharmacological Properties

Mechanism of Action

Calcium dobesilate, the active component in Modet, works through multiple mechanisms to improve microcirculation and vascular health. It acts primarily on capillary walls by regulating impaired physiological functions, specifically addressing increased permeability and decreased resistance. This vasoprotective agent stabilizes the blood-retinal barrier of capillaries, reducing retinal blood exudation and maintaining normal dilution factors in blood.

Pharmacodynamic Effects

The therapeutic effects of Modet are multifaceted:

1. It reduces blood hyperviscosity and improves rheological properties, enhancing blood flow and tissue irrigation, which is particularly beneficial in diabetic retinopathy.

2. It increases erythrocyte (red blood cell) flexibility, allowing for improved circulation through smaller vessels.

3. It inhibits platelet hyperaggregation, thereby reducing the tendency toward thrombosis and improving circulation.

4. It reduces capillary hyperpermeability, leading to decreased edema (swelling) in affected tissues.

5. It improves lymphatic drainage, further helping to reduce peripheral edema.

Pharmacokinetics

Following oral administration, calcium dobesilate is rapidly absorbed from the gastrointestinal tract with approximately 80% bioavailability. After ingestion of a 500 mg dose, blood levels peak at around 8 μg/ml between 3 and 10 hours post-administration. The compound has limited protein binding (20-25%) and is primarily eliminated through the kidneys, with approximately 50% excreted unchanged in urine and 50% in feces. The elimination half-life ranges from 1 to 5 hours.

Medical Uses and Indications

Diabetic Microangiopathy

Modet is primarily indicated for the treatment of microangiopathies, with a particular focus on diabetic retinopathy. Diabetic retinopathy involves damage to the blood vessels in the retina and is a common complication of diabetes. Clinical studies have shown that calcium dobesilate can reduce retinal hemorrhages and improve visual fields in patients with diabetic eye disease.

Chronic Venous Insufficiency

Modet is indicated for the treatment of clinical signs of chronic venous insufficiency in the lower limbs, including pain, cramps, paresthesia, edema, and stasis dermatosis. It helps alleviate symptoms by improving circulation and reducing edema in affected limbs.

Hemorrhoidal Disorders

The medication is also prescribed for hemorrhoidal syndromes and post-thrombotic syndrome, where it helps reduce inflammation, pain, and bleeding associated with hemorrhoids by improving local circulation.

Other Microcirculation Disorders

Additional indications include microcirculation disorders of arteriovenous origin and other conditions where improved blood flow to small vessels is beneficial.

Dosage and Administration

Standard Dosage

For adult patients, the recommended dosage of Modet is typically:

• General treatment: 1000 to 2000 mg (1-2 tablets) daily, usually divided into morning and evening doses.

• For diabetic microangiopathy: Initial treatment of 1.5-2 g/day, followed by a maintenance dose of 1 g/day.

• For other vascular disorders and hemorrhoids: 0.5-1 g/day, depending on the severity of the condition.

Administration Method

Modet tablets should be taken orally with a sufficient amount of water, preferably during or immediately after meals to minimize gastric discomfort. The tablets should be swallowed whole and not crushed or chewed.

Duration of Treatment

The duration of treatment varies based on the condition being treated and individual response:

• For acute conditions, shorter courses may be sufficient.

• For chronic conditions like diabetic retinopathy, longer-term therapy under medical supervision may be necessary.

• Generally, treatment duration should be determined by a healthcare provider based on clinical response.

Special Populations

• Renal impairment: Dosage should be reduced in patients with severe renal impairment, particularly those requiring dialysis.

• Hepatic impairment: Specific dosage adjustments for hepatic impairment are not well established, but caution is advised.

• Elderly patients: No specific dosage adjustment is required for elderly patients, but careful monitoring is recommended.

Precautions and Warnings

General Precautions

Patients taking Modet should be aware of several important precautions:

1. For patients with diabetic eye problems, it is essential to strictly follow dietary recommendations and continue other medications prescribed for blood sugar control.

2. For venous disorders, especially varicose veins, lifestyle modifications are crucial, including weight management, avoiding prolonged standing, and elevating legs when resting.

3. Regular medical follow-up is important during treatment to monitor efficacy and potential side effects.

Special Warnings

In very rare cases, calcium dobesilate may induce agranulocytosis (severe decrease in white blood cells), likely linked to a hypersensitivity reaction. Patients experiencing fever, sore throat, infection of the mouth (tonsillitis), or genital inflammation during treatment should immediately discontinue Modet and consult their healthcare provider. Blood counts and other appropriate tests may be necessary in such cases.

Contraindications

Modet is contraindicated in the following circumstances:

1. Hypersensitivity to calcium dobesilate or any of the excipients in the formulation.

2. Moderate to severe hepatic impairment, although specific information for Modet is limited.

3. Generally not recommended during pregnancy unless clearly necessary.

Side Effects

Common Side Effects

The most frequently reported side effects of Modet include:

1. Gastrointestinal disturbances:

   • Nausea

   • Diarrhea

   • Vomiting

   • Abdominal pain

2. Other common effects:

   • Itching

   • Headache

These side effects are generally mild and transient. If they persist or become bothersome, patients should consult their healthcare provider.

