DISSENTEN "2 MG TABLETS" 15 TABLETS"

Name
DISSENTEN 2 mg tablets
Loperamide


What is it and what is it for?
DISSENTEN contains the active ingredient loperamide which helps stop diarrhoea by slowing down bowel movements.

This medicine is indicated:
- for the treatment of both occasional and recurrent diarrhea (acute diarrhea and exacerbations of chronic diarrhea).

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


What you need to know before taking the medicine
Do not take DISSENTEN
- if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6);
- if the patient is a child under 6 years of age;
- 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 antibiotics, medicines used to treat bacterial infections;
- 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, intestinal obstruction (ileus), or abdominal swelling (abdominal distension) during treatment, stop taking this medicine immediately and contact your doctor.


Warnings and precautions
Talk to your doctor or pharmacist before taking DISSENTEN.

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.

Diarrhea causes significant fluid and mineral loss, especially in children. For this reason, it's important to drink plenty of fluids and/or take mineral supplements.

Stop taking this medicine and contact your doctor if:
- you do not notice an improvement in your condition within 48 hours of taking DISSENTEN;
- you have AIDS and experience abdominal swelling during treatment with this medicine; if you are taking DISSENTEN to treat diarrhoea caused by bacteria or viruses (infectious colitis), you are at increased risk of developing other disorders associated with blocked intestinal activity (toxic megacolon).

Take this medicine with caution and under medical supervision if you have liver problems (impaired liver function), because toxic effects affecting the central nervous system may occur (See the section If you take more DISSENTEN than you should).

Do not take 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 DISSENTEN.


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

Stop taking DISSENTEN and consult your doctor immediately if you notice:
- severe allergic reactions that may manifest themselves with swelling and difficulty breathing;
- abdominal swelling associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
- severe skin reactions that may include blistering and peeling of the skin;
- upper abdominal pain, abdominal pain spreading to the back, tenderness of the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis) (frequency not known, frequency cannot be estimated from the available data).

When taking this medicine, the following side effects may occur, listed in order of frequency:

Common (may affect up to 1 in 100 people)
- headache (cephalgia), dizziness;
- constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 people)
- abdominal pain, especially in the upper abdomen, abdominal discomfort;
- dry mouth;
- vomit;
- digestive disorders (dyspepsia);
- skin irritation (rash).

Rare (may affect up to 1 in 10,000 people)
- abdominal swelling.

In addition, the following adverse reactions have been reported (post-marketing reports), the frequency of which cannot be established on the basis of 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);
- disorders indicative of intestinal blockage (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;
- reduced need to urinate (urinary retention);
- fatigue.

Additional side effects in children and adolescents
In children and adolescents (from 12 years of age), the same side effects reported for adults may occur.

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.