Leaflet: information for the user

orlistat cinfa 120 mg hard capsules

Read 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 youonlyand should not be given to others even if they have the same symptomsas you,as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

1.What orlistat cinfa is and what it is used for

2.What you need to knowbeforestarting totake orlistat cinfa

3.How to take orlistat cinfa

4.Possible side effects

5Storage of orlistat cinfa

6.Contents of the pack and additional information

orlistatis a medication used to treat obesity. It acts on your digestive systempreventing approximately one-third of the fat contained in the food you consume from being digested.Orlistatbinds to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fat you have ingested during a meal. 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 cinfa

• 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 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 cinfa.

Weight loss may also affect the dose of medicines you take 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 that you need an adjustment in the dose of these medicines.

To get the maximum benefit from 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 on weight loss.

This medicine 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 cinfa is taken with a diet rich 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 case 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

Orlistat cinfa is not indicated for use in children.

Other medicines and orlistat cinfa

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

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

Orlistat may modify the action of:

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

• Ciclosporin. The concurrent administration of ciclosporin with orlistat is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.

• Iodine and/or levothyroxine salts. They may produce cases of hypothyroidism and/or alterations in thyroid control.

• Amiodarone. Consult your doctor.

• Medicines for treating HIV/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 and take a balanced diet rich in fruit and vegetables. Your doctor may recommend a multivitamin supplement.

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

Orlistat cinfa is not recommended for those taking acarbose (a medication used to treat type 2 diabetes).

Taking orlistat cinfa with food, drinks, and alcohol

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

Orlistat cinfa is not recommended during pregnancy.

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

Driving and operating machines

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

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

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

The recommended dose is one capsule of 120 mg taken 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.

Orlistat should be taken with a calorie-controlled, well-balanced diet rich in fruits and vegetables and containing a mean of 30% of 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 containing 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 medicine exactly as prescribed, tell your doctor.If you do not, 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 cinfa than 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 Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take orlistat cinfa

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 yourself unless your doctor tells you to.

If you have any other doubts 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.

Most unwanted effects related to the use of orlistat are the 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 the treatment and follow the recommended diet.

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

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

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

Rectal pain or discomfort, soft stools, incontinence (fecal), 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. Elevated levels of liver enzymes 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 sensitivity (indicated by pain under 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, Taking orlistat cinfa with other medicines. Interactions with anticoagulants.

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 the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thepackagingafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect it from thelight and humidity.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging andmedicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging andmedicines that you no longer need. In this way, you will help protect the environment.

Composition of orlistat cinfa

• The active ingredient is orlistat. Each capsule contains 120 mg of orlistat.
• The other components are: capsule content microcrystalline cellulose PH 112, sodium carboxymethyl starch (type A) (from potato), hydrophobic colloidal silica, and sodium lauryl sulfate. The capsule body is composed of gelatin, indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

orlistat cinfa are hard blue capsules, size 1, containing white powder or slightly compacted agglomerate.

It is available in blister packs containing 21, 42, and 84 capsules.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

or

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 – Larisa, 41004 – Greece

Last review date of this leaflet: October 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83274/P_83274.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83274/P_83274.html