1. Why am I using ORLISTAT VIATRIS?

ORLISTAT VIATRIS contains the active ingredient orlistat.

ORLISTAT VIATRIS is used to treat people who are obese (BMI ≥ 30) or overweight (BMI ≥ 27) with other risk factors (e.g. high blood pressure, high cholesterol, high blood lipid profile).

Your Body Mass Index (BMI) is calculated by dividing your weight (in kg) by your height (in metres) squared.

ORLISTAT VIATRIS belongs to a group of medicines called lipase inhibitors.

These medicines work by targeting the absorption of dietary fat in your body rather than suppressing your appetite.

Dietary fats are large molecules that need to be broken down before they can be absorbed into the body. They are broken down by enzymes called lipases. That is, lipases play an important role in the digestion of dietary fat. When taken with a meal, ORLISTAT VIATRIS interferes with the activity of these enzymes. This allows about 30% of the fat eaten in the meal to pass through the gut undigested. Therefore, your body cannot store these excess calories as fatty tissue or use them as a source of energy. This helps you to reduce your weight by burning up fat that you are already carrying, maintain your lower weight and minimise any weight regain.

Losing even small amounts of weight and keeping it off produces additional health benefits for you, especially when you are at risk for other diseases such as heart disease and diabetes. ORLISTAT VIATRIS can also help to improve risk factors, such as high blood pressure, high cholesterol and high blood sugar. If these are not treated, they could lead to other diseases such as hypertension and diabetes.

Ask your pharmacist or doctor if you have any questions about obesity related risk factors.

ORLISTAT VIATRIS should be taken in conjunction with a well- balanced calorie-controlled diet and other appropriate measures such as exercise.

Ask your pharmacist or doctor if you have any questions or if you are not sure why ORLISTAT VIATRIS has been recommended for you.

ORLISTAT VIATRIS is not addictive.

2. What should I know before I use ORLISTAT VIATRIS?

Warnings

Do not use ORLISTAT VIATRIS if:

• you are allergic to ORLISTAT VIATRIS (orlistat), or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• your body does not absorb essential nutrients as well as it should. This is called chronic malabsorption syndrome.
• you have certain pancreatic problems.
• you have had recent major surgery to your stomach or intestines.
• you have a blockage of your bile duct (gall stones).
• if the packaging is torn or shows signs of tampering or the capsules do not look quite right.
• if the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be taking ORLISTAT VIATRIS, talk to your pharmacist or doctor.

Do not give ORLISTAT VIATRIS to children or adolescents under 18 years of age.

The safety and effectiveness in children have not been established.

Check with your doctor or pharmacist if you:

• are pregnant or plan to become pregnant.
• are breast-feeding or intend to breast-feed.
• are taking oral contraceptives.
• have vitamin deficiencies.
• have kidney stones.
• have any allergies to any other substances, such as foods, preservatives or dyes.
• have peptic (stomach) ulcer disease.
• receive long term treatment for mental or nerve disorders.
• have symptomatic cholelithiasis (painful gall stones).
• have post surgical adhesions.
• have an eating disorder.
• take large doses of laxatives.
• have epilepsy or suffer from fits.
• have significant heart, kidney, liver, gastrointestinal or endocrine disorders.
• are taking medicines for HIV.
• have a thyroid disorder.
• have any other health problems.

If you have not told your pharmacist or doctor about any of the above, tell them before you take any ORLISTAT VIATRIS.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

It is not known whether ORLISTAT VIATRIS is harmful to an unborn baby when taken by a pregnant woman. It should not be used in pregnant women.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

It is not known whether ORLISTAT VIATRIS passes into breast milk. You should not breast-feed while taking ORLISTAT VIATRIS.

If you are taking oral contraceptives, commonly known as birth control pills, the use of an additional method of contraception is recommended. This is because you might experience severe diarrhoea whilst taking ORLISTAT VIATRIS which may decrease the absorption of oral contraceptive into your body. It is recommended that you use an additional method of contraception to prevent pregnancy.

3. What if I am taking other medicines?

Because weight loss has many beneficial effects, it may also affect the dose of medication taken for conditions such as high cholesterol or diabetes. Be sure to discuss these and other drugs you may be taking with your pharmacist or doctor. Losing weight may mean you need adjustments to these medications.

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ORLISTAT VIATRIS and affect how it works. These include:

• ciclosporin, a transplant rejection drug
• amiodarone, a medicine used to treat irregular heart beat
• warfarin or other anticoagulants, medicines that prevent blood clots
• acarbose, a medicine used to treat diabetes and any other medicine used for diabetes
• medicines used to treat epilepsy or fits
• medicines for HIV
• drugs to control hypothyroidism
• lithium and other medicines used for mental or sleep disorders
• other weight-loss medicines
• some vitamin supplements.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ORLISTAT VIATRIS.

4. How do I use ORLISTAT VIATRIS?

How much to take

• Follow all directions given to you by your pharmacist and doctor carefully.

They may differ from the information contained in this leaflet.

• Take ORLISTAT VIATRIS exactly as your pharmacist or doctor has prescribed.
• The recommended dose of ORLISTAT VIATRIS for adults over 18 years of age is one 120 mg capsule taken three times a day.
• Taking more than the recommended dose will not provide an additional benefit.
• It is also recommended that you take a daily multivitamin supplement containing vitamins A, D E and K.
• Use by people under 18 years of age is not recommended except on medical advice.
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

When to take ORLISTAT VIATRIS

• You will usually take 1 capsule with each of the 3 main meals per day. This means that you will usually take one capsule at breakfast, lunch and dinner. It can be taken during the meal or up to 1 hour after the meal is consumed.
• ORLISTAT VIATRIS only works in the presence of dietary fat in your body. Therefore, if you miss a main meal or if you know that the meal contains no fat, then ORLISTAT VIATRIS need not be taken.

