- ispaghula husk
- ispaghula seed
- senna pods tinnevelly
This information is intended for use by health professionals
Each 5 g dose contains:2.6 g Ispaghula seed (Plantago ovata Forssk.);0.11g Ispaghula husk (Plantago ovata Forssk.);0.34 - 0.66g Tinnevelly Senna fruit (Cassia angustifolia Vahl ), corresponding to 15 mg hydroxyanthracene glycosides calculated as sennoside B.
Excipients:Each 5g dose contains 1.04g of sucrose (See Section 4.4. 'Special warnings and precautions for use')For the full list of excipients, see section 6.1.
Method of administration:Manevac should be placed dry on the tongue and, without chewing or crushing, swallowed with a glass of water, warm drink, milk, fruit juice or similar aqueous liquid; then maintain adequate fluid intake.
Adults, the elderly and children over 12 years:Using the measuring spoon provided, one or two level measuring spoons OR one or two sachets (equivalent to 5g or 10g of granules respectively) to be taken once daily at night at least ½ to 1 hour before or after intake of other medicines. Warning: not to be taken immediately prior to bed-time. The maximum daily dose of hydroxyanthracene glycosides is 30 mg. This is equivalent to two level measuring spoons or two sachets (10g of granules) of Manevac. The correct individual dose is the smallest required to produce a comfortable soft-formed motion.Normally it is sufficient to take this medicinal product up to two to three times a week.
Children under 12 years:Not recommended for use in children under 12 years of age (see section 4.3 Contraindications).
Pregnant women:One or two level measuring spoons OR one or two sachets (equivalent to 5g or 10g of granules respectively) once daily at night.
Duration of use:Use for more than 1 2 weeks requires medical supervision. If the symptoms persist during the use of Manevac, a doctor or a pharmacist should be consulted. See also section 4.4 Special warnings and precautions for use.
WarningTake each single dose of Manevac with at least 150 ml of water or similar aqueous fluid. Taking Manevac without adequate fluid may cause it to swell and block your throat or oesophagus and may cause choking. Intestinal obstruction may occur if adequate fluid intake is not maintained. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking Manevac, seek immediate medical attention. The treatment of debilitated patients requires medical supervision. The treatment of elderly patients should be supervised.Special note for diabetics: Each measuring spoon or sachet contains approximately 5g of Manevac, equivalent to approximately 1.04g of sucrose.Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking Manevac concomitantly.If laxatives are needed every day the cause of the constipation should be investigated. Like all laxatives, Manevac should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of pure bulk forming agents.Long-term use of laxatives should be avoided. If stimulant laxatives are taken for longer than a brief period of treatment, this may lead to impaired function of the intestine and dependence on laxatives. Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria.Prolonged use may precipitate the onset of an atonic, non-functioning colon. When Manevac is administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.Patients with kidney disorders should be aware of possible electrolyte imbalance.Laxatives do not help in long-term weight loss.
FertilityStudies on fertility have not been performed.
PregnancyThere are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage schedule.As a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe-emodin, the use is to be avoided during the first trimester. Manevac should only be used intermittently and if other actions like behavioural modification, dietary changes and use of bulk forming agents failed.
LactationUse during breast-feeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk.Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (Website: www.yellowcard.mhra.gov.uk).
Single dose toxicityThe LD50 in rats was greater than the highest dose tested corresponding to 3,360 mg/kg ispaghula husk administered by gavage of an aqueous suspension. The LD50 in mice was greater than the highest dose tested corresponding to 2,940 mg/kg ispaghula husk also administered by gavage of an aqueous suspension. These studies were conducted prior to the establishment of good laboratory practices.Subchronic toxicityPsyllium was fed to rats at levels high as 10 % of the diet for periods up to 13 weeks (three 28-day studies, one 13-week study). Psyllium consumption ranged from 3,876 to 11,809 mg/kg/day. Because the absorption of psyllium is very limited, histopathological evaluations were limited to the gastrointestinal tract, liver, kidneys and gross lesions without observing any treatment-related effect. Effects considered to be biologically significant and related to psyllium supplementation were lower serum total protein, albumin, globulin, total iron-binding capacity, calcium, potassium, and cholesterol; and higher aspartate transaminase (AST) and alanine transaminase (ALT) activities relative to control. Several of these effects are considered to be secondary effects to others. The reasons for the lower serum total protein, albumin and globulin are not clear, but the absence of any increases in urinary protein, any evidence of gastrointestinal pathology, which could account for protein loss, and any differences in growth or feed efficiency in psyllium fed rats may give evidence that there are no adverse effect of psyllium on protein metabolism.
