120 mg hard capsules
Orlistat
What Orlistat STADA is and what it is used for
Orlistat Stada is a medicine used to treat obesity. It acts in your digestive system and blocks about a third of the fat in the food you eat from being absorbed by the gut.
Orlistat Stada binds to enzymes in your digestive system ( lipases ) and blocks them from breaking down some of the fat you have eaten during your meal. The fat that has not been broken down cannot be absorbed but is removed by the body.
Orlistat Stada is used to treat obesity along with a low-calorie diet.
What you need to know before using Orlistat STADA
Do not use Orlistat STADA
- 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 (insufficient absorption of nutrients via the gastrointestinal tract)
- if you have cholestasis (liver disease)
- if you are breast-feeding.
Warnings and cautions
Talk to your doctor or pharmacist before taking Orlistat Stada.
Weight loss will also be followed by a dose of one of the medicines you are taking for other ailments (eg high cholesterol or diabetes ). Therefore, remember to tell your doctor if you are taking these medicines or other medicines. Weight loss may cause you to adjust the dose of one of these medicines.
To get the maximum effect from Orlistat Stada, you should follow the diet program recommended by your doctor. As with other weight loss programs, an excessive intake of fat and calories can counteract a weight loss.
This medicine can cause harmless changes in bowel movements. The stool may be more greasy and oily because your stool contains fat that has not been broken down. The risk of this happening increases if you take Orlistat Stada with high-fat foods. The daily fat intake should therefore be evenly distributed over the day’s three main meals, as gastrointestinal problems are likely to increase if Orlistat Stada is taken with a very high-fat meal.
The use of an additional contraceptive is recommended to prevent the possible lack of oral contraceptives that can occur in severe diarrhea.
The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease.
Tell your doctor if you suffer from kidney problems.
Children and young people
Orlistat Stada is not intended for the treatment of children and adolescents under 18 years of age.
Other medicines and Orlistat STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because the use of more than one medicine at the same time may lead to an increase or decrease in the effect of any of these medicines.
Orlistat Stada may alter the effect of:
- anticoagulants (eg warfarin ). Your doctor may need to check your blood’s ability to coagulate.
- cyclosporine (a drug that inhibits the body’s immune system). Concomitant use of ciclosporin is not recommended. However, if this cannot be avoided, your doctor may need to check your ciclosporin blood levels more often than usual.
- iodine salts and / or levothyroxine. Impaired thyroid function and / or reduced control of impaired thyroid function may occur.
- amiodarone (a medicine used to treat irregular heartbeats). Ask your doctor for advice.
- drugs used to treat HIV .
- medicines for depression, mental disorders or anxiety.
Orlistat Stada reduces the absorption of certain fat-soluble nutrients, especially beta-carotene and vitamin E. You should therefore follow the advice you receive from your doctor to eat a well-balanced diet rich in fruits and vegetables. Your doctor may suggest that you supplement with a multivitamin.
Orlistat may affect the effect of antiepileptic drugs by reducing the uptake of antiepileptic drugs. This can lead to seizures. Contact a doctor if you think that the frequency and/or severity of seizures have changed when using Orlistat Stada with antiepileptic medicines.
Orlistat Stada is not recommended for people taking Akarbos (a medicine used to treat type 2 diabetes mellitus ).
Orlistat STADA with food, drink and alcohol
Orlistat Stada can be taken immediately before, during a meal, or up to an hour after a meal. The capsule should be swallowed with water.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Taking Orlistat Stada during pregnancy is not recommended.
You should not breastfeed your baby during treatment with Orlistat Stada as it is not known if Orlistat Stada passes into breast milk.
Driving and using machines
Orlistat Stada has no known effect on your ability to drive or use machines.
Orlistat STADA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Orlistat STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosage:
The usual dose of Orlistat Stada is a 120 mg capsule that is taken with each of the three main meals of the day. Dose one can be taken just before, with the meal, or within an hour after the meal. The capsules should be swallowed with water.
