Orlistat Sandoz 60 mg 84 capsules weight loss
It is used to reduce body weight in overweight 18-year-old adults who have a BMI equal to or greater than 28. Orlistat Sandoz 60 mg should be taken with a low calorie and low fat diet.
Detailed product information
PACKAGE LEAFLET: INFORMATION FOR THE USER
Orlistat Sandoz 60 mg
Read this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you must use it carefully according to the instructions to make the most of it.
- Keep the package leaflet in case you need to read it again.
- Ask your pharmacist if you need more information or advice.
- If your weight does not decrease after 12 weeks of taking Orlistat Sandoz 60 mg, you should consult a doctor or pharmacist. You may have to stop taking Orlistat Sandoz 60 mg.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In the package leaflet you will find:
1. What Orlistat Sandoz 60 mg is and what it is used for
2. What you need to know before you take Orlistat Sandoz 60 mg
3. How to take Orlistat Sandoz 60 mg
4. Possible side effects
5. How to store Orlistat Sandoz 60 mg
6. Further information
1. WHAT ORLISTAT SANDOZ 60 mg IS AND WHAT IT IS USED FOR
Orlistat Sandoz 60 mg is used to reduce body weight in overweight 18-year-olds who have a body mass index (BMI) equal to or greater than 28. Orlistat Sandoz 60 mg should be taken with a low calorie diet and a low fat content.
BMI is the way to find out whether you have a normal body weight relative to your body height or if you are overweight. The table below will help you determine whether you are overweight and whether Orlistat Sandoz 60 mg is suitable for you.
Find your height in the table. If your body weight is less than the body weight corresponding to your body height, do not take Orlistat Sandoz 60 mg.
|1.50 m||63 kg|
|1,55 m||67.25 kg|
|1.60 m||71.75 kg|
|1.65 m||76.25 kg|
|1,70 m||81 kg|
|1,75 m||85.75 kg|
|1,80 m||90.75 kg|
|1.85 m||95.75 kg|
|1,90 m||101 kg|
Risk of overweight
Overweight increases the risk of serious illnesses such as diabetes and heart disease. These illnesses may not cause a feeling of sickness, so you should visit a doctor and have a general examination done.
How Orlistat Sandoz 60 mg works
The active substance in Orlistat Sandoz 60 mg focuses on the fat in your digestive system. It prevents absorption of about a quarter of the fat intake. This fat is excreted from the body by the faeces. You may experience the effects of diet-related treatment (see section 4). Therefore, it is important to follow a low fat diet to manage these effects. If you do so, the action of the drug will support your efforts by losing more weight compared to the diet itself. For every 2 kg that you lose through the diet itself, Orlistat Sandoz 60 mg will help you lose weight by another 1 kg.
2. BEFORE YOU USE ORLISTAT SANDOZ 60 MG
Do not take Orlistat Sandoz 60 mg
- if you are under 18 years of age
- if you are pregnant or breast-feeding
- if you are taking cyclosporin, which is given after organ transplantation, to treat severe rheumatoid arthritis and some serious skin diseases
- if you are taking warfarin or other blood thinners
- if you are allergic (hypersensitive) to orlistat or other ingredients of Orlistat Sandoz 60 mg: For further information, see section 6.
- if you have cholestasis (liver disease)
- if you have problems with food absorption (chronic malabsorption syndrome) confirmed by your doctor.
Take special care with Orlistat Sandoz 60 mg
If you have diabetes, tell your doctor who may need to adjust the dose of the medicine you take against diabetes.
If you have kidney disease. If you have kidney problems talk to your doctor before taking Orlistat Sandoz 60 mg. The use of orlistat may be associated with kidney stones in patients with chronic kidney disease.
Interaction with other medicinal products
Orlistat Sandoz 60 mg may affect the effects of some medicines you must take.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Orlistat Sandoz 60 mg with the following medicines:
- Cyclosporine: Cyclosporine is used after organ transplantation to treat severe rheumatoid arthritis and some serious skin diseases.
- warfarin or other medicines used to thin the blood.
Oral contraceptive pills and Orlistat Sandoz 60 mg
Oral contraceptive tablets may be less effective if you have severe diarrhea. If you get severe diarrhea, use a complementary method of contraception.
