When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4.3 Contraindications
Additional Text:
Glucobay is also contra-indicated in patients with severe hepatic impairment (e.g. liver cirrhosis)
4.4 Special warnings and precautions for use
Glucobay has an antihyperglycaemic effect, but does not itself induce hypoglycaemia. If Glucobay is prescribed in addition to other blood glucose lowering drugs (e.g sulphonylureas metformin, or insulin) a fall of the blood glucose values into the hypoglycaemic range may require a dose adaption of the respective co-medication. If acute hypoglycemia develops glucose should be used for rapid correction of hypoglycemia. (see: 4.5)
4.5 Interaction with other medicinal products and other forms of interaction
During treatment with Glucobay, sucrose (cane sugar) as well as foods containing sucrose, often cause abdominal discomfort or even diarrhoea as a result of the increased fermentation of carbohydrates in the colon.
Glucobay has an anti-hyperglycaemic effect but, by itself, does not cause hypoglycaemia. In patients treated simultaneously with Glucobay and sulphonylurea, metformin or insulin, the glycaemia values may drop to hypoglycaemic levels and so dose adjustment of these medicinal products may be necessary.
The simultaneous administration of cholestyramine, intestinal adsorbents and medicinal products with digestive enzymes should be avoided as they may possibly influence the action of Glucobay.
Deleted text:
No interaction has been observed with dimeticone or simeticone.
4.8 Undesirable effects
Section updated.
The undesirable effects of acarbose found in the placebo controlled clinical trials and classified according to CIOMS III frequency categories (placebo controlled studies in the clinical trial database: acarbose N = 8595; placebo N = 7278; status: 10 February 2006) are described below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000). The ADRs identified only during postmarketing surveillance (status: 31 Dec 2005), and for which a frequency could not be estimated, are listed under “not known”.
System Organ Class (MedDRA)
Very common
Common
Uncommon
Rare
Not known
Blood and lymphatic system disorders
Thrombocytopenia
Immune system disorders
Drug hypersensivity and hypersensivity (rash, erythema, exanthema, urticaria)
Vascular disorders
Oedema
Gastrointestinal disorders
Flatulence
Diarrhea
Gastrointestinal and abdominal pains
Nausea
Vomiting
Dyspepsia
Subileus/Ileus
Pneumatosis cystoidis intestinalis [1]
Hepatobiliary Disorders
increase in transami-nases.
Jaundice
Hepatitis
< The MedDRA preferred term is used to describe a certain reaction and its synonyms and related conditions. ADR term representation is based on MedDRA version 11.1. >
In addition events reported as liver disorder, hepatic function abnormal, and liver injury have been received especially from Japan.
Isolated cases of sudden hepatitis with a fatal outcome have been reported in Japan. It is not clear whether those are as a result of taking Glucobay.
The lack of compliance with the prescribed diet may give rise to intensification of intestinal side effects. In the event that they should appear in spite of complying with the prescribed diabetic diet, the doctor should be consulted and the dose reduced either temporarily or permanently.
In patients treated with the recommended daily dose of 150 mg to 300 mg Glucobay a day, clinically relevant abnormal liver function tests (3 times above normal limits) were rarely observed. Abnormal values may be transient during treatment with Glucobay (see section 4.4: Special warnings and special precautions for use).
4.6 Fertility, Pregnancy and lactation
Glucobay should not be administered during pregnancy as no information is available from clinical studies on its use in pregnant women.
After the administration of radioactively marked acarbose to nursing rats, a small amount of radioactivity was recovered in the milk. To date there have been no similar findings in humans.
Nevertheless, as the possibility of drug induced effects on nursing infants can not be excluded, the prescription of Glucobay is not recommended during breastfeeding.
Deleted Text:
The use of glucobay is contraindicated in pregnancy and in nursing mothers.
4.7 Effects on ability to drive and use machines
No data are available on alteration of the ability to drive vehicles or use machines while on treatment with Glucobay.
None Known.
