IMODIUM 2 mg Orally Disintegrating Tablet

Зміст інструкції

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

IMODIUM 2 mg hard capsules

loperamide hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use 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 would like 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 of treatment.

Contents of this leaflet:

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

1. What is IMODIUM and what is it used for

This medicine contains loperamide hydrochloride, an active ingredient that acts on the intestine reducing the
intestinal movements and the urge to defecate.
IMODIUM is indicated for the symptomatic treatment of occasional (acute) diarrhea.
See a 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 IMODIUM

Do not take IMODIUM if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have a high fever and blood in your stools (signs of acute dysentery);
• you suffer from an inflammation of the intestine called ulcerative colitis;
• you have diarrhea caused by the use of antibiotics (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella and Campylobacter;
• you are using medicines that reduce the movements of the intestine.

IMODIUM should not be administered to children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM.
Pay particular attention:

• if you have diarrhea your body loses fluids and mineral salts: to restore normal levels, it may be useful to take aqueous solutions based on sugar and salts;
• treatment with IMODIUM is only symptomatic and does not eliminate the cause of your condition;
• if you have reduced liver function, see your doctor or pharmacist before taking IMODIUM.

Immediately stop treatment with IMODIUM and consult your doctor:

• if you have AIDS and notice abdominal swelling;
• if you notice difficulty in defecation (constipation), bloating and/or abdominal pain.

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 IMODIUM, serious heart problems have been reported (with
symptoms including a rapid or irregular heartbeat).
See a doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder
occurs repeatedly.

Children from 6 to 12 years of age
IMODIUM must be used under medical supervision.

Other medicines and IMODIUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. This is particularly important if you are taking:

• quinidine (a medicine used in heart rhythm disorders);
• ritonavir (a medicine used in viral infections);
• ketoconazole and itraconazole (medicines used in fungal infections);
• gemfibrozil (a medicine that lowers fat levels in the blood);
• desmopressin (a medicine used for example in type 1 diabetes);
• medicines with effects similar to those of IMODIUM;
• medicines that speed up or slow down intestinal peristalsis (e.g. anticholinergics);
• medicines that inhibit cytochrome CYP450.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take IMODIUM.

Driving and using machines
IMODIUM can cause fatigue, dizziness or lightheadedness. Pay particular attention before
driving vehicles or using machinery.

IMODIUM 2 mg hard capsules contains lactose: if your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

3. How to take IMODIUM

Take this medicine following the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take IMODIUM hard capsules by mouth (orally) with a little water.

Adults
Start treatment with 2 capsules (4 mg); if necessary, continue with 1 capsule (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose is 8 capsules per day (16 mg).

Children and adolescents(aged between 6 and 17 years)
Start treatment with 1 capsule (2 mg); if necessary, continue with 1 capsule (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose must be calculated based on body weight (3 capsules every 20 Kg), but must not exceed 8 capsules per day.
In children from 6 to 12 years of age, IMODIUM must be used under medical supervision.
Stop using IMODIUM when stools return to normal, or if you have no more bowel movements for 12 hours or if you have difficulty evacuating (constipation).
Do not use IMODIUM for more than 2 days. If this period passes without appreciable results, stop treatment and consult your doctor.

If you take more IMODIUM than you should
If you have taken too much IMODIUM, 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, weak breathing, constricted pupils, torpor (depression of the nervous system), difficulty or inability to evacuate (constipation or intestinal obstruction).
These effects are more likely to occur in children, especially under 4 years of age.
Compared to adults, children's reaction to high doses of IMODIUM is stronger. If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stop taking IMODIUM and consult your doctor immediately if you notice:

• severe allergic reactions (anaphylactic or anaphylactoid reactions) which may manifest with skin rashes, swelling of the hands, feet, face, eyes, lips, throat, difficulty breathing or a sudden drop in blood pressure;
• abdominal swelling associated with pain, nausea, vomiting, inability to have a bowel movement, signs of intestinal obstruction or megacolon;
• severe skin rashes with redness, exfoliation and/or blister formation (e.g. Stevens-Johnson Syndrome, toxic epidermal necrolysis).

Steven-Johnson, toxic epidermal necrolysis).

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

• upper abdominal pain, abdominal pain that spreads 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 consult your
doctor immediately.
Other side effects that may occur are:
Headache, dizziness
Difficulty in having a bowel movement (constipation), nausea, presence of gas in the abdomen (flatulence).
Drowsiness
Abdominal pain or discomfort (especially located in the upper part of the abdomen), dry mouth,
vomiting, indigestion (dyspepsia).
Pupil constriction (miosis)
Skin rashes, characterized by blisters, skin spots (urticaria) and/or itching
Decreased urination (urinary retention)
Tongue pain (glossodynia), abdominal bloating
Complete cessation of movements with detachment from external reality (stupor), slowing of mental
functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone
(hypertonia), muscle coordination disorders, fatigue.

