Active ingredients: Orlistat
Xenical 120 mg hard capsules
Indications Why is Xenical used? What is it for?
Xenical is a medicine used to treat obesity. It acts on the digestive system by blocking the digestion of about 30% of the fat ingested during a meal.
Xenical acts on the enzymes of the digestive system (lipase) and blocks their action on some of the fats eaten during the meal. Undigested fats cannot be absorbed and are eliminated by the body.
Xenical is indicated for the treatment of obesity in association with a low calorie diet.
Contraindications When Xenical should not be used
Do not take XENICAL
- if you are allergic (hypersensitive) to orlistat or any of the other ingredients of Xenical,
- if you suffer from chronic malabsorption syndrome (insufficient absorption of nutrients from the digestive system),
- if you suffer from cholestasis (liver disorder),
- if you are breastfeeding.
Precautions for use What you need to know before taking Xenical
Weight loss can also affect the dose of medicines taken to treat other conditions (for example, hypercholesterolemia or diabetes). Be sure to tell your doctor about these or any other medicines you may be taking. Weight loss may require dose adjustments of these medicines.
To get the best results with Xenical, you should follow the diet advice your doctor has told you. As with any weight control program, excessive consumption of fat and calories can reduce any weight loss effects.
This medicine may cause a change, although not harmful, in bowel habits, such as the appearance of fatty or oily stools, due to the elimination of undigested fat in the stool. The likelihood of these events may increase if Xenical is taken. with a high-fat diet. In addition, the daily fat intake must be distributed equally over the three main meals, as if Xenical is taken in conjunction with a very high-fat meal, the likelihood of gastrointestinal effects may increase .
The use of an additional contraceptive method is recommended to prevent the possible failure of oral contraceptives which could occur in case of severe diarrhea.
The use of orlistat may be associated with kidney stones in patients with chronic kidney disease. Tell your doctor if you have kidney problems.
Children
Xenical is not suitable for use in children.
Interactions Which drugs or foods can modify the effect of Xenical
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.
This is very important as taking several medicines at the same time can increase or decrease the effectiveness of the medicines.
Xenical can modify the activity of
- Anticoagulant medicines (e.g. warfarin). Your doctor may need to check for blood clotting.
- Cyclosporine. Co-administration with cyclosporine is not recommended. Your doctor may need to check your blood levels of cyclosporine more often than usual.
- Salts of iodine and / or levothyroxine. Cases of hypothyroidism and / or reduced control of hypothyroidism may occur.
- Amiodarone. Ask your doctor for advice.
- Medicines for the treatment of HIV.
Xenical reduces the absorption of some nutrients soluble in fat administered in addition to the diet, in particular beta-carotene and vitamin E. You must therefore follow your doctor's instructions by taking a well-balanced diet rich in fruit and vegetables. may suggest that you take a multivitamin supplement.
Orlistat may unbalance anticonvulsant treatment by decreasing the absorption of antiepileptic medicines and thus leading to seizures. Contact your doctor if you think that the frequency and / or severity of seizures have changed by taking Xenical at the same time as antiepileptic medicines.
Xenical is not recommended for people taking acarbose (an anti-diabetic medicine used to treat type 2 diabetes mellitus).
Xenical with food and drink
Xenical can be taken immediately before, during a meal or up to one hour after a meal. The capsules should be swallowed with water.
Warnings It is important to know that:
Pregnancy and breastfeeding
The use of Xenical during pregnancy is not recommended.
As it is not known whether Xenical is excreted in breast milk, you should not breastfeed while being treated with Xenical.
Driving and using machines
Xenical has no known effect on the ability to drive or use machines.
Dosage and method of use How to use Xenical: Dosage
Always take Xenical exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist. The usual dose of Xenical is one 120 mg capsule to be taken with each of the three main meals per day. The capsule can be taken immediately before, during a meal or up to one hour after a meal. The capsule should be swallowed with water.
Xenical should be taken with a well-balanced, calorie-reduced diet rich in fruits and vegetables, containing on average 30% of the calories from fat. The daily intake of fats, carbohydrates and proteins must be distributed over the three main meals. This means that you will generally have to take one capsule with breakfast, one with lunch and one with dinner. For best results, avoid taking between meals. main foods containing fat, such as biscuits, chocolate and pretzels.
Xenical works only in the presence of fats in the diet. Therefore, if you miss a main meal or if you eat a meal that does not contain fat, it is not necessary to take Xenical.
