LOPERAMIDE EG 2 MG ORODISPERSIBLE TABLETS 12 TABLETS IN AL/AL BLISTER

Name
LOPERAMIDE EG 2 mg orodispersible tablets
Adolescents aged 12 and over and adults


What is it and what is it used for?
Loperamide EG is a medicine for the symptomatic treatment of acute diarrhoea in adolescents aged 12 years and above and in adults, unless treatment to address the cause of the diarrhoea is not available.

Loperamide should not be used for more than 2 days unless advised by a doctor or with careful monitoring.


What you need to know before taking the medicine
DO NOT take Loperamide EG if:
• are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• your child is under 12 years of age (see also the "Children" section below);
• suffers from pathologies in which slowing of intestinal passage must be avoided, such as abdominal distension, constipation and intestinal obstruction.
Loperamide EG should be discontinued immediately in case of constipation, abdominal distension or intestinal obstruction (ileus);
• suffers from diarrhea associated with the presence of blood in the stool and/or fever;
• suffers from a form of diarrhea that occurs during or following the use of antibiotics;
• suffers from chronic diarrheal diseases (these diseases can be treated with loperamide hydrochloride only on medical advice);
• suffer from an acute form of ulcerative colitis (a type of inflammatory bowel disease).

Loperamide EG should only be taken on medical advice in the presence of liver disease or in case of persistent liver disease, as the metabolism of loperamide may be delayed resulting in an increased risk of side effects in patients with severe liver disease.


Warnings and precautions
Do not take this medicine for any other indication than those given (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (symptoms include a rapid or irregular heartbeat), loss of consciousness, and even death have been reported in patients who have taken too much loperamide, the active substance in Loperamide EG.

Talk to your doctor or pharmacist before taking Loperamide EG
• if you have AIDS and are taking Loperamide EG to treat acute diarrhoea. At the first signs of a distended (swollen) abdomen, stop treatment with Loperamide EG and contact your doctor. There have been isolated reports of constipation with an increased risk of severe inflammatory enlargement of the large intestine (toxic megacolon) in AIDS patients. These patients suffered from inflammation of the colon (colitis) caused by bacteria or viruses and were being treated with loperamide hydrochloride;
• if you suffer from liver disease.

Make sure you replenish your fluids and salts (electrolytes). This is the most important measure to take when treating diarrhea, which causes increased fluid and mineral loss, especially in children. Loperamide EG can be used in conjunction with oral rehydration products.

Loperamide EG stops diarrhea, but does not treat the cause. Therefore, when the cause of diarrhea can be identified, it should be treated with specific therapy. You should not use Loperamide EG as primary treatment in cases where the cause of diarrhea can be identified and treated. For this reason, consult your doctor.

Abuse and misuse of loperamide hydrochloride, the active ingredient in Loperamide EG, have been reported.
Take Loperamide EG only for the treatment of the indications described in section 1.
Do not take Loperamide EG for more than 2 days. Using Loperamide EG at higher doses or for longer than recommended may cause severe constipation.

If diarrhoea persists after two days of treatment with Loperamide EG, stop treatment with Loperamide EG and contact your doctor.

Children Loperamide-containing medicines should not be given to children under 2 years of age .

Loperamide-containing medicines can only be administered to children aged 2 to 12 years with a doctor's prescription . The high loperamide content in Loperamide EG makes this medicine unsuitable for use in this age group. Other formulations are available for this age group and can be obtained with a doctor's prescription.


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

The most commonly reported side effects in clinical studies were constipation, flatulence, headache, nausea, and dizziness.

If you experience any of the following (rare) side effects, observed in relation to treatment with loperamide hydrochloride, stop using Loperamide EG and seek immediate medical attention:
• hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions such as unexplained wheezing, shortness of breath which may be accompanied by a rash or hives, fainting or swelling of the face, tongue or throat;
• body stiffness, abnormal increase in muscle tension, coordination problems;
• skin rashes which may be severe and include blistering and peeling of the skin (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), swelling of the skin or mucous membranes due to fluid retention (angioedema);
• distended (swollen) abdomen;
• intestinal obstruction (ileus, including paralytic ileus), dilation of the colon (megacolon, including toxic megacolon). Signs include bloating, vomiting, severe constipation, loss of appetite, and cramps;
• loss of consciousness, reduced level of consciousness;
• difficulty urinating (urinary retention).

Not known (frequency cannot be estimated from the available data)
• 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).

Other side effects are:

Common (may affect up to 1 in 10 people)
• constipation, nausea, flatulence;
• dizziness, headache.

Uncommon (may affect up to 1 in 100 people)
• drowsiness;
• abdominal pain and discomfort, dry mouth;
• upper abdominal pain, vomiting;
• indigestion;
• skin rash.

Rare (may affect up to 1 in 1,000 people)
• constriction of the pupils in the eye (miosis);
• burning sensation on the tongue;
• hives, itching sensation;
• tiredness.

Soon after taking loperamide hydrochloride in the form of orodispersible tablets, some patients have reported a temporary burning or tingling sensation of the tongue.

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.