Imodium for diarrhea 2 mg x6 capsules McNeil

IMODIUM capsules 2 mg * 6 Leaflet: patient informationIMODIUM 2 mg hard capsulesIMODIUM 2 mg capsules, hardLoperamide hydrochloride
Read all of this leaflet carefully before you start taking 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 told you.

Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 2 days or your condition worsens, you should seek medical attention.

What this leaflet contains:
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 IMODIUM is and what it is used for
In diarrhea, IMODIUM hardens the stool and reduces the frequency of bowel movements.
You could take IMODIUM for sudden (acute) diarrhea or for long-term (chronic) diarrhea.
Imodium is part of the group of drugs called antidiarrheal, anti-inflammatory/intestinal antiseptic, and antipropulsive.
You could also use IMODIUM if you have diarrhea after surgical removal of part of your intestine.
2. What you need to know before you take IMODIUM Do not take IMODIUM

 if there is blood in the stool or if you have a high fever.
 if you have been diagnosed with inflammation of the lower abdomen (such as ulcerative colitis or pseudomembranous colitis resulting from antibiotic treatment);
 if your doctor has told you that you have a condition called delayed bowel transit. Examples of such a condition are constipation or bloating;
 if you know that you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6)
 in the case of bacterial enterocolitis caused by microorganisms such as salmonella, shigella and campylobacter.
in children under 6 years of age.

If in doubt, ask your pharmacist or doctor for advice.
Warnings and special precautions
Although IMODIUM stops diarrhoea, it does not treat the underlying cause. Whenever possible, the underlying cause of the diarrhoea should also be treated.

 If you have diarrhea, you should know that you are losing a significant amount of fluids. Therefore, you should compensate for the loss by increasing your fluid intake. This is especially true for children. Your pharmacist can prescribe a special powder containing sugar and salts. When added to water, it will also replace the salt losses caused by diarrhea. The solution is especially suitable for children.
 In the case of a sudden (acute) attack of diarrhoea, IMODIUM usually stops the symptoms within 48 hours. Otherwise, stop taking the medicine and see your doctor.
 If you have AIDS and are being treated for diarrhea with IMODIUM, if you develop any signs of abdominal bloating, stop taking IMODIUM immediately and tell your doctor.
 Do not take this product for anything other than what it is intended for (see section 1) and never take more than the recommended amount (see section 3). There have been reports of serious heart problems (symptoms of which include a fast or irregular heartbeat) in patients who have taken too much loperamide, the active ingredient in Imodium.

Other medications
Tell your doctor if you are taking other medicines that suppress the peristalsis of the stomach and intestines (for example, anticholinergics), as they could significantly enhance the effect of IMODIUM.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
IMODIUM with food and drink
The capsules should be taken with liquid.
Pregnancy, breastfeeding and fertility
Consult your doctor or pharmacist before using any medicine.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
We advise you not to take IMODIUM while breastfeeding, as small amounts of it pass into your breast milk.
Driving and using machines
IMODIUM has no effect on driving or operating machinery.
Along with diarrhea, fatigue, dizziness, or drowsiness may occur. Therefore, it is advisable to be careful when driving or operating machinery.
Important information about some of the ingredients of IMODIUM
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially „sodium-free“.
Other medicines and IMODIUM
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription or herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

 ritonavir (used to treat HIV)
 quinidine (used to treat heart rhythm disorders)
 oral desmopressin (used to treat excessive urination)
 itraconazole or ketoconazole (used to treat fungal infections)
gemfibrozil (used to lower cholesterol)

