Orlistat Stada 120 mg hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Orlistat Stada 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, ask 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, because 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
- What Orlistat Stada is and what it is used for
- What you need to know before taking Orlistat Stada
- How to take Orlistat Stada
- Possible adverse effects
- How to store Orlistat Stada
- Contents of the pack and other information
1. What Orlistat Stada is and what it is used for
Orlistat is a medicine used to treat obesity. It works in your digestive system by 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), preventing them from breaking down some of the fat you have consumed in your meals. 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 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 (inadequate absorption of nutrients through the digestive tract).
- If you have cholestasis (liver disorder).
- If you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting orlistat.
Weight loss may affect the dosage of medications 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 a dosage adjustment of these medications.
To get the maximum benefit from orlistat, you should follow the nutritional program recommended by your doctor. As with any weight control program, 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 feces. The likelihood of this occurring may increase if orlistat is taken with a high-fat diet. In addition, your daily 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 diarrhea, oral contraceptives may fail; therefore, 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.
Use of Orlistat Stada 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 coagulation.
- Cyclosporine. Concomitant administration with cyclosporine is not recommended. Your doctor may need to monitor your plasma levels of cyclosporine more frequently than usual.
- Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or altered control of hypothyroidism may occur.
- Amiodarone. Consult your doctor.
- Medicines for treating 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 maintain 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 drugs, which may lead to seizures. Consult your doctor if you notice any change in the frequency or severity of seizures while taking orlistat together with antiepileptic medicines.
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 a meal. Swallow the capsule with water.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Orlistat is not recommended during pregnancy.
Breastfeeding
You should not breastfeed while taking orlistat, as it is unknown 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; i.e., essentially “sodium-free”.
3. How to take Orlistat Stada
Follow exactly the instructions for use provided 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 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 along with a calorie-controlled, well-balanced diet rich in fruits and vegetables, and containing approximately 30% of calories from fat. Your daily intake of fats, carbohydrates, and proteins should be distributed across three meals. This means you will usually take one capsule at breakfast, one at lunch, and one at dinner. To achieve optimal benefits, avoid consuming fatty foods between meals, such as cookies, chocolate, or salty snacks.
Orlistat works only in the presence of dietary fat. Therefore, you do not need to take orlistat if you skip a main meal or if your meal contains no fat.
If for any reason you have not taken your medicine exactly as prescribed, inform your doctor. Otherwise, your doctor may assume that this medication was ineffective or poorly 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 Stada than you should
If you take more capsules than your doctor has prescribed, or if someone else accidentally takes your medicine, contact your doctor, pharmacist, 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 91 562 04 20, stating the name of the medication and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet 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 it is within one hour after eating your meal, and then continue taking it at your 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 about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 due to its local action on the digestive system. These symptoms are generally mild, occur at the beginning of treatment, and mainly appear after meals high in fat.
Usually, these symptoms disappear if you continue with the treatment and follow the recommended diet.
Very common adverse 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,
- oily or fatty stools,
- liquid stools,
- low blood sugar levels (experienced by some patients with type 2 diabetes).
Common adverse effects (may affect up to 1 in 10 people)
- rectal pain or discomfort,
- soft stools,
- fecal incontinence,
- bloating (experienced by some patients with type 2 diabetes),
- dental and gingival disorders,
- menstrual irregularities,
- fatigue.
The following adverse 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,
- blisters on the skin (including ruptured blisters),
- diverticulitis,
- 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-colored urine, stomach pain, and liver tenderness (indicated by pain below the front of the rib cage on the right side), sometimes accompanied by loss of appetite. Discontinue orlistat and inform your doctor if these symptoms occur,
- gallstones,
- pancreatitis (inflammation of the pancreas),
- oxalate nephropathy (caused by calcium oxalate, which may lead to kidney stones). See section 2, Warnings and precautions,
- interactions with anticoagulants.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 on the blister or bottle after EXP. The expiry date refers to the last day of the month indicated.
Blister:
Do not store above 25°C.
Keep in the original packaging to protect from light and moisture.
Bottle:
Do not store above 25°C.
Keep in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are:
- Capsule contents: Microcrystalline cellulose PH112 (E460), sodium carboxymethyl starch from potato (Type A), colloidal anhydrous silica, and sodium lauryl sulfate.
- Capsule shell: Gelatin, titanium dioxide (E171), and indigo carmine (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.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
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 most recent revision of this leaflet: September 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es