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 IMODIUM

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. 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 IMODIUM contains
The active ingredient is: loperamide hydrochloride.
Each hard capsule contains: 2 mg of loperamide hydrochloride.
The other ingredients are: lactose, corn starch, talc, magnesium stearate; erythrosine (E 127); indigotine (E 132); yellow iron oxide (E 172); black iron oxide (E 172); titanium dioxide and gelatin.

Description of IMODIUM and contents of the pack
IMODIUM 2 mg hard capsules are available in packs of 8.

Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROMA)

Manufacturer
JANSSEN – CILAG S.p.A., Via C. Janssen - LATINA

IMODIUM 2 mg soft capsules

loperamide hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use 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 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 of treatment.

Contents of this leaflet:

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

1. What is IMODIUM and what is it used for

This medicine contains loperamide hydrochloride, an active ingredient that acts on the intestine reducing the
intestinal movements and the urge to defecate.
IMODIUM is indicated for the symptomatic treatment of occasional (acute) 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 you take IMODIUM

Do not take IMODIUM if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have a high fever and blood in your stools (signs of acute dysentery);
• you suffer from an inflammation of the intestine called ulcerative colitis;
• you have diarrhoea caused by the use of antibiotics (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella and Campylobacter;
• you are using medicines that reduce the movements of the intestine.

IMODIUM should not be administered to children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking IMODIUM.
Pay particular attention:

• if you have diarrhoea, your body loses fluids and mineral salts: to restore normal levels, it may be helpful to take aqueous solutions based on sugar and salts;
• treatment with IMODIUM is only symptomatic and does not eliminate the cause of your condition;
• if you have reduced liver function, consult your doctor or pharmacist before taking IMODIUM.

Stop treatment with IMODIUM immediately and consult your doctor:

• if you have AIDS and notice abdominal swelling;
• if you notice difficulty in defecation (constipation), bloating and/or abdominal pain.

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 IMODIUM, serious heart problems have been reported (with
symptoms including a rapid or irregular heartbeat).
Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder
occurs repeatedly.

Children from 6 to 12 years of age
IMODIUM must be used under medical supervision.

Other medicines and IMODIUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. This is particularly important if you are taking:

• quinidine (a medicine used in heart rhythm disorders);
• ritonavir (a medicine used in viral infections);
• ketoconazole and itraconazole (medicines used in fungal infections);
• gemfibrozil (a medicine that lowers fat levels in the blood);
• desmopressin (a medicine used for example in type 1 diabetes);
• medicines with effects similar to those of IMODIUM;
• medicines that speed up or slow down intestinal peristalsis (e.g. anticholinergics);
• medicines that inhibit cytochrome CYP450.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take IMODIUM.

Driving and operating machinery
IMODIUM can cause fatigue, dizziness or drowsiness. Pay particular attention before
driving vehicles or using machinery.

Important information about some excipients:

IMODIUM 2 mg soft capsules contains propylene glycol:this medicine contains 115.31 mg of
propylene glycol per single dose, equivalent to 1.65 mg/kg for an adult of 70 kg and to 5.77 mg/kg for a
child of 20kg.
This medicine contains less than 1 mmol (23 mg) of sodium per single dose, i.e. it is essentially ‘sodium-free’.

3. How to take IMODIUM

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take IMODIUM soft capsules by mouth (orally) with a little water.

Adults
Start treatment with 2 capsules (4 mg); if necessary, continue with 1 capsule (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose is 8 capsules per day (16 mg).

Children and adolescents(aged between 6 and 17 years)
Start treatment with 1 capsule (2 mg); if necessary, continue with 1 capsule (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose must be calculated based on body weight (3 capsules every 20 Kg), but must not exceed 8 capsules per day.
In children from 6 to 12 years of age, IMODIUM must be used under medical supervision.
Stop using IMODIUM when stools return to normal, or if you have no more bowel movements for 12 hours or if you have difficulty evacuating (constipation).
Do not use IMODIUM for more than 2 days. If this period passes without appreciable results, stop treatment and consult your doctor.

