ORLISTAT TEVA 120 mg HARD CAPSULES

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

Do not take Orlistat Teva

? 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 Teva.

Weight loss may also affect the dose of medicines 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 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 of 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 elimination of undigested fat in the stool. The likelihood of this happening 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 likelihood of gastrointestinal effects.

In the event 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 is not indicated for use in children.

Taking Orlistat Teva 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), so your doctor may need to monitor your blood coagulation.

? Cyclosporin. Concomitant administration with cyclosporin is not recommended. Your doctor may need to monitor your cyclosporin blood 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 (used for heart rhythm problems). Consult your doctor.

? Medicines for treating AIDS.

? Medicines 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 medicines, which may lead to the appearance of convulsions. Consult your doctor if you think the frequency or severity of convulsions has changed when taking this medicine with antiepileptic medicines.

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

Taking Orlistat Teva 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

Pregnancy

Orlistat Teva is not recommended during pregnancy.

Breast-feeding

You should not breast-feed your child during treatment with Orlistat Teva, 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 Teva contains sodium

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

3. How to take Orlistat Teva

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

The recommended dose of orlistat 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 swallowed 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 over 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 fat. Therefore, you do not need to take this medicine if you miss a main meal or if you have 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 Teva than you should

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

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

If you forget to take Orlistat Teva

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 are not feeling well while taking Orlistat Teva, tell your doctor 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,
• infection of the upper respiratory tract,
• abdominal pain or discomfort,
• urgency or increased need to defecate,
• flatulence (gas),
• flatulence (gas) with fecal incontinence,
• oily or fatty stools,
• liquid stools,
• more frequent bowel movements,
• flu,
• low blood sugar levels (experienced by some patients with type 2 diabetes).

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

• infection of the lower respiratory tract,
• rectal pain or discomfort,
• soft stools,
• fecal incontinence (inability to control bowel movements),
• swelling (experienced by some patients with type 2 diabetes),
• changes in teeth and gums,
• urinary tract infection,
• irregular menstrual cycle,
• fatigue,
• anxiety.

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 (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 (the most common symptom is abdominal pain. Cramps, nausea, vomiting, fever, chills, or a change in bowel habits may also appear),
• 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, abdominal pain, and liver sensitivity (indicated by pain under 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.
• interactions with anticoagulants,

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 Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orlistat Teva

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

Do not store above 25°C.

Store in the original package 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. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orlistat Teva

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

Capsule content: microcrystalline cellulose, sodium starch glycolate type A (from potato), colloidal anhydrous silica, and sodium lauryl sulfate.

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

Appearance of the product and pack contents

Orlistat Teva 120 mg hard capsules are blue.

They are 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

Teva Pharma, S.L.U.

c/ Anabel Segura, 11 Edificio Albatros B 1ª Planta

Alcobendas 28108 Madrid

Spain

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,

Larisa, 41004

Greece

Date of last revision of this leaflet:May 2023

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/

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81233/P_81233.html