ORLISTAT CINFA 120 mg HARD CAPSULES

2. What you need to know before taking orlistat cinfa

Do not take orlistat cinfa

• 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 absorption of nutrients 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 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 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 on weight loss.

This medication 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 cinfa 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 likelihood 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

Orlistat cinfa is not indicated for use in children.

Other Medications and Orlistat Cinfa

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

This is important because using more than one medication at the same time can 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.

• Cyclosporine. Concomitant administration with cyclosporine is not recommended. Your doctor may need to monitor your cyclosporine 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.

• AIDS medications.

• Medications for 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 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 cinfa is not recommended for those taking acarbose (an antidiabetic medication used for type 2 diabetes).

Taking Orlistat Cinfa 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 Breastfeeding

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

Orlistat cinfa is not recommended during pregnancy.

You should not breastfeed your child during treatment with orlistat cinfa, 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 use machines.

Orlistat Cinfa Contains Sodium.This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

3. How to Take Orlistat Cinfa

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

The recommended dose 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 meals. The capsule should be taken with water.

Orlistat should be taken with a calorie-controlled, balanced diet 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 consuming high-fat foods between meals, such as cookies, chocolate, or salty snacks.

Orlistat acts only in the presence of dietary fat. 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 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 without necessity.

Your doctor will stop the treatment with orlistat if, after 12 weeks, you have not lost at least 5% of your initial weight.

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

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 need medical attention.

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

If You Forget to Take Orlistat Cinfa

If you forget to take your medication at any time, take it as soon as you remember, provided it is within one hour after eating, and then continue taking it at the 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.

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone 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 generally mild, occur at the beginning of treatment, and are more common after meals with high fat levels.

Normally, these symptoms disappear if you continue 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 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 patients)

Rectal pain or discomfort, soft stools, incontinence (fecal), 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 (slightly raised 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, Taking orlistat cinfa with other medications. Interactions with anticoagulants.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Orlistat Cinfa

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Orlistat Cinfa

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

Appearance of the Product and Contents of the Pack

Orlistat cinfa are hard capsules of blue color, size 1, containing white or slightly compacted powder.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

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

Date of the Last Revision of this Package Leaflet:October 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the package 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