If you take more IMODIUM than you should
If you have taken too much IMODIUM, contact your doctor or hospital immediately for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, constricted pupils, torpor (depression of the nervous system), difficulty or inability to evacuate (constipation or intestinal obstruction).
These effects are more likely to occur in children, especially under 4 years of age.
Compared to adults, children's reaction to high doses of IMODIUM is stronger. If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking IMODIUM and consult your doctor immediately if you notice:

• severe allergic reactions (anaphylactic or anaphylactoid reactions) which can manifest with skin rashes, swelling of the hands, feet, face, eyes, lips, throat, difficulty breathing or a sudden drop in blood pressure;
• abdominal swelling associated with pain, nausea, vomiting, inability to have a bowel movement, signs of intestinal obstruction or megacolon;
• severe skin rashes with redness, exfoliation and/or blister formation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Seek immediate medical attention:
Not known (frequency cannot be estimated from available data)
upper abdominal pain, abdominal pain that spreads to the back, tenderness to the touch
of the abdomen, 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 consult
your doctor immediately.
Other side effects that may occur are:
Headache, dizziness
Difficulty evacuating the bowels (constipation), nausea, presence of gas in the abdomen (flatulence).
Drowsiness
Abdominal pain or discomfort (especially located in the upper part of the abdomen), dry mouth,
vomiting, indigestion (dyspepsia).
Pupil constriction (miosis)
Skin rashes, characterized by blisters, skin spots (urticaria) and/or itching
Decreased urination (urinary retention)
Tongue pain (glossodynia), abdominal bloating
Complete cessation of movements with detachment from external reality (stupor), slowing of
mental functions (reduced level of consciousness), fainting (loss of consciousness), increased
muscle tone (hypertonia), muscle coordination disorders, fatigue.

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 IMODIUM

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. 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 IMODIUM contains
The active ingredient is: loperamide hydrochloride.
One soft capsule contains: 2 mg of loperamide hydrochloride.
The other ingredients are: propylene glycol monocaprylate, propylene glycol, distilled water, gelatin,
glycerol 99%, FD& C blue n. 1.

Description of the appearance of IMODIUM and contents of the pack
IMODIUM 2 mg soft capsules are available in a pack containing 12 capsules.

Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROMA)

Manufacturer
Catalent France Beinheim SA - 74 rue Principale CS10012, F67930 Beinheim - France

IMODIUM 2 mg orodispersible tablets

loperamide hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use 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 would like 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 your symptoms do not improve or worsen after 2 days of treatment.

Contents of this leaflet:

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

1. What is IMODIUM and what it is used for

This medicine contains loperamide hydrochloride, an active ingredient that acts on the intestine reducing the
intestinal movements and the urge to defecate.
IMODIUM is indicated for the symptomatic treatment of occasional (acute) diarrhea.
See a 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 IMODIUM

Do not take IMODIUM if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have a high fever and blood in your stools (signs of acute dysentery);
• you suffer from an inflammation of the intestine called ulcerative colitis;
• you have diarrhea caused by the use of antibiotics (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella and Campylobacter;
• you are using medicines that reduce the movements of the intestine.

IMODIUM should not be administered to children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking IMODIUM.
Pay particular attention:

• if you have diarrhea your body loses fluids and mineral salts: to restore normal levels, it may be useful to take aqueous solutions based on sugar and salts;
• treatment with IMODIUM is only symptomatic and does not eliminate the cause of your disorder;
• if you have reduced liver function, consult your doctor or pharmacist before taking IMODIUM.

Immediately stop treatment with IMODIUM and consult your doctor:

• if you have AIDS and notice abdominal swelling;
• if you notice difficulty in defecation (constipation), abdominal bloating and/or pain.

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 IMODIUM, serious heart problems have been reported (with
symptoms including a rapid or irregular heartbeat).
See a doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder
occurs repeatedly.

Children from 6 to 12 years of age
IMODIUM must be used under medical supervision.

Other medicines and IMODIUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. This is particularly important if you are taking:

• quinidine (medicine used in heart rhythm disorders);
• ritonavir (medicine used in viral infections);
• ketoconazole and itraconazole (medicines used in fungal infections);
• gemfibrozil (medicine that decreases the levels of fats in the blood);
• desmopressin (medicine used for example in type 1 diabetes);
• medicines with effects similar to those of IMODIUM;
• medicines that speed up or slow down intestinal peristalsis (e.g. anticholinergics);
• medicines that inhibit cytochrome CYP450.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding do not take IMODIUM.

Driving and operating machinery
IMODIUM can cause fatigue, dizziness or lightheadedness. Pay particular attention before getting
in a car or operating machinery.

