DISSENTEN*15CPR 2MG

DISSENTEN 2 mg tablets
Loperamide

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

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

Consult 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 stools and high fever;
- if you have inflammation of the intestine characterised 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 Campylobacter);
- if you have a severe form of diarrhoea (pseudomembranous colitis) caused by the use of antibiotics, medicines used for the treatment of bacterial infections;
- 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, intestinal obstruction (ileus) or abdominal bloating (abdominal distension), stop treatment with this medicine immediately and contact your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking DISSENTEN.

The use of this medicine improves the symptoms of diarrhoea (symptomatic treatment), but does not cure its cause. Therefore, when the cause of diarrhoea can be established, it must be treated with a specific therapy that your doctor will indicate.

Do not take this medicine for more than 2 days.

Diarrhoea causes a marked loss of fluids and mineral salts, especially in children. For this reason, it is important to take a high amount of fluids and/or preparations based on mineral salts.

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

Take this medicine with caution and under medical supervision if you have liver problems (impaired liver function), as 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 purposes other than those intended (see section 1) and never take a dose higher than that recommended (see section 3). Severe heart problems (with symptoms including rapid or irregular heartbeat) have been reported in patients who have taken an excessive dose of 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 which may manifest as swelling and breathing difficulties;
- abdominal bloating associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
- severe skin reactions which may include blistering and peeling of the skin;
- 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) (frequency not known, frequency cannot be estimated from the available data).

When taking this medicine, the following side effects may occur, listed according to frequency:

Common (may affect up to 1 in 100 people)
- headache, 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;
- vomiting;
- indigestion (dyspepsia);
- skin irritation (rash).

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

In addition, the following side effects have been reported (post-marketing reports), the frequency of which cannot be established from the available data:
- allergic (hypersensitivity) reactions, including severe ones (anaphylactic reaction, including shock and anaphylactoid reaction);
- drowsiness, loss of consciousness, mental disturbances, also 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 pupil size, the black part of the eye (miosis);
- disorders indicative of intestinal obstruction (ileus, paralytic ileus, megacolon, toxic megacolon);
- pain and burning sensation in the mouth (glossodynia);
- severe skin disorders that may 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.

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 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.