Active ingredients: Budesonide
Intesticort 3 mg gastro-resistant capsules
Intesticort package leaflets are available for packs:- Intesticort 3 mg gastro-resistant capsules
- Intesticort 2 mg / dose rectal foam
Indications Why is Intesticort used? What is it for?
Intesticort 3 mg capsules contain the active ingredient budesonide, a type of locally acting steroid used to treat chronic inflammatory bowel diseases.
Intesticort is used in the treatment of:
- Crohn's disease: acute mild or moderate attacks of a chronic inflammation of the intestine affecting the last part of the small intestine (ileum) and / or the upper part of the large intestine (ascending colon).
Note: Intesticort is not indicated in patients with Crohn's disease of the upper gastrointestinal tract. Sometimes, the disease can cause symptoms outside the gut (eg affecting the skin, eyes and joints) that are unlikely to respond to this medicine.
- Acute forms of collagen colitis (a disease with chronic inflammation of the large intestine, characterized by chronic watery diarrhea).
Contraindications When Intesticort should not be used
DO NOT take Intesticort:
- if you are allergic (hypersensitive) to budesonide or any of the other ingredients of this medicine (listed in section 6 and end of Section 2)
- if you have severe liver disease (liver cirrhosis)
Precautions for use What you need to know before taking Intesticort
Before treatment with this medicine, tell your doctor if you suffer from:
- tuberculosis
- high blood pressure
- diabetes, or if your family has been diagnosed with diabetes
- bone fragility (osteoporosis)
- ulcers of the stomach or the first part of the small intestine (peptic ulcer)
- increased pressure in the eye (glaucoma) or eye problems such as clouding of the lens (cataract) or if your family has been diagnosed with glaucoma
- severe liver problems
Typical effects of cortisone preparations may appear, which can affect all parts of the body, especially if you take Intesticort in high doses and for a long time (see section 4. Possible side effects).
Other precautions during treatment with Intesticort:
- Stay away from people with chickenpox or shingles if you have never had these diseases, as they can seriously damage you. If you come into contact with chickenpox or shingles, contact your doctor immediately.
- Tell your doctor if you haven't had measles yet.
- If you know you need to have a vaccination, consult your doctor first.
- If you know you are going to have surgery, please tell your doctor that you are using Intesticort.
- If you received a stronger cortisone preparation before starting treatment with Intesticort, your symptoms may reappear when the medicine is changed. In this case, consult your doctor.
Interactions Which drugs or foods can modify the effect of Intesticort
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Particularly:
- Cardiac glycosides such as digoxin (medicines used to treat heart conditions)
- Diuretics (to eliminate excess fluids from the body)
- Ketoconazole or itraconazole (to treat fungal infections)
- Antibiotics used to treat infections (such as clarithromycin)
- Ritonavir (for HIV infections)
- Carbamazepine (used in the treatment of epilepsy)
- Rifampicin (to treat tuberculosis)
- Estrogen or oral contraceptives
- Cimetidine (used to inhibit stomach acid production)
If you take cholestyramine (for hypercholesterolemia as well as to treat diarrhea) or antacids (for indigestion) in addition to Intesticort, take these medicines at least 2 hours apart.
Taking Intesticort with food and drink
You should not drink grapefruit juice while taking this medicine as this may alter its effect.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
You should take Intesticort during pregnancy only if expressly prescribed by your doctor.
Do not breast-feed while taking Intesticort, as the medicine can pass into breast milk.
Driving and using machines
Intesticort should not impair driving skills or use of machinery.
Intesticort 3 mg capsules contain sucrose and lactose
Each capsule contains 240 mg of sucrose and 12 mg of lactose monohydrate; if you have been told by your doctor that you have an "intolerance to some sugars, talk to your doctor before taking this medicine.
Dose, Method and Time of Administration How to use Intesticort: Posology
Always take Intesticort exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Dosage
Crohn's disease
Adults (over 18 years old)
Take three capsules once a day in the morning, or one capsule three times a day (morning, noon and evening), unless otherwise prescribed by your doctor.
Collagen colitis
Adults (over 18 years old)
Take three capsules once a day in the morning, unless otherwise directed by your doctor.
Use in children (all indications)
Intesticort 3mg capsules should NOT be used in children as there is only limited experience on the use of this medicine in children and adolescents.
Method of administration
Intesticort 3 mg capsules are for oral use only.
The capsules should be swallowed whole, with a glass of water, approximately half an hour before meals. Do not chew the capsules.
Duration of treatment
Your doctor will decide how long you need to continue the therapy, depending on your health condition.
