SANDOZ
LOPERAMIDE HEXAL "2 MG HARD CAPSULES"15 CAPSULES"
LOPERAMIDE HEXAL "2 MG HARD CAPSULES"15 CAPSULES"
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Description
Description
Loperamide Hexal 2 mg hard capsules
Equivalent medicine
What is it and what is it for?
Loperamide Hexal contains the active substance loperamide, which belongs to a class of medicines called antidiarrheals and antipropulsives, which help 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 to increase stool consistency after intestinal surgery (ileostomy).
What you need to know before taking the medicine
Do not take Loperamide Hexal
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant or breastfeeding;
- if you suffer from an intestinal disease, acute dysentery, characterised by the presence of blood in the stool and high fever;
- if you have inflammation of the intestine characterised by the presence of lesions (acute ulcerative colitis);
- if you have an infection of the intestine (bacterial enterocolitis caused by invasive organisms, such as Salmonella, Shigella and Campylobacter);
- if you have a severe form of diarrhoea (pseudomembranous colitis) caused by the use of medicines used to treat infections caused by bacteria (antibiotics);
- if using this medicine may put you at risk of complications that can cause intestinal obstruction (ileus, megacolon, and toxic megacolon). If you experience constipation, ileus, or abdominal bloating during treatment, stop taking this medicine immediately and contact your doctor;
- if you are using medicines that reduce bowel movements.
Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide Hexal.
Pay particular attention:v - 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 serve to eliminate the cause of your disorder;
- if you have reduced liver function, talk to your doctor or pharmacist before taking Loperamide Hexal.
This medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure the cause. Therefore, when the cause of diarrhea can be determined, it is necessary to treat it with a specific therapy prescribed by your doctor.
Do not take this medicine for more than 2 days.
Stop taking this medicine immediately and contact your doctor if:
- you do not notice an improvement in your condition within 48 hours of taking Loperamide Hexal;
- has AIDS and experiences abdominal swelling 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) you have an increased risk of developing other conditions associated with blockage of the intestine (toxic megacolon).
Do not use this medicine for any purpose other than that intended (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (with symptoms including a rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in Loperamide Hexal.
Take this medicine with caution and under medical supervision if you have liver problems (impaired liver function, liver dysfunction), because 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 problem occurs repeatedly.
Children aged 6 to 12
Loperamide Hexal must 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 diarrhoea (acute diarrhoea), 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;
- vomit;
- skin irritation (rash).
Rare (may affect up to 1 in 10,000 people)
- abdominal swelling.
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 (cephalalgia);
- abdominal pain, abdominal discomfort;
- dry mouth;
- digestive disorders (dyspepsia).
In addition, the following adverse reactions have been reported (post-marketing reporting)
Seek medical attention immediately:
Not known (frequency cannot be estimated from the available data)
- allergic (hypersensitivity) reactions, including severe ones (anaphylactic reaction, including shock and anaphylactoid reaction);
- drowsiness, loss of consciousness, mental disturbances, including those associated with detachment from reality (stupor), depressed level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination which makes it difficult to perform certain movements;
- reduction in the size of the pupil, the black part of the eye (miosis);
- intestinal disorders, including those associated with reduced intestinal function (ileus, paralytic ileus, megacolon, toxic megacolon);
- pain and burning sensation in the mouth (glossodynia);
- serious skin disorders which may manifest themselves with the formation of blisters (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 that spreads to the back, tenderness 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 experience 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.
SANDOZ
LOPERAMIDE HEXAL "2 MG HARD CAPSULES"15 CAPSULES"
LOPERAMIDE HEXAL "2 MG HARD CAPSULES"15 CAPSULES"
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