- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and breastfeeding
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Lecicarbon A Suppository
2. Qualitative and quantitative composition
Each suppository of Lecicarbon A Suppository containsSodium hydrogen carbonate 0.500 g, sodium dihydrogen phosphate 0.680 g.Lecicarbon A Suppository contains (3-sn-Phosphatidyl)cholin (= soybean oil, lecithines, as phosphatides, 36 mg phosphatides per suppository).For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Suppository.Lecicarbon A Suppository is a cream coloured, homogenous, torpedo shaped suppository; packed in PVC/PE blisters of five, with batch number and expiry date embossed.
4. Clinical particulars
4.1 Therapeutic indications
All forms of frequent constipation (habitual or chronic constipation), especially where the rectal emptying reflex is weak, constipation due to low-fibre food or insufficient exercise (bedridden patients), to ease bowel movements after operations or labour before child birth.Lecicarbon A Suppository can be used to evacuate the bowel prior to surgery or diagnostic procedures (e.g. x-rays, rectoscopy and before childbirth). Lecicarbon A Suppository can also be added if other laxatives have proved ineffective.
4.2 Posology and method of administration
PosologyUnless otherwise directed, insert one suppository into the rectum when needed. If necessary, this can be repeated after 30 60 minutes.The dosage is the same in adults, children and infants, taking care to use the appropriate type of suppository.Lecicarbon A Suppository is safe to use for long periods and are not habit-forming.
Method of administrationRemove from the packaging by separating one suppository from the strip. Grasp the plastic tabs in both hands and pull apart. Insert one suppository into the rectum. Insertion is made easier if the suppository is first dipped into water. Do not use oil or petroleum jelly as a lubricant.For a child, it may be necessary to press the two halves of the child's bottom together to avoid the suppository being immediately expelled.The onset of action is between 15 and 30 minutes.
This medicinal product must not be used in cases of ileus (intestinal obstruction), in case of all anal and rectal region diseases that can lead to an excessive absorption of carbon dioxide, especially in children and infants, and in case of hypersensitivity against soybean, peanut or to one of the excipients of Lecicarbon A Suppository. In the presence of toxic megacolon (pathological enlargement of the end of the large intestine due to various causes) the product should only be used with explicit permission of the treating physician. This medicinal product contains (3-sn-Phosphatidyl)cholin (= Soybean oil, lecithines). If you are allergic to peanut or soya, do not use this medicinal product.
4.4 Special warnings and precautions for use
None known and not likely in view of the pharmacological properties.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and breastfeeding
PregnancyLecicarbon A Suppository may be used during pregnancy after a careful risk to benefit evaluation of the treating physician. Based on current knowledge the effect of the expanding volume of the carbon dioxide may be negligible.BreastfeedingLecicarbon A Suppository may be used during breastfeeding. The developed carbon dioxide will not be excreted in the human breast milk.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Rarely Soya Lecithin has been known to cause allergic reactions.The insertion of the suppository can very occasionally cause a slight burning sensation, which quickly disappears.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Carbon dioxide producing drugs, ATC code: A06AX02Lecicarbon A Suppository functions by a physical induction of reflex bowel evacuation caused when carbon dioxide is liberated when the suppository contacts moisture.Carbon dioxide (CO2) is the main constituent of the gaseous products of metabolism which are formed on digestion of the intestinal contents. Of all the intestinal gases, it is the one which causes the most intense stimulation of movement of the rectum.Lecicarbon A Suppository overcomes constipation according to the same principle, exclusively via the supply of CO2 which is slowly released in fine bubbles from the suppositories after they are inserted into the rectum. The CO2 activates the intestinal movement and triggers the evacuation process within 15 30 minutes, without causing irritation, cramps or other side effects.
5.2 Pharmacokinetic properties
If any hydrogen carbonate is not converted to carbon dioxide it may be absorbed and excreted as hydrogen carbonate ions in the urine. Any absorbed phosphate will also eventually be excreted in the urine.
5.3 Preclinical safety data
Preclinical studies were not conducted. Systemic toxic effects are not to be expected. Carbon dioxide is a physiological intestinal gas.
6. Pharmaceutical particulars
6.1 List of excipients
• (3-sn-Phosphatidyl)cholin (= soya lecithin, phosphatides),• hard fat and• silica, colloidal anhydrous.
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25 °C.
6.5 Nature and contents of container
Each suppository is contained in a twin layer PVC and foil shell. The shells are supplied in strips of 5 or 6 suppositories in a cardboard carton.Original Pack Sizes containing 10, 30 or 100 suppositories of Lecicarbon A Suppository.Hospital Pack Sizes containing 50x10 or 500 suppositories of Lecicarbon A Suppository.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
athenstaedt GmbH & Co KGAm Beerberg 135088 Battenberg (Eder)Germany
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Aspire Pharma Ltd
Bellamy House, Winton Road, Petersfield, Hampshire, GU32 3HA, UK
Medical Information Direct Line
+44 (0)1730 231148
+44 (0)1730 231148
Customer Care direct line
+44 (0)1730 231148