Dissenten for diarrhea

Package leaflet: Information for the patient

DISSENTEN ANTIDIARRHOEA 2 mg tablets

loperamide
Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after two days of treatment.

Contents of this leaflet:

1. What DISSENTEN ANTIDIARRHOEA is and what it is used for
2. What you need to know before taking DISSENTEN ANTIDIARRHOEA
3. How to take DISSENTEN ANTIDIARRHOEA
4. Possible side effects
5. How to store DISSENTEN ANTIDIARRHOEA
6. Contents of the pack and other information

1. What DISSENTEN ANTIDIARREA is and what it is used for

DISSENTEN ANTIDIARREA contains the active substance loperamide, which helps stop diarrhoea by slowing down the movement of the intestines.
This medicine is indicated:

• for the treatment of occasional diarrhoea (acute diarrhoea).

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

2. What you need to know before taking DISSENTEN ANTIDIARREA

Do not take DISSENTEN ANTIDIARREA

• if you are allergic to loperamide or to 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, characterized by blood in the stool and high fever;
• if you have an inflammation of the intestine characterized by 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 taking this medicine may expose you to the risk of complications that could cause intestinal paralysis (ileus, megacolon and toxic megacolon). If during treatment you develop constipation (stipsis), intestinal obstruction (ileus) or abdominal swelling (abdominal distension), stop treatment with this medicine immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking DISSENTEN ANTIDIARREA.
This medicine improves the symptoms of diarrhoea (symptomatic treatment), but does not cure
its underlying cause. Therefore, when the cause of diarrhoea can be identified, specific treatment
should be administered as directed by your doctor.
Do not take this medicine for more than 2 days.
Diarrhoea causes a significant loss of fluids and electrolytes, especially in children. For this
reason, it is important to drink large amounts of fluids and/or electrolyte preparations.
Stop taking this medicine and consult your doctor if:

• you do not see an improvement in your condition within 48 hours after taking DISSENTEN ANTIDIARREA;
• you have AIDS and develop 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 an increased risk of developing other disorders associated with intestinal paralysis (toxic megacolon).

Take this medicine with caution and under medical supervision if you have liver problems
(impaired hepatic function), as toxic effects affecting the central nervous system may occur
(see section "If you take more DISSENTEN ANTIDIARREA than you should").
Do not take this medicine for uses other than those intended (see section 1) and never take a
dose higher than recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in DISSENTEN ANTIDIARREA, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.

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

Other medicines and DISSENTEN ANTIDIARREA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• desmopressin, a medicine used to treat diabetes;
• quinidine, a medicine used to treat certain heart disorders;
• ritonavir, a medicine used to treat AIDS;
• itraconazole and ketoconazole, medicines used to treat fungal infections;
• gemfibrozil, a medicine used to reduce blood lipid levels;
• medicines with effects similar to those of DISSENTEN ANTIDIARREA;
• medicines that accelerate intestinal motility;
• cytochrome CYP450 inhibitor medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant or breastfeeding.
Discuss with your doctor the most appropriate treatment.

Driving and using machines
During treatment with DISSENTEN ANTIDIARREA, you may experience tiredness, dizziness or drowsiness.
Exercise particular caution before driving or operating machinery.

3. How to take DISSENTEN ANTIDIARREA

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablets with a glass of water.
During treatment with this medicine, you must reduce the dose as soon as you notice an improvement in your condition (normalization of stools). Discontinue treatment with this medicine if constipation occurs (see section Warnings and precautions).
Do not take this medicine for more than 2 days.

Use in adults
The recommended initial dose is 2 tablets (4 mg). Afterwards, take 1 tablet (2 mg) after each unformed (soft) bowel movement. Do not exceed the maximum daily dose of 8 tablets (16 mg).

Use in children and adolescents (from 6 to 17 years of age)
The recommended initial dose is 1 tablet (2 mg). Afterwards, take 1 tablet (2 mg) after each unformed (soft) bowel movement. The maximum daily dose is based on body weight (3 tablets/20 kg body weight), but must not exceed 8 tablets per day.

Use in children under 6 years of age
This medicine must not be administered to children under 6 years of age.

Use in patients with liver problems
Take this medicine with caution if you have liver problems (see section Warnings and precautions).

If you take more DISSENTEN ANTIDIARREA than you should
If you have taken too much DISSENTEN ANTIDIARREA, contact your doctor or hospital immediately for advice. Symptoms may include:

• increased heart rate, irregular heartbeat, changes in heart rhythm (these symptoms may have potentially serious and life-threatening consequences);
• muscle stiffness (hypertonia);
• uncoordinated movements;
• drowsiness;
• difficulty urinating (urinary retention);
• weak breathing (respiratory depression);
• depression of the central nervous system;
• disorientation or detachment from reality (stupor);
• reduction in pupil size, the black part of the eye (miosis);
• symptoms suggestive of intestinal blockage (ileus).

Compared to adults, children's reactions to high doses of DISSENTEN are stronger. If a child takes an excessive amount or shows any of the above symptoms, contact your doctor immediately.
In such cases, the patient should be closely observed for 48 hours.
Management of overdose may include gastric lavage, induction of vomiting, or administration of medicines that promote intestinal emptying (laxatives). In addition, if symptoms of overdose occur, naloxone, an antidote medicine, may be administered. In such cases, the patient must be monitored for at least 48 hours.

If you forget to take DISSENTEN ANTIDIARREA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking DISSENTEN ANTIDIARREA and contact your doctor immediately if you notice:

• severe allergic reactions which may present 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, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreas inflammation (acute pancreatitis) (frequency not known, frequency cannot be estimated from the available data).

The following side effects may occur with this medicine, listed according to frequency:
Common (may affect up to 1 in 100 people)

• headache (cephalalgia), 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;
• digestive disturbances (dyspepsia);
• skin irritation (rash).

Rare (may affect up to 1 in 10,000 people)

• abdominal distension.

In addition, the following side effects have been reported (post-marketing reports), for which the frequency cannot be estimated from the available data:

• allergic-type reactions (hypersensitivity), even severe (anaphylactic reaction, including shock and anaphylactoid reaction);
• drowsiness, loss of consciousness, mental disturbances, even with detachment from reality (stupor), decreased level of consciousness, muscle disorders (hypertonia), and loss of muscle coordination making certain movements difficult;
• reduction in pupil size, the black part of the eye (miosis);
• disorders indicating intestinal blockage (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders which may present with blister formation (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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DISSENTEN ANTIDIARREA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DISSENTEN ANTIDIARREA contains

• The active substance is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
• The other components are magnesium stearate and microcrystalline cellulose.

Description of the appearance of DISSENTEN ANTIDIARREA and pack contents
Pack containing 10 tablets of 2 mg.
Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILAN.
Manufacturers
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. – Via Grignano, 43 – 24041 Brembate (BG).
DOPPEL Farmaceutici S.r.l. - Facility at Via Volturno, 48 - 20089 Quinto De' Stampi - Rozzano (MI).