INTRODUCTION

ORLEAN 60MG contains Orlistat which belongs to the group of medicines called Anti-obesity drugs. It is used for weight reduction in adults (18 years and above) who are overweight and have a body mass index (BMI) of 28 or more. Obesity occurs when there is an imbalance between energy consumption and energy expenditure over time, resulting in increased energy storage.

Orlistat works by attaching to the enzymes in the digestive system (lipases) and prevents them from breaking down some of the fat that you’ve consumed during your meal. The fat that is not digested cannot be absorbed and it is removed by your body. Along with this treatment, your doctor might ask you to consume a reduced calorie and low-fat diet.

Before taking ORLEAN 60MG, inform your doctor if you have cholestasis, malnutrition syndrome, diabetes, or kidney disease. ORLEAN 60MG is not recommended for use among pregnant or breastfeeding women. ORLEAN 60MG is not recommended for use in children and adolescents (below 18 years of age), therefore consult your doctor before taking it. The most common side effects of taking ORLEAN 60MG are flatulence, with or without oily spotting, sudden bowel motions, fatty, oily, or soft stools, stomach pain. Contact your doctor if any of the symptoms worsen.

USES OF ORLEAN 60MG

• Used for obesity (weight loss) along with a reduced calorie and lower-fat diet

HOW ORLEAN 60MG WORKS

ORLEAN 60MG works by attaching to the enzymes in your digestive system (lipases) and prevents them from breaking down some of the fat that you’ve consumed during your meal. The fat that is not digested cannot be absorbed and it is removed by your body.

DIRECTIONS FOR USE

Take ORLEAN 60MG as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking ORLEAN 60MG unless your doctor advises you to stop.

SIDE EFFECTS OF ORLEAN 60MG

HOW TO MANAGE SIDE EFFECTS

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

Diarrhea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor.

Flatulence:

Eat smaller meals more frequently. Eat and drink slowly, and exercise regularly. If the symptom does not improve, contact your doctor.

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Ask your doctor before taking any medicine other than ORLEAN 60MG.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking ORLEAN 60MG, inform your doctor if you are taking any of the following medicine:

• ciclosporin (used after organ transplants)
• medicines used to thin the blood (Ex. warfarin, clopidogrel)
• oral contraceptives (used to prevent pregnancy) (Ex. ethinyl estradiol, progestin)
• acarbose (used to treat diabetes)
• levothyroxine (used to treat hypothyroidism)
• medicines used to treat epilepsy (Ex. carbamazepine, phenytoin)
• medicines used to treat HIV (Ex. abacavir, lamivudine)
• medicines for depression, psychiatric disorders, or anxiousness (Ex. amitriptyline, phenobarbital, fluoxetine)
• medicines used to lower blood pressure (Ex. enalapril, atenolol)
• medicines used to lower cholesterol levels in blood (Ex. atorvastatin, simvastatin)

Overdosage:

If you or anyone else accidentally take too much of ORLEAN 60MG, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep ORLEAN 60MG out of reach of children
• Do not store above 25°C

FAQs ABOUT ORLEAN 60MG

What is ORLEAN 60MG used for?

ORLEAN 60MG contains Orlistat which is used for weight reduction in obese adults (18 years and above) who are overweight and have a body mass index (BMI) of 28 or more. Consult your doctor for correct dose and duration for you depending upon your age, body weight and disease condition.

Does ORLEAN 60MG have side effects?

Yes, taking ORLEAN 60MG may cause few side effects in some individuals such as stomach pain, anxiety, tiredness, headache, flatulence with or without oily spotting, sudden bowel motions, inability to control bowel movements, rectal pain or discomfort and may also cause some other systemic effects such as respiratory tract infection, low blood sugar levels, tooth or gum disorders, urinary tract infection or irregular menses. Consult your doctor before using and report if any of side effects worsens after taking ORLEAN 60MG.

What happens if you take ORLEAN 60MG without eating?

ORLEAN 60MG works on the fats that are taken along with the food, hence it is advisable not take the medicine if you miss a meal or if there is no fat in one of your meals.

Can ORLEAN 60MG cause flatulence?

Yes. Flatulence or wind is a common side effect of ORLEAN 60MG. Eat smaller meals more frequently. Eat and drink slowly, and exercise regularly. If the symptom does not improve, contact your doctor.

Can I take multivitamins with ORLEAN 60MG?

Yes. Take a multivitamin (containing vitamins A, D, E and K) everyday if you are taking ORLEAN 60MG as it can lower the levels of some vitamins absorbed by your body. Take the medicines as told by your physician.

Can I take ORLEAN 60MG on an empty stomach?

Take ORLEAN 60MG as advised by your physician. It can be taken immediately before, during, or up to an hour after a meal. It should be swallowed with water.

Do I need to follow any diet while taking ORLEAN 60MG?

While taking ORLEAN 60MG, make sure your three main meals are well balanced, reduced calorie, and low-fat. Eat lower-fat meals to decrease the chance of diet-related treatment effects. You should choose foods which contain a range of different nutrients and learn to eat healthily in the long run.

For how long should I take ORLEAN 60MG?

Take ORLEAN 60MG as long as your doctor advises you to take it. It should be taken for no longer than six months. Consult your doctor and stop the medication if you do not experience any weight loss 12 weeks after starting your treatment with this medicine.

What if I forget to take a dose of ORLEAN 60MG?

If it is less than an hour since your last main meal, take the forgotten dose of ORLEAN 60MG. If it is more than an hour since your last main meal, do not take the missed dose. Wait and take the next dose around your next meal as usual.

Can ORLEAN 60MG cause stomach pain?

Yes. Stomach pain is a common side effect of ORLEAN 60MG. Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

REFERENCES

1. Joseph T. DiPiro, Robert L. Talbert, Gary C. Yee, Gary R. Matzke, Barbara G. Wells, L. Michael Posey. Obesity. Pharmacotherapy- A Pathophysiologic Approach. Eighth edition. Page - 2571.

2. Suyog S. Jain, Sunita J. Ramanand, Jaiprakash B. Ramanand, Pramod B. Akat, Milind H. Patwardhan, and Sachin R. Joshi. Evaluation of efficacy and safety of orlistat in obese patients. PMC Pubmed Central. NCBI. National Library of Medicine, National Institute of Health. June 2011. [Accessed on 13th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3125014/

3. GlaxoSmithKline. Effect of Orlistat in Body Composition. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in March 2013] [Accessed on 13th May 2022] https://www.clinicaltrials.gov/ct2/show/NCT00752726

4. Famar S.A. Electronic Medicines Compendium (EMC). [Revised in April 2021] [Accessed on 13th May 2022] https://www.medicines.org.uk/emc/files/pil.6533.pdf

5. Pharmaceutical Works Polpharma SA. Orlistat. [Revised in June 2020] [Accessed 13th May 2022] https://products.tevauk.com/mediafile/id/49360.pdf

USEFUL DIAGNOSTIC TESTS

• Body Mass Index (BMI)