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Macrogol Oral Powder Compound

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Macrogol Oral Powder, Compound

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains the following active ingredients:

Macrogol 3350    13.125 g

Sodium chloride    350.7 mg

Sodium hydrogen carbonate 178.5 mg Potassium chloride    46.6 mg

The content of electrolyte ions per sachet when made up to 125 ml of solution is as follows:

Sodium    65 mmol/l

Chloride    53 mmol/l

Hydrogen carbonate    17 mmol/l

Potassium    5.4 mmol/l

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Powder for oral solution.

A white powder.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

• For the treatment of chronic constipation.

Resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2 Posology and method of administration Chronic constipation

Adults, adolescents and the elderly: 1 -3 sachets daily in divided doses. Normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed.

A course of treatment for constipation does not normally exceed 2 weeks, although this can be repeated if required.

For extended use, the lowest effective dose should be used.

Children below 12 years old: Not recommended. Alternative products are available for children.

Patients with renal insufficiency: No dosage change is necessary for the treatment of chronic constipation.

Faecal impaction

A course of treatment for faecal impaction does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old: Not recommended. Alternative products are available for children.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than 2 sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for the treatment of faecal impaction.

Administration

Each sachet should be dissolved in 125 ml water. For use in faecal impaction 8 sachets may be dissolved in 1 litre of water.

4.3 Contraindications

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon.

Hypersensitivity to the active substances or to any of the excipients.

Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

The cause of constipation should be investigated if daily use of laxatives is necessary. Patients using this preparation should seek medical advice if there is no improvement after two weeks.

Long term use can be necessary in serious chronical or refractory constipation due to i.e. multiple sclerosis (MS) or Parkinson’s disease, or constipation induced by drugs, especially opioides or antimuscarine products.

If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) treatment should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by this medicinal product (see section 4.5).

There is no clinical data on the use of Macrogol Oral Powder, Compound in children, therefore it is not recommended.

4.5 Interaction with other medicinal products and other forms of interaction

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with this medicinal product (see section 4.4)..

4.6 Pregnancy and lactation

Pregnancy:

There is no documented experience from the use of macrogol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal reproductive development, delivery or postnatal development (see section 5.3). As Macrogol has a molecular weight above 3000 da very little if any will be absorbed. Therefore it seems unlikely

that the use of this product will cause problems during pregnancy. For this reason this product can be used during pregnancy, if necessary.

Breast-feeding:

There is no documented experience from the use of macrogol during breastfeeding. Macrogol with a molecular weight above 3000 da will not or hardly be resorbed. For this reason this product can be used during breast-feeding, as far as known.

4.7 Effects on ability to drive and use machines

Macrogol Oral Powder, Compound has no influence on the ability to drive and use machines.

4.8 Undesirable effects

The frequency of the adverse reactions listed below is defined using the following convention: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); and very rare (<1/10,000); not known (cannot be estimated from the available data).

Reactions related to the gastrointestinal tract are the most common to occur. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacological effects of the product. Mild diarrhoea usually responds to dose reduction.

System Order Class

Adverse Event

Frequency (if known)

Immune

system

disorders

Allergic reactions, including anaphylaxis, angioedema, dyspnoea, allergic rash, erythema, urticaria and pruritus

Very rare

Metabolism and nutrition disorders

Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia

Not known

Nervous

system

disorders

Headache

Not known

Gastrointestin al disorders

Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort

Common

General disorders and administration site conditions

Peripheral oedema

Not known

4.9 Overdose

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group:    Osmotically acting laxatives.

ATC code:    A06A D65

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.

For the indication of faecal impaction controlled comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 27 adult patients, macrogol with electrolytes cleared the faecal impaction in 12/27 (44%) after 1 day's treatment; 23/27 (85%) after 2 days' treatment and 24/27 (89%) at the end of 3 days.

Clinical studies in the use of macrogol with electrolytes in chronic constipation have shown that the dose needed to produce normal formed stools tends to reduce over time. Many patients respond to between 1 and 2 sachets a day, but this dose should be adjusted depending on individual response.

5.2 Pharmacokinetic properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

5.3 Preclinical safety data

Preclinical data do not indicate a special risk for humans. These data are originated from conventional studies in the field of pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Acesulfame potassium (E950)

Lemon Flavour (contains acacia gum (E414) and flavouring)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

36 months.

Reconstituted solution: 24 hours.

Store in a refrigerator (2°C - 8°C).

6.4    Special precautions for storage

This medicinal product does not require any special storage conditions. Reconstituted product: See section 6.3.

6.5    Nature and contents of container

Sachet: laminate consisting of four layers (inner to outer): low density polyethylene, aluminium, low density polyethylene and paper.

Pack sizes: Boxes of 8, 10, 20, 30, 50 or 100 sachets.

Not all pack sizes may be marketed.

Any unused solution should be discarded within 24 hours.

7    MARKETING AUTHORISATION HOLDER

Chanelle Medical, Loughrea, Co. Galway, Ireland.

8    MARKETING AUTHORISATION NUMBER(S)

PL 13931/0048

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/12/2010

10    DATE OF REVISION OF THE TEXT

14/03/2011