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Orlistat (Tablets, Capsules) Instructions for Use

ATC Code

A08AB01 (Orlistat)

Active Substance

Orlistat (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug for the treatment of obesity – inhibitor of gastrointestinal lipases

Pharmacotherapeutic Group

Drugs for the treatment of obesity, except dietary products; drugs for the treatment of obesity of peripheral action

Pharmacological Action

Lipase inhibitor. When taken orally, Orlistat inhibits gastric and pancreatic lipases. As a result, the breakdown of dietary fats is disrupted and their absorption from the gastrointestinal tract is reduced. With systematic use, this effect leads to a decrease in body weight in patients with obesity.

Orlistat is practically not absorbed from the gastrointestinal tract and therefore has almost no resorptive effect.

Pharmacokinetics

Absorption is low. Orlistat is metabolized mainly in the intestinal wall to form pharmacologically inactive metabolites.

97% of the administered dose is excreted in the feces, of which 83% is unchanged orlistat. The cumulative renal excretion of all orlistat metabolites is less than 2% of the administered orlistat dose.

Indications

Obesity (in combination with a moderate-calorie diet).

ICD codes

ICD-10 code Indication
E66 Obesity
ICD-11 code Indication
5B81.Z Obesity, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take one 60 mg capsule or tablet three times daily with each main meal containing fat, or up to one hour after eating.

Ensure the daily fat intake is distributed evenly across all three meals. The maximum daily dose is 180 mg.

Limit the duration of the treatment course to no more than six months without re-evaluation by a physician.

If a meal is missed or contains no fat, omit the dose of orlistat for that meal.

Take a multivitamin supplement containing fat-soluble vitamins (A, D, E, K) at least two hours before or after taking orlistat, or at bedtime.

Adverse Reactions

From the immune system: frequency unknown – skin itching, rash, urticaria, angioedema, bronchospasm, anaphylaxis.

From the digestive system: very common – oily discharge from the rectum, passage of gas with some discharge, imperative urge to defecate, steatorrhea, flatulence; common – abdominal pain, fecal incontinence, loose stools, increased frequency of defecation; frequency unknown – minor bleeding from the rectum, diverticulitis, pancreatitis.

From the liver and biliary tract: frequency unknown – increased activity of “hepatic” transaminases, alkaline phosphatase, hepatitis, cholelithiasis.

From the urinary system: frequency unknown – hyperoxaluria, oxalate nephropathy, which can sometimes lead to the development of renal failure.

From the skin and subcutaneous tissues: frequency unknown – bullous rash.

Other: frequency unknown – feeling of anxiety; with simultaneous use of orlistat and indirect anticoagulants, a decrease in plasma prothrombin concentration and an increase in the international normalized ratio (INR) were noted.

Contraindications

Hypersensitivity to orlistat; chronic malabsorption syndrome, cholestasis; simultaneous use with warfarin or other oral indirect anticoagulants, concomitant therapy with cyclosporine, simultaneous use with sitagliptin; pregnancy, lactation period (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Use in Hepatic Impairment

Can be used in patients with impaired liver function according to indications, in recommended doses.

Use in Renal Impairment

Patients with kidney disease should consult a doctor before using orlistat, as the development of oxalate nephropathy is possible, which can sometimes lead to the development of renal failure. An increased risk is noted in patients with chronic renal failure and/or dehydration.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age (efficacy and safety have not been established).

Geriatric Use

Can be used in elderly patients (>65 years) according to indications, in recommended doses.

Special Precautions

Diet and exercise are an important component of a weight loss program. It is recommended to start a dietary program and exercise before starting therapy with orlistat. During the use of orlistat, the patient should receive a moderately hypocaloric diet with a balanced content of nutrients, in which approximately 30% are fats. It is recommended that the diet be rich in fruits and vegetables. The diet and exercise program should be continued even after orlistat use is discontinued.

