LOPERAMIDE DOC*15TAB 2MG

LOPERAMIDE DOC Generici 2 mg tablets

Equivalent medicine

What it is and what it is used for
LOPERAMIDE DOC Generici contains the active ingredient loperamide, which belongs to the class of medicines called antidiarrheals and antipropulsives, which help reduce diarrhea by decreasing intestinal motility.

This medicine is indicated for the treatment of acute episodes of both occasional and persistent diarrhea.

Consult your doctor if you do not notice improvements or if your symptoms worsen after 2 days.

What you need to know before taking the medicine
Do not take LOPERAMIDE DOC Generici
- if you are allergic to loperamide or any of the other ingredients of this medicine (listed in paragraph 6);
- if the patient is a child under 2 years of age;
- if you suffer from an intestinal disease, acute dysentery, characterized by the presence of blood in the stools and high fever;
- if you have severe intestinal inflammation characterized by the presence of lesions (acute ulcerative colitis);
- if you have an intestinal infection (bacterial enterocolitis caused by aggressive germs, such as Salmonella, Shigella, and Campylobacter);
- if you have a severe form of diarrhea (pseudomembranous colitis) caused by the use of medicines used to treat infections caused by bacteria (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 during treatment you experience constipation (stipsi), intestinal obstruction (ileus) or abdominal bloating (abdominal distension), stop treatment with this medicine immediately and consult your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking LOPERAMIDE DOC Generici.

The use of this medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure its cause.

Therefore, when the cause of diarrhea can be determined, it must be treated with specific therapy that will be indicated by your doctor.
Diarrhea causes a significant loss of fluids and mineral salts, especially in children. For this reason, it is important to consume a high amount of fluids and/or mineral salt preparations.

Stop treatment with this medicine and consult your doctor if:
- you do not observe an improvement in your condition within 48 hours of taking LOPERAMIDE DOC Generici;
- you have AIDS and during treatment with this medicine you experience abdominal bloating; if you are taking LOPERAMIDE DOC Generici to treat diarrhea caused by bacteria or viruses (infectious colitis) you have a higher risk of experiencing other disorders associated with blockage of intestinal activity (toxic megacolon).

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

Do not take this medicine for purposes 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 DOC Generici, serious heart problems have been reported (with symptoms including a rapid or irregular heartbeat).

Children
This medicine should be administered to children aged 2 to 6 years only with a medical prescription and under direct medical supervision.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 people)
- headache (cephalalgia);
- 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)
- abdominal bloating.

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 people)
- dizziness;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 people)
- headache (cephalalgia);
- abdominal pain, especially in the upper abdomen, abdominal discomfort;
- dry mouth;
- indigestion (dyspepsia).

In addition, the following side effects have been reported after its marketing (post-marketing reports)
Consult a doctor immediately:

Not known (frequency cannot be estimated from the available data)
- allergic reactions (hypersensitivity), including severe ones (anaphylactic reaction, including shock and anaphylactoid reaction);
- drowsiness, loss of consciousness, mental disorders, also associated with detachment from reality (stupor), depressed level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination making certain movements difficult;
- reduction in pupil size, the black part of the eye (miosis);
- pain and burning sensation in the mouth (glossodynia);
- severe skin disorders that can manifest with blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), skin irritation (urticaria), itching;
- facial swelling due to fluid accumulation, especially around the mouth and eyes;
- reduced need to urinate (urinary retention);
- fatigue;
- intestinal disorders, also associated with reduced intestinal function (ileus, paralytic ileus, megacolon, toxic megacolon); upper abdominal pain, abdominal pain spreading to the back, tenderness to touch of the abdomen, fever, rapid pulse, nausea, vomiting, which can be symptoms of pancreatic inflammation (acute pancreatitis).

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

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.