Orlistat Teva 120 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orlistat Teva 120 mg hard capsules

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Orlistat Teva is and what it is used for
2. What you need to know before taking Orlistat Teva
3. How to take Orlistat Teva
4. Possible side effects
5. How to store Orlistat Teva
6. Contents of the pack and other information

1. What Orlistat Teva is and what it is used for

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

Orlistat binds to enzymes in your digestive system (lipases), thereby preventing the breakdown of some of the fats you have ingested with your meals. The undigested fat cannot be absorbed and is eliminated from your body.

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

2. What you need to know before taking Orlistat Teva

Do not take Orlistat Teva

• if you are allergic to orlistat or to any of the other ingredients of this medicine (listed in section 6),

• if you have chronic malabsorption syndrome (inadequate absorption of nutrients through the digestive tract),

• if you have cholestasis (a liver disorder),

• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Orlistat Teva.

Weight loss may also affect the dose of medicines you are taking for other conditions (e.g., high cholesterol or diabetes). Be 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 eating plan recommended by your doctor. As with any other weight-control programme, excessive intake of fat and calories may reduce the weight-loss effect.

This medicine may cause a harmless change in your bowel habits, such as oily or fatty stools, due to the excretion of undigested fat in the faeces. The likelihood of this happening may increase if orlistat is taken with a high-fat diet. In addition, your fat intake should be evenly distributed among the three main meals, since taking orlistat with a very high-fat meal may increase the likelihood of gastrointestinal effects.

In case of severe diarrhoea, oral contraceptives may become less effective; therefore, the use of 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.

Taking Orlistat Teva with other medicines

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

This is important because using more than one medicine at the same time may increase or decrease their effects.

Orlistat may alter the action of:

• Anticoagulants (e.g., warfarin); therefore, your doctor may need to monitor your blood clotting.

• Cyclosporine. Concomitant administration with cyclosporine is not recommended. Your doctor may need to monitor your cyclosporine blood levels more frequently than usual.

• Iodide salts and/or levothyroxine. Cases of hypothyroidism and/or altered control of hypothyroidism may occur.

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

• Medicines for HIV/AIDS.

• Medicines for depression, psychiatric disorders, or anxiety.

Orlistat reduces the absorption of supplements of certain fat-soluble nutrients, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's advice and eat a balanced diet rich in fruit and vegetables. Your doctor may recommend taking a multivitamin supplement.

Orlistat may interfere with anticonvulsant treatment by reducing the absorption of antiepileptic medicines, which could lead to seizures. Consult your doctor if you notice any change in the frequency or severity of seizures while taking this medicine together with antiepileptic drugs.

Orlistat is not recommended for people 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 breastfeeding

Pregnancy

Orlistat Teva is not recommended during pregnancy.

Breastfeeding

You should not breastfeed while taking Orlistat Teva, as it is unknown whether orlistat passes into breast milk.

Driving and use of 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; i.e., essentially “sodium-free”.

3. How to take Orlistat Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If 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 may 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, well-balanced diet rich in fruits and vegetables, in which approximately 30% of the calories come from fat. Your daily intake of fat, carbohydrates, and protein should be distributed over three meals. This means that you will usually take one capsule at breakfast, one at lunch, and one at dinner. To achieve optimal benefits, avoid eating foods containing fat between meals, such as biscuits, chocolate, or salty snacks.

Orlistat works only in the presence of dietary fat. Therefore, you do not need to take this medicine if you miss a main meal or if you eat a meal that contains no fat.

If for any reason you have not taken your medicine exactly as prescribed, inform your doctor. Otherwise, your doctor may think that this medicine has not been 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 body weight.

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

If you take more Orlistat Teva than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

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 after eating your meal, 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 by them.

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

If you have any further questions about 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 everyone gets them.

If you do not feel 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 beginning of treatment, and mainly appear after meals high in fat. Normally, these symptoms disappear if you continue 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 fecal incontinence,
• oily or fatty stools,
• liquid stools,
• more frequent bowel movements,
• influenza,
• low blood sugar levels (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),
• bloating (experienced by some patients with type 2 diabetes),
• dental and gingival disorders,
• urinary tract infection,
• menstrual irregularity,
• 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, skin rash, hives (slightly raised, itchy areas of skin that are paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and malaise. Skin blisters (including blisters that burst),
• diverticulitis (the most common symptom is abdominal pain. Cramps, nausea, vomiting, fever, chills, or changes in bowel habits may also occur),
• rectal bleeding,
• increased liver enzyme levels may be detected in blood tests,
• hepatitis (liver inflammation). Symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver tenderness (indicated by pain under the front part of the rib cage on the right side), sometimes with loss of appetite. Stop taking orlistat if these symptoms occur and inform your doctor.
• gallstones,
• pancreatitis (inflammation of the pancreas),
• oxalate nephropathy (developed due to calcium oxalate, which may lead to kidney stones). See section 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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.

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please consult your pharmacist on how to dispose of medicines and packaging you no longer need. 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 components are:

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

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

Appearance of the product and contents of the pack

Orlistat Teva 120 mg hard capsules are blue in colour.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, 11 Edificio Albatros B 1st Floor
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 the most recent 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 about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81233/P_81233.html