Imodium

Package leaflet: Information for the patient

IMODIUM 2 mg hard capsules

loperamide hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use 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 of treatment.

Contents of this leaflet:

1. What IMODIUM is 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

1. What IMODIUM is and what it is used for

This medicinal product contains loperamide hydrochloride, an active substance that acts on the intestine by reducing 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 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 substance or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have high fever and blood in your stools (signs of acute dysentery);
• you suffer from an intestinal inflammation called ulcerative colitis;
• you have diarrhea caused by antibiotic use (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella, and Campylobacter;
• you are taking medicines that reduce intestinal motility.

IMODIUM must not be administered to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM.
Exercise particular caution:

• if you have diarrhea, your body loses fluids and mineral salts; to restore normal levels, it may be helpful to take sugar- and salt-based aqueous solutions;
• treatment with IMODIUM is only symptomatic and does not address the underlying 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 experience difficulty in defecation (constipation), abdominal distension and/or abdominal pain.

Do not use this medicine for conditions other than those indicated (see section 1), and never take a dose higher than recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in IMODIUM, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.
Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment, or if the condition recurs repeatedly.
Children aged 6 to 12 years
IMODIUM should be used under medical supervision.
Other medicines and IMODIUM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take IMODIUM.
Driving and using machines
IMODIUM may cause fatigue, dizziness, or drowsiness. Exercise particular caution before driving or operating machinery.
IMODIUM 2 mg hard capsules contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take IMODIUM

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take IMODIUM hard capsules by mouth (orally) with a glass of water.

Adults
Start treatment with 2 capsules (4 mg); if necessary, continue with 1 capsule (2 mg) after each subsequent passage of loose 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 passage of loose stools.
The maximum dose should be calculated based on body weight (3 capsules per 20 kg), but must not exceed 8 capsules per day.
In children aged 6 to 12 years, IMODIUM should be used under medical supervision.

Stop using IMODIUM when stools return to normal, or if you have not had a bowel movement for 12 hours, or if you experience difficulty passing stools (constipation).
Do not use IMODIUM for more than 2 days. If there is no improvement after this period, 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 heart rhythm (these symptoms may have potentially serious or life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, constricted pupils, stupor (depression of the central nervous system), difficulty or inability to pass stools (constipation or intestinal obstruction).

These effects are more likely to occur in children, especially those under 4 years of age.
Compared to adults, children's reactions to high doses of IMODIUM are stronger. If a child takes an excessive amount or shows any of the above 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 may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, breathing difficulties, or 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, peeling and/or blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• 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 contact your doctor immediately.
Other possible side effects that may occur are:
Headache, dizziness
Difficulty passing stools (constipation), nausea, presence of gas in the abdomen (flatulence)
Drowsiness
Abdominal pain or discomfort (especially in the upper abdomen), dry mouth, vomiting, indigestion (dyspepsia)
Constriction of the pupil (miosis)
Skin rashes characterized by blisters, skin spots (urticaria) and/or itching
Reduced urine output (urinary retention)
Pain in the tongue (glossodynia), abdominal swelling
Complete cessation of movement with detachment from external reality (stupor), slowing of mental functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone (hypertonia), disturbances in muscle coordination, fatigue.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at "www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMODIUM

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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 IMODIUM contains
The active substance is: loperamide hydrochloride.
Each hard capsule contains: 2 mg of loperamide hydrochloride.
The other components are: lactose, maize starch, talc, magnesium stearate; erythrosine (E 127); indigo carmine (E 132); yellow iron oxide (E 172); black iron oxide (E 172); titanium dioxide; gelatin.
Description of the appearance of IMODIUM and the contents of the pack
IMODIUM 2 mg hard capsules are available in a carton containing 8 capsules.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROME)
Manufacturer
JANSSEN – CILAG S.p.A., Via C. Janssen - LATINA

Patient information leaflet

IMODIUM 2 mg soft capsules

Loperamide hydrochloride
Please read this entire leaflet carefully before using this medicine because it contains important information for you.
Always use 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 any side effects occur, 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 of treatment.