Tell your doctor if, for any reason, you have not taken the medicine exactly as prescribed, otherwise your doctor may think that the medicine is not effective or is not well tolerated and may therefore decide to change therapy, but this is not really necessary.
Your doctor will stop treatment with Xenical after 12 weeks if you have not lost at least 5% of your body weight recorded at the start of Xenical therapy.
Xenical has been studied in long-term clinical trials lasting up to 4 years.
Overdose What to do if you have taken an overdose of Xenical
If you take more XENICAL than you should
If you take more capsules than prescribed or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital, as medical attention may be required.
If you forget to take XENICAL
If you forget to take your medicine, take it as soon as you remember, provided this is done within one "hour" of your last meal, and then continue taking it according to the prescribed schedule. Do not take a double dose. If you have failed to take it several times, please tell your doctor and follow his instructions.
Do not change your prescribed dose unless your doctor tells you to.
If you have any further questions on the use of Xenical, ask your doctor or pharmacist.
Side Effects What are the side effects of Xenical
Like all medicines, Xenical can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you experience any complaints while taking Xenical.
Most of the undesirable effects related to the use of Xenical are the direct consequence of its local action in the digestive system. These symptoms are generally mild, occur at the start of treatment and occur particularly after meals with a high fat content. These symptoms usually disappear with continued therapy and if the prescribed diet is followed.
Very common side effects (affecting more than 1 in 10 patients)
Headache, abdominal discomfort / pain, urgent urge to defecate, excess intestinal gas with stool emission, oily bowel movement, greasy / oily stools, liquid stools, low blood sugar levels (found in some patients with diabetes of type 2).
Common side effects (affecting 1 to 10 users in 100)
Rectal discomfort / pain, soft stools, fecal incontinence, swelling (found in some patients with type 2 diabetes), dental / gum changes, menstrual irregularities, 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 reactions, wheals (small skin lumps paler or more intense than the surrounding skin, accompanied by itching), severe difficulty in breathing, nausea, vomiting and feeling of malaise. Bullous rashes (including burning blisters). Diverticulitis. Rectal bleeding. Increases in liver enzyme levels. Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain and achy liver (indicated by pain under the front of the rib cage on the right side), occasionally with loss of appetite. Stop taking Xenical if these symptoms occur and tell your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (calcium oxalate buildup which can lead to kidney stones). See section 2, Face special attention with XENICAL.
Effects on coagulation in association with anticoagulants.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep out of the sight and reach of children.
Blister
Do not use Xenical after the expiry date stated on the carton.
Do not store above 25 ° C.
Store in the original package and keep the blister in the outer carton to protect the medicine from light and moisture.
Glass bottles
Do not use Xenical after the expiry date which is stated on the bottle.
Do not store above 30 ° C.
Keep the container tightly closed to protect the medicine against moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What XENICAL contains
- The active ingredient is orlistat 120 mg. Each capsule contains 120 mg of orlistat.
- The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium lauryl sulfate and talc. The capsule shell consists of gelatin, indigo carmine (E 132), titanium dioxide (E171) and food grade printing ink.
Description of what XENICAL looks like and contents of the pack
Xenical capsules are turquoise imprinted with "ROCHE XENICAL 120" and are available in blisters and glass bottles containing 21, 42 and 84 capsules.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
XENICAL 120 MG HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg of orlistat.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Hard capsule.
The capsule has a turquoise colored cap and body imprinted with "ROCHE XENICAL 120".
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Xenical is indicated in combination with a moderately low-calorie diet for the treatment of obese patients with a body mass index (BMI) greater than or equal to 30 kg / m2, or overweight patients (BMI ≥28 kg / m2) with risk factors. Associates.
Treatment with orlistat should be stopped after 12 weeks if the patient has been unable to lose at least 5% of the body weight recorded at the start of therapy.
04.2 Posology and method of administration
Adults:
The recommended dosage of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is skipped or contains no fat, orlistat should be omitted.
The patient must follow a nutritionally balanced, moderately low-calorie diet containing approximately 30% of calories from fat. The diet is recommended to be rich in fruits and vegetables. The daily intake of fats, carbohydrates and proteins must be distributed over the three main meals.
Doses of orlistat greater than 120 mg three times a day have not been shown to be more effective.
The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after administration. After discontinuation of treatment, the fat content in the faeces generally returns to pre-treatment levels within 48 to 72 hours.
Particular groups of patients:
The effect of orlistat in patients with impaired hepatic and / or renal function, children and elderly patients has not been studied.
There are no indications regarding the use of Xenical in children.
04.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Chronic malabsorption syndrome.
