SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Loperamide Capsules 2mg Superdrug Acute Diarrhoea Relief Capsules Asda Anti-Diarrhoea Capsules Sainsbury’s Anti-Diarrhoea Capsules Morrisons Anti-Diarrhoea Capsules Numark Anti-Diarrhoea Capsules Tesco Diarrhoea relief Capsules DiaFix Capsules

Vantage Anti-Diarrhoea Capsules Co-operative Diarrhoea Relief 2mg Capsules Entrocalm Diarrhoea Relief 2mg Capsules Galpharm Diarrhoea Relief 2mg Capsules Kirkland Signature Diarrhoea Relief 2mg Capsules Dioraleze 2mg Capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Loperamide Hydrochloride BP 2mg

3. PHARMACEUTICAL FORM

Capsules for oral administration.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For symptomatic treatment of acute diarrhoea.

4.2. Posology and Method of Administration

Adults, the elderly and children over 12 years of age:

GSL status:

Two capsules to be taken initially, followed by one capsule after each loose motion, up to a maximum of six capsules in any 24 hours.

Not recommended in children under 12 years of age.

P status

Two capsules to be taken initially, followed by one capsule after each loose motion, up to a maximum of eight capsules in any 24 hours.

Not recommended for children under 12 years of age.

4.3. Contra-indications

Patients with acute ulcerative colitis or pseudomembranous colitis.

Patients with abdominal distension and where ileus and constipation are present. Patients with known hypersensitivity to loperamide or to any of the excipients. Patients with bacterial enterocolitis.

Patients with acute dysentery characterised by blood in stools and elevated body temperatures.

Patients with inflammatory bowel disease.

Patients where inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.

4.4. Special warnings and precautions for use

This medicine must be used with caution when the hepatic function necessary for the drug’s metabolism is defective (e.g. in cases of severe hepatic disturbance), as this might result in a relative overdose leading to CNS toxicity.

Loperamide relieves the symptoms of diarrhoea only and is not a substitute for rehydration therapy.

Since persistent diarrhoea can be an indicator of potentially more serious conditions. This medicine should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated.

GSL product: Use should not exceed 24 hours unless advised by a doctor. A doctor should be consulted if diarrhoea is still present after 24 hours treatment.

P product: A doctor should be consulted if diarrhoea is still present after 24 hours treatment. Further investigation into the cause of diarrhoea should be considered if there is no improvement within 2 days of starting treatment.

Patients with AIDS treated with loperamide for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5. Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6. Pregnancy and Lactation

Although no evidence exists of teratogenic effects, use is best avoided during pregnancy.

Only a very small amount of loperamide is excreted in breast milk, however, it should be used with caution in lactating women.

4.7. Effects on Ability to Drive and Use Machines

None.

4.8 Undesirable effects

In clinical trials, constipation and dizziness have been reported with greater frequency in loperamide hydrochloride treated patients than placebo treated patients.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

The following adverse events have also been reported with use of loperamide hydrochloride:

Immune system disorders:

Very rare: isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions.

Nervous system disorders:

Very rare: Dizziness, somnolence

Gastrointestinal disorders:

Very Rare: Abdominal pain, dry mouth, ileus, abdominal distension, nausea, constipation, vomiting, megacolon including toxic megacolon, flatulence, dyspepsia

Skin and subcutaneous tissue disorders:

Very rare: rash, urticaria and pruritus.

Isolated occurrences of angioedema and bullous eruptions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis

Renal and urinary disorders

Very rare: Isolated reports of urinary retention

General disorders and administration site conditions:

Very rare: Fatigue

A number of the adverse events reported during the clinical investigations and postmarketing experience with loperamide are frequent symptoms of the underlying diarrhoeal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

In case of overdose the following effects may be observed; constipation, urinary retention, ileus, raised levels of pancreatic enzymes and neurological symptoms (miosis, muscular hypotonia, somnolence and bradypnoea).

If intoxication is suspected, naloxone may be used as an antidote. Since the duration of action of loperamide is longer than that of naloxone, the patient should be kept under the constant observation for at least 48 hours in order to detect any possible depression of the central nervous system. Children, and patients with hepatic dysfunction, may be more sensitive to CNS effects.

Gastric lavage may be recommended.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Loperamide is an anti-diarrhoeal agent, it inhibits peristalsis and gastrointestinal secretions. Clinical trials undertaken in patients with acute diarrhoea have demonstrated that following a single 4 mg dose of Loperamide, onset of anti-diarrhoeal action was achieved within 1 hour.

Comparisons with other anti-diarrhoeal drugs have confirmed the exceptionally rapid onset of action of Loperamide.

5.2. Pharmacokinetic Properties

Following partial absorption in the gastro-intestinal tract, Loperamide undergoes considerable first pass metabolism in the liver and is excreted predominantly in the faeces. The elimination half-life is reported to be about 10 hours.

5.3. Preclinical Safety Data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Lactose BP Maize starch BP Talc BP

Magnesium stearate BP

Capsule shell is comprised of:

Gelatin BP

Quinoline Yellow (E104) Erythrosine (E127)

Patent Blue (E131)

Titanium Dioxide (E171)

6.2. Incompatibilities

None.

6.3. Shelf Life

4 years.

Special Precautions for Storage

Store below 25°C in a dry place.

6.5. Nature and Contents of Container

Aluminium / PVC blister strips enclosed in an outer carton containing 2, 4, 6, 8, 10, 12, 18, 24 or 30 capsules.

Aluminium / PVC/ PVdC blister strips enclosed in a cardboard outer containing 2, 4, 6, 8, 10, 12, 18, 24 or 30 capsules.

6.6. Instruction for Use, Handling and Disposal

Not applicable.

7.    MARKETING AUTHORISATION HOLDER

Galpharm Healthcare Limited

Wrafton

Braunton

Devon

EX33 2DL

United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 16028/0032

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17^th July 1998

10 DATE OF REVISION OF THE TEXT

04/06/2015