IMODIUM 2 mg orodispersible tablets contains aspartame.This medicine contains 0.750 mg of
aspartame per single dose which is equivalent to 0.011 mg/kg for an adult of 70 kg and to 0.038 mg/kg for a
child of 20 kg.
Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare genetic disease
that causes the accumulation of phenylalanine because the body is unable to dispose of it correctly.

IMODIUM 2 mg orodispersible tablets contains sodium bicarbonate.This medicine contains less than
1 mmol (23 mg) of sodium per single dose i.e. it is essentially ‘sodium-free’.

IMODIUM 2 mg orodispersible tablets contains mint flavour, which:

• may contain traces of sulphites.Sulphites can rarely cause serious hypersensitivity reactions and bronchospasm;
• contains 0.00066 mg of benzyl alcohol per single tablet. Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis);
• contains 0.00003 mg of alcohol(ethanol) in each tablet. The amount of alcohol in this medicine is equivalent to less than 0.00000075 ml of beer or 0.0000003 of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take IMODIUM

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.

Adults
Start treatment with 2 tablets (4 mg); if necessary, continue with 1 tablet (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose is 8 tablets per day (16 mg).

Children and adolescents(aged between 6 and 17 years)
Start treatment with 1 tablet (2 mg); if necessary, continue with 1 tablet (2 mg) after each subsequent bowel movement of unformed stools.
The maximum dose must be calculated based on body weight (3 tablets every 20 Kg), but must not exceed 8 tablets per day.
In children from 6 to 12 years of age, IMODIUM must be used under medical supervision.
Stop using IMODIUM when stools return to normal, or if you have no bowel movements for 12 hours or if you have difficulty evacuating (constipation).
Do not use IMODIUM for more than 2 days. If this period passes without appreciable results, discontinue treatment and consult your doctor.

Method of administration
Take IMODIUM orodispersible tablets by mouth (orally), allowing the tablet to dissolve on the tongue for a few seconds. Saliva will quickly dissolve the tablet without the need to drink water.
Orodispersible tablets are fragile. To release the tablet from the blister:

• lift the edge of the aluminum foil
• pull the foil
• press lightly to push the tablet out.

Do not push the tablet through the blister foil, to avoid breaking it.

If you take more IMODIUM than you should
If you have taken too much IMODIUM, contact your doctor or hospital immediately for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, constricted pupils, numbness (depression of the nervous system), difficulty or inability to evacuate (constipation or intestinal obstruction).
These effects are more likely to occur in children, especially under 4 years of age.
Compared to adults, children's reaction to high doses of IMODIUM is stronger. If a child takes an excessive amount or exhibits some of the aforementioned symptoms, contact a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking IMODIUM and consult your doctor immediately if you notice:

• severe allergic reactions (anaphylactic or anaphylactoid reactions) which can manifest with skin rashes, swelling of the hands, feet, face, eyes, lips, throat, difficulty breathing or a sudden drop in blood pressure;
• abdominal swelling associated with pain, nausea, vomiting, inability to defecate, signs of intestinal obstruction or megacolon;
• severe skin rashes with redness, exfoliation and/or blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• upper abdominal pain, abdominal pain that spreads to the back, abdominal tenderness to the touch, 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 contact your doctor immediately.Other side effects that may occur are:

Headache, dizziness
Difficulty in defecation (constipation), nausea, presence of gas in the abdomen (flatulence).
Drowsiness
Abdominal pain or discomfort (especially located in the upper part of the abdomen), dry mouth,
vomiting, indigestion (dyspepsia).
Pupil constriction (miosis)
Skin rashes, characterized by blisters, skin spots (urticaria) and/or itching
Decreased urination (urinary retention)
Tongue pain (glossodynia), abdominal bloating
Complete cessation of movements with detachment from external reality (stupor), slowing of mental functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone (hypertonia), muscle coordination disorders, fatigue.

Reporting of side effects
If you get any side effects, talk to 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 IMODIUM

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date which is stated on the packaging. 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 IMODIUM contains
The active ingredient is: loperamide hydrochloride.
One orally disintegrating tablet contains: 2 mg of loperamide hydrochloride.
The other ingredients are: gelatin, mannitol, aspartame, peppermint flavour, sodium bicarbonate.

Description of the appearance of IMODIUM and contents of the pack
IMODIUM 2 mg orally disintegrating tablets is available in a pack containing 12 tablets.

Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROMA)

Manufacturer
JANSSEN – CILAG S.p.A., Via C. Janssen – LATINA
JANSSEN-CILAG, Domaine de Maigremont - 27100 Val-De-Reuil France