Imodium for diarrhea and flatulence

Patient Information Leaflet

Imodium Diarrhoea and Bloating 2 mg/125 mg tablets

Loperamide hydrochloride, Simethicone
Generic medicine
Please read all of 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, 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 Diarrhoea and Bloating is and what it is used for
2. What you need to know before taking Imodium Diarrhoea and Bloating
3. How to take Imodium Diarrhoea and Bloating
4. Possible side effects
5. How to store Imodium Diarrhoea and Bloating
6. Contents of the pack and other information

1. What Imodium Diarrea e Meteorismo is and what it is used for

The tablets contain two active substances:

• Loperamide hydrochloride, which helps reduce diarrhoea by slowing down the overactive intestine. It may also help the body absorb more water and salts from the intestine.
• Simeticone, which disperses trapped air in the intestine that causes cramps, bloating, and flatulence.

Imodium Diarrea e Meteorismo is used in adults and adolescents aged 12 years and older to treat a short-duration episode of diarrhoea when it occurs with stomach cramps, bloating, and flatulence.

2. What you need to know before taking IMODIUM DIARRHOEA AND BLOATING

Do not take IMODIUM DIARRHOEA AND BLOATING:

• in children under 12 years of age
• if you are allergic (hypersensitive) to loperamide hydrochloride, simethicone, or to any of the other ingredients of the tablets (listed in section 6)
• if you have a high temperature (e.g. above 38°C) or blood in your stools
• if you have an acute flare-up of an inflammatory bowel condition such as ulcerative colitis
• if you have severe diarrhoea following antibiotic treatment
• if you are constipated or your stomach appears swollen.

Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM DIARRHOEA AND BLOATING.

• IMODIUM DIARRHOEA AND BLOATING treats only the symptoms of diarrhoea. In some cases, the underlying cause of your diarrhoea may require specific treatment; if symptoms persist or worsen, contact your doctor.

If you have severe diarrhoea, your body loses more fluids, sugars and salts than usual. You should
replenish fluids by drinking more than normal. Ask your pharmacist for advice on oral rehydration
powders to replace lost sugars and salts.

• if you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor.
• if you have liver problems, consult your doctor before using the tablets. Some side effects may be more pronounced. Do not use this medicine for conditions 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 ingredient in IMODIUM DIARRHOEA AND BLOATING, serious heart problems (with symptoms such as rapid or irregular heartbeat) have been reported.

In acute diarrhoea, symptoms usually resolve within 2 days. If symptoms persist beyond this period,
stop taking the tablets and contact your doctor.
Important information about some excipients in Imodium Diarrhoea and Bloating:
Each tablet of Imodium Diarrhoea and Bloating contains less than 0.026 mg of benzyl alcohol. Benzyl
alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney
diseases, if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may
accumulate in the body and may cause side effects (called "metabolic acidosis").
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".
This medicine contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of
alcohol in this medicine will not produce any significant effects.
This medicine contains maltodextrin, which contains glucose. If you have been diagnosed by your
doctor with an intolerance to certain sugars, consult your doctor before taking this medicine.
Children
Children under 12 years of age must not take IMODIUM DIARRHOEA AND BLOATING.
Other medicines and IMODIUM DIARRHOEA AND BLOATING
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including:

• quinidine (a medicine used for heart rhythm disorders or for malaria);
• ketoconazole and itraconazole (medicines used for fungal infections);
• gemfibrozil (a medicine used to treat high cholesterol levels in the blood);
• ritonavir (a medicine used to treat HIV infection and AIDS);
• desmopressin (a medicine used to control thirst and urine production in patients with diabetes insipidus). Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as Imodium Diarrhoea and Bloating may interact with them.

Pregnancy and breastfeeding
Pregnancy: if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your
doctor or pharmacist before taking this medicine.
Breastfeeding: IMODIUM DIARRHOEA AND BLOATING is not recommended during breastfeeding. Small
amounts of the medicine may pass into breast milk.
Driving and using machines
This medicine may cause dizziness, fatigue or drowsiness. If you experience any of these symptoms, do not drive or operate machinery.

3. How to take IMODIUM DIARRHOEA AND FLATULENCE

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Swallow the tablets whole with a little water
• For oral use only
• Do not take more tablets than the recommended dose

Use in adults over 18 years
Initially take 2 tablets, followed by 1 tablet after each episode of diarrhoea (bowel movement). Do not take more than 4 tablets per day. If you do not feel better after 2 days, stop taking the tablets and contact your doctor.

Use in adolescents aged 12 to 18 years
Initially take 1 tablet, followed by 1 tablet after each episode of diarrhoea (bowel movement). Do not take more than 4 tablets per day. If you do not feel better after 2 days, stop taking the tablets and contact your doctor.

Use in children under 12 years
Do not give these tablets to children under 12 years of age.

If you take more IMODIUM DIARRHOEA AND FLATULENCE than you should
If you have taken too much IMODIUM DIARRHOEA AND FLATULENCE, 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, dry mouth, constricted pupils, stomach pain, nausea, vomiting or constipation.

Compared to adults, children’s reactions to high doses of IMODIUM DIARRHOEA AND FLATULENCE are stronger. If a child has taken an excessive amount or shows any of the symptoms listed above, contact a doctor immediately.

If you forget to take Imodium Diarrhoea and Flatulence
Take 1 tablet after the next episode of diarrhoea (bowel movement). Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Stop taking IMODIUM DIARREA E METEORISMO and consult your doctor immediately if you notice:
Allergic reactions including swelling of the face, tongue and throat, difficulty swallowing, unexplained shortness of breath, breathlessness, which may be accompanied by skin rash or hives.

If you experience any of the following side effects, stop using the medicine and speak to your doctor:

• Difficulty passing urine
• Severe abdominal pain, abdominal protrusion or swelling, or fever which may be due to a blocked or enlarged intestine
• Severe constipation

Other possible side effects include:
Common side effects (affect less than 1 in 10 people but more than 1 in 100):

• Headache
• Nausea
• Taste disturbances

Uncommon side effects (affect less than 1 in 100 people but more than 1 in 1,000):

• Drowsiness
• Dizziness
• Weakness
• Constipation
• Vomiting
• Indigestion
• Flatulence
• Dry mouth
• Skin rash

Rare side effects (affect less than 1 in 1,000 people but more than 1 in 10,000):

• Loss of consciousness or decreased level of consciousness
• Excessive contraction of the eye pupil
• Skin rash, which may lead to severe blistering and skin peeling
• Hives
• Itching sensation
• 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store IMODIUM DIARREA E METEORISMO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 DIARRHOEA AND BLOATING contains
The active substances are: Loperamide hydrochloride (2 mg per tablet) and Simeticone (measured as 125 mg of
dimethicone per tablet).
The other components are: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, acesulfame potassium,
artificial vanilla flavour (includes propylene glycol, maltodextrin and benzyl alcohol), sodium starch
glycolate (Type A) and stearic acid.
Description of the appearance of IMODIUM DIARRHOEA AND BLOATING and package contents
White, capsule-shaped tablet, with "IMO" engraved on one side and "2" and "125" on the other side separated by
a line.
Each pack contains 6 or 12 tablets in blister strips. It is possible that not all pack sizes are
marketed.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba Pomezia (ROME)
Manufacturer
Janssen Cilag – Domaine de Maigremont F27100 Val de Reuil, France