Loperamide Doc Generici

Package leaflet: Information for the patient

LOPERAMIDE DOC Generici 2 mg tablets

Generic medicine
Please read all of 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 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 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

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

LOPERAMIDE DOC Generici contains the active substance loperamide, which belongs to a class of
medicines called antidiarrhoeals and antipropulsives, which help reduce diarrhoea by decreasing intestinal
motility.
This medicine is indicated for the treatment of acute episodes of both occasional and persistent diarrhoea.
Consult your doctor if you do not notice improvement or if you experience 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 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 have an intestinal disease, acute dysentery, characterized by blood in the stool and high fever;
• if you have severe inflammation of the intestine with lesions present (acute ulcerative colitis);
• if you have an intestinal infection (bacterial enterocolitis caused by aggressive germs such as Salmonella, Shigella, and Campylobacter);
• if you have a severe form of diarrhoea (pseudomembranous colitis) caused by medicines used to treat bacterial infections (antibiotics);
• if taking this medicine may expose you to the risk of complications that could lead to intestinal paralysis (ileus, megacolon, and toxic megacolon); if during treatment you develop constipation (stasis), intestinal obstruction (ileus), or abdominal swelling (abdominal distension), stop treatment immediately with this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking LOPERAMIDE DOC Generici.
This medicine improves the symptoms of diarrhoea (symptomatic treatment), but does not treat the underlying
cause. Therefore, when the cause of diarrhoea can be identified, it is necessary to treat it with a specific
therapy as advised by your doctor.
Diarrhoea causes a significant loss of fluids and electrolytes, especially in children. For this reason, it is
important to drink plenty of fluids and/or electrolyte replacement solutions.
Stop treatment with this medicine and consult your doctor if:

• you do not see an improvement in your condition within 48 hours of taking LOPERAMIDE DOC Generici;
• you have AIDS and develop abdominal swelling during treatment with this medicine; if you are taking LOPERAMIDE DOC Generici 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 (hepatic insufficiency), as toxic effects affecting the central nervous system may occur.
Do not take this medicine for uses other than those indicated (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 substance in LOPERAMIDE DOC Generici, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.

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

Other medicines and LOPERAMIDE DOC Generici
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;
• other medicines that slow down intestinal activity (e.g. anticholinergics, including some medicines used for asthma), or medicines that stimulate intestinal activity;
• 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;
• other medicines (cytochrome CYP450 inhibitors and P-glycoprotein inhibitors).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or 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, as they will need to assess whether treatment is necessary.
Do not take this medicine if you are breastfeeding.

Driving and using machines
During treatment with LOPERAMIDE DOC Generici, you may experience fatigue, dizziness, or drowsiness. If this occurs, avoid driving or operating machinery.

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

3. How to take LOPERAMIDE DOC Generici

Take this medicine exactly as stated 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, you must 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).
If you do not experience any benefit within 2 days, you must stop treatment with LOPERAMIDE DOC Generici and contact your doctor immediately.

Adults and children aged between 6 and 17 years
Treatment of acute diarrhoea (occasional episode): The initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; thereafter, 1 tablet (2 mg) after each episode of diarrhoea.
Treatment of persistent diarrhoea (chronic): The initial dose is 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children. Your doctor will adjust the dose according to your health condition. The usual maintenance dose ranges between 1 and 6 tablets per day (2 mg – 12 mg). Do not exceed the maximum recommended daily dose for adults. In children, the dose should be based on body weight (3 tablets per 20 kg 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, possibly associated with disconnection from reality (stupor) and coordination difficulties;
• drowsiness;
• reduction in pupil size, the black part of the eye (miosis);
• muscle disorders (hypertonia);
• breathing difficulties (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 reactions to high doses of LOPERAMIDE DOC Generici are stronger.
If a child has taken an excessive amount or shows any of the above 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 the 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.
If you are taking this medicine to treat occasional diarrhoea (acute diarrhoea), the following side effects may occur:
Common (may affect up to 1 in 100 people)

• headache (cephalalgia);
• constipation, nausea, flatulence.

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

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

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

• abdominal swelling.

If you are taking this medicine to treat persistent diarrhoea (chronic diarrhoea), the following side effects may occur:
Common (may affect up to 1 in 100 people)

• dizziness;
• constipation, nausea, flatulence.