General information:
Orlistat Stada should be taken with a well-balanced, low-calorie diet rich in fruits and vegetables, where about 30% of the calories should come from fat. Your daily intake of fat, carbohydrates, and protein should be spread over three meals, which means that you usually take one capsule for breakfast, one capsule for lunch, and one capsule for dinner. To achieve the best results with the treatment, you should avoid high-fat foods between meals such as cakes, chocolate, and snacks.
Orlistat Stada only works in the presence of foods that contain fat. You, therefore, do not need to take Orlistat Stada if you miss a meal or if you eat a meal that does not contain any fat.
Tell your doctor if for any reason you have not taken your medicine as you were asked to. Your doctor may otherwise think that the medicine has not been effective or that you have not tolerated it and may therefore change your treatment unnecessarily.
If after 12 weeks you have not lost at least 5% of the bodyweight measured at the beginning of treatment with Orlistat Stada, your doctor will end your treatment with Orlistat Stada.
Orlistat Stada has been studied in long-term studies of up to 4 years of treatment.
If you take more Orlistat STADA than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital for assessment of the risk and advice.
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 an hour of your last meal, and then continue to take your medicine as usual at your next meal. Do not take a double dose to make up for a forgotten dose. If you forget to take several doses in a row, tell your doctor and follow the advice given to you.
Do not change the prescribed dose unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist immediately if you are not feeling well with Orlistat Stada.
Most of the side effects that may occur during treatment with Orlistat Stada are due to the local action of the medicine in the digestive system. These symptoms are usually mild and occur at the beginning of treatment and occur mainly after consuming high-fat meals.
Normally, these symptoms go away if you continue treatment and stick to the recommended diet.
Serious side effects ar – Has been reported (affects an unknown number of users):
Severe allergic reactions
- Signs of a severe allergic reaction include: severe difficulty breathing, sweating, rash, itching , swelling of the face, rapid pulse , collapse.
Stop taking the capsules. Seek medical attention immediately.
Stop taking the capsules. Seek medical attention immediately.
Other serious side effects are
- bleeding from the rectum .
- diverticulitis ( inflammation of the colon). Symptoms may include pain in the lower abdomen, especially on the left side, possibly with fever and constipation
- severe abdominal pain caused by gallstones .
- hepatitis ( inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching , dark colored urine, abdominal pain and tenderness in the liver (felt as pain on the right side below the chest), sometimes even with loss of appetite
- skin blisters (including defective blisters)
- pancreatitis ( inflammation of the pancreas). The symptoms can be severe abdominal pain that sometimes radiates to the back, possibly with fever, nausea and vomiting.
- oxalate nephropathy (accumulation of calcium oxalate which may lead to kidney stones ). See section 2. Warnings and Precautions.
Stop taking the capsules. Tell your doctor if you get any of these side effects.
Very common side effects ( may affect more than 1 user in 10)
- headache
- stomach ache / discomfort
- acute or increased need for bowel movements
- gas formation with bowel emptying
- oily stools
- high-fat / oily stools
- runny stools
- low blood sugar levels (in some patients with type 2 diabetes ).
Common side effects ( may affect up to 1 in 10 people)
- pain / discomfort in the rectum
- soft stools
- incontinence (stool)
- bloating (in some patients with type 2 diabetes )
- tooth / gum problems
- irregular menstrual bleeding
- fatigue.
Has been reported (occurs in an unknown number of users):
- Elevated liver enzyme levels can be found in blood tests
- effects on coagulation with anticoagulants .
How to store 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 after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Sensitive to light. Moisture sensitive.
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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is orlistat. Each hard capsule contains 120 mg of orlistat.
Other ingredients are:
Capsule contents: microcrystalline cellulose, sodium starch glycolate (type A), colloidal hydrophobic silica, sodium lauryl sulfate.
capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132).
What the medicine looks like and contents of the pack
Orlistat Stada capsules are blue and are supplied in blister packs containing 21, 42, or 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmaceutical Works Polpharma SA
19 Pelpinska Street
83-200 Starogard Gdanski
Poland
PharmaCoDane ApS.
Marielundvej 46A
2730 Herlev
Denmark
RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS SA
PO BOX 3012 Larisa Industrial Area,
Larisa, 41004
Greece
Local representative
PharmaCoDane ApS
Marielundvej 46 A
2730 Herlev
Denmark