Multivitamins and Orlistat Sandoz 60 mg
You should use a multivitamin medicine every day. Orlistat Sandoz 60 mg may reduce the levels of some vitamins absorbed by your body. The multivitamin should contain vitamins A, D, E and K. The multivitamin should be taken at bedtime when you will not take Orlistat Sandoz 60 mg to help ensure that the vitamins are absorbed.
Ask your doctor if you are taking Orlistat Sandoz 60 mg before taking this medicine
- amiodarone, used to treat heart rhythm disorders
- acarbose used to treat diabetes
- a medicine for the treatment of thyroid gland (levothyroxine), as it may be necessary to adjust the dose and take these medicines at different times of the day.
- epilepsy, because any changes in frequency and strength of convulsions should be discussed with your doctor.
If you are taking Orlistat Sandoz 60 mg, talk to your doctor or pharmacist
- if you are taking medicines to reduce high blood pressure because it may be necessary to adjust the dosage,
- if you are taking medicines to reduce high cholesterol because it may be necessary to adjust the dosage.
Taking Orlistat Sandoz 60 mg with food and drink
Orlistat Sandoz 60 mg should be taken with a low-fat, low-calorie diet. Try to start keeping this diet before you start treatment. For information on how to set your calorie and fat targets, read the Additional Useful Information section
Orlistat Sandoz 60 mg should take your meal. This usually means one tablet during breakfast, lunch and dinner. If you miss a meal or your food is fat-free, do not take the capsule. Orlistat Sandoz 60 mg does not work unless the food contains at least some fat.
If you eat a high fat meal do not take a higher dose of Orlistat Sandoz 60 mg than the recommended dose. Taking a capsule containing too much fat can increase the likelihood of the effects of diet-related treatment (see section 4). Take care to avoid high fat foods while taking Orlistat Sandoz 60 mg.
Pregnancy and breast-feeding
Do not take Orlistat Sandoz 60 mg if you are pregnant or breast-feeding.
Driving and using machines
Effects on the ability to drive or operate machinery have not been observed.
3. HOW TO TAKE ORLISTAT SANDOZ 60 MG
1. Set the starting day
Choose the day before you start taking the capsules. Before you start taking the capsules, start low-calorie, low-fat diet and let your body stay for a few days to get used to new eating habits. Record what you eat in your diary. Catering diaries are effective because you are aware of what you eat, and how much you eat and provide the basis for making changes.
2. Set your weight loss target
Think about how much you want to lose weight and then determine the target body weight. The real goal is to reduce the initial weight by 5 to 10%. Weight loss may fluctuate week to week. Try to reduce the body weight gradually, at an even rate of about 0.5 kg per week.
3. Set your target values for calories and fats
To make it easier to achieve weight reduction goals, you need to set two daily targets, one for calories and one for fats. Refer to Additional Useful Information in Section 6 for further instructions.
Taking Orlistat Sandoz 60 mg
Adults from 18 years of age
- Take one capsule three times a day.
- Take Orlistat Sandoz 60 mg at meal time. This usually means one capsule at breakfast, lunch and dinner. Make sure your three main meals are well balanced, have a low calorie count and a low fat content.
- If you miss a meal or your food contains no fat, do not take the capsule. Orlistat Sandoz 60 mg does not work unless the food contains at least some fat.
- Orlistat Sandoz 60 mg should be taken just before the meal, during the meal or at most one hour after a meal.
- Swallow the capsule whole and drink it with water.
- Do not take more than 3 capsules a day.
- Eat low fat foods to reduce the likelihood of dietary effects (see section 4).
- Try to be physically active before taking the capsules. Physical exercise is an important part of weight loss program. If you have not previously practiced, do not forget to talk to your doctor.
- Stay on for as long as you are taking Orlistat Sandoz 60 mg and after you stop taking it.
How long to take Orlistat Sandoz 60 mg
- Orlistat Sandoz 60 mg should not be taken for more than six months.
- If you do not lose 12 weeks of taking Orlistat Sandoz 60 mg, talk to your doctor or pharmacist. You may need to stop taking Orlistat Sandoz 60 mg.
- Successful weight reduction is not just a short-term change in diet and a subsequent return to old habits. People who lose weight and maintain their condition change their lifestyle, including changing eating habits and increasing physical activity.
