product information

PROFESSIONAL INFORMATION
SCHEDULING STATUS:

S0

PROPRIETARY NAME AND DOSAGE FORM:

Metamucil Orange Smooth (powder)
Metamucil Berry Smooth (powder)
Metamucil Lemon Smooth (powder)
Metamucil FibreCaps (capsules)

COMPOSITION:

Metamucil Orange Smooth

Each 5,9 g sachet or serving contains: Psyllium husk 3,4 g
Excipients: Aspartame, citric acid anhydrous, FD&C yellow no 6 (CI 15985), maltodextrin, orange flavour.
Contains Sweetener: Aspartame 44,7 mg

Metamucil Lemon Smooth

Each 5,8 g serving contains: Psyllium husk 3,4 g
Excipients: Aspartame, citric acid anhydrous, citrus flavour, FD&C yellow no 6 (CI 15985), maltodextrin.
Contains Sweetener: Aspartame 44,4 mg

Metamucil Berry Smooth

Each 5,8 g serving contains: Psyllium husk 3,4 g
Excipients: Aspartame, citric acid anhydrous, mixed berry flavour, FD&C blue no 1 (CI 42091),
FD&C red no 40 (CI 16035), maltodextrin.
Contains Sweetener: Aspartame 28 mg, Acesulfame potassium 28 mg

Metamucil FibreCaps

Each gelatin capsule contains: Psyllium husk 525 mg
Excipients: Sodium lauryl sulphate
Sugar Free

CATEGORY AND CLASS:

Complementary medicine: Health Supplements: Category D 34.10
Saccharides (including prebiotics)

PHARMACOLOGICAL ACTION:

Metamucil contains psyllium husk which acts as a bulk forming agent that increase the mass of stool, its water content, and rate of colonic transit. Psyllium husk contains a high level of soluble dietary fibre. Upon oral ingestion, soluble fibres form a viscous gel in the intestine. Psyllium husk absorbs water in the gastrointestinal tract to form a mucilaginous mass which increases the volume of faeces and hence promotes peristalses.

Pharmacodynamics
Psyllium husk is rich in alimentary fibres and mucilages, Gut motility and transit rate can be modified through mechanical stimulation of the gut wall as a result of the increase in intestinal bulk by water and the decrease in viscosity of the luminal contents. Psyllium husk usually acts as a laxative within 12 to 24 hours after single administration. Sometimes the maximum effect is reached after 2 to 3 days.

Pharmacokinetics
Psyllium husk hydrates and swells to form a mucilage because it is only partially solubilised. Polysaccharides, such as those which dietary fibres are made of, must be hydrolysed to monosaccharides before intestinal uptake can occur. The sugar residues of the xylan backbone and the side chains are joined by ß-linkages, which cannot be broken by human digestive enzymes. Less than 10% of the mucilage gets hydrolysed in the stomach, with formation of free arabinose. Intestinal absorption of the free arabinose is approximately 85% to 93%. To varying degrees, dietary fibre is fermented by bacteria in the colon, resulting in production of carbon dioxide, hydrogen, methane, water, and short-chain fatty acids, which are absorbed and brought into the hepatic circulation. In humans, such fibre reaches the large bowel in a highly polymerised form that is fermented to a limited extent, resulting in increased faecal concentration and excretion of short-chain fatty acids.

INDICATIONS:

Metamucil helps to maintain regularity. It is a bulk-forming laxative especially in conditions such as constipation, diverticular diseases, IBS and whenever excessive straining at stool must be avoided (i.e. as stool softener). Metamucil promotes bowel movements by increasing bulk volume and water content and to provide gentle relief of constipation and/or irregularity / infrequent, difficult or painful passage of stools. Metamucil helps to maintain healthy cholesterol levels. Metamucil is a source of fibre for the maintenance of good health.

CONTRAINDICATIONS:

Metamucil powder or Metamucil fibrecaps is contraindicated in:

• Hypersensitivity to psyllium husk or to any of the ingredients of Metamucil powder or Metamucil fibrecaps. (see COMPOSITION).
• Patients who are PHENYLKETONURICS. Metamucil contains a source of phenylalanine which may be harmful for people with phenylketonuria (For Metamucil powder only).
• Pre-existing faecal impaction, intestinal obstruction or colonic atony or conditions likely to lead to intestinal obstruction.
• Patients with a sudden change in bowel habits that has persisted for more than 2 weeks.
• Patients with undiagnosed rectal bleeding or failure to defaecate following the use of another laxative product.
• Patients with diabetes mellitus in which blood sugar is difficult to regulate.
• Patients who have difficulty in swallowing.
• Children under the age of 12.

