LOPERAMIDE DOK JENERIKI 2 MG Коированная таблетка

Содержание инструкции

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

LOPERAMIDE DOC Generici 2 mg tablets

Generic medicine

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 to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, 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 2 days.

Contents of this leaflet:

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

1. What is LOPERAMIDE DOC Generici and what is it used for

LOPERAMIDE DOC Generici contains the active ingredient loperamide which belongs to the class of
medicines called antidiarrheals and antiperistaltics, which help to reduce diarrhoea by decreasing the motility
of the intestine.
This medicine is indicated for the treatment of acute episodes of both occasional diarrhoea and persistent
diarrhoea.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 2 days.

2. What you need to know before taking LOPERAMIDE DOC Generici

Do not take LOPERAMIDE DOC Generici

• 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 2 years of age;
• if you suffer from an intestinal disease, acute dysentery, characterized by the presence of blood in the stool and high fever;
• if you have severe inflammation of the intestine characterized by the presence of lesions (acute ulcerative colitis);
• if you have an intestinal infection (bacterial enterocolitis caused by aggressive germs, such as Salmonella,Shigellaand Campylobacter);
• if you have a severe form of diarrhea (pseudomembranous colitis) caused by the use of medicines used for the treatment of infections caused by bacteria (antibiotics);
• if the use of this medicine may expose you to the risk of complications, which can cause blockage of intestinal activity (ileus, megacolon and toxic megacolon); if you experience constipation, bowel obstruction (ileus) or abdominal bloating during treatment, immediately stop taking this medicine and consult your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking LOPERAMIDE DOC Generici.
The use of this medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure the
cause. Therefore, when it is possible to establish the cause of the diarrhea, it is necessary to treat it with specific
therapy that will be indicated by your doctor.
Diarrhea 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 mineral salt-based preparations.
Stop treatment with this medicine and consult your doctor if:

• you do not observe an improvement in your condition within 48 hours of taking LOPERAMIDE DOC Generici;
• you are affected by AIDS and during treatment with this medicine you experience abdominal bloating; if you are taking LOPERAMIDE DOC Generici to treat diarrhea caused by bacteria or viruses (infectious colitis) you have a higher 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 (hepatic
insufficiency), because toxic effects affecting the central nervous system may occur.
Do not take this medicine for uses other than those intended (see section 1) and never
take a dose higher than the recommended one (see section 3). In patients who have taken an excessive
dose of loperamide, the active ingredient of LOPERAMIDE DOC Generici, serious
heart problems (with symptoms including a rapid or irregular heartbeat) have been reported.

Children
This medicine should only be administered to children aged 2 to 6 years with a medical prescription
and under direct medical supervision.

Other medicines and LOPERAMIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with caution and inform your doctor if you are taking:

• desmopressin, a medicine used to treat diabetes;
• other medicines that slow down intestinal activity (e.g. anticholinergics, including some medicines used for asthma), or medicines that promote intestinal activity;
• 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;
• other medicines (cytochrome CYP 450 inhibitors and P-glycoprotein inhibitors).

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 or breastfeeding, 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 LOPERAMIDE DOC Generici you may experience fatigue, dizziness or
drowsiness. If this occurs, avoid driving vehicles and using machinery.

LOPERAMIDE DOC Generici contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.

3. How to take LOPERAMIDE DOC Generici

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 you experience constipation (See section Warnings and precautions).
If you do not experience any benefit within 2 days, you should stop treatment with LOPERAMIDE DOC Generici and contact your doctor immediately.

Adults and children aged between 6 and 17 years
Treatment of acute diarrhea (occasional episode):the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; then 1 tablet (2 mg) after each bowel movement.

Treatment of persistent (chronic) diarrhea:the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children per day. The doctor will adjust the dose according to your health condition, generally the maintenance dose is between 1 and 6 tablets per day (2 mg -12 mg) per day.
Do not exceed the recommended maximum daily dose of tablets for adults. In children, the dose must be correlated to body weight (3 tablets every 20 Kg of body weight) but must not exceed a maximum of 8 tablets per day.

LOPERAMIDE DOC Generici should not be used in children under 2 years of age
If you take more LOPERAMIDE DOC Generici than you should
In case of overdose, the following effects may occur:

• depression of the central nervous system, also associated with detachment from reality (stupor) and coordination difficulties;
• drowsiness;
• reduction in the size of the pupil, the black part of the eye (miosis);
• muscle disorders (hypertonia);
• difficulty breathing (respiratory depression);
• reduced need to urinate (urinary retention);
• intestinal disorders (ileus).

If you have taken too much LOPERAMIDE DOC Generici, 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, uncoordinated movements, drowsiness, difficulty urinating or weak breathing.
Compared to adults, children's reaction to high doses of LOPERAMIDE DOC Generici is stronger.
If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact your doctor immediately.

