Loperamide 2 mg - treatment of acute and chronic diarrhoea 15 capsules

Product Description

Loperamide Hexal 2 mg is an antidiarrheal and antipropulsive drug, useful for reducing diarrhea by decreasing intestinal motility.

Indications

Loperamide Hexal is indicated in cases of:

• acute (or occasional) diarrhea;
• chronic (or persistent) diarrhea;
• ileostomy (intestinal surgery) because It helps reduce the number and volume of bowel movements and increase stool consistency.

Composition

Each Loperamide Hexal 2 mg capsule contains:

Active ingredient

Loperamide hydrochloride 2 mg equivalent to loperamide 1.8 mM.

Excipients

Lactose, corn starch, magnesium stearate, talc. Capsule shell: gelatin, black iron oxide (E172), yellow iron oxide (E172), patent blue (E131), titanium dioxide (E171).

Dosage and Directions for Use

Loperamide Hexal 2 mg capsules should be taken with a little water. During treatment with this medicine, the dose should be reduced as soon as improvement is felt (normalization of stools).

Do not take this medicine for more than 2 days.

Use in adults

Treatment of occasional diarrhea: The recommended initial dose is 2 capsules. Thereafter, the maintenance dose will be 1 capsule to be taken after each bout of diarrhea. Do not exceed the maximum recommended dose of 8 capsules per day.

Treatment of persistent (chronic) diarrhea: The recommended initial dose is 2 capsules. Your doctor will adjust the dose based on your health condition; generally, the maintenance dose is between 1 and 6 capsules per day. Do not exceed the maximum recommended dose of 8 capsules.

Use in children and adolescents (6 to 17 years of age)

Treatment of occasional diarrhea and persistent (chronic) diarrhea: The recommended starting dose is 1 capsule. In the treatment of persistent diarrhea, the doctor will adjust the dose based on the child's health condition. Generally, the maintenance dose is between 1 and 6 capsules per day. The maximum dose is calculated based on body weight. For every 20 kg of body weight, 3 capsules should be administered; it is recommended not to exceed 8 tablets per day.

Reduce the dose as soon as stool normalizes; Discontinue treatment in case of constipation.

Contraindications

Known individual hypersensitivity to the active substance or the components.

Loperamide Hexal 2 mg must not be used:

• when any inhibition of intestinal peristalsis must be avoided;
• in case of allergy to the active substance or to any of the other components of this medicine;
• in case of an intestinal disease, acute dysentery, characterised by the presence of blood in the stool and high fever;
• in case of inflammation of the intestine characterised by the presence of lesions (acute ulcerative colitis);
• in case of intestinal infection (bacterial enterocolitis caused by invasive organisms, such as Salmonella, Shigella and Campylobacter);
• in case of severe diarrhoea (pseudomembranous colitis) caused by the use of medicines used for the treatment of infections caused by bacteria (antibiotics);
• if the use of this medicine may cause the risk of complications, which can cause blockage of the intestine (ileus, megacolon and toxic megacolon).

If constipation, ileus or abdominal swelling (abdominal distension) occurs during treatment, stop treatment with this medicine immediately and contact your doctor.

Warnings and precautions

The use of this medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure the cause. Therefore, when the cause of diarrhea can be established, it is necessary to treat it with specific therapy, indicated by your doctor.

Diarrhea causes a marked loss of fluids and mineral salts, especially in children. For this reason, it is important to drink plenty of fluids and/or mineral salt preparations.

Do not take this medicine for more than 1 month. 2 days.

Stop taking this medicine and contact your doctor if:

• you do not see an improvement in your condition within 48 hours of taking Loperamide Hexal;
• you have AIDS and abdominal swelling occurs during treatment with this medicine;
• if you experience constipation (constipation), ileus or abdominal swelling (abdominal distension) during treatment.

If you are taking Loperamide Hexal to treat diarrhoea caused by bacteria or viruses (infectious colitis), there is an increased risk of developing other disorders associated with blockage of the intestine (toxic megacolon).

Take this medicine with caution and under medical supervision if you suffer from liver problems (impaired liver function, liver dysfunction), because it may affect your liver. Toxic effects affecting the central nervous system may occur.

Pregnancy and breastfeeding

In pregnant women, especially in the first trimester, the medicine should be used only if clearly needed and under direct medical supervision. Loperamide Hexal should not be used during breastfeeding.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you are taking this medicine to treat occasional diarrhoea (acute diarrhoea), the following side effects may occur:

Common (may affect up to 1 in 100 people)

- headache;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 people)

- dizziness;
- abdominal pain, especially in the upper abdomen, abdominal discomfort;
- dry mouth;
- vomiting;
- skin irritation (rash).

Rare (may affect up to 1 in 10,000 people)

- swelling of the abdomen.

If you are taking this medicine to treat persistent diarrhoea (chronic diarrhoea), the following side effects may occur:

Common (may affect up to 1 in 100 people)

- dizziness;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 people)

- headache;
- abdominal pain, abdominal discomfort;
- dry mouth;
- digestive disorders (dyspepsia).

Storage

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton.

Format

Pack of 15 capsules.