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IMODIUM LIQUICAPS BOX OF 12 SOFTGELS


€3.89

Description: IMODIUMLIQUICAPS® is the first softgel capsule that releases a liquid solution to treat your diarrhea.


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1. NAME OF THE MEDICINAL PRODUCT

IMODIUMLIQUICAPS 2 mg, soft capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Loperamide hydrochloride .................................................................................................................. 2 mg

For one softgel.

For a complete list of excipients see

3. PHARMACEUTICAL FORM

Softgel capsule.

Light blue, oval softgel capsule.

4. CLINICAL DATA

4.1 Therapeutic indications

Short-term treatment of acute transient diarrhoea in adults and children over 15 years.

This treatment is a complement to dietary measures.

4.2. Dosage and method of administration

Oral use.

For adults and children over 15 years of age only.

Initial dosage: 2 capsules, then 1 additional capsule, to be taken after each unmoulded stool,

But: never exceed 6 capsules per day, never exceed 2 days of treatment.

4.3. Contraindications

This medicine should not be used in the following cases:

  • Children under 15 years of age.
  • Known hypersensitivity (allergy) to any of the components of this medicine.
  • Blood in the stool or high fever.
  • Acute attacks of ulcerative colitis (risk of colectasis).
  • Diarrhoea occurring during broad-spectrum antibiotic treatment due to the risk of pseudomembranous colitis.
  • Bacterial enterocolitis due to invasive bacteria such as Salmonella, Shigella and Campylobacter.

In general, this drug should not be used when inhibition of peristalsis should be avoided because of the possible risk of significant sequelae including ileus, megacolon and colectasis syndrome. If constipation, subileus and/or abdominal distension occur, the drug should be discontinued promptly.

4.4. Special warnings and precautions for use

Special warnings:

The patient should be informed of the need to:

  • Rehydrate with plenty of salty or sweet drinks to compensate for fluid losses due to diarrhoea (the average daily water intake for adults is 2 litres),
  • Eat during the diarrhea,

oExclude certain foods, especially raw vegetables, fruits, green vegetables, spicy dishes and iced foods or drinks,

oFavouring grilled meats and rice.

If after 2 days of treatment diarrhoea persists, the course of action should be reassessed and the need for rehydration by oral rehydration solution or intravenously should be considered.

Special precautions for use:

Patients with impaired hepatic function should be carefully monitored because of the significantfirst-pass hepatic effect.

In patients with severe hepatic disorders, this drug should be used only on medical prescription.

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable.

4.6. Pregnancy and lactation

Pregnancy

Animal studies have not shown any evidence of a teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species.

Clinically, the use of loperamide in a limited number of pregnancies has apparently revealed no specific malformative or fetotoxic effects to date.

However, further studies are needed to assess the consequences of exposure during pregnancy.

Therefore, the use of loperamide should be considered during pregnancy only if necessary.

In case of prolonged treatment, take into account its opioid properties which may affect the digestive functions of the newborn.

Breastfeeding

The passage of loperamide into breast milk is very low; consequently, breast-feeding is possible in the case of occasional treatment with this drug.

In case of prolonged treatment, take into account its opiate properties.

4.7. Effects on ability to drive and use machines

This medicinal product sometimes causes discrete and transient drowsiness. Attention is drawn, particularly in drivers of vehicles and users of certain machines, to the possible risks of drowsiness associated with the use of this medicinal product.

4.8. Undesirable effects

Adverse reactions are classified by organ system and order of frequency using the following convention:

Very common: >1/10

Common: >1/100, <1/10

Uncommon: >1/1000, <1/100

Rare: >1/10000, <1/1000

Very Rare: <1/10000

No frequency is indicated when it could not be estimated on the basis of available data:

Skin and subcutaneous tissue disorders:

Rash, urticaria, pruritus

Immune system disorders:

Allergic reactions and in some cases, severe hypersensitivity reactions including angioedema, anaphylactic shock and anaphylactoid reactions.

Gastrointestinal disorders:

Common: nausea, constipation, abdominal cramps.

Abdominal pain, ileus, abdominal distension, vomiting, megacolon including colectasis syndrome, flatulence, dyspepsia, dry mouth.

Kidney and urinary tract disorders:

Urinary retention.

Central nervous system disorders:

Very rare: Drowsiness, dizziness, loss of consciousness and decreased level of consciousness.

General disorders and administration site conditions:

Asthenia

4.9. Overdose

Symptoms:

In case of overdose (including overdose related to liver failure), central nervous system depression (decreased alertness, drowsiness, miosis, hypertonia, respiratory depression, motor incoordination) and ileus may be observed. Children may be more susceptible to central nervous system effects.

Emergency procedure, antidote:

Naloxone may be used as an antidote. Since the duration of action of the speciality is longer than that of Naloxone (1 to 3 hours), it may be necessary to repeat the administration of the latter. Therefore, the patient should be kept under medical supervision for at least 48 hours to detect any central nervous system depression.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: Anti-diarrhoeal, ATC code: A07DA03.

  • Anti-diarrheal structural analogue of opiates.
  • Antisecretory activity by increasing the hydro-electrolytic flow from the intestinal lumen to the plasma pole of the enterocyte and reducing the reverse flow.
  • Slowing down of colonic transit with increase of segmental contractions.
  • Rapid and lasting effects
  • Respects the bacteriological and parasitological characteristics of the stool.

5.2. Pharmacokinetic properties

Loperamide is poorly resorbed by the digestive tract. It undergoes a significant first-pass hepatic effect.

Plasma concentrations are low (2 ng/ml after approximately 8 mg of loperamide per day).

Peak plasma levels in humans are between 2 and 4 hours.

Loperamide is primarily metabolized by the liver and has an elimination half-life of 10 to 15 hours.

Elimination is primarily in the feces.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Capsule: Propylene glycol monocaprylate, propylene glycol, purified water.

Capsule shell: Gelatin, glycerol 99 %, propylene glycol, FCF brilliant blue (E133), soya lecithin, medium chain triglycerides.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store at a temperature not exceeding 30°C.

6.5. Nature and contents of the outer packaging

6, 10 or 12 softgels in blister packs (PVC/PVDC/Aluminium).

Not all presentations may be marketed.

6.6. Special precautions for disposal and handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with applicable regulations.

7. MARKETING AUTHORIZATION HOLDER

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY LES MOULINEAUX

3400921801019

Specific References