WARNINGS AND SPECIAL PRECAUTIONS:

• The use of METAMUCIL is not recommended for children under the age of 12.
• A sufficient amount of liquid should always be taken e.g. 250 ml of liquid per serving or sachet of Metamucil (approximately 1 ½ level teaspoons).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.
• METAMUCIL should not be used by patients with faecal impaction and 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 abdominal pain occurs or in cases of any irregularity of faeces, the use of METAMUCIL should be discontinued, and medical advice must be sought.
• The treatment of debilitated patients and / or elderly patients requires medical supervision.
• In order to decrease the risk of gastrointestinal obstruction (ileus) METAMUCIL should be used together with medicinal products known to inhibit peristaltic movement (e.g. opioids) only under medical supervision.

Powder formulations:
Warning on hypersensitive reactions: In individuals with continued occupational contact to powder of Psyllium seeds or husks (i.e. healthcare workers, caregivers) allergic sensitisation may occur due to inhalation, this is more frequent in atopic individuals. This sensitisation usually leads to hypersensitivity reactions which could be serious (see Side Effects). It is recommended to assess clinically the possible sensitisation of individuals at risk and, if justified, to perform specific diagnostic tests. In case of proven sensitisation leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see Contraindications). The use of Psyllium husk as an adjuvant to diet in hypercholesterolemia requires medical supervision.

INTERACTIONS:

• METAMUCIL must be taken at least 2 hours before or after other medications before or after intake of other medicinal products.
• Co-administering METAMUCIL with other medicines may delay the gastrointestinal absorption of: cardiac glycosides, coumarin derivatives, carbamazepine, lithium, certain vitamins (e.g. Vitamin. B12) and minerals.
  • if you are currently using medication to control your blood sugar levels.
• Use of METAMUCIL concomitantly with the following medicines require medical supervision as dosage adjustments may be necessary:
  • cholesterol maintenance program
  • anti-diabetic medicines (e.g. insulin or oral anti-diabetics)
  • thyroid hormones

HUMAN REPRODUCTION:

If you fall pregnant whilst on this medication, immediately consult your doctor, pharmacist or other healthcare professional and stop the medication.
Pregnancy
There is limited amount of data (from the use of psyllium husk in pregnant women. The use of psyllium husk may be considered during pregnancy.
Lactation
The use of psyllium husk may be considered during lactation, if necessary and if change of nutrition is not successful. Laxative bulk producers should be used before using other purgatives.
Fertility
No known effects.

DOSAGE AND DIRECTIONS FOR USE:

Dosage age:
Adults and children (≥ 12 years of age)
Note: Children aged 12 years and over are usually given adult doses.
The use in children under 12 years of age is not recommended (see CONTAINDICATIONS)
Metamucil should be taken during the day 2 hours before or after intake of other medicines, not immediately prior to bed-time. The effect starts 12 - 24 hours later.
Method of administration
Metamucil Orange Smooth Powder Formulation
A sufficient amount of liquid (water, milk, fruit juice or similar aqueous liquid) should always be taken e.g. 250 ml of water per 5,9 g of Metamucil Orange Smooth.
Metamucil Lemon Smooth and Berry Smooth Powder Formulations
A sufficient amount of liquid (water, milk, fruit juice or similar Aqueous liquid) should always be taken e.g. 250 ml of water per 5,8 g of Metamucil Lemon Smooth or Berry Smooth
Powder formulations:
When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimise the risk of sensitisation to the active ingredient.
Dosage range and Directions for use:
Metamucil Sachets:
Simply add one sachet to at least 250 ml of water. Stir briskly and drink promptly. Drink plenty of water.
New Users: Start with 1 sachet per day and gradually increase to 3 sachets per day.
Metamucil Orange Smooth Powder formulation
Simply add 5,9 g of Metamucil (approximately 1½ level teaspoons) to at least 250 ml of water. Stir briskly and drink promptly. Drink plenty of water.
New Users: Start with 1 serving per day (1½ level teaspoons), and gradually increase to 3 servings per day.
Serving Size: 5,9 g (1½ level teaspoons)
Metamucil Lemon Smooth and Berry Smooth Powder Formulations
Simply add 5,8 g of Metamucil (approximately 1½ level teaspoons) to at least 250 ml of water. Stir briskly and drink promptly. Drink plenty of water.
New Users: Start with 1 serving per day (1½ level teaspoons), and gradually increase to 3 servings per day.
Serving Size: 5, 8 g (1½ level teaspoons)
Metamucil Fibrecaps:
New Users: Start with 1 serving per day and gradually increase to 3 servings per day.
Serving Size: 7 Capsules.
Maximum dosing: 3 servings (21 capsules) per day. Take 7 capsules, one at a time, with a 250 ml glass of water. Drink plenty of water and take whilst in an upright position.
Duration of use
If the symptoms persist during the use of the Metamucil longer than 3 days, a doctor or a pharmacist should be consulted.