If you think you have taken an excessive dose of LOPERAMIDE DOC Generici contact your doctor or go
immediately to the nearest hospital.
If you forget to take LOPERAMIDE DOC Generici
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of 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.
If you are taking this medicine to treat occasional diarrhea (acute diarrhea), you may experience
the following side effects:

Common(may affect up to 1 in 10 people)

• headache;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• dizziness;
• abdominal pain, especially in the upper abdomen, abdominal discomfort;
• dry mouth;
• vomiting;
• skin irritation (rash).

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

• abdominal bloating.

If you are taking this medicine to treat persistent diarrhea (chronic diarrhea), you may
experience the following side effects:

Common(may affect up to 1 in 10 people)

• dizziness;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• headache;
• abdominal pain, especially in the upper abdomen, abdominal discomfort;
• dry mouth;
• digestive disorders (dyspepsia).

In addition, the following side effects have been reported after marketing authorization (post-marketing
surveillance)

Seek immediate medical attention:
Not known (frequency cannot be estimated from available data)

• allergic (hypersensitivity) reactions, including severe ones (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;
• pupil constriction, the black part of the eye (miosis);
• 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;
• facial swelling due to fluid accumulation, especially around the mouth and eyes;
• reduced need to urinate (urinary retention);
• fatigue;
• intestinal disorders, also associated with reduced bowel function (ileus, paralytic ileus, megacolon, toxic megacolon), 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).

If you experience any of these symptoms, stop using the medicine and seek immediate medical
attention.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at https://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 LOPERAMIDE DOC Generici

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 “Scad.”. 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 LOPERAMIDE DOC Generici contains

• The active ingredient is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
• The other ingredients are magnesium stearate, corn starch, lactose monohydrate, microcrystalline cellulose.

Description of the appearance of LOPERAMIDE DOC Generici and contents of the pack
Pack of 8 or 15 tablets of 2 mg.

Marketing Authorisation Holder
DOC Generici S.r.l. Via Turati 40, 20121 Milano

Manufacturers
SIIT S.r.l - Via Ariosto 50/60, Trezzano sul Naviglio (MI)
Francia Farmaceutici S.r.l. - Via dei Pestagalli 7, Milano (MI)

LOPERAMIDE DOC Generici 2 mg tablets

Generic medicine

Read this leaflet carefully before 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 LOPERAMIDE DOC Generici is and what it is used for
• 2. What you need to know before you take LOPERAMIDE DOC Generici
• 3. How to take LOPERAMIDE DOC Generici
• 4. Possible side effects
• 5. How to store LOPERAMIDE DOC Generici
• 6. Contents of the pack and other information

1. What is LOPERAMIDE DOC Generici and what is it used for

LOPERAMIDE DOC Generici contains the active ingredient loperamide which belongs to the class of
medicines called antidiarrheals and antiperistaltics, which help to reduce diarrhea by decreasing the motility
of the intestine.
This medicine is indicated for the treatment of acute episodes of both occasional and persistent diarrhea

2. What you need to know before you take LOPERAMIDE DOC Generici

Do not take LOPERAMIDE DOC Generici

• 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 2 years of age;
• if you suffer from an intestinal disease, acute dysentery, characterized by the presence of blood in the stool and high fever;
• if you have severe inflammation of the intestine characterized by the presence of lesions (acute ulcerative colitis);
• if you have an intestinal infection (bacterial enterocolitis caused by aggressive germs, such as Salmonella,Shigellaand Campylobacter);
• if you have a severe form of diarrhea (pseudomembranous colitis) caused by the use of medicines used for the treatment of infections caused by bacteria (antibiotics);
• if the use of this medicine may expose you to the risk of complications, which can cause blockage of intestinal activity (ileus, megacolon and toxic megacolon); if you experience constipation, intestinal obstruction (ileus) or abdominal bloating (abdominal distension) during treatment, immediately stop treatment with this medicine and consult your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking LOPERAMIDE DOC Generici.
The use of this medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure the
cause. Therefore, when it is possible to establish the cause of the diarrhea, it is necessary to treat it with a
specific therapy that will be indicated by your doctor.
Diarrhea 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 LOPERAMIDE DOC Generici;
• you are affected by AIDS and during treatment with this medicine you experience abdominal bloating; if you are taking LOPERAMIDE DOC Generici to treat diarrhea caused by bacteria or viruses (infectious colitis) you have a higher 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 disorders (hepatic
insufficiency), because toxic effects affecting the central nervous system may occur.
Do not take this medicine for uses other than those intended (see section 1) and never
take a dose higher than the recommended dose (see section 3). In patients who have taken an
excessive dose of loperamide, the active ingredient of LOPERAMIDE DOC Generici, serious
heart problems (with symptoms including a rapid or irregular heartbeat) have been reported.