10. DATE OF REVISION OF THE TEXT
Updated to:
February 2011
Section 3 (Pharmaceutical form) has been updated to read as follows: 'Tablets Glucobay 50 mg Tablets White to yellow-tinged round, convex tablets of 7 mm diameter and 10 mm radius of curvature. On one side the tablet code is “G” and “50” and on the other side “Bayer cross”. Glucobay 100 mg Tablets White to yellow-tinged oval oblong, convex tablets of 13 mm length, 6 mm width and 5.5 mm radius of curvature. On one side the tablet code is “G”, ”score” and “100” and on the other side “score”. The tablet can be divided into equal halves.' In section 4.2 (Posology and method of administration), the following paragraph has been included: In , the following paragraph has been included: Recommended usual dose for additional therapy in association with diet in patients with diabetes mellitus; The dosage must be adjusted by the doctor to suit each patient, because efficacy and tolerability vary from one individual to another. Dosage regimen Unless otherwise prescribed the recommended dosage is as follows. Initially 3x 1 tablet of 50 mg Glucobay/day or 3x ½ tablet of 100 mg Glucobay/day up to 3x 2 tablets of 50 mg Glucobay/day or 3x 1 tablet of 100 mg Glucobay/day A further increase in dosage to 3x 200 mg Glucobay/day may occasionally be necessary. The dose may be increased after 4 ‑ 8 weeks, and if patients show an inadequate clinical response in the later course of the treatment. If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further, and if necessary should be somewhat reduced. The average dose is 300 mg Glucobay/day (corresponding to 3x 2 tablets of Glucobay tablets 50 mg/day, or 3x 1 tablet of Glucobay tablets 100 mg/day). Recommended usual dose for the prevention of type 2 diabetes in patients with impaired glucose tolerance; Recommended dose: 3x 100 mg/day Treatment should be initiated with a dose of 50 mg once daily and escalated to 3x 100 mg/day within 3 months. Method of administration Glucobay tablets are effective only if swallowed whole with a little liquid directly before the meal or be chewed with the first few mouthfuls of the meal. In Section 4.8 (Undesirable effects), the following has been included: 'In addition events reported as liver disorder, hepatic function abnormal, and liver injury have been received especially from Japan.'
In section 4.2 (Posology and method of administration), the following paragraph has been included:
The dosage must be adjusted by the doctor to suit each patient, because efficacy and tolerability vary from one individual to another.
Unless otherwise prescribed the recommended dosage is as follows.
Initially 3x 1 tablet of 50 mg Glucobay/day or 3x ½ tablet of 100 mg Glucobay/day
up to 3x 2 tablets of 50 mg Glucobay/day or 3x 1 tablet of 100 mg Glucobay/day
A further increase in dosage to 3x 200 mg Glucobay/day may occasionally be necessary.
The dose may be increased after 4 ‑ 8 weeks, and if patients show an inadequate clinical response in the later course of the treatment. If distressing complaints develop in spite of strict adherence to the diet, the dose should not be increased further, and if necessary should be somewhat reduced. The average dose is 300 mg Glucobay/day (corresponding to 3x 2 tablets of Glucobay tablets 50 mg/day, or 3x 1 tablet of Glucobay tablets 100 mg/day).
Treatment should be initiated with a dose of 50 mg once daily and escalated to 3x 100 mg/day within 3 months. Method of administration Glucobay tablets are effective only if swallowed whole with a little liquid directly before the meal or be chewed with the first few mouthfuls of the meal. In Section 4.8 (Undesirable effects), the following has been included: 'In addition events reported as liver disorder, hepatic function abnormal, and liver injury have been received especially from Japan.'
Glucobay tablets are effective only if swallowed whole with a little liquid directly before the meal or be chewed with the first few mouthfuls of the meal. In Section 4.8 (Undesirable effects), the following has been included: 'In addition events reported as liver disorder, hepatic function abnormal, and liver injury have been received especially from Japan.'
Section 4.8: addition of Pneumatosis cystoidis intestinalis
Section 4.4 Special warnings and precautions for use
The sentence “It is intended primarily to minimise the postprandial serum glucose peaks often difficult to control.” was changed to “It is intended primarily to minimise the postprandial serum glucose peaks that are often difficult to control.”
Section 7, Section 8, Section 9 and Section 10 changed to:
7. MARKETING AUTHORISATION
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
8. MARKETING AUTHORISATION NUMBER
Glucobay 50 mg Tablets PA 1410/29/1
Glucobay 100 mg Tablets PA 1410/20/2
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Glucobay 50 mg Tablets
Date of first authorisation: 4th June 1992
Date of last renewal: 4th June 2007
Glucobay 100 mg Tablets
Date of last renewal:4th June 2007
10.DATE OF (PARTIAL) REVISION OF THE TEXT
Glucobay 50 mg Tablets November 2007
Glucobay 100 mg Tablets January 2008
Section 4.3 - the contraindication for children under 18 has been removed and added as a warning to section 4.4 instead.
Section 4.4 - a warning for use in children under 18 has been added.
Section 4.8 - has been completely revised and now uses MedDRA terminology.
4.5 addition of metformin in interactions.
Correction of spelling of colestyramine has been updated to rINN spelling.
10. revision date.