Package Insert: Information for the User

OrlistatSandoz120 mg Hard Capsules

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Orlistat Sandoz and for what it is used

2. What you need to know before starting to take Orlistat Sandoz

3. How to take Orlistat Sandoz

4. Possible adverse effects

5. Storage of Orlistat Sandoz

6. Contents of the package and additional information

Orlistatis a medication used to treat obesity. It acts on your digestive system by preventing the digestion of approximately one-third of the fat contained in the food you consume.

Orlistatbinds to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fats you have ingested during a meal. The undigested fat cannot be absorbed and your body eliminates it.

Orlistatis indicated for the treatment of obesity, in conjunction with a low-calorie diet

Do not take Orlistat Sandoz

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• if you have chronic malabsorption syndrome (insufficient nutrient absorption through the digestive tract),
• if you have cholestasis (liver disorder),
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take orlistat.

Weight loss may also affect the dosage ofother medications you are taking for other conditions (e.g. high cholesterol or diabetes). Make sure to inform your doctor if you are taking these or other medications. Weight loss may mean that you need an adjustment in the dosage of these medications.

To get the maximum benefit from orlistatyou must follow the nutrition program recommended by your doctor. As with any other weight control program, excessive fat and calorie intake can reduce the effect on weight loss.

This medication may cause a non-harmful change in your bowel habits, such as the presence of greasy or oily stools, due to the elimination of undigested fat through the stool. The likelihood of this occurring may increase if orlistat is taken with a diet high in fat. Additionally, your fat intake should be distributed evenly among the three main meals, as taking orlistat with a meal very high in fat may increase the likelihood of gastrointestinal side effects.

In the event of severe diarrhea, there may be a failure of oral contraceptives, so an additional contraceptive method is recommended.

In patients with chronic kidney disease, the use of orlistat may be associated with kidney stones. Inform your doctor if you have kidney problems.

Children and adolescents

Orlistat is not indicated for use in children and adolescents under 18 years.

Other medications and Orlistat SandozSandoz

Informyour doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is important as taking multiple medications at the same time may increase or decrease their effect.

Consult your doctor before taking orlistat if you are taking:

• anticoagulants(e.g. warfarin).Yourdoctormayneed to monitor your blood coagulation,
• ciclosporin. Do not administer orlistatconcurrently withciclosporin. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual,
• iodine and/or levotiroxine salts. They may produce cases of hypothyroidism and/or alterations in thyroid control,
• amiodarone.Consult your doctor,
• medicationsfortreatmentoftheAcquired Immunodeficiency Syndrome (AIDS),
• medications for depression, for psychiatric disorders or for anxiety.

Orlistat reduces the absorption of fat-soluble supplements, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's adviceand take a balanced diet rich in fruits and vegetables. Your doctor may recommend a multivitamin supplement.

Orlistat may alter anticonvulsant treatment by reducing the absorption of antiepileptic medications, which may lead to the appearance of seizures. Consult your doctor if you consider that the frequency or severity of seizures has changed while takingthis medicationalong with antiepileptic medications.

Orlistat Sandoz intake with food and beverages

OrlistatSandozcan be taken immediately before, during themealor up to one hour after. Youshouldswallowthecapsulewith water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take orlistatduring pregnancy.

Breastfeeding

Do not breastfeed your babyduring treatment with orlistat, as it is unknown whether orlistatpasses into breast milk.

Driving and operating machinery

Orlistathas no known effect on your abilityto driveor operate machinery.

Orlistat Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is one capsule of 120 mg with each of the three main meals of the day. It can be taken immediately before, during, or up to one hour after eating. The capsule should be taken with water.

General Information

Orlistat should be taken with a calorie-controlled, well-balanced diet rich in fruits and vegetables and containing approximately 30% of its calories from fat. Your daily intake of fat, carbohydrates, and proteins should be distributed in three meals. This means that you will usually take a capsule at breakfast, another at lunch, and another at dinner. To achieve optimal benefits, avoid consuming foods high in fat between meals, such as cookies, chocolate, or salty snacks.

Orlistat acts only in the presence of dietary fats. Therefore, you do not need to take this medication if you do not take a main meal or if you take a meal that does not contain fat.

If for any reason you have not taken your medication exactly as prescribed, tell your doctor. Otherwise, your doctor may think that this medication was not effective or well-tolerated and may change your treatment unnecessarily.

Your doctor will discontinue treatment with orlistat if, after 12 weeks, you have not lost at least 5% of your initial weight at the start of treatment.

Orlistat has been studied in clinical trials of up to 4 years' duration.

If you take moreOrlistat Sandozthan you should

If you take more capsules than your doctor has prescribed, or if someone else accidentally ingests your medication, contact your doctor, pharmacist, or hospital as you may need medical attention.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Orlistat Sandoz

If you forget to take your medication at any time, take it as soon as you remember, provided it is up to one hour after eating your meal, and then continue taking it at the usual intervals. Do not take a double dose to compensate for the missed doses. If you have missed several doses, please inform your doctor and follow their advice.

Do not change the prescribed dose without your doctor's advice.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

If you do not feel well while taking orlistat, tell your doctor as soon as possible.

The majority of unwanted effects related to the use oforlistat are a result of its local action on the digestive system. These symptoms are generally moderate, occur at the beginning of treatment, and are mainly present after meals with high levels of fat. Normally, these symptoms disappear if you continue with treatment and follow the recommended diet.

Very common side effects(may affect more than 1 in 10 people).

• headache,
• abdominal pain or discomfort,
• urgency or increased need to defecate,
• flatulence (gas) with fecal incontinence,
• oily or greasy feces,
• liquid stools,
• low blood sugar (experienced by some patients with type 2 diabetes).

Common side effects(may affect up to 1 in 10 people).

• rectal pain or discomfort,
• soft stools,
• fecal incontinence (inability to control bowel movements),
• swelling (experienced by some patients with type 2 diabetes),
• oral and gum changes,
• irregular menstrual cycle,
• fatigue.

The following side effects have also been reported, but their frequencies cannot be estimated from the available data:

• allergic reactions. The main symptoms are: itching, skin rash, hives (slightly raised areas of skin that itch and are paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and discomfort.Blisteringontheskin(includingblisteringthatruptures), diverticulitis,
• rectal bleeding,
• increases in liver enzyme levels may be detected in blood tests,
• hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver tenderness (indicated by pain below the front part of the chest cavity on the right side), sometimes with loss of appetite. Stop taking orlistat if these symptoms appear andinformyourdoctor,gallstonespancreatitis (inflammation of the pancreas),
• oxalate nephropathy (accumulation ofcalcium oxalate that may produce kidney stones). Seesection 2: Warnings and precautions,
• interactionswithanticoagulants.

Reporting of side effects

If you experience any type of side effect, consult your doctor orpharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of OrlistatSandoz

• The active ingredient is orlistat. Each hard capsule contains 120 mg of orlistat
• The other components are:

Content of the capsule:microcrystalline cellulose Ph 112,sodium carboxymethyl starch (type A) from potato, colloidal anhydrous silica andsodium lauryl sulfate.

Capsule body:gelatin, indigo carmine (E132) and titanium dioxide (E171).

Appearance of the product and content of the packaging

OrlistatSandoz 120 mg hard capsules are blue in color and are supplied in PVC/PVDC/Al blister packs containing 21, 42 and 84 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and Responsible for themanufacturingction

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for the manufacturing

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Lek S.A

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

Last revision date of this leaflet:January 2016

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http//www.aemps.gob.es/