Orlistat CINFA 120 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
orlistat cinfa 120 mg hard capsules
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could 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.
Contents of the leaflet
- What orlistat cinfa is and what it is used for
- What you need to know before taking orlistat cinfa
- How to take orlistat cinfa
- Possible side effects
- Storage of orlistat cinfa
- Contents of the pack and other information
1. What orlistat cinfa is and what it is used for
Orlistat is a medicine used to treat obesity. It works on 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), thereby preventing the breakdown of part of the fat you have consumed during 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 cinfa
Do not take orlistat cinfa
- 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 (liver disorder).
- If you are breastfeeding.
Warnings and precautions
Consult your doctor or pharmacist before starting to take orlistat cinfa.
Weight loss may also affect the dose of medications you are taking 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 you require an adjustment in the dose of these medications.
To get the maximum benefit from orlistat, you should follow the eating plan recommended by your doctor. As with any other 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 faeces. The likelihood of this occurring may increase if orlistat cinfa 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.
If you experience severe diarrhoea, 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 cinfa is not indicated for use in children.
Other medicines and orlistat cinfa
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:
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Anticoagulants (e.g. warfarin); therefore, your doctor may need to monitor your blood clotting.
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Cyclosporine. Concomitant administration with cyclosporine is not recommended. Your doctor may need to monitor your cyclosporine plasma levels more frequently than usual.
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Iodine salts and/or levotiroxine. Cases of hypothyroidism and/or altered control of hypothyroidism may occur.
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Amiodarone. Consult your doctor.
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Medicines for treating HIV/AIDS.
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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 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 cinfa is not recommended for those taking acarbose (an antidiabetic drug used for Type 2 diabetes).
Taking orlistat cinfa 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.
It is not recommended to take orlistat cinfa during pregnancy.
You should not breastfeed while taking orlistat cinfa, 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 operate machinery.
orlistat cinfa 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 cinfa
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose 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 with a reduced-calorie, 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 across 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 fatty foods 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 orlistat if you skip 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 assume that this medicine 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 body weight.
Orlistat has been studied in clinical trials lasting up to 4 years.
If you take more orlistat cinfa 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take orlistat cinfa
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 a missed dose. If you have missed several doses, please inform your doctor and follow the advice given by them.
Do not change the prescribed dose on your own unless instructed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can 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 associated with 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 appear mainly after meals high in fat.
Normally, these symptoms disappear if you continue treatment and follow the recommended diet.
Very common adverse effects (may affect more than 1 in 10 patients)
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 patients)
Rectal pain or discomfort, soft stools, incontinence (fecal), 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, urticaria (slightly raised areas of skin that are itchy and paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and malaise. 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). Symptoms may include yellowing of the skin and eyes, itching, dark-colored 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, Taking orlistat cinfa with other medicines. Interactions with anticoagulants.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 cinfa
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 packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 ºC.
Keep in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of orlistat cinfa
- The active substance is orlistat. Each capsule contains 120 mg of orlistat.
- The other components are: capsule contents microcrystalline cellulose PH 112, sodium carboxymethylstarch (type A) (from potato), colloidal anhydrous silica, and sodium lauryl sulfate. The capsule shell consists of gelatin, indigo carmine (E-132), and titanium dioxide (E-171).
Appearance of the medicine and contents of the pack
orlistat cinfa is a hard blue capsule of size 1, containing white powder or slightly compacted agglomerated powder.
It is available in blister packs containing 21, 42, and 84 capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
or
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 review of this leaflet: October 2020
Detailed information on this medicine is available on the website of the Spanish Agency of 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 in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83274/P_83274.html
QR code link: https://cima.aemps.es/cima/dochtml/p/83274/P_83274.html