Crohn's disease and collagenic colitis
The treatment usually lasts about 8 weeks.
If you forget to take Intesticort
If you forget to take a dose, simply continue your treatment at the prescribed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Intesticort
If you want to stop or stop treatment early, please contact your doctor. It is important that you do not stop the medicine abruptly, as it can hurt you. Keep taking the medicine until your doctor tells you to stop, even if you start to feel better.
Your doctor will probably want to reduce the dose gradually, first from three to two capsules for 1 week (one in the morning and one in the evening) and then only one capsule per day in the last week of treatment (taken in the morning).
If you have any further questions on the use of Intesticort, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Intesticort
If you have taken too much medicine at one time, take the next dose as prescribed. Do not take less. If in doubt, ask your doctor, who can decide what to do; if possible, take the box and this leaflet with you.
Side Effects What are the side effects of Intesticort
Like all medicines, Intesticort can cause side effects, although not everybody gets them.
If you experience any of the following symptoms after taking this medicine, contact your doctor immediately:
- Infection
- Headache
- Behavioral changes or psychiatric effects, such as depression, irritability and euphoria
The following side effects have also been reported:
Very rare (affects less than 1 user in 10,000)
- Cushing's syndrome - roundness of the face, weight gain, impaired glucose tolerance, increased blood sugar, fluid retention, increased potassium excretion (hypokalaemia), decreased growth in children, irregular menstruation in women, increased hair unwanted in the woman, impotence, abnormal laboratory test results (reduced adrenal function), swelling of the legs (due to fluid retention, edema)
- increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disc) in adolescents
- constipation
- pain and weakness of muscles and joints, muscle fasciculations
- bone fragility (osteoporosis)
- tiredness, generally feeling unwell.
The following side effects are typical of steroid therapy and may appear depending on the dose, duration of treatment, any current or past treatments with other cortisone preparations and individual susceptibility. Most of the following side effects have been observed after the use of potent steroids, so they should be less frequent with Intesticort 3 mg capsules:
- Cushing's syndrome (see above for a description of typical symptoms).
- Increased risk of infections.
- Mood changes, such as depression, irritability or euphoria.
- Blurred vision (caused by increased pressure in the eye (glaucoma) or clouding of the lens (cataract)).
- High blood pressure, increased risk of blood clotting, inflammation of blood vessels (associated with stopping the use of steroids after long-term therapy).
- Stomach pain and discomfort, nausea, vomiting, stomach and / or small intestine ulcers, inflammation of the pancreas.
- Rash from hypersensitivity reactions, red streaks on the skin, bleeding in the skin, acne, delayed wound healing, local skin reactions such as contact dermatitis.
- Loss of bone and cartilage (aseptic bone necrosis).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children. Do not store above 25 ° C.
Do not use Intesticort after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of that month.
Deadline "> Other information
What Intesticort 3 mg capsules contains
The active ingredient is budesonide. Each gastro-resistant pellet capsule contains 3 mg of budesonide.
The other ingredients are ammonium methacrylate copolymer (type A) (Eudragit RL), ammonium methacrylate copolymer (type B) (Eudragit RS), lactose monohydrate, maize starch, methacrylic acid-methyl methacrylate copolymer (1: 1) (Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (1: 2) (Eudragit S 100), povidone K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine (E127), titanium dioxide (E171), red and black iron oxide (E172), sodium lauryl sulfate (for further important information on lactose and sucrose, see also end of Section 2).
Description of the appearance of Intesticort and contents of the pack
Intesticort 3 mg capsules are pink, gastro-resistant, hard and are contained in blister strips.
Intesticort 3 mg capsules are available in packs of 10, 50, 90, 100 or 120 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 -
INTESTICORT 3 MG
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Active ingredient: budesonide 3 mg.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM -
Hard gastro-resistant capsule.
The color of the capsule is pink.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
• Induction of remission in patients with mild and moderate Crohn's disease affecting the ileus and / or ascending colon.
• Symptomatic relief of chronic collagenous colitis diarrhea.
Note:
Treatment with Intesticort 3 mg is not useful for the treatment of patients with Crohn's disease affecting the upper gastrointestinal tract.
Extraintestinal symptoms involving for example the skin, eyes or joints are unlikely to respond to Intesticort due to its local action.
04.2 Posology and method of administration -
Dosage
Adults over 18 years of age:
The recommended daily dose is one capsule (containing 3 mg of budesonide) three times a day (morning, noon and evening) about half an hour before meals.
Children:
Intesticort 3 mg should not be given to children due to insufficient experience available in this age group.
