LOPERAMID AL 2 mg orodispersible tablets, 12 pcs

Instructions for use for LOPERAMID AL 2 mg orodispersible tablets, 12 pcs

Instructions for use

Adolescents aged 12 and over	1 Orodispersible tablet	1-4 times daily	after each loose stool
Adults	1 Orodispersible tablet	1-6 times daily	after each loose stool

Indications

Mode of action

How does the active ingredient in this medicine work?

The active ingredient directly targets receptors in the intestinal tract. It can partially inhibit bowel movements that transport intestinal contents, thereby reducing the urge to defecate and the frequency of bowel movements. In addition, loperamide causes muscle contraction of the anal sphincter in the rectum.

Composition

Contraindications

What are the contraindications?

Always:
- Hypersensitivity to the ingredients
- Conditions with slowed bowel function
- Intestinal obstruction
- Permanent dilation of the colon (megacolon)
- Constipation, possibly also other conditions in which further slowing of bowel function should be avoided, e.g., severe flatulence
- Flatulence
- Intestinal inflammation associated with antibiotic therapy
- Inflammation of the large and small intestine caused by bacteria (bacterial enterocolitis)
- Chronic diarrhea
- Ulcerative colitis, acute attack

In certain circumstances - consult your doctor or pharmacist:
- Liver disease

Which age group What should be considered?
- Infants and young children under 2 years of age: This medicine should not be used.
- Children under 12 years of age: This medicine should generally not be used in this group. There are preparations that are more suitable in terms of active ingredient strength and/or dosage form.

What about pregnancy and breastfeeding?
- Pregnancy: Consult your doctor. Various considerations play a role in whether and how the medication can be used during pregnancy.
- Breastfeeding: According to current knowledge, there is no evidence that the medication should not be used during breastfeeding.

If you have been prescribed the medication despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may outweigh the risk associated with use with a contraindication.

Side effects

What adverse effects may occur?

- Gastrointestinal complaints, such as:
- Nausea
- Vomiting
- Flatulence
- Constipation
- Abdominal pain
- Dry mouth
- Headache
- Fatigue
- Dizziness
- Rash
- Upper abdominal pain

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information provided here, we primarily consider side effects that occur in at least one in 1,000 treated patients.

Notes

What should you be aware of?
- Aspartame/phenylalanine may be harmful to patients with phenylketonuria.
- There may be medications with which interactions occur. Therefore, you should generally inform your doctor or pharmacist of any other medications you are already taking before starting treatment with a new medication. This also applies to medications you buy yourself, use only occasionally, or have used for some time.

Detailed instructions for LOPERAMID AL 2 mg orodispersible tablets, 12 pcs

Indications

Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 tablets) is a medicinal product for the symptomatic treatment of acute diarrhea in adolescents 12 years of age and older and adults, provided no causal treatment is available.

Active ingredients / Ingredients

Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 tablets) contains:

Each orodispersible tablet contains 2 mg loperamide hydrochloride.

Excipient with known effect: Loperamide AL Contains 3 mg aspartame per orodispersible tablet.

List of other ingredients: Mannitol (Ph. Eur.) (E 421), Aspartame (E 951), Crospovidone (Type B), Citric acid (E 330), Colloidal silicon dioxide (E 551), Spearmint flavor (flavorings, modified food starch), Talc, Magnesium stearate (Ph. Eur.) [pflanzlich] (E 470b).

Contraindications

If you are known to be hypersensitive to any of the above-mentioned ingredients, the product should not be used.

Dosage

Recommended use of Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 tablets):

Adolescents 12 years and older should take:
Initial dose: 1 orodispersible tablet
Repeat dose: 1 orodispersible tablet
Maximum daily dose: 4 orodispersible tablets

Adults should take:
Initial dose: 2 orodispersible tablets
Repeat dose: 1 orodispersible tablet
Maximum daily dose: 6 orodispersible tablets

Start treatment of acute diarrhea with the initial dose.
Then, the repeat dose should be taken after each loose stool.
The recommended maximum daily dose should not be exceeded.

Children under 12 years:
Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 pcs) are not suitable for children under 12 years of age due to their high active ingredient content. Other dosage forms are available upon medical prescription.

Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 pcs) are placed on the tongue. The orodispersible tablet dissolves immediately on the tongue and can be swallowed. No further fluid intake is required.

Do not take Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 pcs) for longer than 2 days.

How to take

• Place the medicine on the tongue. The orodispersible tablet dissolves immediately on the tongue and is swallowed with saliva. No further fluid intake is required.

Patient Information

Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 tablets) contains 3 mg aspartame per orodispersible tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare congenital disorder in which phenylalanine builds up because the body cannot break it down sufficiently.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Although no clear evidence of teratogenic effects has been found in a limited number of women who took the active ingredient loperamide during pregnancy, you should not take Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 pcs) during pregnancy.

Breast-feeding
Do not take this medicine while breastfeeding, as small amounts of the active ingredient in Loperamide AL 2 mg Orodispersible Tablets (Pack size: 12 pcs) may pass into breast milk. Consult your doctor about appropriate treatment.

Notes

Manufacturer:  ALIUD Pharma GmbH, Gottlieb-Daimler-Straße 19