Reproductive toxicityA rat multigeneration reproduction/teratology study showed no evidence of any adverse effects of psyllium on reproduction or development. Psyllium as 0, 1.25, or 5% (w/w) of the diet was administered in a standard (NIH-07) rat and mouse meal diet ad libitum through gestation of the third generation.A segment II study in rabbits also showed no evidence of any adverse effect. Psyllium as 0, 2.5, 5 or 10% (w/w) of diet was administered in a purine certified rabbit chow diet for days 2 - 20 of gestation.
Genotoxicity and carcinogenicityTests on genotoxicity and carcinogenicity have not been performed.Most data refer to senna pod extracts containing 1.4 to 3.5% of anthranoids, corresponding to 0.9 to 2.3% of potential rhein, 0.05 to 0.15% of potential aloe- emodin and 0.001 to 0.006% of potential emodin or isolated active constituents, e.g. rhein or sennosides A and B. The acute toxicity of senna pods, specified extracts thereof, as well as of sennosides in rats and mice was low after oral treatment. As a result of investigations with parenteral application in mice, extracts are supposed to possess a higher toxicity than purified glycosides, possibly due to the content of aglyca. In a 90-day rat study, senna pods were administered at dose levels from 100 mg/kg of up to 1,500 mg/kg. The tested drug contained 1.83 % sennosides A-D, 1.6 % potential rhein, 0.11 % potential aloe-emodin and 0.014 % potential emodin. In all groups epithelial hyperplasia of the large intestine of minor degree was found and was reversible within the 8-week recovery period. The hyperplastic lesions of the forestomach epithelium were reversible as well. Dose-dependent tubular basophilia and epithelial hypertrophy of the kidneys were seen at a dose of, or greater than 300 mg/kg per day without functional affection. These changes were also reversible. Storage of a brown tubular pigment led to a dark discoloration of the renal surface and still remained to a lesser degree after the recovery period. No alterations were seen in the colonic nervous plexus. A no-observable-effect-level (NOEL) could not be obtained in this study.A 104-week study on rats of both genders did not reveal any carcinogenic effects with the same senna pods preparation at oral dosages of up to 300 mg/kg.In addition a specified senna extract given orally for 2 years was not carcinogenic in male or female rats. The extract investigated contained approximately 40.8% of anthranoids from which 35% were sennosides, corresponding to about 25.2% of potential rhein, 2.3% of potential aloe-emodin and 0.007% of potential emodin and 142 ppm free aloe-emodin and 9 ppm free emodin.Further 2-year studies on male and female rats and mice with emodin gave no evidence of carcinogenic activity for male rats and female mice, and equivocal evidence for female rats and male mice.Sennosides displayed no specific toxicity when tested at doses up to 500 mg/kg in dogs for 4 weeks and up to 100 mg/kg in rats for 6 months.There was no evidence of any embryolethal, teratogenic or foetotoxic actions in rats or rabbits after oral treatment with sennosides. Furthermore, there was no effect on the postnatal development of young rats, on rearing behaviour of dams or on male and female fertility in rats. Data for herbal preparations are not available.An extract and aloe-emodin were mutagenic in in vitro tests, sennoside A, B and rhein gave negative results. Comprehensive in vivo examinations of a defined extract of senna pods were negative.Chronic laxative use as a risk factor in colorectal cancer (CRC) was investigated in some clinical trials. Some studies revealed a risk for CRC associated with the use of anthraquinone-containing laxatives, some studies did not. However, a risk was also revealed for constipation itself and underlying dietary habits. The short-term use of senna pods as recommended can be regarded as safe.
36 months (400g composite container)
Mylan Products Ltd,
Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL
+44 (0)1707 853 000
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+44 (0)1707 853 000 select option 2
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