- Cholestasis.
- Feeding time.
04.4 Special warnings and appropriate precautions for use
In clinical studies, the decrease in body weight from orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Treatment with antidiabetic drugs may require close monitoring while taking orlistat.
Co-administration of orlistat with cyclosporine is not recommended (see section 4.5).
Patients should be advised to observe the dietary recommendations received (see section 4.2).
The possibility of gastrointestinal side effects occurring (see section 4.8) may be increased if orlistat is taken with a high-fat diet (e.g. in a diet of 2000 kcal per day, greater than 30% calorie intake from fat equals to over 67 g of fat). The daily fat intake should be spread over the three main meals. If orlistat is taken with a very high fat meal, the likelihood of gastrointestinal adverse reactions may increase.
Cases of rectal bleeding have been reported with Xenical.In case of severe and / or prolonged symptoms, prescribers must make further investigations.
The use of an additional contraceptive method is recommended to prevent the possible failure of oral contraceptives which could occur in case of severe diarrhea (see section 4.5).
Coagulation parameters should be monitored in patients on concomitant treatment with oral anticoagulants (see sections 4.5 and 4.8).
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy which sometimes leads to renal failure. The risk is increased in patients with underlying chronic kidney disease and / or volume depletion (see section 4.8).
Hypothyroidism and / or reduced control of hypothyroidism may rarely occur. The mechanism, although not established, may involve reduced absorption of iodine salts and / or levothyroxine (see section 4.5).
Patients treated with antiepileptics: orlistat may unbalance anticonvulsant treatment by decreasing the absorption of antiepileptic drugs and thus lead to seizures (see section 4.5).
HIV antiretrovirals: Orlistat has the potential to reduce the absorption of HIV antiretroviral medicinal products and could adversely affect their efficacy in the treatment of HIV (see section 4.5).
04.5 Interactions with other medicinal products and other forms of interaction
Cyclosporine:
A decrease in plasma levels of cyclosporine was observed in a drug interaction study and was also reported in many cases when orlistat was administered concomitantly. This may result in decreased immunosuppressive efficacy. Therefore this combination is not recommended (see section 4.4). However, if such concomitant use is unavoidable, cyclosporine blood levels should be monitored more frequently both after the addition of orlistat and after discontinuation of orlistat treatment in patients treated with ciclosporin. Blood levels of ciclosporin should be monitored until stabilized.
Acarbose:
Co-administration of orlistat with acarbose should be avoided as no pharmacokinetic interaction studies are available.
Oral anticoagulants:
If warfarin or other anticoagulant drugs are administered in combination with orlistat, International Normalized Ratio (INR) values should be monitored (see section 4.4).
Fat-soluble vitamins:
Orlistat therapy has the potential to alter the absorption of fat-soluble vitamins (A, D, E and K).
In clinical studies, plasma levels of vitamins A, D, E and K, and beta-carotene were maintained within the normal range in a "large majority of patients receiving orlistat therapy for up to four years. adequate nutritional intake, patients who adhere to a weight control diet should be advised an "abundant intake of fruit and vegetables, and a multivitamin supplement may be considered. If a multivitamin supplement is recommended, it should be taken at least two hours after orlistat administration or at bedtime.
Amiodarone:
A slight decrease in plasma levels of amiodarone, given as a single dose, was observed in a limited number of healthy volunteers treated concomitantly with orlistat. In patients undergoing amiodarone treatment, the clinical significance of this effect remains unknown but in some cases it may become clinically relevant. Closer clinical and ECG monitoring is required in patients receiving concomitant treatment with amiodarone.
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs, eg valproate, lamotrigine for which the interaction cannot be excluded as a cause. Therefore, these patients should be monitored for possible changes in frequency and / or severity. seizures.
Hypothyroidism and / or reduced control of hypothyroidism may occur rarely. The mechanism, although not established, may involve reduced absorption of iodine salts and / or levothyroxine (see section 4.4).
There are some reports of reduced efficacy of HIV antiretrovirals, antidepressants and antipsychotics (including lithium) occurring at initiation of orlistat treatment in previously well-controlled patients. Therefore, orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Absence of interactions:
No interactions have been observed with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GTS), slow-release nifedipine, sibutramine or alcohol. The absence of these interactions has been demonstrated in specific drug interaction studies.
The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug interaction studies. However, orlistat may indirectly reduce the availability of oral contraceptives and in some cases lead to unwanted pregnancy. A contraceptive method is recommended. in case of severe diarrhea (see section 4.4).