It must be borne in mind that the frequency and severity of side effects increase with an increase in the fat content in the diet. When the fat content in the diet decreases, the likelihood of side effects decreases. It is recommended that the daily amount of fat consumed be distributed fairly evenly across all meals.

During treatment with orlistat, as body weight decreases, an improvement in the course of pathological processes often accompanying obesity, including arterial hypertension, diabetes mellitus, and lipid metabolism disorders, is possible. Patients with type 2 diabetes mellitus should consult a doctor before starting therapy with orlistat and, if necessary, adjust the dose of hypoglycemic drugs. Patients taking antihypertensive and hypolipidemic drugs together with orlistat should consult a doctor and, if necessary, adjust the dose of these drugs.

If diarrhea occurs while using orlistat, it is recommended to use an additional method of contraception to prevent possible ineffectiveness of oral contraceptives.

If symptoms such as weakness, fatigue, increased body temperature, jaundice and darkening of urine appear, it is necessary to consult a doctor to exclude impaired liver function.

Rare cases of the development of hypothyroidism and/or impaired control of it have been reported with the use of orlistat, which may be due to reduced absorption of iodized salt and/or levothyroxine sodium.

Drug Interactions

With simultaneous use of orlistat and cyclosporine, a decrease in the concentration of cyclosporine in the blood plasma is possible, which can lead to a decrease in the immunosuppressive effectiveness of cyclosporine. Simultaneous use of orlistat and cyclosporine is contraindicated.

With simultaneous use of orlistat with amiodarone, a decrease in the concentration of amiodarone in the blood plasma after a single use was noted. The use of this combination is possible only on the recommendation of a doctor.

With simultaneous use of orlistat and warfarin or other anticoagulants, a decrease in prothrombin concentration and an increase in INR may be observed, which leads to a change in hemostatic parameters. Simultaneous use of orlistat and warfarin or other oral anticoagulants is contraindicated.

Taking orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E, K and beta-carotene). If taking multivitamins is indicated, they should be taken no earlier than 2 hours after taking orlistat or at bedtime.

Orlistat may reduce the absorption of antiepileptic drugs, which may lead to seizures.

Orlistat can indirectly reduce the effectiveness of oral contraceptives, which in some cases can lead to unplanned pregnancy. If diarrhea develops while using orlistat, it is recommended to use an additional method of contraception.

With simultaneous use with levothyroxine sodium, due to reduced absorption of inorganic iodine and/or levothyroxine sodium, hypothyroidism and/or decreased control of hypothyroidism may develop.

Cases of decreased effectiveness of antiretroviral drugs for the treatment of HIV, antidepressants and antipsychotics (including lithium preparations) have been reported, coinciding with the start of orlistat use in previously compensated patients.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle Rx Icon Orlistat Capsules 120 mg: 7, 14, 21, 28, 42, 63, 84, 126, or 252 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #1, with a blue body and cap; the contents of the capsules are a mixture of powder and granules, white or almost white.

1 caps.
Orlistat 120 mg

Excipients: microcrystalline cellulose, sodium carboxymethyl starch type A (sodium starch glycolate, type A), sodium lauryl sulfate, povidone K30, talc.

Composition of the hard gelatin capsule: titanium dioxide, gelatin, patent blue dye.

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
21 pcs. – contour cell packaging (1) – cardboard packs.
21 pcs. – contour cell packaging (2) – cardboard packs.
21 pcs. – contour cell packaging (3) – cardboard packs.
21 pcs. – contour cell packaging (4) – cardboard packs.
21 pcs. – contour cell packaging (6) – cardboard packs.
21 pcs. – contour cell packaging (12) – cardboard packs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle OTC Icon Orlistat Capsules 60 mg: 7, 14, 21, 28, 42, 63, or 84 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #3, with a white body and a blue cap; the contents of the capsules are pellets, white or almost white.

1 caps.
Orlistat* 60 mg

* as orlistat, substance-pellets 50% – 120 mg.

