Orlistat stada 120 mg capsulas duras

Leaflet: information for the user

Orlistat Stada 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 Stada is and what it is used for

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

3. How to take Orlistat Stada

4. Possible side effects

5. Storage of Orlistat Stada

6. Contents of the pack and additional information

Orlistat 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 Stada:

−If you are allergic to the active ingredient or to any of the other components of this medication (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.

The weight loss may also affect the dosage 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 an adjustment in the dosage of these medications.

To get the maximum benefit from orlistat, you must follow the recommended nutrition program by your doctor. As with any other weight control program, excessive consumption of fat and calories may reduce the effect on weight loss.

This medication 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 stool. The likelihood of this occurring may increase if orlistat is taken with a diet rich in fat. Additionally, your daily intake of fat 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.

Use of Orlistat Stada and other medications

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

This is important as using more than one medication 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. Co-administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.
• Sodium and/or levothyroxine salts. They may cause cases of hypothyroidism and/or alterations in thyroid control.
• Amiodarone. Consult your doctor.
• Medications for HIV/AIDS.
• Medications for depression, psychiatric disorders, or anxiety.

Orlistat reduces the absorption of 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 medications, 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 orlistat with antiepileptic medications.

Orlistat is not recommended for those taking acarbose (a medication 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 a meal. Swallow the capsule with water.

Pregnancy and breastfeeding

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

Pregnancy

Do not take orlistat during pregnancy.

Breastfeeding

Do not breastfeed your child during treatment with orlistat, as it is unknown whether orlistat passes into breast milk.

Driving and operating machines

Orlistat has no known effect on the ability to drive or operate machines.

This medication contains sodium

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

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 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 the meal. The capsule should be taken with water.

Orlistat should be taken with a calorie-controlled, well-balanced diet rich in fruits and vegetables and containing approximately 30% of its 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 Orlistat 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 Stada 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Orlistat Stada

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.

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, tell your doctor or pharmacist as soon as possible.

Most unwanted effects related to the use of orlistat are the result of its local action on the digestive system. These symptoms are generally moderate, occur at the beginning of treatment, and are mainly present after meals with high levels of 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 fecal incontinence,
• greasy 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),
• oral and gum changes,
• irregular menstrual cycle,
• fatigue.

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
• skin blisters (including blisters that burst)
• diverticulitis
• rectal bleeding
• increased levels of liver enzymes 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 on 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). 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Blister:

Do not store at a temperature above 25°C.

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

Bottle:

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Orlistat Stada

The active ingredient is orlistat. Each hard capsule contains 120 mg of orlistat. The other components are:

Appearance of the product and content of the packaging

Orlistat Stada 120 mg hard capsules have a blue-colored 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.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible for manufacturing

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

Last review date of this leaflet:September 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http//www.aemps.gob.es