Leaflet: information for the user

Orlistat Teva 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as 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 Teva is and what it is used for

2. What you need to know before you start taking Orlistat Teva

3. How to take Orlistat Teva

4. Possible side effects

5. Storage of Orlistat Teva

6. Contents of the pack and additional information

Orlistat Teva is a medication used to treat obesity. It acts on your digestive system by preventing about a third of the fat contained in the food you eat from being digested.

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 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 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 Teva.

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 fat and calorie consumption can reduce the effect of 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 is taken with a diet rich in fat. Additionally, your fat intake 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 is not indicated for use in children.

Orlistat Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, 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 blood levels more frequently than usual.

?Sodium and/or levothyroxine salts. They may produce cases of hypothyroidism and/or alterations in the control of hypothyroidism,

?Amiodarone.(used for heart rhythm problems). Consult your doctor.

?Medicines for treating HIV/AIDS.

?Medicines for depression, psychiatric disorders, or anxiety.

Orlistat reduces the absorption of some fat-soluble supplements, 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 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 this medicine with antiepileptic medicines.

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

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 taken with water.

Pregnancy and breastfeeding

Pregnancy

Do not take Orlistat Teva during pregnancy.

Breastfeeding

Do not breastfeed your child during treatment with Orlistat Teva, 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 Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 taken with water.

Orlistat should be taken with a calorie-controlled diet, well-balanced, rich in fruits and vegetables, and containing approximately 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 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 this medication 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. 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 Teva than you should

If you take more capsules than your doctor has indicated, or if someone else accidentally ingests your medication, 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 medication and the amount ingested.

If you forgot to take Orlistat Teva

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 questions about the use of this product, 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 Teva, tell your doctor 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 presented 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,
• upper respiratory tract infection,
• abdominal pain or discomfort,
• urgency or increased need to defecate,
• flatulence (gas),
• flatulence (gas) with fecal incontinence,
• oily or greasy feces,
• liquid stools,
• more frequent bowel movements,
• flu,
• low blood sugar (experienced by some patients with type 2 diabetes).

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

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

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 raised 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(the most common symptom is abdominal pain. Cramps, nausea, vomiting, fever, chills, or a change in bowel habits may also appear),
• rectal bleeding,
• increasesin 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 tenderness (indicated by pain below the front part of the chest in the right side), sometimes with loss of appetite. Stop taking orlistat if these symptoms appear and inform your doctor.
• bile stones,
• pancreatitis (inflammation of the pancreas),
• oxalate nephropathy (developed by calcium oxalate that may cause kidney stones). Seesection 2:Warnings and precautions.
• 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 25°C.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Orlistat Teva

• The active ingredient is orlistat. Each hard capsule contains 120 mg of orlistat.
• The other componentsare:

Capule contents: microcrystalline cellulose,sodium carboxymethyl starch type A (from potato), anhydrous colloidal silica and sodium lauryl sulfate.

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

Appearance of the product and contents of the packaging

Orlistat Teva 120 mg hard capsules are blue in color.

They are available in blister packs containing 21, 42, and 84 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid

Spain

Responsible 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

Last review date of this leaflet:May 2023

The detailed informationabout 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 carton 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