SIDE EFFECTS:

Immune System Disorders:
Frequency unknown: hypersensitivity reactions* such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxis. Cutaneous symptoms such as exanthema and/or pruritus.
Gastrointestinal disorders:
Frequency unknown: Flatulence, abdominal distension, abdominal pain, diarrhoea, constipation, dyspepsia, nausea, intestinal obstruction, oesophageal obstruction, faecal impaction.
Skin and subcutaneous tissue disorders:
Frequency unknown: rash*, urticaria
Nervous system disorders:
Less frequent: Headache
Musculoskeletal, connective tissue and bone disorders:
Less frequent: backache
Respiratory, thoracic and mediastinal disorders:
Less frequent: bronchospasm, rhinitis*, increased cough, and sinusitis.
Eye Disorders:
Frequency unknown: Conjunctivitis*
*Psyllium/psyllium husk contains potent allergens. The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation. As a consequence, to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Overdose with psyllium husk may cause abdominal discomfort, flatulence and intestinal obstruction.Management: adequate fluid intake should be maintained, particularly if the granules have been taken without water contrary to administration instructions, and management should be symptomatic.

IDENTIFICATION:

Metamucil Orange Smooth: Light beige to tan, free-flowing agglomerated powder with no foreign objects.
Metamucil Berry Smooth: Light beige to tan, free-flowing agglomerated powder with no foreign objects.
Metamucil Lemon Smooth: Light beige to tan, free-flowing agglomerated powder with no foreign objects.
Metamucil FibreCaps: Clear, unprinted capsules containing beige powder with some dark particles.

PRESENTATION:

Metamucil Orange Smooth:
17 oz High density white polyethylene bottles with an orange coloured polypropylene cap,
containing 283 g powder.
26 oz High density white polyethylene bottles with an orange coloured polypropylene cap,
containing 425 g powder.
10, 14 or 30 Sachets, containing 5,9 g powder made from aluminium foil lined with low density polyethylene contained in an outer cardboard unit carton.
Metamucil Berry Smooth:
17 oz High density white polyethylene bottles with a purple coloured polypropylene cap,
containing 283 g powder.
26 oz High density white polyethylene bottles with a purple coloured polypropylene cap,
containing 425 g powder.
Metamucil Lemon Smooth:
17 oz High density white polyethylene bottles with a yellow coloured polypropylene cap,
containing 283 g powder.
26 oz High density white polyethylene bottles with a yellow coloured polypropylene cap,
containing 425 g powder.
Metamucil FibreCaps:
100 capsules contained in a high density white polyethylene bottles with a green coloured polypropylene cap.

STORAGE INSTRUCTIONS:

Store at or below 30 °C. Keep in original packaging until required for use.

KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER

To be allocated

NAME AND BUSINESS ADDRESS OF THE HOLDER OF
THE CERTIFICATE OF REGISTRATION/APPLICANT

Procter & Gamble South African Trading (Pty) Ltd.
15 Alice Lane Towers, Alice Lane
Sandton
2196
Johannesburg
South Africa

DATE OF PUBLICATION OF THE PROFESSIONAL
INFORMATION FOR MEDICINES FOR HUMAN USE

January 2019

DISCLAIMER:

This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. Health supplements are intended only to complement health or supplement the diet.