ORLISTAT STADA 120 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Orlistat Stada 120 mg Hard Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Orlistat is a medicine used to treat obesity. It works on your digestive system to prevent the digestion of about a third of the fat contained in the food you eat.

Orlistat attaches to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fats you have ingested during meals. The undigested fat cannot be absorbed and your body eliminates it.

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

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

Do not take Orlistat Stada:

• If you are allergic to the active substance or to 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 starting to take orlistat.

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 medicine 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 happening may increase if orlistat is taken with a high-fat diet. Additionally, your daily fat intake should be evenly distributed among the three main meals, as if orlistat is taken with a very high-fat meal, it may increase the possibility 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.

Tell your doctor if you have kidney problems.

Children

Orlistat is not indicated for use in children.

Use of Orlistat Stada and other medicines

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

This is important because when using more than one medicine at the same time, it 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. Concomitant administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin 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.
• Medicines for the treatment of AIDS.
• Medicines for the treatment of 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 may lead to the appearance of convulsions. Consult your doctor if you think that the frequency or severity of convulsions has changed when taking orlistat along with antiepileptic medications.

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

Taking Orlistat Stada 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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Orlistat is not recommended during pregnancy.

Breast-feeding

You should not breast-feed your child during treatment with orlistat, 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.

This medicine 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 Stada

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 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 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 in 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 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 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 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 Stada than you should

If you take more capsules than your doctor has told you, or if someone else has taken your medicine accidentally, 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, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Orlistat Stada

If you forget to take your medicine at any time, take it as soon as you remember, provided that 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 forgotten doses. If you have missed several doses, please inform your doctor and follow the advice given.

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 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 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 the treatment and follow the recommended diet.

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

• 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 people)

• rectal pain or discomfort,
• soft stools,
• fecal incontinence,
• swelling (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 elevated areas of skin that are paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and discomfort
• skin blisters (including blisters that burst)
• diverticulitis
• rectal bleeding
• increases in liver enzyme levels may be detected in blood tests
• hepatitis (inflammation of the liver). The 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, Warnings and precautions
• interactions with anticoagulants.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orlistat Stada

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

Do not use this medicine after the expiry date which is stated on the carton and blister or bottle after EXP. The expiry date is the last day of the month stated.

Blister:

Do not store above 25°C.

Store in the original package to protect from light and moisture.

Bottle:

Do not store above 25°C.

Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Orlistat Stada

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

• Capsule content: Microcrystalline cellulose PH112 (E460), potato starch carboxymethyl ether (Type A), hydrophobic colloidal silica, and sodium lauryl sulfate.
• Capsule body: Gelatin, titanium dioxide (E171), and carmine indigo (E132).

Appearance of the product and contents of the pack

Orlistat Stada 120 mg hard capsules have a blue body and cap.

Orlistat Stada 120 mg hard capsules are available in Al/PVC/PVDC blisters containing 42 and 84 hard capsules and in HDPE bottles containing 42 and 84 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmaceutical Works Polpharma S.A.

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 leaflet:September 2018

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