If you take more Orlistat Sandoz 60 mg than you should
Do not take more than three capsules per day.
If you take too many capsules, contact your doctor as soon as possible.
If you forget to take Orlistat Sandoz 60 mg
If you forget to take a capsule:
- If less than one hour has elapsed since the last main meal, take the omitted dose.
- If it has elapsed for more than one hour since the last main meal, do not take the missed dose. Wait and take the next dose at your next major meal as usual.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Orlistat Sandoz 60 mg can cause side effects, although not everybody gets them.
The cause of most common side effects associated with the use of Orlistat Sandoz 60 mg (eg, flatulence with or without oily spotting, sudden or more frequent stools and soft stools) is due to the way it works (see section 1). Eat low fat foods to help you better manage the effects of diet-related treatments.
Severe side effects (it is not known how often these side effects occur)
Severe allergic reactions
- Signs of severe allergic reactions include: severe breathing difficulties, sweating, rash, itching, swelling of the face, rapid heartbeat, collapse.
- ►To use the capsules. Get medical help immediately.
Other serious side effects
- Bone from the rectum (rectum)
- Diverticulitis (inflammation of the large intestine). Symptoms may include pain in the lower abdomen, especially on the left, sometimes associated with fever and constipation
- Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain, which can sometimes spread to the back and may be accompanied by fever, nausea and vomiting.
- Blistering of the skin (including blisters that crack)
- Strong stomach pain caused by bile stones
- Hepatitis (inflammation of the liver). Symptoms include yellow skin and eye color, itching, stomach pain and liver sensitivity.
- ►To use the capsules. Tell your doctor if you experience any of these side effects.
Very common side effects (may affect more than 1 in 10 people)
- Winds (gas) that are or are not associated with oily dirt
- Sudden coercion
- Fat or oily stool
- Soft stool
- ► Tell your doctor or pharmacist if any of these side effects are serious or uncomfortable.
Common side effects (may affect up to 1 in 10 people)
- Stomach (abdominal) pain
- Inability to maintain stool
- Liquid / watery stools
- More frequent stools
- ► Tell your doctor or pharmacist if any of these side effects are serious or uncomfortable.
Effects found in blood tests (it is not known how often these effects occur)
- Elevated levels of some liver enzymes
- Effects on blood clotting in people taking warfarin or other blood coagulation lowering drugs (anticoagulants).
- ► Tell your doctor when taking blood tests that you are taking Orlistat Sandoz 60 mg.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Learn how to manage the effects of diet-related treatments
The cause of the very common side effects is the way the capsules work and these side effects are the result of leaving a certain amount of fat left out of the body. Such effects typically occur during the first few weeks of taking the capsules before you learn to limit the amount of fat in your diet. These dietary effects may be a sign that you ate more fat than you had. You can learn to minimize the impact of diet-related effects by following these guidelines:
- Start with a low fat diet a few days or a week before taking the capsules.
- Learn more about how much fat your favorite foods usually contain and the size of your portions. By getting to know the portion size, you will reduce the chance of accidentally exceeding the target fat value.
- Fill your daily fat portion evenly into all meals during the day. Do not "consume" the permitted amount of fat and calories to allow them to crash into a fatty meal or a dessert, as you may have done in other weight loss programs.
- Most users who experienced these effects found that they could manage them and regulate them by adjusting the diet.
If none of these issues appear with you, do not worry about it. This does not mean that capsules do not work.
5. HOW TO STORE ORLISTAT 60 mg
Keep out of the reach and sight of children.
Do not store above 25 ° C. Store in the original package in order to protect from light and moisture.
Do not use Orlistat Sandoz 60 mg after the expiry date which is stated on the carton. Shelf life refers to the last day of that month. Capsules packaged in bottles should be used within 6 months after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of products you no longer need. These measures help to protect the environment.
6. FURTHER INFORMATION
What Orlistat Sandoz 60 mg contains
The active substance is orlistat. One hard capsule contains 60 mg orlistat.
Excipients are: Capsule: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, sodium lauryl sulphate. Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
Pharmaceutical Works POLPHARMA SA, 19, Pelpinska Street, 83-200 Starogard Gdański, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
SC Sandoz, SRL, Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
LEK SA, Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia