MANEVAC

For oral administration.

Method of administration:

The patient should be sitting in an upright position prior to administration of the granules. 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.

An interval of half an hour to one hour should be kept after taking another medicinal product.

Posology:

Adults, the elderly and children over 12 years: Sachets One sachet (5g) or two sachets (10g) to be taken once daily at night. Granules One (5g) or two (10g) level measuring spoons to be taken once daily at night. 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. Manevac may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon.

However, these symptoms may also occur generally as a consequence of individual overdosage. 8). This product should not be taken immediately prior to bed-time. 4). Usually it is sufficient to take this medicinal product up to two to three times during that week.

If the symptoms persist during the use of Manevac , a doctor or a pharmacist should be consulted.

Flatulence may occur with the use of Manevac, this generally disappears in the course of the treatment. g. dysphagia) and faecal impaction may occur, particularly if swallowed with insufficient fluid. The frequency is not known. Manevac contains potent allergens.

As a consequence after oral administration or contact with the skin, Manevac may cause hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylaxis.. Cutaneous hypersensitivity reactions such as local or general exanthema urticaria and/or pruritus have also been reported.

The frequency is not known. Manevac may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdosage.

In such cases dose reduction is necessary. Nausea and vomiting may occur. The frequency is not known. Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria. Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.

Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment. The frequency is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk) or search for MHRA Yellow Card in the Google Play or Apple App Store.

The stated dose should not be exceeded. Manevac should always be taken with liquid. When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat and oesophagus with choking and intestinal obstruction.

Symptoms can be chest pain, vomiting, or difficulty in swallowing or breathing. Like all laxatives, Manevac should not be used by patients with faecal impaction and undiagnosed, acute or persistent gastro intestinal symptoms such as abdominal pain, nausea and vomiting unless advised by a doctor because these symptoms can be signs of potential or existing intestinal blockage (ileus).

If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives (more than 1 week) should be avoided. 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.

If the constipation does not resolve within 3 days or if abdominal pain occurs or in cases of any irregularity of faeces, the use of Manevac should be discontinued and medical advice must be sought. The treatment of debilitated patients and / or elderly patients requires medical supervision.

g. opioids,) only under medical supervision. 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.

Long-term use of stimulant 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.

Patients with kidney disorders should be aware of possible electrolyte imbalance. Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria. g. renal insufficiency, elderly patients) use of the product should be discontinued and only be restarted under medical supervision.

1. • Children under 12 years of age. 3). • Patients with a sudden change in bowel habit that persists for more than 2 weeks • Undiagnosed rectal bleeding and failure to defecate following the use of a laxative. g. Crohn’s disease, ulcerative colitis, appendicitis) • severe dehydration (with loss of fluid and electrolytes) • abdominal pain of unknown origin • dysphagia