Children
This medicine should only be given to children between the ages of 2 and 6 years with a doctor's prescription
and under direct medical supervision.

Other medicines and LOPERAMIDE DOC Generici
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;
• other medicines that slow down the activity of the intestine (e.g. anticholinergics, including some medicines used for asthma), or medicines that promote intestinal activity;
• 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 levels of fats in the blood;
• other medicines (cytochrome CYP 450 inhibitors and P-glycoprotein inhibitors).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, 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 LOPERAMIDE DOC Generici you may experience fatigue, dizziness or
drowsiness. If this occurs, avoid driving vehicles and operating machinery.

LOPERAMIDE DOC Generici contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this
medicine.

3. How to take LOPERAMIDE DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
During treatment with this medicine, it is necessary that you reduce the dose as soon as you notice an
improvement in your health conditions (normalization of stools). Stop treatment with
this medicine if you should experience constipation (See section Warnings and precautions).
Do not take this medicine for more than 2 days.

Adults and children aged between 6 and 17 years
Treatment of acute diarrhea (occasional episode):the initial dose is 2 tablets (4 mg) for
adults and 1 tablet (2 mg) for children; subsequently 1 tablet (2 mg) after each bowel movement.

Treatment of persistent (chronic) diarrhea:the initial dose is 2 tablets (4 mg) for adults and 1
tablet (2 mg) for children per day. The doctor will adjust the dose according to your health conditions,
generally the maintenance dose is between 1 and 6 tablets per day (2 mg -12 mg) per day.
Do not exceed the recommended maximum dose of 8 tablets per day for adults. In children, the dose must
be related to body weight (3 tablets every 20 Kg of body weight) but must not exceed a
maximum of 8 tablets per day.

LOPERAMIDE DOC Generici must not be used in children under 2 years of age
If you take more LOPERAMIDE DOC Generici than you should
In case of overdose, the following effects may occur:

• depression of the central nervous system, also associated with detachment from reality (stupor) and coordination difficulties;
• drowsiness;
• reduction in the size of the pupil, the black part of the eye (miosis);
• muscle disorders (hypertonia);
• difficulty breathing (respiratory depression);
• reduced need to urinate (urinary retention);
• intestinal disorders (ileus).

If you have taken too much LOPERAMIDE DOC Generici, contact your doctor or hospital immediately for
advice. Symptoms may include: increased heart rate, irregular heartbeat,
changes in heartbeat (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or weak breathing.
Compared to adults, children's reaction to high doses of LOPERAMIDE DOC Generici is stronger.
If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact
your doctor immediately.

If you think you have taken an excessive dose of LOPERAMIDE DOC Generici contact your doctor or go
immediately to the nearest hospital.
If you forget to take LOPERAMIDE DOC Generici
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of 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.
If you are taking this medicine to treat occasional diarrhoea (acute diarrhoea), you may experience
the following side effects:

Common(may affect up to 1 in 10 people)

• headache;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• dizziness;
• abdominal pain, especially in the upper abdomen, abdominal discomfort;
• dry mouth;
• vomiting;
• skin irritation (rash).

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

• abdominal bloating.

If you are taking this medicine to treat persistent diarrhoea (chronic diarrhoea), you may
experience the following side effects:

Common(may affect up to 1 in 10 people)

• dizziness;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• headache;
• abdominal pain, especially in the upper abdomen, abdominal discomfort;
• dry mouth;
• digestive disorders (dyspepsia).

In addition, the following side effects have been reported after marketing authorisation (post-marketing
surveillance)

Seek medical attention immediately:
Not known(frequency cannot be estimated from available data)

• allergic (hypersensitivity) reactions, including severe ones (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);
• 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;
• intestinal disorders, also associated with reduced bowel function (ileus, paralytic ileus, megacolon, toxic megacolon), 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);

If you experience any of the following symptoms, stop using the medicine and seek medical
attention immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at https://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 LOPERAMIDE DOC Generici

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 “Scad.”. 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 LOPERAMIDE DOC Generici contains

• The active ingredient is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
• The other ingredients are magnesium stearate, corn starch, lactose monohydrate, microcrystalline cellulose.

Description of the appearance of LOPERAMIDE DOC Generici and contents of the pack
Pack of 30 tablets of 2 mg.

Marketing Authorisation Holder
DOC Generici S.r.l. Via Turati 40, 20121 Milano

Manufacturers
SIIT S.r.l - Via Ariosto 50/60, Trezzano sul Naviglio (MI)
Francia Farmaceutici S.r.l. - Via dei Pestagalli 7, Milano (MI)