Liver problems
Tell your doctor if you have liver problems, you may need close medical supervision during treatment with IMODIUM.
3. How to take IMODIUM
The dose of IMODIUM you need depends on your age and the type of diarrhoea.
IMODIUM is available in the form of capsules for oral administration.
You can take IMODIUM at any time of the day.
The capsules should be taken with liquid.
Adults and children over 6 years of age:
Acute diarrhea: the initial dose is 2 capsules (4 mg) in adults and 1 capsule (2 mg) in children over 6 years of age; treatment is continued by taking 1 capsule (2 mg) after each loose stool.
Chronic diarrhea: the initial dose is 2 capsules (4 mg) daily in adults and 1 capsule (2 mg) daily in children over 6 years of age; this initial dose can be adjusted to achieve 1-2 formed stools per day, which is usually achieved with a maintenance dose of 1-6 (2-12 mg) capsules per day. The maximum dose for acute and chronic diarrhea is 8 capsules (16 mg) daily in adults; in children over 6 years of age, the dose should be based on body weight (3 capsules/20 kg), but should not exceed 8 capsules per day.
Warning: do not take more than 8 capsules in 24 hours!
Always take IMODIUM exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
If you take more IMODIUM than you should
If you take too much IMODIUM, contact a doctor or hospital for advice immediately. Symptoms may include: rapid heartbeat, irregular heartbeat, changes in heart rate (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or shortness of breath.
Children react more strongly to large amounts of IMODIUM than adults. If a child takes too much of the product or shows any of the symptoms described above, call a doctor immediately.
Information for the doctor in case of overdose:
Inject naloxone.
If necessary, re-inject naloxone after 1-3 hours.
If necessary, monitor the patient's condition for at least the next 48 hours.
If you forget to take IMODIUM
Do not take a double dose to make up for a missed IMODIUM capsule.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them and they are usually mild.
Seek medical attention immediately in case of:

 Sudden swelling of the face, lips or throat, shortness of breath, hives (or urticaria), severe irritation, redness or blistering of the skin. These may be signs of a severe hypersensitivity or allergic reaction:
 Excessive fatigue, inability to move in a coordinated manner, loss of consciousness.
 Severe stomach pain, stomach swelling, or fever, which may be due to a blockage or dilation of the intestines

If you experience any of the side effects listed above, stop taking the medicine and seek medical attention immediately.
Consult a doctor as soon as possible in case of:

 Dry mouth, indigestion, stomach pain, abdominal discomfort or bloating, nausea, vomiting, flatulence, constipation
 Headache, dizziness, drowsiness or tiredness, feeling weak
 Rash
 Urinary retention (inability to urinate or empty the bladder completely)
 Constriction of the pupils

Very rare (affects less than 1 in 10,000 people)

Hypersensitivity reaction,
 anaphylactic reaction (including anaphylactic shock) and anaphylactoid reaction,
impaired coordination,
depressed level of consciousness,
 hypertension,
loss of consciousness,
drowsiness,
stupor,
 miosis (narrowing of the pupil of the eye),
 ileus (intestinal obstruction),
 megacolon (dilation of the colon),
 glossodynia (sensation of pain in the tongue area),
 angioedema (swelling),
 bullous rash,
 urticaria,
 itching,
urinary retention,
fatigue.

Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street 1303 Sofia
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store IMODIUM
This medicine can only be stored for a limited period of time. Do not use IMODIUM after the date (month and year) stated after “EXP.”, even if the medicine has been stored correctly.
Keep out of the reach of children. Do not use IMODIUM after the expiry date which is stated on the carton.
The expiry date corresponds to the last day of the month indicated. Do not use IMODIUM if you notice any visible signs of deterioration in the quality of the product.
Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. Contents of the pack and other information What IMODIUM contains

The active substance is: loperamide hydrochloride.

One capsule contains 2 mg loperamide hydrochloride.

The other ingredients are:

Lactose monohydrate, corn starch, talc, magnesium stearate
Composition of the empty gelatin capsule: titanium dioxide (E171) yellow iron oxide (E172) black iron oxide (E172) indigotine (E132) gelatin erythrosine (E127)
What IMODIUM looks like and contents of the pack
IMODIUM capsules are gray/green in color, containing white powder.
Each carton contains 6 capsules packed in a transparent PVC/aluminium foil blister.
Marketing Authorisation Holder
McNeil Healthcare (Ireland) Ltd, Ireland
Manufacturer
Janssen-Cilag, France
Date of last revision of the leaflet: 01/2019