Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ispaghula; Senna fruit
Waymade Healthcare Plc
A06AB56
Ispaghula; Senna fruit
542mg/1gram ; 124mg/1gram
Oral granules
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060200
MANEVAC (Ispaghula Seed, Ispaghula Husk and Tinnevelly Senna Pods) PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 7 of days. WHAT IS IN THIS LEAFLET: 1. What Manevac is and what it is used for 2. What you need to know before you take Manevac 3. How to take Manevac 4. Possible side effects 5. How to store Manevac 6. Contents of the pack and other information 1. WHAT MANEVAC IS AND WHAT IT IS USED FOR Manevac is one of a group of medicines called laxatives. The medicine contains Ispaghula Seed, Ispaghula Husk (bulk-forming laxatives) and Tinnevelly Senna Pods (a stimulant laxative). Manevac can be used occasionally to relieve constipation (infrequent passing of hard stools). Manevac is also used to maintain normal bowel action in bed-ridden patients and pregnant women. Manevac can also help reduce pain when emptying the bowels for patients suffering from haemorrhoids (piles). Manevac does not help with weight loss. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANEVAC Do not take Manevac • if you are allergic to Ispaghula Seed, Ispaghula Husk, Tinnevelly Senna Pods or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath). • if you have narrowing of the gastrointestinal tract • if you have difficulty in swallowing or any throat problems • if you have a blocked bowel (intestinal obstruction or paralysis of the intestines) • if you suffer from any bowel disor Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Manevac 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 3 PHARMACEUTICAL FORM Brown, sugar-coated granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (a) For short-term use in cases of occasional constipation. (b) For bowel regulation in bed-ridden patients and pregnant women. (c) For pain free evacuation in cases of haemorrhoids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _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. _POSOLOGY:_ _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 (equiva Read the complete document