ORLISTAT AUROVITAS 120 mg HARD CAPSULES

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

Do not take Orlistat Aurovitas

• If you are allergic to orlistat 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 taking Orlistat Aurovitas.

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 medications. Weight loss may mean that you need a dose adjustment of these medications.

To get the maximum 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 of weight loss.

This medicine may cause a harmless change in your bowel habits, such as the presence of oily or fatty stools, due to the elimination of undigested fat through the stool. The possibility of this occurring may increase if orlistat is taken with a high-fat diet. Additionally, your daily fat intake should be evenly distributed among the three main meals, as taking orlistat with a very high-fat meal can 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.

Use in children

Orlistat is not indicated for use in children.

Taking Orlistat Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is important because using more than one medicine at the same time can increase or decrease its effect.

Orlistat may alter the action of:

• Anticoagulants (e.g., warfarin). Your doctor may need to monitor your blood coagulation.
• Ciclosporin (a medicine that suppresses the immune system). Concomitant administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.
• Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or alterations in the control of hypothyroidism may occur.
• Amiodarone (a medicine used for irregular heartbeats). Consult your doctor.
• Medicines for the treatment of AIDS.
• Medicines for depression, psychiatric disorders, or anxiety.

Orlistat reduces the absorption of some fat-soluble nutrient supplements, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's advice to 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 medications, which can lead to the occurrence of seizures. Consult your doctor if you think the frequency or severity of seizures has changed while taking orlistat with antiepileptic medications.

Orlistat is not recommended for those taking acarbose (an antidiabetic drug used for type 2 diabetes).

Taking Orlistat Aurovitas with food, drinks, and alcohol

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

Pregnancy and breast-feeding

Orlistat is not recommended during pregnancy.

You should not breast-feed your child during treatment with 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 Aurovitas contains sodium

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

3. How to take Orlistat Aurovitas

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

The recommended dose of orlistat is one 120 mg capsule taken 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.

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 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 dietary fats. Therefore, you do not need to take orlistat 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 more Orlistat Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Orlistat Aurovitas

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, 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 or pharmacist as soon as possible.

Most of the unwanted effects related to the use of orlistat are the result of its local action on the digestive system. These symptoms are usually mild, occur at the start of treatment, and are most likely to occur after meals that are high in 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 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, rash, hives (slightly elevated areas of skin that are 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. 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 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. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (developed by calcium oxalate that can cause kidney stones). See section 2, Warnings and precautions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orlistat Aurovitas

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

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.

Do not store above 25°C.

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

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 Orlistat Aurovitas

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

Capsule filling:microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), hydrophobic colloidal silica, sodium lauryl sulfate.

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

Appearance of the product and pack contents

Orlistat Aurovitas are blue capsules and are supplied in blister packs of 21 and 84 capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91.630.26.64

Manufacturer

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

Or

Rontis Hellas Medical and Pharmaceutical Products S.A.

p.o. BOX 3012 Larisa Industrial Area

41004 Larisa

Greece

Date of last revision of this leaflet: September 2020

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/).