DISSENTEN ANTIDIARRHEAL*10TABLETS2MG

DISSENTEN ANTIDIARREA 2 mg tablets
Loperamide

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

This medicine is indicated for:
- the treatment of occasional diarrhoea (acute diarrhoea).

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 ANTIDIARREA
- 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 to treat bacterial infections;
- if the use of this medicine may expose you to the risk of complications, which may cause intestinal blockage (ileus, megacolon and toxic megacolon). If you experience constipation (stipsi), intestinal obstruction (ileus) or abdominal swelling (abdominal distension) during treatment, immediately stop treatment with this medicine and contact your doctor.

Warnings and precautions
Contact your doctor or pharmacist before taking DISSENTEN ANTIDIARREA.

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 consume a high amount of fluids and/or preparations based on mineral salts.

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

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

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

Children aged 6 to 12 years
DISSENTEN ANTIDIARREA should be used under medical supervision.

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

Stop taking DISSENTEN ANTIDIARREA and consult your doctor immediately if you notice:
- severe allergic reactions which may manifest as swelling and breathing difficulties;
- abdominal swelling associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
- severe skin reactions which may include blisters and skin peeling;
- 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 swelling.

In addition, the following side effects have been reported (post-marketing reports), the frequency of which cannot be established 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 it difficult to perform certain movements;
- reduction in pupil size, 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);
- severe skin disorders which may manifest with the formation of blisters (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.