Orlistat Sandoz 120 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orlistat Sandoz 120 mg hard capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Orlistat Sandoz is and what it is used for
2. What you need to know before taking Orlistat Sandoz
3. How to take Orlistat Sandoz
4. Possible side effects
5. How to store Orlistat Sandoz
6. Contents of the pack and other information

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

Orlistat is a medicine used to treat obesity. It acts on your digestive system, preventing about one-third of the fat contained in the food you eat from being digested.

Orlistat binds to enzymes in your digestive system (lipases), preventing them from breaking down some of the fat you have consumed during a meal. Undigested fat cannot be absorbed and is eliminated from your body.

Orlistat is indicated for the treatment of obesity, in conjunction with a low-calorie diet.

2. What you need to know before taking Orlistat Sandoz

Do not take Orlistat Sandoz

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you have chronic malabsorption syndrome (inadequate absorption of nutrients through the digestive tract),
• if you have cholestasis (liver disorder),
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting orlistat.

Weight loss may also affect the dose of 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 medicines. Weight loss may mean you need a dose adjustment of these medications.

To get the maximum benefit from orlistat, you should follow the nutritional program recommended by your doctor. As with any weight control program, excessive intake of fat and calories may reduce the effect on weight loss.

This medicine may cause a harmless change in your bowel habits, such as oily or fatty stools, due to the excretion of undigested fat in the feces. The likelihood of this occurring may increase if orlistat is taken with a high-fat diet. In addition, your fat intake should be evenly distributed among the three main meals, since taking orlistat with a very high-fat meal may increase the likelihood of gastrointestinal effects.

In case of severe diarrhea, oral contraceptives may become less effective; therefore, use of 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 of age.

Other medicines and Orlistat Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because taking more than one medicine at the same time may increase or decrease their effects.

Consult your doctor before taking orlistat if you are taking:

• anticoagulants (e.g. warfarin). Your doctor may need to monitor your blood clotting,
• cyclosporine. Concomitant administration of orlistat with cyclosporine is not recommended. Your doctor may need to monitor your cyclosporine plasma levels more frequently than usual,
• iodine salts and/or levothyroxine. Cases of hypothyroidism and/or altered control of hypothyroidism may occur,
• amiodarone. Consult your doctor,
• medicines for HIV/AIDS,
• medicines for depression, psychiatric disorders, or anxiety.

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

Orlistat may interfere with anticonvulsant treatment by reducing the absorption of antiepileptic drugs, which could lead to seizures. Consult your doctor if you notice any change in the frequency or severity of seizures while taking this medicine together with antiepileptic drugs. Orlistat is not recommended for patients taking acarbose (an antidiabetic medicine used for type 2 diabetes mellitus).

Taking Orlistat Sandoz with food and drink

Orlistat Sandoz can be taken immediately before, during, or up to one hour after a meal. Swallow the capsule with water.

Pregnancy and breastfeeding

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

Pregnancy

Orlistat is not recommended during pregnancy.

Breastfeeding

You should not breastfeed while taking orlistat, as it is unknown whether orlistat passes into breast milk.

Driving and using machines

Orlistat has no known effect on the ability to drive or operate machinery.

Orlistat Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., essentially “sodium-free”.

3. How to take Orlistat Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

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

General information

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

Orlistat works only in the presence of dietary fat. Therefore, you do not need to take this medicine if you skip a main meal or if you eat a meal that contains no fat.

If for any reason you have not taken your medicine exactly as prescribed, inform your doctor. Otherwise, your doctor may believe that this medicine 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 body weight.

Orlistat has been studied in clinical trials lasting up to 4 years.

If you take more Orlistat Sandoz than you should

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

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Orlistat Sandoz

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

Do not change the prescribed dose yourself unless your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Most of the unwanted effects associated with the use of orlistat are the result of its local action on the digestive system. These symptoms are usually mild, occur at the beginning of treatment, and mainly appear after meals high in fat. Normally, these symptoms disappear if you continue treatment and follow the recommended diet.

Very common adverse 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 fecal incontinence,
• oily or fatty stools,
• liquid stools,
• low blood sugar levels (experienced by some patients with type 2 diabetes).

Common adverse effects (may affect up to 1 in 10 people):

• rectal pain or discomfort,
• soft stools,
• fecal incontinence (inability to control bowel movements),
• bloating (experienced by some patients with type 2 diabetes),
• dental and gum disorders,
• menstrual irregularities,
• fatigue.

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

• allergic reactions. Main symptoms are: itching, skin rash, hives (slightly raised areas of skin that are itchy and paler or redder than surrounding skin), severe difficulty breathing, nausea, vomiting, and malaise. Skin blisters (including blisters that burst), 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 of the rib cage on the right side), sometimes with loss of appetite. Stop taking orlistat if these symptoms occur and inform your doctor, gallstones, pancreatitis (inflammation of the pancreas),
• oxalate nephropathy (accumulation of calcium oxalate that may lead to kidney stones). See section 2: Warnings and precautions,
• interactions with anticoagulants.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Orlistat Sandoz

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

Do not store above 25°C.

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

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP/CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orlistat Sandoz

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

Capsule contents: microcrystalline cellulose Ph 112, sodium carboxymethylstarch (type A) from potato, colloidal anhydrous silica, and sodium lauryl sulfate.

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

Appearance of the product and pack contents

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Lek S.A

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

Date of latest revision of this leaflet: January 2016

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/