Prospecto: information for the user

OrlistatAurovitas120 mg hard capsules

Read this prospect carefully before starting to take the medicine because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is OrlistatAurovitasand for what it is used

2.What you need to know before starting to take OrlistatAurovitas

3.How to take OrlistatAurovitas

4.Adverse effects

5.Storage of OrlistatAurovitas

6.Contents of the package and additional information

OrlistatAurovitasis a medication used to treat obesity. It acts on your digestive system by preventing the digestion of about a third of the fat contained in the food you eat.

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

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

Do not take OrlistatAurovitas

•If you are allergic to orlistat 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 Aurovitas.

The weight loss may also affect the dosage of medications you take 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 of orlistat, you must follow the nutrition program recommended by your doctor. As with any other weight control program, excessive consumption of fat and calories may reduce the effect of weight loss..

This medication may cause a non-harmful change in your bowel habits, such as the presence of fatty or oily stools, due to the elimination of undigested fat through the stools. The likelihood of this occurring may increase if orlistat is taken with a diet high in fat. Additionally, your daily intake of fat 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.

Use in children

Orlistat is not indicated for use in children.

Orlistat Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is important as using more than one medication at the same time may increase or decrease its effect.

Orlistat may modify the action of:

•Anticoagulants (e.g. warfarin). Your doctor may need to monitor your blood coagulation.

•Ciclosporin (medication that reduces the immune system). The concurrent administration of ciclosporin with orlistat is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.

•Sodium and/or levothyroxine salts. Cases of hypothyroidism and/or alterations in thyroid control may occur.

•Amiodarone (medication used for irregular heartbeats). Consult your doctor.

•Medications for HIV/AIDS.

•Medications for depression, psychiatric disorders, or anxiety.

Orlistat reduces the absorption of fat-soluble 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 reducing the absorption of antiepileptic medications, which may lead to the occurrence of seizures. Consult your doctor if you consider that the frequency or severity of seizures has changed while taking orlistat with antiepileptic medications.

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

Orlistat Aurovitas intakewith food, drinks, and alcohol

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

Pregnancy and breastfeeding

Orlistat is not recommended during pregnancy.

You should not breastfeed your child during treatment with orlistat, as it is unknown whether orlistat passes into breast milk.

Driving and operating machinery

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

Orlistat Aurovitas contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 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.

The recommended doseof 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 must be taken with water.

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 only acts in the presence of dietary fats.Therefore, you do not need to take orlistat 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 more Orlistat Aurovitasthan you should

If you take more capsules than your doctor has indicated, or if someone else accidentally ingests your medication, contact your doctor, pharmacist or hospital as you may require 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 medication and the amount ingested.

If you forgot to take Orlistat Aurovitas

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, inform your doctor and follow their advice.

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

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

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

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

The majority of unwanted effects related to the use of orlistat 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 fatty feces, liquid feces, 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), alterations in teeth and gums, 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 elevated areas of skin that itch and 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-colored urine, stomach pain, and liver tenderness (indicated by pain below the front part of the thoracic 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 may cause kidney stones). See section 2, Warnings and precautions.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 usethis medicationafter the expiration date that appears onthe box and on the blisterpack after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of OrlistatAurovitas

-The active ingredient is orlistat. Each hard capsule contains 120 mg of orlistat.

-The other components are:

Filling of the capsule:microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), colloidal hydrated silica, sodium lauryl sulfate.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AurovitasSpain,S.A.U.

Avda.deBurgos,16-D

28036Madrid

Spain

Tel.: 91 630 86 45

Fax: 91.630.26.64

Responsible for manufacturing

Pharmaceutical Works POLPHARMA SA

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

O

Rontis Hellas Medical and Pharmaceutical Products S.A.

p.o. BOX 3012 Larisa Industrial Area

41004 Larisa

Greece

Last review date of this leaflet: September 2020

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).