Excipients: microcrystalline cellulose, sodium carboxymethyl starch (sodium starch glycolate), sodium lauryl sulfate, povidone K30.

Composition of the hard gelatin capsule[capsule body: titanium dioxide, gelatin; capsule cap: titanium dioxide, patent blue dye, brilliant black dye, gelatin].

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
21 pcs. – contour cell packaging (1) – cardboard packs.
21 pcs. – contour cell packaging (2) – cardboard packs.
21 pcs. – contour cell packaging (3) – cardboard packs.
21 pcs. – contour cell packaging (4) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Orlistat Capsules 120 mg: 5, 6, 10, 12, 15, 18, 20, 21, 24, 25, 30, 35, 36, 40, 42, 45, 48, 50, 54, 60, 70, 80, 84, 90, 100, 120, or 140 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #0; body and cap are blue, opaque; the contents of the capsules are white or almost white pellets.

1 caps.
Orlistat, substance-pellets 50% 240 mg,
   Equivalent to orlistat content 120 mg

Excipients: microcrystalline cellulose – 98.64 mg, sodium carboxymethyl starch – 10.08 mg, sodium lauryl sulfate – 6.24 mg, povidone K30 – 5.04 mg.

Composition of the capsule body: patent blue dye – 0.2786%, titanium dioxide – 2%, gelatin – up to 100%.
Composition of the capsule cap: patent blue dye – 0.2786%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (7) – cardboard packs.
5 pcs. – contour cell packaging (8) – cardboard packs.
5 pcs. – contour cell packaging (9) – cardboard packs.
5 pcs. – contour cell packaging (10) – cardboard packs.
5 pcs. – contour cell packaging (14) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
6 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (7) – cardboard packs.
6 pcs. – contour cell packaging (8) – cardboard packs.
6 pcs. – contour cell packaging (9) – cardboard packs.
6 pcs. – contour cell packaging (10) – cardboard packs.
6 pcs. – contour cell packaging (14) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (7) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (14) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
42 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
84 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
120 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Orlistat Capsules 60 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 42, 50, 56, 60, 70, 80, 84, 100, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #2; body is light green, cap is light blue, opaque; the contents of the capsules are white or almost white pellets.

1 caps.
Orlistat, substance-pellets 50% 120 mg,
   Equivalent to orlistat content 60 mg

Excipients: microcrystalline cellulose – 49.32 mg, sodium carboxymethyl starch – 5.04 mg, sodium lauryl sulfate – 3.12 mg, povidone K30 – 2.52 mg.

Composition of the capsule body: indigo carmine – 0.017%, iron oxide yellow dye – 0.25%, titanium dioxide – 2%, gelatin – up to 100%.
Composition of the capsule cap: indigo carmine – 0.0312%, titanium dioxide – 4%, gelatin – up to 100%.

7 pcs. – contour cell packaging (1) – cardboard packs.
7 pcs. – contour cell packaging (2) – cardboard packs.
7 pcs. – contour cell packaging (3) – cardboard packs.
7 pcs. – contour cell packaging (4) – cardboard packs.
7 pcs. – contour cell packaging (5) – cardboard packs.
7 pcs. – contour cell packaging (6) – cardboard packs.
7 pcs. – contour cell packaging (8) – cardboard packs.
7 pcs. – contour cell packaging (10) – cardboard packs.
7 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (8) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
21 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
42 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
80 pcs. – jars (1) – cardboard packs.
84 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Orlistat Capsules 120 mg: 5, 10, 15, 20, 25, 30, 40, 45, 50, 60, 80, 90, 100, 120 or 160 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0; body and cap are blue, opaque; capsule contents are white or almost white pellets.

1 caps.
Orlistat, substance-pellets 50% 240 mg,
   Equivalent to orlistat content 120 mg

Excipients: microcrystalline cellulose – 98.64 mg, sodium carboxymethyl starch – 10.08 mg, sodium lauryl sulfate – 6.24 mg, povidone K30 – 5.04 mg.