04.6 Pregnancy and breastfeeding
For orlistat, no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing the medicine to pregnant women.
Since it is not known whether orlistat is excreted in human milk, orlistat is contraindicated during lactation.
04.7 Effects on ability to drive and use machines
Xenical does not affect the ability to drive or use machines.
04.8 Undesirable effects
Adverse reactions to orlistat are predominantly gastrointestinal in nature. The incidence of these reactions decreased with prolonged use of orlistat.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥1 / 10), common (≥1 / 100 to
Within each frequency class, undesirable effects are reported in descending order of severity.
The following table of undesirable effects (first year of treatment) is based on adverse reactions seen with a frequency> 2% and with an incidence ≥1% compared to placebo in clinical trials of 1 and 2 years duration:
* unique on-treatment adverse events with a frequency> 2% and an incidence ≥1% compared to placebo only in obese patients with type 2 diabetes.
In a 4-year clinical study, the overall pattern of adverse event distribution was similar to that reported for the 1 and 2-year studies with the total incidence of gastrointestinal adverse events in the first year decreasing from year to year. year over the four years.
The following table of undesirable effects is based on spontaneous post-marketing reports and therefore the frequency remains unknown:
Reporting of suspected adverse reactions:
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address http://www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Single doses of 800 mg of orlistat and multiple doses of up to 400 mg three times daily for 15 days were studied in normal weight and obese subjects without the occurrence of significant side effects. In addition, doses of 240 mg three times a day were administered to obese patients for 6 months. The majority of post-marketing orlistat overdose cases reported no adverse events or reported adverse events similar to those reported with the recommended dose.
Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours. Based on clinical and animal studies, any systemic effects attributable to orlistat's lipase inhibiting properties are expected to be rapidly reversible.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: peripherally acting anti-obesity drug. ATC code: A08AB01.
Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active site of the serine of the gastric and pancreatic lipases. The inactivated enzyme is therefore not available to hydrolyze the fat consumed to absorbable free fatty acids and monoglycerides. with the diet in the form of triglycerides.
In the 2-year studies and in the 4-year study, both orlistat-treated and placebo-treated patients were associated with a reduced calorie diet.
The pooled data from five 2-year studies with orlistat and a low-calorie diet showed that 37% of the orlistat-treated patients and 19% of the placebo-treated patients had a loss of at least 5% of the their baseline body weight after 12 weeks of treatment. Of these, 49% of orlistat-treated patients and 40% of placebo-treated patients went on to lose 10% or more of their baseline body weight after one year. , among patients who failed to lose 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat-treated patients and 2% of placebo-treated patients went on to lose 10% or more than their baseline body weight after one year. Overall, after one year of treatment, the proportion of patients who lost 10% or more of their body weight was 20% in patients taking orlistat 120 mg compared to " 8% in patients taking placebo. The mean difference in weight loss between the drug and placebo was 3.2 kg.
Data from the 4-year XENDOS clinical trial showed that 60% of orlistat-treated patients and 35% of placebo-treated patients had a loss of at least 5% of their baseline body weight after 12 weeks of treatment. Of these, 62% of orlistat-treated patients and 52% of placebo-treated patients went on to lose 10% or more of their baseline body weight after one year. Conversely, among patients who failed to lose 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat-treated patients and 4% of placebo-treated patients went on to lose 10 weeks. % or more of their baseline body weight after one year. After 1 year of treatment, 41% of orlistat-treated patients versus 21% of placebo-treated patients had ≥10% weight loss, with a mean difference of 4.4 kg between the two groups. After 4 years of treatment, 21% of orlistat-treated patients versus 10% of placebo-treated patients achieved ≥10% weight loss, with a mean difference of 2.7 kg.
More patients, both on orlistat and on placebo, had a baseline body weight loss of at least 5% after 12 weeks or at least 10% after one year in the XENDOS study compared to the five 2-year studies . The reason for this difference is that the five 2-year studies included an initial 4-week diet and placebo period during which patients lost an average of 2.6 kg before starting treatment.
Data from the 4-year clinical study also suggested that the weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (incidences of overall diabetes cases: 3.4% in the orlistat group compared with 5.4% in the placebo group). The vast majority of diabetes cases occurred in the subgroup of patients with impaired glucose tolerance at baseline, which accounted for 21% of randomized patients. It is not known whether these results translate into long-term clinical benefits.
