1. Name Of The Medicinal Product
Diareze Diarrhoea Relief Loperamide Hydrochloride 2mg Capsules
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsules, hard
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for up to 5 days in adults and children over 9 years. For the symptomatic treatment of chronic diarrhoea in adults. (POM)
For the symptomatic treatment of acute diarrhoea in adults and children over 12 years. (P and GSL)
For the symptomatic treatment of acute diarrhoea associated with irritable bowel syndrome in adults, previously medically diagnosed. (P only)
4.2 Posology And Method Of Administration
For oral administration.
a) Acute diarrhoea
i. P and POM
Adults, including the elderly and children over 12 years
Two capsules initially followed by 1 capsule after each loose motion, up to a maximum of eight capsules in 24 hours. The usual dose is 3 to 4 capsules daily.
ii. POM
1. Children 9-12 years
One capsule four times daily until diarrhoea is controlled (up to 5 days).
2. Children under 9 years
Not recommended.
iii. GSL
Adults, including the elderly and children over 12 years:
Two capsules initially followed by 1 capsule after every loose motion, up to a maximum of six capsules in 24 hours.
b) Chronic diarrhoea in adults and the elderly (POM)
Initially two to four capsules to be taken daily in divided doses depending on severity. The dose can subsequently be adjusted as necessary up to a maximum of 8 capsules daily.
c) Symptomatic treatment of diarrhoea associated with irritable bowel syndrome in adults and the elderly (P)
Two capsules to be taken initially. The usual dose is between two and four capsules daily in divided doses, depending on severity. If necessary, the dose may be increased up to a maximum daily dosage of 8 capsules.
4.3 Contraindications
This medicine should not be used in patients hypersensitive to any of the ingredients or in children under 9 years of age. Loperamide should not be used when inhibition of peristalsis is to be avoided, in particular where ileus or constipation occur and should be avoided in patients with abdominal distension. Toxic megacolon has occurred in patients with inflammatory bowel disease or pseudomembranous colitis given antidiarrhoeal therapy. Loperamide should not be used alone in patients with dysentery.
Loperamide should not be used when inflammatory bowel disease is present (GSL).
4.4 Special Warnings And Precautions For Use
P and GSL
This medicine should be given with caution to patients with impaired liver function. Loperamide is for the symptomatic relief of acute diarrhoea and is not a suitable substitute for rehydration therapy. This product should not be used for prolonged periods.
Keep all medicines out of the reach of children.
If symptoms persist for more than 24 hours consult your doctor.
Ponceau 4R (E124) can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
Also for P use only
If you are an adult taking this medicine to control episodes of diarrhoea associated with irritable bowel syndrome, diagnosed by your doctor, you should seek medical advice if your symptoms continue for more than two weeks or if you need to take this product for more than two weeks.
Diarrhoea is a common presentation of a number of serious gastrointestinal conditions and this medicine should not be used for prolonged periods until the underlying cause for persistent diarrhoea has been investigated.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant drug interactions known.
4.6 Pregnancy And Lactation
The safety of loperamide during pregnancy has not been established and therefore the product should be avoided during this period.
Whilst the fraction of loperamide secreted into breast milk is extremely low, caution is advised if the drug is to be given during lactation.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
Abdominal pain, nausea, vomiting, constipation, dry mouth, dizziness, fatigue and hypersensitivity reactions, such as skin rashes including urticaria. Occasionally associated with the development of paralytic ileus and bloating.
4.9 Overdose
Symptoms of overdosage include constipation, paralytic ileus and CNS depression. Initial treatment consists of gastric lavage followed by the administration of activated charcoal and naloxone if necessary. Since the duration of action of loperamide is longer than that of naloxone the patient should be kept under constant observation for at least 48 hours in order to detect any possible CNS depression.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Loperamide hydrochloride is a synthetic opioid which inhibits gut motility by binding to opiate receptors in the gut wall and may also reduce gastrointestinal secretions, resulting in improvement in diarrhoea symptoms. Loperamide also increases the tone of the anal sphincter.
In a double blind randomised trial in 213 patients with acute diarrhoea, loperamide (56 patients) was compared with two other common antidiarrhoeal agents and placebo. Onset of antidiarrhoeal effect occurred as soon as one hour after intake of a 4mg dose of loperamide.
5.2 Pharmacokinetic Properties
More than 65% of a dose of loperamide is reported to be absorbed from the gastrointestinal tract. The drug undergoes considerable first pass metabolism in the liver and excretion via the bile in the faeces as the inactive conjugate. As a result of the drug's high affinity for the gut wall and its high first pass metabolism very little loperamide reaches the systemic circulation and therefore there is only a small amount of urinary excretion. The elimination half life is reported to be about 10 hours.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose monohydrate
Magnesium stearate
Maize starch (pregelatinised)
Hard gelatin capsule (gelatin, Ponceau 4R-E124, Indigo Carmine-E132, Titanium dioxide-E171, Yellow and black iron oxides E172)
Ink (Black iron oxide E172, Shellac, Propylene glycol)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 30°C. Store in the original package.
6.5 Nature And Contents Of Container
1. Blister of clear 250 micron PVC and 20 micron aluminium foil.
Pack size: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 48.
2. Blister of clear 250 micron PVC coated with 40 gsm PVdC and 20 micron aluminium foil.
Pack size: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 48.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL 00014/0611
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation:
14 August 2000
10. Date Of Revision Of The Text
April 2007
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