MANEVAC

For oral administration.

Method of administration:

The patient should be sitting in an upright position prior to administration of the granules Manevac 12 Year Plus 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 12 Year Plus. The correct individual dose is the smallest required to produce a comfortable soft-formed motion. Manevac 12 Years Plus 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 12 Year Plus, a doctor or a pharmacist should be consulted.

Flatulence may occur with the use of Manevac 12 Year Plus, 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 12 years plus contains potent allergens. As a consequence after oral administration or contact with the skin, Manevac 12 Year Plus may cause hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylaxis.

Cutaneous hypersensitivity reactions such as local or generalized exanthema, urticaria and/or pruritus have also been reported. The frequency is not known. Manevac 12 Year Plus 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.

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The stated dose should not be exceeded. Manevac 12 Year Plus should always be taken with a glass of water or other 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. 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 12 Year Plus 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 If there is no bowel movement after three days, a doctor or pharmacist should be consulted. Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives.

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 12 Year Plus product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.

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) Manevac 12 Year Plus should be discontinued and only be restarted under medical supervision. Stimulant laxatives (including Manevac 12 Year Plus) do not help with weight loss. Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor/physician before taking Manevac 12 Year Plus concomitantly.

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