Contents of this leaflet:

1. What IMODIUM is 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

1. What IMODIUM is and what it is used for

This medicine contains loperamide hydrochloride, an active substance that acts on the intestine by reducing
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 taking IMODIUM

Do not take IMODIUM if:

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

IMODIUM must not be administered to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM.
Exercise particular caution:

• if you have diarrhoea, your body loses fluids and mineral salts: to restore normal levels, it may be helpful to take sugar- and salt-based aqueous solutions;
• treatment with IMODIUM is only symptomatic and does not address the underlying 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 experience difficulty in defecation (constipation), abdominal 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 recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in IMODIUM, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.
Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the condition recurs repeatedly.
Children aged 6 to 12 years
IMODIUM should be used under medical supervision.
Other medicines and IMODIUM
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is particularly important if you are taking:

• quinidine (a medicine used for heart rhythm disorders);
• ritonavir (a medicine used for viral infections);
• ketoconazole and itraconazole (medicines used for fungal infections);
• gemfibrozil (a medicine that lowers blood fat levels);
• desmopressin (a medicine used, for example, in type 1 diabetes);
• medicines with effects similar to those of IMODIUM;
• medicines that accelerate or slow 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 may cause tiredness, dizziness or drowsiness. Exercise particular caution before driving or operating machinery.
Important information about some excipients:
IMODIUM 2 mg soft capsules contain propylene glycol: this medicine contains 115.31 mg of propylene glycol per single dose, equivalent to 1.65 mg/kg for a 70 kg adult and 5.77 mg/kg for a 20 kg child.
This medicine contains less than 1 mmol (23 mg) of sodium per single dose, i.e. essentially 'sodium-free'.

3. How to take IMODIUM

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.
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 passage 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 passage of unformed stools.
The maximum dose should be calculated based on body weight (3 capsules per 20 kg), but must not exceed 8 capsules per day.
In children aged 6 to 12 years, IMODIUM should be used under medical supervision.

Stop using IMODIUM when stools return to normal, or if you have not had a bowel movement for 12 hours, or if you experience difficulty passing stools (constipation).
Do not use IMODIUM for more than 2 days. If there is no improvement after this period, 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 heart rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, constricted pupils, numbness (central nervous system depression), difficulty or inability to pass stools (constipation or intestinal obstruction).
These effects are more likely to occur in children, especially those under 4 years of age.
Compared to adults, children's reactions to high doses of IMODIUM are stronger. If a child has taken an excessive amount or shows any of the above 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 contact your doctor immediately if you notice:

• severe allergic reactions (anaphylactic or anaphylactoid reactions) which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, breathing difficulties, or 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, peeling and/or blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Seek immediate medical advice:
Not known (frequency cannot be estimated from the available data)
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 contact your doctor immediately.
Other possible side effects include:
Headache, dizziness
Difficulty passing stools (constipation), nausea, presence of gas in the abdomen (flatulence).
Drowsiness
Abdominal pain or discomfort (especially in the upper abdomen), dry mouth, vomiting, indigestion (dyspepsia).
Pupil constriction (miosis)
Skin eruptions characterized by blisters, skin spots (urticaria) and/or itching
Reduced urine output (urinary retention)
Tongue pain (glossodynia), abdominal swelling
Complete cessation of movement with detachment from the external environment (stupor), slowing of mental functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone (hypertonia), coordination disorders of muscles, fatigue.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at "www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMODIUM

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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. Pack contents and other information

What IMODIUM contains
The active substance is: loperamide hydrochloride.
Each soft capsule contains: 2 mg of loperamide hydrochloride.
The other components are: propylene glycol monocaprylate, propylene glycol, distilled water, gelatin, glycerol 99%, FD&C Blue No. 1.
Description of the appearance of IMODIUM and pack contents
IMODIUM 2 mg soft capsules are available in a carton containing 12 capsules.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROME), Italy
Manufacturer
Catalent France Beinheim SA - 74 rue Principale CS10012, F67930 Beinheim, France

