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SPC, UK: LOPERAMIDE HYDROCHLORIDE Capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Loperamide Hydrochloride 2 mg Hard Capsules.

Qualitative and quantitative composition

Each capsule contains 2 mg loperamide hydrochloride. Excipient with known effect: Each capsule contains 100 mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Capsule, hard. Hard gelatin capsules size 4 with a mauve opaque body and a dark green opaque cap. Marked LOPERA-MIDE 2 on the cap.

Therapeutic indications

For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in ...

Posology and method of administration

Posology Acute Diarrhoea Adults and children aged 12 years and over The initial dose is 2 capsules (4 mg), followed by 1 capsule after every subsequent loose stool. The usual dose is 3-4 capsules (6-8 ...

Contraindications

This medicine is contraindicated: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In children under the age of 12 years old. In patients with acute dysentery, ...

Special warnings and precautions for use

Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. The priority in acute diarrhoea is ...

Interaction with other medicinal products and other forms of interaction

Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, ...

Fertility, pregnancy and lactation

Pregnancy Safety in human pregnancy has not been established. Although from animal studies there are no indications that loperamide HCL possess any teratogenic or embryotoxic properties. As with other ...

Effects on ability to drive and use machines

Loss of consciousness, depressed level of consciousness, tiredness, dizziness or drowsiness may occur when diarrhoea is treated with loperamide HCl. Therefore, it is advisable to exercise caution when ...

Undesirable effects

Adults and children aged ≥12 years The safety of loperamide HCl was evaluated in 2755 adults and children aged ≥12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide ...

Overdose

Symptoms In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, and respiratory depression), ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antipropulsives ATC code: A07DA03 By binding to opiate receptors in the gut wall, loperamide hydrochloride reduces propulsive peristalsis, increases intestinal transit time and ...

Pharmacokinetic properties

Absorption Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%. Distribution Studies on distribution ...

Preclinical safety data

Acute and chronic studies on loperamide showed no specific toxicity. Results of in vivo and in vitro studies carried out indicated that loperamide is not genotoxic. In reproduction studies, very high doses ...

List of excipients

Each capsule contains: Lactose monohydrate Maize starch Magnesium stearate The capsule cap contains: Quinoline yellow (E104) Indigo carmine (E132) Titanium dioxide (E171) Gelatin The capsule body contains: ...

Incompatibilities

None known.

Shelf life

Shelf life Blisters: 5 years. Bottles: 4 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Blister packaging in packs of 4, 6, 8, 10, 12, 16, 18, 20, 24, 28 and 30 capsules. Polypropylene pots with white polyethylene caps with optional polyethylene ullage fillers in packs of 4, 6, 8, 10, 12, ...

Special precautions for disposal and other handling

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization number(s)

PL 04569/0201

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 November 1987 Date of latest renewal: 29 March 2000

Date of revision of the text

March 2019

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