How long to take ORLISTAT VIATRIS

• Continue taking ORLISTAT VIATRIS for as long as your pharmacist or doctor prescribes, for up to four years.
• ORLISTAT VIATRIS should be taken every day to be effective.

Weight loss normally starts within 2 weeks and continues for 6 to 12 months on ORLISTAT VIATRIS treatment. ORLISTAT VIATRIS will then help you to maintain this new lower weight and help to prevent weight being regained.

The improvement in risk factors (such as reduction in high blood pressure, normalising blood sugar levels and lowering cholesterol levels) is usually observed within 1 month of starting therapy and has been maintained during the course of ORLISTAT VIATRIS treatment.

If you forget to take ORLISTAT VIATRIS

• If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
• Otherwise, take it as soon as you remember provided this is within 1 hour of your last meal and then go back to taking it as you would normally.
• If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
• Do not double a dose to make up for one you have missed.

How to take ORLISTAT VIATRIS

• Swallow capsules whole with a glass of water.
• Do not open the capsules and do not take any capsules that are damaged.

ORLISTAT VIATRIS should be taken with a well-balanced calorie - controlled diet that is rich in fruit and vegetables and contains an average of 30% calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over 3 main meals. To gain the most benefit, avoid eating food containing fat between meals, such as biscuits, chocolate, or savoury snacks.

Look out for fats in foods by reading all food labels. Your fat intake may also be reduced by removing all fat from meat, skin from chicken and using non-fat or low-fat milk.

Be careful not to replace the fat in your diet with large quantities of other foods, such as sugar and alcohol.

For further dietary advice, refer to the NH&MRC website at https://www.nhmrc.gov.au

Because increased exercise will help weight loss, it is advisable to follow a regular exercise program (e.g. walking, swimming). See your doctor before starting an exercise program.

If you are concerned that ORLISTAT VIATRIS is not working, talk to your pharmacist or doctor.

If you use too much ORLISTAT VIATRIS

If you think that you have used too much ORLISTAT VIATRIS, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ORLISTAT VIATRIS?

Things you should do

• Tell your pharmacist or doctor if you become pregnant while taking ORLISTAT VIATRIS.
• Tell your pharmacist or doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your pharmacist or doctor may think that it was not effective and change your treatment unnecessarily.
• Tell your pharmacist or doctor if you feel the capsules are not helping your condition.
• If you have high blood sugar or cholesterol levels, your doctor may ask you to have regular blood tests to monitor your blood sugar or blood cholesterol levels.
• If you are being treated for epilepsy and/or fits, please contact your doctor if you think that the frequency or severity of convulsions have changed while taking ORLISTAT VIATRIS.
• To gain the most benefit from ORLISTAT VIATRIS you should follow the nutrition program recommended to you by your doctor or pharmacist. As with any weight-control program, over-consumption of fat and calories may counteract any weight loss effect.

Remind any doctor, dentist or pharmacist you visit that you are using ORLISTAT VIATRIS.

Things you should not do

• Do not give ORLISTAT VIATRIS to anyone else even if they have the same condition as you.
• Do not take any other medicines whether they require a prescription or not without first telling your pharmacist or doctor.

Weight reduction diet

People on a weight reduction diet may become deficient in some vitamins and minerals. To avoid this, you should follow your doctor's or pharmacist's advice in taking a well-balanced diet rich in fruit and vegetables. Because ORLISTAT VIATRIS works by preventing the absorption of some of the fat from the diet, it may affect absorption of some fat-soluble nutrients. Although most people taking ORLISTAT VIATRIS will still have normal vitamin levels, you should take a multivitamin supplement containing fat-soluble vitamins. This supplement should be taken at least 2 hours before or after ORLISTAT VIATRIS, or at bedtime.

ORLISTAT VIATRIS can cause harmless changes in your bowel habits, such as fatty or oily stools. This is due to the removal of undigested fat in your faeces. The possibility of this happening will increase if ORLISTAT VIATRIS is taken with a diet high in fat. In addition, your daily intake of fat should be distributed over 3 main meals. If ORLISTAT VIATRIS is taken with any one meal very high in fat, the possibility of unwanted effects on the digestive system will increase.

Oral contraceptive use

If you are taking oral contraceptives, commonly known as birth control pills, the use of an additional method of contraception is recommended. This is because you might experience severe diarrhoea whilst taking ORLISTAT VIATRIS which may decrease the absorption of oral contraceptive into your body. It is recommended that you use an additional method of contraception to prevent pregnancy.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ORLISTAT VIATRIS affects you.

ORLISTAT VIATRIS may cause dizziness in some people.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol is not expected to interact with ORLISTAT VIATRIS.

Looking after your medicine

• Keep your capsules in the blister pack until it is time to take them.
• Keep the blister packs inside the original carton to protect from light and moisture.

If you take the capsules out of the packaging they will not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking the capsules or the capsules have passed their expiry date.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

The majority of unwanted effects related to ORLISTAT VIATRIS use result from its local action in your digestive system.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Serious side effects

Very serious side effects

These very serious side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What ORLISTAT VIATRIS contains

Do not take this medicine if you are allergic to any of these ingredients.

What ORLISTAT VIATRIS looks like

ORLISTAT VIATRIS is a 120 mg capsule (AUST R 453806) with a turquoise cap and body bearing the imprint of "LO1" in black ink.

ORLISTAT VIATRIS capsules are available in blister packs containing 42 and 84 capsules.

Who distributes ORLISTAT VIATRIS

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke St

Melbourne VIC 3000

Australia

Phone: 1800 134 988

Distributor

ORLISTAT VIATRIS is distributed in Australia by:

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

This leaflet was prepared in November 2025.