NUMARK DIARRHOEA RELIEF

The capsules should be taken with liquid. For oral administration. The total daily dose should not exceed 6 capsules (12mg). SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH IRRITABLE BOWEL SYNBROME IN ADULTS AGED 18 YEARS AND OVER.

Two capsules (4mg) to be taken initially, followed by 1 capsule (2mg) after ever loose stool (motion), or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12mg). USE IN ELDERLY No dose adjustment is required for the elderly.

RENAL IMPAIRMENT. No dose adjustment is required for patients with renal impairment. HEPATIC IMPAIRMENT. Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Hydrochloride should be used with caution in such patients because of reduced first pass metabolism.

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Adults and children aged 12 years and over. The safety of Loperamide hydrochloride was evaluated in 2755 adults and children aged 12 years and over who participated in 26 controlled and uncontrolled clinical trials of Loperamide hydrochloride used for the treatment of acute diarrhoea.

e. 1%). Table 1 displays ADRs that have been reported with the use of Loperamide Hydrochloride from either clinical trial (acute diarrhoea) or post marketing experience.

The frequency categories use 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); Very Rare ( 1/10,000).

Table 1:

Adverse Drug Reactions IndicationSystem Organ Class Common Uncommon Rare Immune System Disorders Hypersensitivity reactiona Anaphylactic reaction (including anaphylactic shock)a Anaphylactoid reactiona Nervous System Disorders Headache Dizziness Loss of consciousness Somnolencea Stupora Depressed level of consciousnessa Hypertoniaa Coordination abnormalitya Eye Disorders Miosisa Gastrointestinal Disorders Constipation Nausea Flatulence Abdominal Pain Abdominal Discomfort Dry Mouth Abdominal pain upper Vomiting Dyspepsiaa Ileusa (including paralytic ileus) Megacolona (including toxic megacolonb) Abdominal distension.

Acute pancreatitis (frequency not known) Skin & Subcutaneous Tissue Disorders Rash Bullous eruptiona (including Stevens- Johnson syndrome, Toxic epidermal necrolysis & Erythema multiforme) Angloedemaa Urticariaa Pruritusa Renal & Urinary Disorders Urinary retentiona General Disorders & Administration Site Conditions Fatiguea a: Inclusion of this term is based on post-marketing reports for Loperamide Hydrochloride.

As the process for determining post marketing ADRs did not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with Loperamide Hydrochloride (acute & chronic), including trials in children aged 12 years or less (N=3683).

4 Special Warnings and Special Precautions for use. 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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4 Special warnings and special precautions for use). 3 Contraindications This medicine is contraindicated: • In patients with known hypersensitivity to Loperamide hydrochloride or to any of the excipients. • In children less than 12 years of age.

• In patients with acute dysentery, which is characterised by blood in the stools and high fever. • In patients with acute ulcerative colitis. • In patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter.

• In patients with pseudomembranous colitis associated with the use of broad- spectrum antibiotics. Loperamide Hydrochloride must not be used when inhibition of peristalsis is to be avoided due to possible risk of significant sequelae including ileus, megacolon and toxic megacolon.

Loperamide Hydrochloride must be discontinued promptly when ileus, constipation or abdominal distension develop. 4 Special warnings and precautions for use Treatment of diarrhoea with Loperamide Hydrochloride is only symptomatic. Whenever an underlying aetiology can be determined, specific treatment should be given when appropriate.

The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion. This is particularly important in young children and in frail and elderly patients with acute diarrhoea. Use of this medicine does not preclude the administration of appropriate fluid and electrolyte replacement 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. In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of Loperamide Hydrochloride should be discontinued and patients should be advised to consult their doctor.

Patients with AIDS treated with this medicine for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with Loperamide Hydrochloride.

Although no pharmacokinetic data are available in patients with hepatic impairment, this medicine should be used with caution in such patients because of reduced first pass metabolism, as it may result in a relative overdose leading to CNS toxicity.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose. If patients are taking this medicine to control episodes of diarrhoea associated with Irritable Bowel Syndrome previously diagnosed by their doctor, and clinical improvement is not observed within 48 hours, the administration of Loperamide Hydrochloride should be discontinued and they should consult their doctor.

Patients should also return to their doctor if the pattern of their symptoms changes or if the repeated episodes of diarrhoea continue for more than two weeks.

Special Warnings to be included on the leaflet:

Only take this medicine to treat acute episodes of diarrhoea associated with Irritable Bowel Syndrome (IBS) if your doctor has previously diagnosed IBS. If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS: • If you are aged 40 or over and it has been some time since your last IBS attack.

• If you are aged 40 or over and your IBS symptoms are different this time. • If you have recently passed blood from the bowel. • If you suffer from severe constipation. • If you are feeling sick or vomiting. • If you have lost your appetite of lose weight.

• If you have difficulty or pain passing urine. • If you have a fever. • If you have recently travelled abroad. Consult your doctor if you develop new symptoms, or if symptoms worsen, or if your symptoms have not improved over two weeks.

Keep all medicines out of the sight and reach of children. Ponceau 4R (E124) can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin. Cardiac events including QT interval and QRS complex prolongation and torsades de pointes have been reported in association with overdose.

9). Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment. Caution is needed in patients with a history of drug abuse. 9). Loperamide is an opioid with low bioavailability and limited potential to penetrate the blood brain barrier at therapeutic doses.

However, addiction is observed with opioids as a class.

This medicine is contraindicated: • In patients with known hypersensitivity to Loperamide hydrochloride or to any of the excipients. • In children less than 12 years of age. • In patients with acute dysentery, which is characterised by blood in the stools and high fever.

• In patients with acute ulcerative colitis. • In patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter. • In patients with pseudomembranous colitis associated with the use of broad- spectrum antibiotics.

Loperamide Hydrochloride must not be used when inhibition of peristalsis is to be avoided due to possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide Hydrochloride must be discontinued promptly when ileus, constipation or abdominal distension develop.