DISSENTEN 2 mg Tablet

Зміст інструкції

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

DISSENTEN 2 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 you take 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 is DISSENTEN and what is it used for

DISSENTEN contains the active ingredient loperamide which helps to stop diarrhoea by slowing down the
movements of the intestine.
This medicine is indicated:

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

See 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 you take 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, 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 may cause blockage of the activity of the intestine (ileus, megacolon and toxic megacolon). If during the

treatment you should experience constipation (constipation), intestinal obstruction (ileus) or
abdominal bloating (abdominal distension), immediately stop the
treatment with this medicine and see your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking DISSENTEN.
The use of this medicine improves the symptoms of diarrhoea (symptomatic treatment), but does not
cure the cause. Therefore, when it is possible to establish the cause of the diarrhoea, it is necessary
to treat it with specific therapy that will be indicated by your doctor.
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 see your doctor if:

• you do not see an improvement in your condition within 48 hours of taking DISSENTEN;
• you are affected by 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 the activity of the intestine (toxic megacolon).

Take this medicine with caution and under the control of your doctor if you have liver problems
(impaired liver function), because toxic effects may occur
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 do not
ever take a dose higher than that recommended (see section 3). In patients who
have taken an excessive dose of loperamide, the active ingredient of DISSENTEN, have
been reported serious heart problems (with symptoms including a rapid or irregular heartbeat).

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 tell your doctor if you are taking:

• desmopressin, a medicine used to treat diabetes;
• quinidine, a medicine used to treat some heart disorders;
• ritonavir, a medicine used to treat AIDS;
• itraconazole and ketoconazole, medicines used to treat fungal infections;
• gemfibrozil, a medicine used to reduce fat levels in the blood;
• medicines with effects similar to those of DISSENTEN;
• medicines that speed up intestinal movement;
• medicines that are cytochrome CYP 450 inhibitors.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, especially in the first trimester, see your doctor before taking
this medicine because they will need to assess the need for treatment.
Do not take this medicine if you are breastfeeding.

Driving and operating machinery
During treatment with DISSENTEN you may experience fatigue, dizziness or drowsiness.
Be particularly careful before driving vehicles or using machinery.

3. How to take DISSENTEN

Take this medicine following the instructions provided 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 little water.
During treatment with this medicine, it is necessary to reduce the dose as soon as you notice an improvement in your health 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 dose of 8 tablets
(16 mg) per day.

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/20 kg of weight), but must not exceed 8 tablets per
day.

Use in children under 6 years of age
This medicine should 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;
• detachment from reality (stupor);
• reduction in the size of the pupil, the black part of the eye (miosis);
• disorders indicative of intestinal blockage (ileus);

Compared to adults, children are more strongly affected by high doses of DISSENTEN. If a
child takes an excessive amount or exhibits some of the aforementioned symptoms, contact
your doctor immediately.
In these cases, the patient should be kept under close observation for 48 hours.
Treatment of overdose includes gastric lavage, induction of vomiting, or the administration of medicines that promote bowel emptying (laxatives). In addition,
if you experience symptoms of overdose, you may be given naloxone, a medicine
used as an antidote. In these cases, you 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 missed dose.
If you have any questions about using this medicine, ask 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 and consult your doctor immediately if you notice:

• severe allergic reactions that can manifest with swelling and difficulty breathing;
• abdominal swelling associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
• severe skin reactions that can include blisters and skin peeling.

When taking this medicine, the following side effects may occur, listed
according to their 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 part of the abdomen, abdominal discomfort;
• dry mouth;
• vomiting;
• digestive disorders (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), whose
frequency cannot be established based on available data:

• allergic (hypersensitivity) reactions, also severe (anaphylactic reaction, including shock and anaphylactoid reaction);
• drowsiness, loss of consciousness, mental disorders, also associated with detachment from reality (stupor), decreased level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination making it difficult to perform certain movements;
• reduction in the size of the pupil, the black part of the eye (miosis);
• disorders indicative of an intestinal blockage (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders that can manifest with blister formation (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), skin irritation (urticaria), itching;
• swelling of the face 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the packaging after
“Expiry”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DISSENTEN contains

• The active ingredient is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
• The other ingredients 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 Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILANO.

Manufacturers
DOPPEL Farmaceutici S.r.l. - Workshop at Via Volturno, 48 - 20089 Quinto De' Stampi - Rozzano (MI).
ALFA WASSERMANN S.p.A. - Workshop at Via Fermi, 1 - 65020 Alanno (PE).