Capsule body composition: patent blue dye – 0.2786%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: patent blue dye – 0.2786%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
5 pcs. – contour cell blisters (3) – cardboard packs.
5 pcs. – contour cell blisters (4) – cardboard packs.
5 pcs. – contour cell blisters (5) – cardboard packs.
5 pcs. – contour cell blisters (6) – cardboard packs.
5 pcs. – contour cell blisters (8) – cardboard packs.
5 pcs. – contour cell blisters (9) – cardboard packs.
5 pcs. – contour cell blisters (10) – cardboard packs.
5 pcs. – contour cell blisters (16) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (16) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
120 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Orlistat Capsules 60 mg: 5, 10, 15, 20, 25, 30, 40, 45, 50, 60, 80, 90, 100, 120, or 160 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, No. 2; capsule body is light green, cap is light blue, opaque; capsule contents are white or almost white pellets.

1 caps.
Orlistat, substance-pellets 50% 120 mg,
   Equivalent to orlistat content 60 mg

Excipients: microcrystalline cellulose – 49.32 mg, sodium carboxymethyl starch – 5.04 mg, sodium lauryl sulfate – 3.12 mg, povidone K30 – 2.52 mg.

Capsule body composition: indigo carmine – 0.017%, yellow iron oxide dye – 0.25%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: indigo carmine – 0.0312%, titanium dioxide – 4%, gelatin up to 100%.

5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
5 pcs. – contour cell blisters (3) – cardboard packs.
5 pcs. – contour cell blisters (4) – cardboard packs.
5 pcs. – contour cell blisters (5) – cardboard packs.
5 pcs. – contour cell blisters (6) – cardboard packs.
5 pcs. – contour cell blisters (8) – cardboard packs.
5 pcs. – contour cell blisters (9) – cardboard packs.
5 pcs. – contour cell blisters (10) – cardboard packs.
5 pcs. – contour cell blisters (16) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (16) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
120 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bottle Rx Icon Orlistat Canon Capsules 120 mg: 21, 30, 42, 60, 63, 84, 90, or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin No. 1, with a white body and a yellow cap; capsule contents are spherical granules without visible defects, white or almost white in color.

1 caps.
Orlistat 120 mg

Excipients: corn starch pellets – 64.5 mg, macrogol 6000 – 4.13 mg, sodium lauryl sulfate – 9.38 mg, povidone K30 – 36.79 mg, polysorbate 80 (tween 80) – 2.06 mg, talc – 3.14 mg.

Capsule body composition: titanium dioxide – 0.9244 mg, gelatin – 45.2956 mg.
Capsule cap composition titanium dioxide – 0.3971 mg, gelatin – 29.1077 mg, quinoline yellow dye – 0.2739 mg, sunset yellow FCF dye – 0.0013 mg.

7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (6) – cardboard packs.
7 pcs. – contour cell blisters (9) – cardboard packs.
7 pcs. – contour cell blisters (12) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (12) – cardboard packs.
14 pcs. – contour cell blisters (3) – cardboard packs.
14 pcs. – contour cell blisters (6) – cardboard packs.
14 pcs. – contour cell blisters (9) – cardboard packs.
14 pcs. – contour cell blisters (12) – cardboard packs.

Marketing Authorization Holder

Promomed Holdings (Cyprus) Limited LLC (Cyprus)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle OTC Icon Orlistat Mini Film-coated tablets, 60 mg: 10, 20, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light blue with a pearlescent effect, oval, biconvex, with a score on one side and an engraving “f” on the other; on the cross-section – a core of white or almost white color.

1 tab.
Orlistat 60 mg

Excipients: sodium lauryl sulfate – 12 mg, mannitol – 848 mg, copovidone – 20 mg, crospovidone – 50 mg, magnesium stearate – 10 mg.

