ORLISTAT SANDOZ 120 mg HARD CAPSULES

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

Do not take OrlistatSandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take orlistat.

Weight loss may also affect the dose of other medicines you are taking (e.g. high cholesterol or diabetes). Make sure to inform your doctor if you are taking these or other medicines. Weight loss may mean that you need a dose adjustment of these medicines.

To get the most benefit from orlistat, you should 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 medicine may cause a non-serious change in your bowel habits, such as the presence of oily or fatty stools, due to the excretion of undigested fat in the stool. The possibility of this occurring may increase if orlistat is taken with a high-fat diet. Additionally, your fat intake should be evenly distributed between the three main meals, as taking orlistat with a very high-fat meal may increase the possibility of gastrointestinal effects.

In case of severe diarrhea, there may be a failure of oral contraceptives, so it is recommended to use an additional contraceptive method.

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 OrlistatSandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because when you use more than one medicine at the same time, it can increase or decrease its effect.

Consult your doctor before taking orlistat if you are taking:

• anticoagulants (e.g. warfarin). Your doctor may need to monitor your blood coagulation,
• ciclosporin. Concomitant administration of orlistat with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual,
• iodine salts and/or levothyroxine. They may cause cases of hypothyroidism and/or alterations in the control of hypothyroidism,
• amiodarone. Consult your doctor,
• medicines for the treatment of HIV,
• medicines for the treatment of depression, psychiatric disorders, or anxiety.

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

Orlistat may alter anticonvulsant treatment by decreasing the absorption of antiepileptic medicines, which can lead to the occurrence of convulsions. Consult your doctor if you consider that the frequency or severity of convulsions has changed when taking this medicine with antiepileptic medicines. Orlistat is not recommended for those taking acarbose (an antidiabetic medicine used for type 2 diabetes mellitus).

Taking OrlistatSandozwith food and drinks

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Orlistat is not recommended during pregnancy.

Breast-feeding

You should not breast-feed while taking orlistat, as it is not known whether orlistat passes into breast milk.

Driving and using machines

Orlistat has no known effect on the ability to drive or use machines.

Orlistat Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; this is essentially "sodium-free".

3. How to take Orlistat Sandoz

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

Dose

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

General information

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

Orlistat only works in the presence of fat from your diet. Therefore, you do not need to take this medicine if you do not eat a main meal or if you eat a meal that does not contain fat.

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

Your doctor will stop the 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 for up to 4 years.

If you take moreOrlistatSandozthan you should

If you take more capsules than your doctor has told you, or if someone else has taken your medicine accidentally, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take OrlistatSandoz

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Most of the unwanted effects related to the use of orlistat are a result of its local action on the digestive system. These symptoms are usually mild, occur at the beginning of treatment, and are more likely to occur after meals high in fat. They usually disappear if you continue 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 fatty stools,
• liquid stools,
• low blood sugar levels (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),
• bloating (experienced by some patients with type 2 diabetes),
• changes in teeth and gums,
• irregular menstrual cycle,
• fatigue.

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

• allergic reactions. The main symptoms are: itching, skin rash, hives (areas of skin that are slightly raised, paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and discomfort. Blisters on the skin (including blisters that burst), diverticulitis,
• rectal bleeding,
• increased 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 sensitivity (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 appear and inform your doctor, kidney stones, pancreatitis (inflammation of the pancreas),
• oxalate nephropathy (accumulation of calcium oxalate that can cause kidney stones). See section 2: Warnings and precautions,
• interactions with anticoagulants.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of OrlistatSandoz

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

Contents of the capsule: microcrystalline cellulose Ph 112, sodium starch glycolate (type A) from potato, hydrophobic colloidal silica, and sodium lauryl sulfate.

Body of the capsule: gelatin, indigo carmine (E132), and titanium dioxide (E171).

Appearance of the product and contents of the pack

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 last revision of this leaflet:January 2016

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