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

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

In addition, the following side effects have been reported after the medicine was marketed (post-marketing reports):
Seek immediate medical advice:
Not known (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), depression of the level of consciousness, muscle disorders (hypertonia) and loss of muscular 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 which may present with 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;
• intestinal disorders, even associated with reduced intestinal function (ileus, paralytic ileus, megacolon, toxic megacolon); upper abdominal pain, abdominal pain radiating to the back, tenderness on abdominal palpation, 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 immediate medical advice.
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 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 stated on the packaging after “Exp.”. 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 LOPERAMIDE DOC Generici contains

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

Description of the appearance of LOPERAMIDE DOC Generici and contents of the pack
Pack containing 8 or 15 tablets of 2 mg.
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan
Manufacturers
SIIT S.r.l. - Via Ariosto 50/60, Trezzano sul Naviglio (MI)
Francia Farmaceutici S.r.l. - Via dei Pestagalli 7, Milan (MI)

Patient Information Leaflet

LOPERAMIDE DOC Generici 2 mg tablets

Generic medicinal product
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 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

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

LOPERAMIDE DOC Generici contains the active substance loperamide, which belongs to a class of
medicinal products known as antidiarrhoeals and antipropulsives, which help reduce diarrhoea by decreasing
intestinal motility.
This medicine is indicated for the treatment of acute episodes of both occasional diarrhoea and persistent
diarrhoea.

2. What you need to know before taking 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 blood in the stool and high fever;
• if you have severe inflammation of the intestine with lesions present (acute ulcerative colitis);
• if you have an intestinal infection (bacterial enterocolitis caused by aggressive germs such as Salmonella, Shigella, and Campylobacter);
• if you have a severe form of diarrhoea (pseudomembranous colitis) caused by medicines used to treat bacterial infections (antibiotics);
• if taking this medicine may expose you to the risk of complications that could lead to intestinal paralysis (ileus, megacolon, and toxic megacolon); if during treatment you experience constipation (stipsis), intestinal obstruction (ileus), or abdominal bloating (abdominal distension), stop treatment with this medicine immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking LOPERAMIDE DOC Generici.
This medicine improves the symptoms of diarrhoea (symptomatic treatment), but does not treat its
underlying cause. Therefore, when the cause of diarrhoea can be identified, it is necessary to treat it with a specific therapy as advised by your doctor.
Diarrhoea causes a significant loss of fluids and electrolytes, especially in children. For this reason, it is important to drink plenty of fluids and/or electrolyte-based preparations.
Stop treatment with this medicine and consult your doctor if:

• you do not notice an improvement in your condition within 48 hours of taking LOPERAMIDE DOC Generici;
• you have AIDS and develop abdominal bloating during treatment with this medicine; if you are taking LOPERAMIDE DOC Generici to treat diarrhoea caused by bacteria or viruses (infectious colitis), you have an increased risk of developing other disorders related to intestinal paralysis (toxic megacolon).

Take this medicine with caution and under medical supervision if you have liver problems (hepatic insufficiency), as this may lead to toxic effects affecting the central nervous system.
Do not take this medicine for uses other than those indicated (see section 1) and never exceed the recommended dose (see section 3). Serious heart problems (with symptoms such as rapid or irregular heartbeat) have been reported in patients who have taken an excessive dose of loperamide, the active ingredient in LOPERAMIDE DOC Generici.

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

Other medicines and LOPERAMIDE DOC Generici
Inform 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 stimulate intestinal activity;
• 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;
• other medicines (cytochrome CYP450 inhibitors and P-glycoprotein inhibitors).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, consult your doctor before taking this medicine, as they will need to assess whether treatment is necessary.
Do not take this medicine if you are breastfeeding.

Driving and using machines
During treatment with LOPERAMIDE DOC Generici, you may experience fatigue, dizziness, or drowsiness. If this occurs, avoid driving or operating machinery.

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

3. How to take LOPERAMIDE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist.
During treatment with this medicine, you must 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.
Adults and children aged between 6 and 17 years
Treatment of acute diarrhoea (occasional episode): the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; thereafter, 1 tablet (2 mg) after each diarrhoeal stool.
Treatment of persistent diarrhoea (chronic): the initial dose is 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children. Your doctor will adjust the dose according to your health condition; the maintenance dose is generally between 1 and 6 tablets per day (2 mg – 12 mg) daily.
Do not exceed the maximum recommended dose of 8 tablets per day for adults. In children, the dose should be based on body weight (3 tablets per 20 kg 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, possibly associated with disconnection from reality (stupor) and coordination difficulties;
• drowsiness;
• reduction in pupil size, the black part of the eye (miosis);
• muscle disturbances (hypertonia);
• breathing difficulties (respiratory depression);
• reduced need to urinate (urinary retention);
• intestinal disturbances (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 rhythm (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 reactions to high doses of LOPERAMIDE DOC Generici are stronger.
If a child takes an excessive amount or shows any of the above 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 the 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.
If you are taking this medicine to treat occasional diarrhoea (acute diarrhoea), the following side effects may occur:
Common (may affect up to 1 in 100 people)

• headache (cephalalgia);
• constipation, nausea, flatulence.

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

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

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

• abdominal distension.

If you are taking this medicine to treat persistent diarrhoea (chronic diarrhoea), the following side effects may occur:
Common (may affect up to 1 in 100 people)

• dizziness;
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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 "Exp.". 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 LOPERAMIDE DOC Generici contains

• The active substance is loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride.
• The other components are magnesium stearate, maize starch, lactose monohydrate, microcrystalline cellulose.

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