DISSENTEN 2 mg tablets

loperamide
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is DISSENTEN and what is it used for

DISSENTEN contains the active ingredient loperamide which helps to stop diarrhoea by slowing down the
movements of the intestine.
This medicine is indicated:

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

2. What you need to know before you take 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, 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 infection of the intestine (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 may cause blockage of intestinal activity (ileus, megacolon and toxic megacolon). If you experience constipation, bowel obstruction (ileus) or abdominal bloating (abdominal distension) during treatment, stop taking this medicine immediately and consult 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 the cause. Therefore, when it is possible to establish the cause of the diarrhoea, it is necessary
to treat it with specific therapy as indicated by your doctor.
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 suffer from 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 greater risk of developing other disorders associated with blockage of intestinal activity (toxic megacolon).

Take this medicine with caution and under the supervision of your doctor if you have liver problems
(impaired liver function), because toxic effects may occur
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 do not
ever take a dose higher than that recommended (see section 3). In patients who
have taken an excessive dose of loperamide, the active ingredient of DISSENTEN, have
been reported serious heart problems (with symptoms including a rapid or irregular heartbeat).

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 for the treatment of diabetes;
• quinidine, a medicine used for the treatment of some heart disorders;
• ritonavir, a medicine used for the treatment of AIDS;
• itraconazole and ketoconazole, medicines used for the treatment of fungal infections;
• gemfibrozil, a medicine used to reduce levels of fats in the blood;
• medicines with effects similar to those of DISSENTEN;
• medicines that speed up intestinal movement;
• medicines that are cytochrome CYP 450 inhibitors.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
If you are pregnant, especially in the first trimester, consult your doctor before taking
this medicine because they will need to assess the need for treatment.
Do not take this medicine if you are breastfeeding.

Driving and operating machinery
During treatment with DISSENTEN you may experience fatigue, dizziness or drowsiness.
Be particularly careful before driving vehicles or using machinery.

3. How to take DISSENTEN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take the tablets with a little water.
During treatment with this medicine, it is necessary to reduce the dose as soon as you notice an improvement in your health 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). Subsequently, take 1 tablet (2 mg) after each unformed (soft) stool. Do not exceed the maximum dose of 8 tablets (16 mg) per day.

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

Use in children under 6 years of age
This medicine should not be given 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
In case of ingestion of an excessive amount of this medicine, seek immediate medical attention or go to the nearest hospital.
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 rate (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;
• detachment from reality (stupor);
• reduction in the size of the pupil, the black part of the eye (miosis);
• disorders indicative of intestinal blockage (ileus); Compared to adults, children's reaction to high doses of DISSENTEN is stronger. If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact your doctor immediately. In these cases, the patient should be kept under close observation for 48 hours.

Treatment of overdose includes gastric lavage, induction of vomiting, or administration of medicines that promote intestinal emptying (laxatives). In addition, if you experience symptoms of overdose, you may be given naloxone, a medicine used as an antidote. In these cases, you 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 missed dose.
If you have any questions about using this medicine, ask 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 and consult your doctor immediately if you notice:

• severe allergic reactions that can manifest with swelling and difficulty breathing;
• abdominal swelling associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
• severe skin reactions that can include blisters and skin peeling.

When taking this medicine, the following side effects may occur, listed according to their 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 part of the abdomen, abdominal discomfort;
• dry mouth;
• vomiting;
• digestive disorders (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 based on available data:

• allergic (hypersensitivity) reactions, also severe (anaphylactic reaction, including shock and anaphylactoid reaction);
• drowsiness, loss of consciousness, mental disorders, also associated with detachment from reality (stupor), decreased level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination making it difficult to perform certain movements;
• reduction in the size of the pupil, the black part of the eye (miosis);
• disorders indicative of a blockage of the intestine (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders that can manifest with the formation of blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), skin irritation (urticaria), itching;
• swelling of the face 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after
“Expiry”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DISSENTEN contains

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

Description of the appearance of DISSENTEN and contents of the pack
Pack of 30 tablets of 2 mg.

Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILANO.

Manufacturers
DOPPEL Farmaceutici S.r.l. - Workshop at Via Volturno, 48 - 20089 Quinto De' Stampi - Rozzano
(MI).
ALFA WASSERMANN S.p.A. - Workshop at Via Fermi, 1 - 65020 Alanno (PE).