Senokot Comfort tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
01-05-2015
Hent Produktets egenskaber (SPC)
18-06-2015

Aktiv bestanddel:

Sulfur; Charcoal medicinal vegetable; Rhubarb extract; Senna leaf powdered

Tilgængelig fra:

Reckitt Benckiser Healthcare (UK) Ltd

ATC-kode:

n/a

INN (International Name):

Sulfur; Charcoal medicinal vegetable; Rhubarb extract; Senna leaf powdered

Dosering:

50mg ; 180mg ; 25mg ; 105mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Never Valid To Prescribe As A VMP

Produkt oversigt:

BNF: 01060200; GTIN: 5000158067769

Indlægsseddel

                                _PACKAGE LEAFLET: INFORMATION FOR THE USER _
_ _
SENOKOT COMFORT TABLETS
SENNA LEAF
RHUBARB ROOT EXTRACT
VEGETABLE CHARCOAL
PURIFIED SULPHUR
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Senokot
Comfort Tablets carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen, or do not improve
after a few days.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Senokot Comfort Tablets are and what they are used for.
2. Before you take Senokot Comfort Tablets.
3. How to take Senokot Comfort Tablets
4. Possible side effects.
5. How to store Senokot Comfort Tablets
6. Further information.
_ _
_1. WHAT SENOKOT COMFORT TABLETS ARE AND WHAT THEY ARE USED FOR _
Senokot Comfort Tablets are used for the short-term relief of
occasional constipation
Senokot Comfort Tablets do not help with weight loss.
The laxative effect of Senokot Comfort Tablets takes place
approximately 8-12 hours after
taking the product.
_ _
_2. BEFORE YOU TAKE SENOKOT COMFORT TABLETS _
DO NOT TAKE SENOKOT COMFORT TABLETS
•
if you are allergic (hypersensitive) to Senna leaf, Rhubarb ,
vegetable charcoal, purified
sulphur or any other ingredients of Senokot Comfort Tablets.
•
If you have blockage or narrowing of the gastro-intestinal tract or
bowel (ileus, intestinal
obstruction or stenosis)
• If you have paralysis or lack of muscle tone in the bowel (atony)
• If you have appendicitis, inflammatory bowel disease such as
Crohn’s disease or
ulcerative colitis
• If you have severe dehydration
• If you have persistent or undiagnosed abdominal complaints e.g.
pain, nausea or vomiting
• If you have faecal impaction or rectal bleeding for which you
don’t kno
                                
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Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Eucarbon Tablets
Senokot Comfort Tablets_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
105 mg of Senna leaf (_Cassia senna_ L. (_C. acutifolia _Delile)
and/or _Cassia _
_angustifolia _Vahl),
25 mg of extract (as dry extract) from Rhubarb root (_Rheum palmatum
_L. or
_Rheum officinale _Baillon, or hybrids of these two species or a
mixture) (3
5:
1)Extraction solvent : Ethanol 70% v/v
Corresponding to 2,65-3,95 mg of hydroxyanthracene glycosides
(calculated
as Rhein),
180 mg of Vegetable Charcoal.
50 mg of purified Sulfur
Excipient(s) with known effect:
Each tablet contains 43.4 mg of sucrose and 0.25 – 11.25 mg of
lactose
monohydrate.
For the full list of excipients, see section 6.
3
PHARMACEUTICAL FORM
Tablets for oral administration.
Grey-black, cylindric, biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The product is a traditional remedy for short-term use in cases of
occasional
constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adolescents over 12 years of age, adults, elderly_
1-2 tablets with or after meals with liquid up to 3 times daily to
obtain a
laxative and purgative effect. If a stronger laxative effect is
desired, the
evening dose can be increased to 3 – 4 tablets of the product.
Herbal substance/preparation corresponding to 2.65 to 3.95 mg of
hydroxyanthracene glycosides (calculated as Rhein) in one tablet.
The maximum daily dose of hydroxyanthracene glycosides is 30 mg. This
is
equivalent to 8 tablets. The correct individual dose is the smallest
required to
produce a comfortable soft-formed motion.
_Paediatric population_
The use in children under 12 years of age is contraindicated (see
section 4.3
Contraindications).
METHOD OF ADMINISTRATION
For oral use.
DURATION OF USE
Use for more than 1 - 2 weeks requires medical supervision.
If the symptoms persist during the use of the medicinal product, a
doctor or a
pharmacist should be consulted.
See also section 4.4 Special war
                                
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