Patient information leaflet

IMODIUM 2 mg orally disintegrating tablets

Loperamide hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement 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 taking 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 IMODIUM is and what it is used for

This medicine contains loperamide hydrochloride, an active substance that acts on the intestine by reducing 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 taking IMODIUM

Do not take IMODIUM if:

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

IMODIUM must not be administered to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM.
Exercise particular caution:

• if you have diarrhoea, your body loses fluids and electrolytes: to restore normal levels, it may be helpful to take aqueous solutions containing sugar and salts;
• treatment with IMODIUM is only symptomatic and does not address the underlying cause of your condition;
• if you have impaired 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 experience difficulty in defecation (constipation), abdominal distension 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 recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in IMODIUM, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.
Contact your doctor if you do not feel better or if you feel worse after 2 days of treatment, or if the condition recurs repeatedly.
Children aged 6 to 12 years
IMODIUM should be used under medical supervision.
Other medicines and IMODIUM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important if you are taking:

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take IMODIUM.
Driving and using machines
IMODIUM may cause fatigue, dizziness or drowsiness. Exercise particular caution before driving or operating machinery.
IMODIUM 2 mg orodispersible tablets contain aspartame. This medicine contains 0.750 mg of aspartame per single dose, equivalent to 0.011 mg/kg for a 70 kg adult and 0.038 mg/kg for a 20 kg child.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
IMODIUM 2 mg orodispersible tablets contain 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 contain mint flavour, which:

• may contain traces of sulphites. Sulphites may rarely cause severe hypersensitivity reactions and bronchospasm;
• contains 0.00066 mg of benzyl alcohol per single tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable 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 ml of wine. The small amount of alcohol in this medicine will not produce any significant effects.

3. How to take IMODIUM

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults
Start treatment with 2 tablets (4 mg); if necessary, continue with 1 tablet (2 mg) after each subsequent loose bowel movement.
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 loose bowel movement.
The maximum dose should be calculated based on body weight (3 tablets per 20 kg), but must not exceed 8 tablets per day.
IMODIUM should be used under medical supervision in children aged 6 to 12 years.
Stop using IMODIUM when stools return to normal, or if you have not had a bowel movement for 12 hours, or if you experience difficulty passing stools (constipation).
Do not use IMODIUM for more than 2 days. If no significant improvement occurs after this period, stop treatment and consult your doctor.
Method of administration
Take IMODIUM orodispersible tablets by mouth (oral use), allowing the tablet to dissolve on the tongue for a few seconds. Saliva will rapidly dissolve the tablet without the need to drink water.
The orodispersible tablets are fragile. To remove the tablet from the blister:

• lift the edge of the aluminium foil
• pull the foil back
• press gently 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 heart rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, weak breathing, constricted pupils, numbness (central nervous system depression), difficulty or inability to pass stools (constipation or intestinal obstruction).
These effects are more likely to occur in children, especially those under 4 years of age.
Compared to adults, children's reactions to high doses of IMODIUM are stronger. If a child has taken an excessive amount or shows any of the symptoms listed above, contact a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking IMODIUM and consult a doctor immediately if you notice:

• severe allergic reactions (anaphylactic or anaphylactoid reactions) which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, breathing difficulties, 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, peeling and/or blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• 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 taking the medicine and seek immediate medical attention.

Other possible side effects include:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at "www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMODIUM

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What IMODIUM contains
The active substance is: loperamide hydrochloride.
Each orosoluble tablet contains: 2 mg of loperamide hydrochloride.
The other components are: gelatin, mannitol, aspartame, peppermint flavour, sodium bicarbonate.
Description of the appearance of IMODIUM and contents of the pack
IMODIUM 2 mg orosoluble tablets are available in a carton containing 12 tablets.
Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 00071 Santa Palomba Pomezia (ROME)
Manufacturer
JANSSEN – CILAG S.p.A., Via C. Janssen – LATINA
JANSSEN-CILAG, Domaine de Maigremont - 27100 Val-De-Reuil France