Method of administration
The hard gastro-resistant capsules are taken before meals and swallowed whole with a large amount of liquid (eg a glass of water).
The duration of treatment in active Crohn's disease and collagenous colitis should be limited to 8 weeks.
Treatment with Intesticort 3 mg should not be stopped abruptly, but should be gradually reduced (with decreasing doses). During the first week the dosage should be reduced to two capsules a day, one in the morning and one in the evening. In the second week, only one capsule should be taken in the morning. Thereafter, the treatment can be stopped.
04.3 Contraindications -
It is not allowed to use Intesticort 3 mg in case of
- hypersensitivity to budesonide or to one of the excipients
- liver cirrhosis with signs of portal hypertension, such as the last stage of primary biliary cirrhosis.
04.4 Special warnings and appropriate precautions for use -
Treatment with Intesticort 3 mg results in lower systemic steroid levels than conventional therapy with orally administered steroids. Switching from other steroid therapies can cause symptoms related to the change in systemic steroid levels.
Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or glaucoma.
Infections: Suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. The risk of bacterial, fungal, amoebic and viral infections during treatment with glucocorticoids must be carefully considered. Clinical manifestations are often atypical, and severe infections such as septicemia and tuberculosis may be masked and then reach an advanced stage before being recognized.
Chickenpox: chickenpox is of particular concern, as this disease, which is normally one of the minor ones, can be fatal for immunosuppressed patients. Patients with no definite history of chickenpox should be advised to avoid close personal contact with chickenpox and shingles. In case of exposure, they should consult their physician urgently. If the patient is a child, parents should be advised of this precaution. . In the case of exposed non-immune patients who are given systemic corticosteroids or who have taken them within the previous three months, passive immunoglobulin immunoglobulin for varicella zoster (VZIG) is required within 10 days of exposure to chickenpox. If one is confirmed. diagnosis of chickenpox, the disease requires specialist attention and urgent treatment.Corticosteroid administration should not be interrupted and a dose increase may be required.
Measles: Patients with impaired immunity who have come in contact with measles should receive normal immunoglobulins as soon as possible after exposure.
Live vaccines: Live vaccines should not be given to patients with impaired immunological response. The antibody response to other vaccines may be reduced.
In patients with severe hepatic functional disorders, the elimination of glucocorticoids, including Intesticort, will be reduced and their systemic bioavailability will therefore be increased.
Corticosteroids can cause suppression of the hypothalamic-pituitary-adrenal axis and reduce the stress response. If patients are subject to surgery or other types of stress, additional treatment with systemic glucocorticosteroids is recommended.
Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Intesticort 3 mg capsules contain lactose and sucrose. Patients with rare hereditary problems of galactose or fructose intolerance, glucose / galactose malabsorption, sucrase and isomaltase enzyme insufficiency, Lapp lactase deficiency or congenital lactase deficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction -
Pharmacodynamic interactions
• Cardiac glycosides:
The action of glycosides can be enhanced by potassium deficiency.
• Diuretics:
It can increase potassium excretion.
Pharmacokinetic interactions
• Cytochrome P450:
- CYP3A4 inhibitors:
Co-administration orally of 200 mg ketoconazole once daily resulted in an approximately six-fold increase in plasma concentrations of budesonide (single 3 mg dose). An approximately three-fold increase in concentrations was observed. in case of administration of ketoconazole 12 hours after budesonide Since there are insufficient data to make dose recommendations, this combination should be avoided.
Other potent CYP3A4 inhibitors such as ritonavir, itraconazole and clarithromycin are also likely to cause markedly increased plasma concentrations of budesonide. In addition, concomitant intake of grapefruit juice should be avoided.
- Inducers of CYP3A4:
Compounds or drugs, such as carbamazepine, which induce CYP3A4, may reduce systemic but also local exposure of budesonide in the gut mucosa. A dose adjustment of budesonide may be required.
- CYP3A4 substrates:
Compounds or drugs that are metabolised by CYP3A4 may compete with budesonide. This may cause an increase in the concentration of budesonide in plasma if the competing substance has a higher affinity for CYP3A4, or - if budesonide binds more tightly to CYP3A4 - the competing substance may increase in plasma and adjustment may be required. / a reduction in the dose of this medicine.
Elevated plasma concentrations and enhanced corticosteroid effects have been observed in female patients taking estrogen or oral contraceptives, but this has not been observed with reduced-dose combination oral contraceptives.
In combination with budesonide, cimetidine in recommended doses has a mild but insignificant effect on budesonide pharmacokinetics. Omeprazole has no effect on the pharmacokinetics of budesonide.
