Dissenten

Package leaflet: Information for the patient

DISSENTEN 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 effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after two days of treatment.

Contents of this leaflet:

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

1. What DISSENTEN is and what it is used for

DISSENTEN contains the active substance loperamide, which helps stop diarrhoea by slowing down intestinal 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.

2. What you need to know before taking DISSENTEN

Do not take DISSENTEN

• 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 diarrhea (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 a blockage of intestinal activity (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.
This medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure its cause. Therefore, when it is possible to determine the cause of diarrhea, it must be treated with a specific therapy which your doctor will indicate.
Do not take this medicine for more than 2 days.
Diarrhea 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 oral rehydration solutions containing electrolytes.
Stop treatment with this medicine and consult your doctor if:

• you do not see an improvement in your condition within 48 hours after taking DISSENTEN;
• you have AIDS and during treatment with this medicine you experience abdominal swelling; if you are taking DISSENTEN to treat diarrhea 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 this may lead to toxic effects affecting the central nervous system (see section "If you take more DISSENTEN 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, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.
Other medicines and DISSENTEN
Tell 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;
• medicines that increase intestinal motility;
• cytochrome CYP450 inhibitor medicines.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, especially during the first trimester, consult your doctor before taking this medicine, as they will need to evaluate whether treatment is necessary.
Do not take this medicine if you are breastfeeding.
Driving and using machines
During treatment with DISSENTEN, you may experience fatigue, dizziness or drowsiness.
Exercise particular caution before driving or operating machinery.

3. How to take DISSENTEN

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are uncertain, 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 per 20 kg of 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 suffer from liver problems (see section Warnings and precautions).

If you take more DISSENTEN than you should
If you have taken too much DISSENTEN, 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;
• disconnection from reality (stupor);
• reduced 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 a doctor immediately.
In such cases, the patient should be closely monitored for 48 hours.
Treatment of overdose may include gastric lavage, induction of vomiting, or administration of medicines that promote bowel 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
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 will get them.
Stop taking DISSENTEN 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 inflammation of the pancreas (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, 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 swelling.

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), including severe reactions (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 it difficult to perform certain movements;
• reduced pupil size, the black part of the eye (miosis);
• symptoms 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

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 no longer required. This will help protect the environment.

6. Package contents and other information

What DISSENTEN 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 and contents of the pack
Pack of 15 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. - Manufacturing site at Via Volturno, 48 - 20089 Quinto De' Stampi - Rozzano (MI).

Patient information leaflet: information for the patient

DISSENTEN 2 mg tablets

loperamide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DISSENTEN is and what it is used for

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

• for the treatment of both occasional diarrhoea and recurrent diarrhoea (acute diarrhoea and acute exacerbations of chronic diarrhoea).

2. What you need to know before taking DISSENTEN

Do not take DISSENTEN

• 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 diarrhea (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 can cause intestinal paralysis (ileus, megacolon and toxic megacolon). If during treatment you experience constipation (stasis), 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.
This medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure its
cause. Therefore, when the cause of diarrhea can be identified, it must be treated with a specific
therapy as advised by your doctor.
Do not take this medicine for more than 2 days.
Diarrhea 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 solutions.
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 develop abdominal swelling; if you are taking DISSENTEN to treat diarrhea 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 than you should").
Do not take this medicine for uses other than those indicated (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, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.

Other medicines and DISSENTEN
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;
• medicines that accelerate intestinal motility;
• medicines that are inhibitors of cytochrome CYP450.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, especially during the first trimester, consult your doctor before taking this
medicine, as your doctor will need to evaluate whether treatment is necessary.
Do not take this medicine if you are breastfeeding.

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

3. How to take DISSENTEN

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the tablets with a little water.
During treatment with this medicine, you must reduce the dose as soon as you notice an improvement in your condition (normalization of stools).
Stop 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 calculated based on body weight (3 tablets per 20 kg of body weight), but must not exceed 8 tablets per day.

Use in children under 6 years of age
This medicine must not be given 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 than you should
If you have taken too much DISSENTEN, 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 obstruction (ileus).

Compared to adults, children's reactions to high doses of DISSENTEN are stronger. If a child has taken 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.
Treatment 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
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 everyone gets them.
Stop taking DISSENTEN 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 inflammation of the pancreas (acute pancreatitis) (frequency not known, frequency cannot be determined from 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, 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.

Additionally, the following side effects have been reported (post-marketing reports), for which the frequency cannot be determined from 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), depression of consciousness level, muscle disorders (hypertonia), and loss of muscle coordination making certain movements difficult;
• reduction in pupil size, the black part of the eye (miosis);
• symptoms indicating intestinal blockage (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders which may manifest as 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website: 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

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 no longer required. This will help protect the environment.

6. Package contents and other information

What DISSENTEN 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 and contents of the pack
Pack containing 30 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. - Via Volturno, 48 - 20089 Quinto De' Stampi - Rozzano (MI).