Cooper: Diaretyl Loperamide (2mg) Capsules – for acute diarrhoea – Pack of 12

1. Product Name Cooper: Diaretyl Loperamide (2mg) Capsules – for acute diarrhoea – Pack of 12 2. Ingredients Per capsule: Loperamide hydrochloride – 2.00 mg – of which loperamide base: 1.86 mg For a full list of excipients, see section 6.1. 3. Dosage Form Capsule 4. Product Information 4.1. Therapeutic IndicationsShort-term treatment of acute (short-term) diarrhoea in adults and adolescents over 15 years. A supplement to dietary modification. 4.2. Dosage and Instructions for UseTo be taken orally. Suitable for ages 15 years and over. Initial Dose: 2 capsules, plus 1 additional capsule after each loose stool. – Do not take more than 6 capsules in any 24-hour period. – Do not use for more than 2 days. 4.3. Contra-indicationsDo NOT use if you have acute haemorrhagic rectocolitis (due to the risk of intestinal dilation) or are allergic to any of this medicine's ingredients. 4.4. Warnings and Precautions for UseWarnings – Not suitable for children under 15 years. – If your diarrhoea does not lessen after 2 days, your treatment must be re-evaluated. Use of an orally- or intravenously-administered rehydration solution should be considered. Precautions for Use – Loperamide should not be used as first-line therapy for acute dysentery accompanied by blood in stools and high fever, nor to treat diarrhoea if the patient is taking broad-spectrum antibiotics. In the case of the latter, there is a risk of pseudomembranous colitis and poisoning. As such, avoid all medicines designed to slow diarrhoea. – Loperamide should not be used when peristalsis must be maintained. If constipation develops or abdominal distension occurs, treatment must be discontinued immediately. – Due to this medicine's significant first-pass extraction in the liver, use by people with liver problems must be monitored. 4.5. Pregnancy and Breast-FeedingIf you are pregnant: – Studies conducted on animals have demonstrated no teratogenic effects due to consumption of this medicine. Therefore, this medicine is not believed to have a malformative effect on the human foetus. – Clinical studies conducted on a limited number of pregnancies have demonstrated no particular malformative or foetotoxic effects. However, further testing is needed to improve our understanding of the effects of loperamide consumption during pregnancy. For this reason, if you are pregnant, use this medicine only if necessary. – If using for a prolonged period, be aware of this medicine's opioid properties, which may impact on your baby's digestion in particular. If you are breast-feeding: – Very little loperamide passes into breast milk. Therefore, you can safely use this medicine on a one-off basis. – If using for a prolonged period, be aware of this medicine's opioid properties. 4.6. Driving and Operating Machinery This medicine can cause short-term drowsiness, the effects of which may not be readily apparent. Therefore, if you drive or operate machinery, use with caution. 4.7. Possible Side Effects– Constipation and/or abdominal distension, combined with ileus in exceptional cases. Misuse or excessive dose can increase the risks of these effects; therefore, use only as instructed and do not exceed the stated dose. – Abdominal pain, bloating, nausea, vomiting and dry mouth. – Weakness, drowsiness and dizziness. – In rare cases, allergic reaction (e.g. in the form of rash, hives or Quincke's oedema).– In very rare cases, anaphylactic shock. 4.8. Excessive DoseSigns of excessive dose: Central nervous system depression (CNS; exhibited by e.g. reduced alertness, drowsiness, miosis, hypertonia, hypoventilation and poor motor control) and ileus. – Children are particularly vulnerable to these effects. Treatment: – Administration of the antidote naloxone. As the effects of loperamide are longer-lasting (at 1 to 3 hours) than those of naloxone, multiple doses of antidote may be required. – The patient must be monitored for at least 48 hours in case CNS occurs. 5. Pharmacological Properties 5.1. Pharmacodynamic PropertiesAnti-diarrhoeal drug (A: Digestive System and Metabolism) – Structurally similar to opiates – Has an anti-secretory effect by increasing the water-electrolyte flow of the intestinal lumen towards the plasmatic centre of enterocytes while reducing the inverse flow. – Slows bowel transit time by increasing segmental contractions. – Fast-acting with long-lasting effect. – Does not alter the bacteriological or parasitological make-up of stools. 5.2. Pharmacokinetic Properties– Very little loperamide is absorbed via the digestive system. It undergoes significant first-pass extraction in the liver. – Blood plasma concentration is weak (2 ng/ml for 8 mg administered per day). In men, peak plasma concentration occurs after 2 to 4 hours. – Loperamide is metabolised mainly by the liver. It has an elimination half-life of 10 to 15 hours. – It is eliminated from the body in stools. 6. Pharmaceutical Information 6.1. ExcipientsModified corn starch (Starch 1500®), microcrystalline cellulose (Avicel® PH-102), talc Capsule Shell Composition: Head (dark green): Quinoline Yellow WS, indigotin Body (light green): Quinoline Yellow WS, Patent Blue V 6.2. Shelf Life3 years 6.3. Storage InstructionsStore below 30°C. 7. Marketing Authorisation Holder COOPERATION PHARMACEUTIQUE FRANCAISE PLACE LUCIEN-AUVERT 77020 MELUN CEDEX FRANCE 8. Marketing Authorisation No. – 341 154-8: 6 capsules sealed in thermoformed blister-pack (composition: PVC/aluminium) – 358 421-4: 12 capsules sealed in thermoformed blister-pack (composition: PVC/aluminium) 9. Prescription and Delivery Conditions Non-prescription medicine