- Steroid-binding compounds:
Theoretically, potential interactions with sequestering agents such as cholestyramine and antacids cannot be excluded. If administered simultaneously with Intesticort 3 mg, these interactions could cause a reduction in the effect of budesonide. For this reason, these compounds should not be taken at the same time, but at least two hours apart.
04.6 Pregnancy and breastfeeding -
Administration during pregnancy should be avoided, unless there are reasons for therapy with Intesticort 3 mg. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause changes in fetal development. The relevance of this data for humans has not been established.
Since it is not known whether budesonide passes into breast milk, the infant should not be breast-fed during treatment with Intesticort 3 mg.
04.7 Effects on ability to drive and use machines -
No effect is known.
04.8 Undesirable effects -
The following side effects of Intesticort 3 mg and their frequencies have been reported spontaneously:
Very rare (
• Alterations in metabolism and nutrition: leg edema, Cushing's syndrome
• Nervous system disorders: pseudotumor cerebri (including papilloedema) in adolescents
• Alterations of the gastrointestinal tract: constipation
• Alterations of the musculoskeletal system, connective tissue and bone tissue: widespread muscle pain and muscle weakness, osteoporosis
• General disorders: fatigue, malaise
Some of these side effects have been seen after prolonged use.
Occasionally, side effects typical for systemic glucocorticosteroids may occur. These side effects are related to dosage, treatment period, concomitant or previous treatment with other glucocorticosteroids and individual sensitivity.
Clinical studies have shown that the frequency of side effects associated with glucocorticosteroids is lower with Intesticort 3 mg (approximately half) than with oral treatment with equivalent doses of prednisolone.
Immune system:
Interference with the immune response (e.g. increased risk of infections).
An exacerbation or reappearance of extraintestinal manifestations (affecting the skin and joints in particular) may occur in patients during the transition from systemic glucocorticosteroids to locally acting budesonide.
Metabolism and nutrition:
Cushing's syndrome: lunar facies, trunk obesity, impaired glucose tolerance, diabetes mellitus, sodium retention with formation of edema, increased potassium excretion, inactivity or atrophy of the adrenal cortex, growth retardation in children, secretion disorders sex hormones (e.g. amenorrhea, hirsutism, impotence).
Nervous system:
Depression, irritability, euphoria.
Eye disorders:
Glaucoma, cataracts.
Vascular system:
Hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy).
Gastrointestinal system:
Stomach pains, duodenal ulcer, pancreatins.
Skin and appendages:
Allergic drug rash, striae distensae, petechiae, bruising, steroid acne, delayed wound healing, contact dermatitis.
Musculoskeletal system, connective tissue and bone tissue:
Aseptic bone necrosis (femur and humerus head).
04.9 Overdose -
There are currently no known cases of overdose with budesonide. Considering the properties of budesonide contained in Intesticort 3 mg, an overdose related to toxic effects is extremely unlikely.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: glucocorticosteroid, ATC code: A07EA06
The exact mechanism of action of budesonide in the treatment of Crohn's disease is not fully understood. The data provided by pharmacological studies and controlled clinical studies strongly indicate that the mechanism of action of Intesticort 3 mg capsules is basically based on a local action in the intestine. Budesonide is a glucocorticosteroid with a high local anti-inflammatory effect. At clinically doses. Equivalent to systemically acting glucocorticosteroids, budesonide causes significantly less suppression of the hypothalamic-pituitary-adrenal axis and has less impact on inflammation markers.
Intesticort 3 mg capsules have a dose-dependent influence on plasma cortisol levels, which with the recommended dose of 3 x 3 mg of budesonide / day is significantly lower than a dose with equivalent clinical efficacy of systemic glucocorticosteroids.
05.2 "Pharmacokinetic properties -
Absorption :
Intesticort 3 mg capsules, containing a coating resistant to gastric juices, have a latency period of 2-3 hours thanks to the special coating of the capsules. In healthy volunteers, as well as in patients with Crohn's disease, mean plasma concentrations of budesonide of 1-2 ng / ml were observed approximately 5 hours after taking an oral dose of Intesticort 3 mg capsules, administered in a single dose of 3 mg before meals, thus maximal release occurs in the terminal ileus and cecum, the main site of inflammation in Crohn's disease.
In patients with ileostomy the release of budesonide from Intesticort 3 mg is comparable to that in healthy subjects or in patients with Crohn's disease. It has been shown that approximately 30-40% of released budesonide is still in the ileostomy pouch. This indicates that a substantial amount of budesonide released by Intesticort 3 mg is intended to be transferred into the colon normally.