Data from four one-year clinical trials in obese patients with type 2 diabetes insufficiently controlled with antidiabetic drugs showed that the percentage of subjects who responded to therapy (≥10% body weight loss) was was 11.3% with orlistat versus 4.5% with placebo. In patients treated with orlistat the mean difference in weight loss versus placebo was 1.83 kg-3.06 kg and the mean difference in reduction in HbA1c compared to placebo was 0.18% -0.55%. The effect on HbA1c has not been shown to be independent of weight reduction.
In a multicenter (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomized to receive 120 mg of orlistat (n = 357) or placebo (n = 182) three times. per day in addition to a low calorie diet and exercise for 52 weeks. Both populations received multivitamin supplements. The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg / m2 in favor of orlistat). 9.5% of orlistat-treated patients versus 3.3% of placebo-treated patients lost ≥10% of body weight after 1 year, with a mean difference of 2.6 kg between the two groups. The difference arises mainly from the result obtained in the group of patients with ≥5% weight loss after 12 weeks of treatment with orlistat, equal to 19% of the initial population. Adverse events were generally similar to those seen in adults. However, there was an unexplained increase in the incidence of bone fractures (6% versus 2.8% in the orlistat and placebo groups, respectively).
05.2 Pharmacokinetic properties
Absorption:
Studies in normal weight and obese volunteers have shown that absorption of orlistat is minimal. Eight hours after oral administration of orlistat, plasma concentrations of unchanged orlistat were not measurable (
In general, at therapeutic dosages, the finding of unchanged orlistat in plasma was occasional and in extremely low concentrations (
Distribution:
The volume of distribution cannot be determined as the drug is minimally absorbed and has no defined systemic pharmacokinetics. In vitro orlistat is over 99% bound to plasma proteins (the major binding proteins are lipoproteins and albumin). Orlistat is insignificantly distributed in erythrocytes.
Metabolism:
Based on the results in the animal, it is likely that orlistat is metabolised predominantly within the gastrointestinal wall. In a study in obese patients, two main metabolites, M1 (hydrolyzed 4-atom lactone ring) and M3 (M1 devoid of the N-formyl leucine group), account for approximately 42% of the total plasma concentration, relative to the smallest fraction of the dose that it is absorbed systemically.
M1 and M3 have an open beta-lactam ring and extremely weak lipase inhibition activity (1000 and 2500 times lower than orlistat, respectively). In view of this reduced inhibitory capacity and reduced plasma levels at therapeutic dosages (mean, 26 ng / mL and 108 ng / mL, respectively), these metabolites are considered to have no evaluable pharmacological activity.
Elimination:
Studies in normal weight and obese subjects have shown that excretion of unabsorbed drug in faeces is the major route of elimination. Approximately 97% of the administered dose was excreted in faeces and 83% of it in the form of unchanged orlistat.
Cumulative renal excretion of all orlistat-related compounds was less than 2% of the administered dose. The time required to achieve complete excretion (faecal plus urinary) was 3-5 days. Elimination of orlistat appears to be similar in normal weight and obese volunteers. Orlistat, M1 and M3 are all subject to biliary excretion.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
No teratogenic effects were observed in reproductive studies in animals. In the absence of a teratogenic effect in animals, no malformation is expected in humans. So far the active substances causing malformations in humans have been found to be teratogenic in animals when appropriate studies in both species have been conducted.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Capsule contents:
Microcrystalline cellulose (E460); sodium starch glycolate (type A); povidone (E1201); sodium lauryl sulfate; talc.
Capsule capsules:
Jelly; indigo carmine (E132); titanium dioxide (E171); printing ink for food use (black iron oxide, concentrated ammonium solution, potassium hydroxide, lacquer, propylene glycol).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Blisters: Do not store above 25 ° C. Store in the original package and keep the blister in the outer carton to protect the medicine from light and moisture.
Bottles: Do not store above 30 ° C. Keep the container tightly closed to keep it away from moisture.
06.5 Nature of the immediate packaging and contents of the package
PVC / PVDC blisters containing 21, 42 and 84 hard capsules.
Glass bottles with desiccant containing 21, 42 and 84 hard capsules.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Roche Registration Limited - 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW - United Kingdom
08.0 MARKETING AUTHORIZATION NUMBER
EU / 1/98/071/001 - AIC: 034195014
EU / 1/98/071/002 - AIC: 034195026
EU / 1/98/071/003 - AIC: 034195038
EU / 1/98/071/004 - AIC: 034195040
EU / 1/98/071/005 - AIC: 034195053
EU / 1/98/071/006 - AIC: 034195065
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 29 July 1998
Date of last renewal: 29 July 2008
10.0 DATE OF REVISION OF THE TEXT
June 2014