Film coating composition Opadry II blue (85F30720) – 34.8 mg [polyvinyl alcohol – 40%, titanium dioxide – 21.4%, macrogol 3350 – 20.2%, talc – 14.8%, indigo carmine – 3.5%, quinoline yellow aluminum lake – 0.1%]; Opadry silver (63F97546) – 5.2 mg [polyvinyl alcohol – 47.03%, talc – 27%, macrogol 3350 – 13.27%, pearlescent pigment – 10%, polysorbate 80 – 2.7%].

10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
20 pcs. – glass jars (1) – cardboard packs.

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Dosage Form

Bottle Rx Icon Orlistat-Akrikhin Capsules 120 mg: 21, 42, or 84 pcs.

Dosage Form, Packaging, and Composition

Capsules blue, hard gelatin; capsule size No. 1; capsule contents are white powder or slightly compacted conglomerates.

1 caps.
Orlistat 120 mg

Excipients: microcrystalline cellulose 57.1 mg, sodium starch glycolate 41.5 mg, colloidal anhydrous silicon dioxide 9.1 mg, sodium lauryl sulfate 2.3 mg.

Capsule shell composition hard gelatin capsule No. 1: gelatin 75.14 mg, titanium dioxide (E171) 0.76 mg, indigo carmine (E132) 0.1 mg

7 pcs. – PVC/PVDC/aluminum foil blisters (3) – cardboard packs.
14 pcs. – PVC/PVDC/aluminum foil blisters (3) – cardboard packs.
14 pcs. – PVC/PVDC/aluminum foil blisters (6) – cardboard packs.

Marketing Authorization Holder

Polpharma Pharmaceutical Works, Sa (Poland)

Dosage Form

Bottle OTC Icon Orlistat-Akrikhin Capsules 60 mg: 42, 60, 84, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, No. 3, light blue; capsule contents are white powder or slightly compacted agglomerates.

1 caps.
Orlistat 60 mg

Excipients: microcrystalline cellulose 28.55 mg, sodium starch glycolate 20.75 mg, colloidal silicon dioxide 4.55 mg, sodium lauryl sulfate 1.15 mg.

Capsule shell composition: hard gelatin capsule No. 3 (gelatin 47.01 mg, titanium dioxide 0.96 mg, indigo carmine 0.03 mg).

14 pcs. – PVC/PVDC/aluminum foil blisters (3) – cardboard packs.
14 pcs. – PVC/PVDC/aluminum foil blisters (6) – cardboard packs.
15 pcs. – PVC/PVDC/aluminum foil blisters (4) – cardboard packs.
15 pcs. – PVC/PVDC/aluminum foil blisters (6) – cardboard packs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Form

Bottle Rx Icon Orlistat-Alium Capsules 120 mg: 7, 14, 21, 28, 42, 63 or 84 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, with a blue body and cap; capsule contents are white or almost white pellets.

1 caps.
Orlistat, substance-pellets 50% 240 mg,
   Equivalent to orlistat content 120 mg

Excipients: microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone K30.

Capsule body and cap composition titanium dioxide, patent blue dye, gelatin.

7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
21 pcs. – contour cell blisters (1) – cardboard packs.
21 pcs. – contour cell blisters (2) – cardboard packs.
21 pcs. – contour cell blisters (3) – cardboard packs.
21 pcs. – contour cell blisters (4) – cardboard packs.

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Tyumen Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Orlistat-LekT Capsules 120 mg: 20, 40, or 80 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, with a white body and cap; capsule contents are granules or a mixture of powder and granules, white or almost white in color; the presence of caked agglomerates that easily crumble when pressed is allowed.

1 caps.
Orlistat 120 mg

Excipients: mannitol – 54.3 mg, sucrose – 34.04 mg, microcrystalline cellulose – 39.2 mg, croscarmellose sodium – 8.44 mg, povidone K30 – 3.44 mg.

Capsule shell composition: titanium dioxide – 2%, gelatin – up to 100%.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.

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