LOPERAMIDE HEXAL*15CAPS 2MG

Loperamide Hexal 2 mg hard capsules
Generic medicine

What it is and what it is used for
Loperamide Hexal contains the active ingredient loperamide, which belongs to the class of medicines called antidiarrheals and anti-propulsives, which help to reduce diarrhea by decreasing intestinal motility.

This medicine is indicated:
- for the treatment of both occasional and persistent diarrhea (acute and chronic diarrhea);
- to reduce diarrhea and increase stool consistency after bowel surgery (ileostomy).

What you need to know before taking the medicine
Do not take Loperamide Hexal
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in paragraph 6);
- if you are pregnant or breastfeeding;
- if you suffer from an intestinal disease, acute dysentery, characterized by the presence of blood in the stools and high fever;
- if you have an inflammation of the intestine characterized by the presence of lesions (acute ulcerative colitis);
- if you have an intestinal infection (bacterial enterocolitis caused by invasive organisms, such as Salmonella, Shigella, and Campilobacter);
- if you have a severe form of diarrhea (pseudomembranous colitis) caused by the use of medicines used for the treatment of bacterial infections (antibiotics);
- if the use of this medicine may expose you to the risk of complications, which can cause blockage of intestinal activity (ileus, megacolon and toxic megacolon). If you experience constipation, ileus, or abdominal swelling (abdominal distension) during treatment, stop treatment with this medicine immediately and contact your doctor;
- if you are using medicines that reduce intestinal movements.

Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide Hexal.
Pay particular attention:
- if you have diarrhea, your body loses fluids and mineral salts: to restore normal levels, it may be useful to take aqueous solutions based on sugar and salts;
- treatment with Loperamide Hexal is only symptomatic and does not eliminate the cause of your disorder;
- if you have reduced liver function, talk to your doctor or pharmacist before taking Loperamide Hexal.

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

Do not take this medicine for more than 2 days.

Stop treatment with this medicine immediately and contact your doctor if:
- you do not observe an improvement in your condition within 48 hours of taking Loperamide Hexal;
- you have AIDS and experience abdominal swelling during treatment with this medicine;
- if you experience constipation, ileus, or abdominal swelling (abdominal distension) during treatment

If you are taking Loperamide Hexal to treat diarrhea caused by bacteria or viruses (infectious colitis), you have a higher risk of developing other disorders associated with blockage of intestinal activity (toxic megacolon).

Do not take this medicine for uses other than those intended (see paragraph 1) and never exceed the recommended dose (see paragraph 3). In patients who have taken an excessive dose of loperamide, the active ingredient of Loperamide Hexal, serious cardiac problems have been reported (with symptoms including a rapid or irregular heartbeat).

Take this medicine with caution and under medical supervision if you have liver problems (impaired liver function, liver dysfunction), as toxic effects affecting the central nervous system may occur.

Contact your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder recurs repeatedly.

Children aged 6 to 12 years
Loperamide Hexal should be used under medical supervision.

Possible 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 diarrhea (acute diarrhea), the following side effects may occur:
Common (may affect up to 1 in 100 patients)
- headache;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 patients)
- 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 patients)
- abdominal swelling.

If you are taking this medicine to treat persistent diarrhea (chronic diarrhea), the following side effects may occur:
Common (may affect up to 1 in 100 patients)
- dizziness;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 patients)
- headache;
- abdominal pain, abdominal discomfort;
- dry mouth;
- indigestion (dyspepsia).

In addition, the following side effects have been reported (post-marketing surveillance)
Seek immediate medical attention:
Not known (frequency cannot be estimated from the available data)
- allergic reactions (hypersensitivity), even severe (anaphylactic reaction, including shock and anaphylactoid reaction);
- drowsiness, loss of consciousness, mental disorders, also associated with detachment from reality (stupor), depression of consciousness level, muscle disorders (hypertonia) and loss of muscle coordination making it difficult to perform certain movements;
- reduction in pupil size, the black part of the eye (miosis);
- intestinal disorders, also associated with reduced intestinal function (ileus, paralytic ileus, megacolon, toxic megacolon);
- pain and burning sensation in the mouth (glossodynia);
- severe skin disorders that may manifest as blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), skin irritation (urticaria), itching;
- swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema);
- reduced need to urinate (urinary retention);
- fatigue;
- upper abdominal pain, abdominal pain radiating to the back, tenderness to the touch of the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you experience any of these symptoms, stop using the medicine and contact your doctor immediately.

Additional side effects in children and adolescents
The same side effects reported for adults may occur in children and adolescents.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.