Simultaneous food intake can delay the release of the granules from the stomach by 2-3 hours, extending the latency period to 4-6 hours, without altering absorption rates.
Distribution :
Budesonide exhibits a high volume of distribution (approximately 3 l / kg). Plasma protein binding averages 85-90%.
Metabolism :
Budesonide undergoes extensive biotransformation in the liver (approximately 90%) to metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide.
Elimination :
The mean elimination half-life is approximately 3-4 hours. Systemic availability in healthy volunteers as well as fasting patients with Crohn's disease is approximately 9-13%. Clearance is approximately 10-15 l / min. for budesonide, determined by HPLC-based methods.
Specific patient populations (liver disease):
Depending on the type and severity of liver disease and as a consequence of the fact that budesonide is metabolised by CYP3A4, there may be a decrease in the metabolism of budesonide. For this reason, systemic exposure to budesonide may be increased in patients with impaired hepatic function, as has been demonstrated in patients with autoimmune hepatitis (AIH). As liver function improves, the metabolism of budesonide normalizes.
The bioavailability of budesonide was seen to be significantly higher in patients with late stage primary biliary cirrhosis (PBC stage IV) compared to patients with early disease (PBC stage I / II). On average, areas under the curves plasma concentrations versus time following repeated daily administration of 3 x 3 mg budesonide are three times greater in patients with late stage primary biliary cirrhosis (PBC) than in patients with early stages of PBC disease.
05.3 Preclinical safety data -
Preclinical data in acute, subchronic and chronic toxicological studies conducted with budesonide showed atrophy of the thymus gland and adrenal cortex and a reduction in lymphocytes in particular. These effects were less pronounced or of equal magnitude to those seen with other glucocorticosteroids. As with other glucocorticosteroids - and depending on the dose, duration and disease - these steroid effects may also be of relevance to humans.
Budesonide did not exhibit mutagenic effects in a series of in vitro and in vivo tests.
A slightly increased number of basophilic liver outbreaks were observed in chronic studies conducted with budesonide in rats and in carcinogenicity studies a higher incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumors (in rats of female). These tumors are probably due to the action on the specific steroid receptor, to the increased metabolic load of the liver and to anabolic effects, effects also known for other glucocorticosteroids and found in studies conducted in rats, which therefore represent a class effect. No similar effect has been observed in humans in relation to budesonide, neither in clinical studies nor in spontaneous reports.
In general, preclinical data reveal no special risk for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause fetal developmental abnormalities, but the relevance of these data to humans has not been established (see also section 4.6).
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Povidone K25; lactose monohydrate; sucrose; talc; cornstarch; methacrylic acid, methyl methacrylate copolymer (1: 1) (Eudragit L 100); methacrylic acid, methyl methacrylate copolymer (1: 2) (Eudragit S 100); poly acid (ethylacrylic, methyl methacrylate, trimethylammonium ethyl methacrylate chloride) (1: 2: 0.1) (Eudragit RS 12.5); poly (ethyl acrylate, methyl methacrylate, trimethylammonium ethyl methacrylate chloride) (1: 2: 0.2) (Eudragit RL 12.5); triethyl citrate; titanium dioxide (E 171); water; jelly; erythrosine (E 127); red iron oxide (E 172); black iron oxide (E 172); sodium lauryl sulfate.
06.2 Incompatibility "-
Not relevant
06.3 Period of validity "-
3 years
The medicinal product should not be used after the expiration date.
06.4 Special precautions for storage -
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
AL / PVC / PVDC blisters in boxes of 10, 50, 90, 100, 120 capsules. Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Dr. Falk Pharma GmbH
Leinenweberstr. 5
D-79108 Freiburg
P.O. Box 6529
D-79041 Freiburg
Dealer for sale in Italy
Sofar S.p.A. - Via Firenze 40, 20060 Trezzano Rosa (Mi)
08.0 MARKETING AUTHORIZATION NUMBER -
3 mg hard gastro-resistant capsules 90 capsules in AL / PVC / PVDC blisters
N. AIC 036507010 / M
3 mg hard gastro-resistant capsules 100 capsules in AL / PVC / PVDC blisters
N. AIC 036507022 / M
3 mg gastro-resistant hard capsules 10 capsules in AL / PVC / PVDC blisters
N. AIC 036507034 / M
3 mg hard gastro-resistant capsules 50 capsules in AL / PVC / PVDC blisters
N. AIC 036507046 / M
3 mg hard gastro-resistant capsules 120 capsules in AL / PVC / PVDC blisters
N. AIC 036507059 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
February 2005
10.0 DATE OF REVISION OF THE TEXT -
April 2013