Serious Side Effects

Though rare, serious adverse effects may occur and require immediate medical attention:

1. Agranulocytosis (severe decrease in white blood cells), which may manifest as:

   • Ulcers in the skin, throat, intestines, or other mucous membranes

   • Infections

   • Fever

2. Hypersensitivity reactions:

   • Skin rash

   • Fever

   • Joint pain

   • Changes in blood formula

If any serious side effects occur, the medication should be discontinued immediately, and medical help should be sought.

Drug Interactions

No significant drug interactions have been reported with calcium dobesilate based on available data. However, as with any medication, patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking before starting Modet.

Laboratory Test Interactions

Calcium dobesilate may interfere with certain laboratory measurements, potentially causing:

• Underestimation of serum creatinine levels

• Interference with measurements of uric acid, cholesterol, triglycerides, and HDL-cholesterol levels (showing lower than actual values)

Healthcare providers should be aware of these potential interferences when interpreting laboratory results.

Use in Special Populations

Pregnancy and Breastfeeding

• Pregnancy: Modet is not recommended during pregnancy unless clearly necessary due to limited data on safety.

• Breastfeeding: Calcium dobesilate passes into breast milk in small amounts. A decision should be made whether to discontinue breastfeeding or to discontinue the medication, taking into account the importance of the medication to the mother.

Pediatric Use

The safety and efficacy of Modet in children and adolescents under 18 years have not been established, and therefore its use is not recommended in this population.

Elderly Patients

No specific dosage adjustments are required for elderly patients (65 years and older), but careful monitoring is advisable due to the higher likelihood of impaired organ function in this population.

Renal Impairment

In patients with severe renal impairment, especially those requiring dialysis, dosage reduction is necessary due to the prolonged elimination half-life of domperidone in these patients.

Storage and Handling

Modet film tablets should be stored:

• At temperatures below 25°C

• In the original packaging to protect from moisture and light

• Out of the sight and reach of children

The medication should not be used after the expiry date stated on the packaging. Any unused product should be disposed of according to local requirements.

Comprehensive Information Table

Conclusion

Modet Film Tablet, containing 1000 mg of calcium dobesilate monohydrate, is an effective medication for treating various microcirculation disorders, particularly diabetic retinopathy, chronic venous insufficiency, and hemorrhoidal conditions. Its multifaceted mechanism of action addresses several pathophysiological aspects of vascular disorders, including blood hyperviscosity, platelet aggregation, and capillary permeability.

While generally well-tolerated, Modet carries the risk of rare but serious side effects, particularly agranulocytosis, necessitating careful monitoring and prompt medical attention if concerning symptoms arise. The medication should be used under medical supervision, with adherence to prescribed dosages and regular follow-up to assess efficacy and safety.

As with all medications, the benefits and risks of Modet should be carefully weighed for each individual patient, with particular caution in special populations such as pregnant women, breastfeeding mothers, and those with severe renal impairment. Proper storage and handling are essential to maintain the medication’s stability and efficacy throughout its shelf life.

тонкая брошюра

                                1
KULLANMA TALİMATI
MODET
 500 MG KAPSÜL
AĞIZDAN ALINIR.
_ETKIN MADDE: _Bir kapsül; etkin madde olarak 479.38 mg kalsiyum
dobesilata eşdeğer 500 mg
kalsiyum dobesilat monohidrat içerir.
_YARDIMCI MADDELER: _Mısır nişastası, magnezyum stearat,
kırmızı demir oksit, titanyum dioksit,
sarı demir oksit, sığır kaynaklı jelatin, indigo karmin-FD&C mavi
2, siyah demir oksit.
BU ILACI KULLANMAYA BAŞLAMADAN ÖNCE BU KULLANMA TALİMATINI
DIKKATLICE
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER I�
                                
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Характеристики продукта

                                1
KISA ÜRÜN BİLGİSİ
1. BEŞERİ TIBBİ ÜRÜNÜN ADI
MODET

500 mg kapsül
2. KALİTATİF VE KANTİTATİF BİLEŞİM
ETKIN MADDE
Her kapsül 479.38 mg kalsiyum dobesilata eşdeğer 500 mg kalsiyum
dobesilat monohidrat
içerir.
YARDIMCI MADDELER
Yardımcı maddeler için, bakınız 6.1.
3. FARMASÖTİK FORM
Sert jelatin kapsül
4. KLİNİK ÖZELLİKLER
4.1. TERAPÖTIK ENDIKASYONLAR
•
Mikroanjiopatide (özellikle diabetik retinopatide)
•
Ağrı, kramp ve tembellikle seyreden kronik venöz yetmezliği
                                
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