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ZEROFIG

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame


To promote this objective, not only we distribute and market our  Veterinary  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Zerofig which contains Orlistat… 60 mg.


 


 


 


 

ZEROFIG

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Details

  Each Capsule Contains

Orlistat………. 60 mg

(As pellets)

Excipients        q.s.

Approved Colour used for Capsule shells

1. WHAT ZEROFIG 60 IS AND WHAT IT IS USED FOR?

ZEROFIG 60 is a medicine used to treat obesity. It works in your digestive system to block about one-third of the fat in the food you eat from being digested.

ZEROFIG 60 attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal. The undigested fat cannot be absorbed and is eliminated by your body.

ZEROFIG 6O is indicated in the treatment of obesity in conjunction with a low calorie diet.

 

2. WHO SHOULD USE ZEROFIG 60?

ZEROFIG 60 may be right for you if you are considerably overweight (at least 30% above ideal weight or a body mass index (BMI) of 30 or greater). ZEROFIG 60 may also be right for you if you are overweight (at least 20% above ideal weight or a body mass index (BMI) of 27 or greater) and also have other conditions such as high blood pressure, high cholesterol, heart disease, or diabetes.

Most weight loss occurs within the first 6 months. Once you stop using ZEROFIG 60, continue with a low calorie diet and an exercise program. If you start to regain weight after you stop using ZEROFIG 60, you may need to start taking ZEROFIG 60 along with a low calorie diet and an exercise program.

You must be of age between 18 to 60 years. If you continue to loose weight after 6 months, your doctor may advise you to take ZEROFIG 60. You may have to take ZEROFIG 60 for 1-2 years, if you have to loose a great deal of weight.

3. BEFORE YOU TAKE ZEROFIG 60

Do not take ZEROFIG 60

  • If you are allergic (hypersensitive) to orlistat or to any of the other ingredients of ZEROFIG 60,
  • If you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),
  • If you have cholestasis (liver disorder)
  • If you are breast feeding

Take special care with ZEROFIG 60

Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes). Be sure to discuss these and about the any other medicines you may be taking with your doctor. Losing weight means you may need to adjust the dose of the medicines you are already taking.

To gain the maximum benefit from ZEROFIG 60 you should follow the nutrition program recommended to you by your 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 your bowel habits, such as fatty or oily stools, due to the elimination of the undigested fat in your stools. If Zerofig 60 is taken with a meal very high in fat, the possibility of gastrointestinal side effects may increase. The use of an additional contraceptive method is recommended in women on oral contraceptives to prevent failure of oral contraception that could occur due to loose stools which is a known side effect.

The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease. Inform your doctor if you suffer from any kidney problems.

Use in Children

ZEROFIG 60 is not intended to be used in children.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.

ZEROFIG 60 may modify the activity of

Anticoagulant Drugs. Your doctor may need to monitor your bleeding and clotting time.

Cyclosporine. Co-administration with Cyclosporine is not recommended. Your doctor may need to monitor your Cyclosporine blood levels more frequently than usual.

Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.

Amiodarone. You may ask your doctor for advice.

ZEROFIG 60 reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctors advice in taking a well balanced diet rich in fruits and vegetables. Your doctor may suggest you take a multivitamin supplement.

Zerofig 60 not to be taken in conjunction with Anti-coagulants, Cyclosporine, Iodine salts, Levothyoxine, Amidarone,  Anti convulsants.

Pregnancy and breast-feeding

Taking ZEROFIG 60 during pregnancy is not recommended. You must not breast-feed your infant during treatment with ZEROFIG 60 as it is not known whether ZEROFIG 60 passes into human milk.

Driving and using machines

ZEROFIG 60 has no known effect on your ability to drive a car or operate machinery.

4. HOW TO TAKE ZEROFIG 60

Always take ZEROFIG 60 exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Recommended dose of ZEROFIG 60 is one 60 mg capsule taken with each of the three main meals per day. It can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.

ZEROFIG 60 should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three meals. This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time. To gain optimal benefit avoid consuming food containing fat such as biscuits, chocolate, savory snacks between meals.

ZEROFIG 60 only works in the presence of dietary fat. Therefore if you miss a main meal, or if you have a meal containing no fat, Do not take Zerofig 60.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.

Your doctor will discontinue the treatment with ZEROFIG 60 after 12 weeks if you have not lost at least 5% of your body weight as measured at the start of treatment with ZEROFIG 60.

ZEROFIG 60 has been studied in long-term clinical studies of up to 4 years duration.

If you take more ZEROFIG 60 than you should

If you take more capsules than you have been told, or if someone else accidentally takes your medicine contact your doctor or a hospital as you may need medical attention.

If you forget to take ZEROFIG 60

If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times. Do not take a double dose.

If you have missed several doses, please inform your doctor and follow the advice given to you.

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

5. POSSIBLE SIDE EFFECTS

The main side effects are caused by the fats which are passed with your stools. They tend to settle with the time, possibly if they occur they remind you that you should be eating low fat diet. Other side effects are rare.

Common side effects

Headache, abdominal pain/discomfort, Urgent or increased need to pass stools, low blood sugar levels (experienced by some people with type 2 diabetes).

These side effects are less likely if you eat low fat diet. They tend to settle down with time, possibly if they occur they remind you that you should be eating low fat diet. Other side effects are rare.

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, rapid heart beating,  nausea, vomiting and feeling unwell.

Other side effects

Bleeding from the back passage (rectum). Increase in levels of some liver enzymes as seen in blood tests. Effects on clotting in conjunction with anti coagulants. If any of the side effects gets serious or you notice any side effects not listed in this leaflet, contact your doctor or a hospital as you may need medical attention.

6. HOW TO STORE ZEROFIG 60?

Keep out of the reach of children. Do not use ZEROFIG 60 after the expiry date stated on the Label.

Store in dry place below 30°C.  Protect from light.

7. What is ZEROFIG 60  pack?

60 Capsules in HDPE Container.

Shelf Life:

24 months

 

 

 

 

 
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