Lesofat

Orlistat.

Each capsule contains: Orlistat 120 mg.
This medicine contains orlistat, an anti-obesity agent which works in the digestive system to block about one-third of the fat in the food the patient eats from being absorbed by the body.

Orlistat (Lesofat) is a medicine used to treat obesity. Lesofat attaches to the enzymes in the digestive system (lipases) and blocks about one-third of the fat from the meal the patient has taken. The undigested fat will not be absorbed and will be eliminated by the patient's body.

Orlistat (Lesofat) is given in a usual dose of 120 mg orally three times daily, immediately before, during or up to 1 hour after meals. If a meal is missed or contains no fat, the dose should be omitted. Orlistat therapy should be discontinued if the patient does not lose at least 5% of their body-weight during the first 12 weeks of therapy. Long-term should not continue beyond 2 years. Or, as directed by a doctor.
Missed Dose: If the patient forgets to take the medicine, take it as soon as remembered provided within one hour of the last meal, then continue to take it as usual times. Do not take double dose. If the patient has missed several doses, please inform the doctor and follow the advice given. Do not change the prescribed dose unless the doctor tells the patient.
If the patient has further questions on the use the of the medicine, as the doctor or pharmacist.

Single doses of 800 mg Orlistat and multiple doses of up 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg three times a day have been administered to obese patients for 6 months without significant increase of adverse findings. Orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported recommended dose.
If the patient has taken more than capsules from recommended dosage please contact the doctor immediately as the patient may need medical attention.

Do not take Orlistat (Lesofat): If the patient is allergic (hypersensitive) to orlistat.
If the patient has chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract).
If the patient has cholestasis (liver disorder).
If the patient is breast-feeding (See Use in Pregnancy & Lactation).

Talk to the doctor or pharmacist before taking Orlistat. Weight loss may also affect the dosing of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and other medicines the patient's may be taking with the doctor. Losing weight mean the patient need adjustment to the dosing of these medicines.
To gain the maximum benefit from Orlistat the patient should follow the nutrition program recommended by the doctor. As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
This medicine can cause harmless changes in the patient's bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in the feces. The possibility of this happening may increase if Orlistat is taken with a high fat diet. In addition, the patient's daily intake of fat should be distributed evenly over three main meals because if Orlistat is taken with a very high fat meal, the possibility of gastrointestinal effects may increase.
The use of an additional contraceptive method is recommended to prevent possible failure or oral contraception that could occur in case of severe diarrhea.
The use of Orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform the doctor whether the patient is suffering from problem with their kidney.
Stop the treatment and consult the doctor if the patient experiences any undesirable effects.
Consult the Doctor: Stop the treatment and consult the doctor if the patient experiences any undesirable effects.
Effect on Ability to Drive or Operate Machinery: Orlistat has no known effect on the patient's ability to drive a car or operate machinery.
Use in Pregnancy & Lactation: Orlistat is not recommended during pregnancy and breast-feeding as it is not known whether it passes into human milk. If the patient wants to take Orlistat but is pregnant or thinks might be pregnant, planning to have a baby and is breast-feeding the patient may consult their doctor first for a case-specific recommendation.
Use in Children: Orlistat is not intended to be used in children.

Orlistat is not recommended during pregnancy and breast-feeding as it is not known whether it passes into human milk. If the patient wants to take Orlistat but is pregnant or thinks might be pregnant, planning to have a baby and is breast-feeding the patient may consult their doctor first for a case-specific recommendation.

Like all medicines, this medicine can cause side effects, although not everybody experience it. Tell the doctor or pharmacist as soon as possible if the patient experiences any adverse effects during the treatment with Orlistat.
The majority of unwanted effects related to the use of Orlistat results from its local action in the digestive system. These symptoms are generally mild, occur at the beginning of treatment are particularly experienced after meals containing high levels of fat. Normally, these symptoms disappear if the patient continues treatment and keep the recommended diet.
Very common (may affect more than 1 in 10 people): headache, abdominal pain/discomfort, urgent or increased number of bowel movements flatulence (intestinal gas) with or without discharge, oily discharge, or fatty stool, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes), upper respiratory infections, flu (influenza).
Common (may affect up to 1 in 10 people): rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness, anxiety, lower respiratory infections, urinary tract infections.
Not known (frequency cannot be estimated from the available data): Allergic reactions: the main symptoms are itching, rash, wheals (slightly elevated, itchy skin, patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell. Contact the doctor immediately if the patient experience any of these.
Skin blistering (including blisters that burst).
Diverticulitis (inflammation of the small outpouchings along the wall of the colon).
Bleeding from the back passage (rectum).
Increased in the levels of some liver enzymes may be found in blood tests.
Hepatitis (inflammation of the liver): symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain, and liver tenderness (indicated by pain under the front of the rib cage on the right hand side), sometimes loss of appetite. Stop Orlistat if such symptoms occur and contact the doctor immediately.
Gallstones.
Pancreatitis.
Oxalate nephropathy (built up of calcium oxalate which may lead to kidney stones).
Effects on clotting with anticoagulants.

Other medicines and Orlistat: Tell the doctor or pharmacist if the patient is taking, has recently taken or might taken any other medicines.
This is important as taking more than one medicine at the same time can strengthen or weaken the effects of the medicines.
Orlistat may modify the activity of: Anticoagulant (medicine used as blood thinners, e.g, warfarin). The doctor may need to monitor the patient's blood coagulation.
Ciclosporin (medicine used to prevent organ rejection in transplant). Co-administration with ciclosporin is not recommended. The doctor may need to monitor the ciclosporin blood levels more frequently than usual.
Iodine salts and/or levothyroxine (medicines used to treat thyroid gland problems). Cases of hypothyroidism (condition when thyroid gland does not produce enough hormones) and/or reduced control of hypothyroidism may occur.
Amiodarone (medicine used for irregular heart beat). The patient may ask the doctor for advice.
Medicines to treat HIV.
Orlistat reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. The patient should therefore follow the doctor's advice in taking a well balanced diet rich in fruit and vegetables. The doctor may suggest the patient to take a multivitamins supplement.
Orlistat may unbalance an anticonvulsant (antiepileptic) treatment, by decreasing the absorption of antiepileptic medicines, thus leading to convulsions. Please contact the doctor if the patient thinks that the frequency and/or severity of the convulsions(seizure) have changed when taking Orlistat together with antiepileptic medicines.
Orlistat is not recommended for people taking acarbose (an anti-diabetic medicine used to treat type 2 diabetes mellitus).
Orlistat with food and drink: Orlistat can be taken immediately before, during a meal or up to one hour after a meal.

Store at temperatures not exceeding 30°C.

Anti-Obesity Agents

A08AB01 - orlistat ; Belongs to the class of peripherally acting antiobesity products.

Non-Rx