LAX-TAB Gastro-resistant tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Lax-Tab 5 mg gastro-resistant tablets.
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 5 mg bisacodyl. <u>Excipient(s) with known effect:</u> This product contains 26.3 mg lactose and 35.396 mg sucrose. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Gastro-resistant tablet. Light yellow, round, gastro-resistant tablets.
4.1. Therapeutic indications
For evacuation of the colon in constipation and in preparation for radiological investigation.
4.2. Posology and method of administration
Short-term treatment for constipation <u>Adults and children over 10 years:</u> 1 to 2 coated tablets (5–10 mg) daily before bedtime. <u>Children 4–10 years:</u> 1 coated tablet (5 mg) daily before bedtime. ...
4.3. Contraindications
Lax-Tab is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with ...
4.4. Special warnings and precautions for use
As with all laxatives, Lax-Tab should not be used on a continuous daily basis for more than five days without investigating the cause of constipation. Prolonged excessive use may lead to fluid and electrolyte ...
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation. The concomitant use of diuretics or adreno-corticosteroids ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of bisacodyl in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...
4.7. Effects on ability to drive and use machines
No studies on the effects of Lax-Tab on the ability to drive and use machines have been performed. However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may ...
4.8. Undesirable effects
The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea. Adverse events have been ranked under headings of frequency using the following convention: Very common (≥1/10); ...
4.9. Overdose
Symptoms If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur. Laxatives when taken in chronic overdose ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for constipation <b>ATC Code:</b> A06AB02 Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, ...
5.2. Pharmacokinetic properties
Following oral administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa. Administration as a gastro-resistant ...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
6.1. List of excipients
<u>Core:</u> Lactose monohydrate Maize starch Povidone Cellulose, microcrystalline Sodium starch glycolate (type A) Silica, colloidal anhydrous Magnesium stearate Talc <u>Coating:</u> Methacrylic acid ...
6.2. Incompatibilities
None stated.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack-sizes of 30, 50, 100 and 1000 gastro-resistant tablets. PP containers with PE closure. Pack-sizes of 50 and 1000 gastro-resistant tablets. Not all pack-sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
None stated.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19734
9. Date of first authorization / renewal of the authorization
Date of first authorization: 08 November 2005 Date of latest renewal: 12 September 2011
10. Date of revision of the text
18/03/2022
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