IMODIUM CPS 2MG N6

ATC code: A07DA03 

Active substances: Loperamidi Hydrochloridum

Vendor, principal: Janssen Pharmaceut.. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

IMODIUM 2MG N6

Package leaflet: Information for the user

IMODIUM, 2 mg hard capsules

Loperamide hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Although this medicine can be obtained without a prescription, you still need to use Imodium 2 mg capsules carefully to achieve the best results.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

What is in this leaflet:

1.   What IMODIUM is and what it is used for
2.   What you need to know before you use IMODIUM
3.   How to use 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

IMODIUM is a medicine used to treat diarrhoea.
In the case of diarrhoea, IMODIUM increases the solidity of faeces and decreases the frequency of defecation.
IMODIUM is used for the symptomatic treatment of acute non-specific diarrhoea in adults and children above the age of 12. In the case of chronic diarrhoea, talk to your doctor who will determine the cause of diarrhoea and prescribe you a suitable treatment.

2. What you need to know before you use IMODIUM

IMODIUM must not be administered to children under the age of 12 without talking to a doctor first
and without a doctor’s supervision.
Do not use IMODIUM:
-   if there is blood in the faeces or if you have a high fever (acute dysentery);
-   if you have inflammation of the intestine (e.g. ulcerative colitis or pseudomembranous colitis which has occurred as a result of using antibiotics);
-   if you have a bacterial bowel inflammation;
-   if you have constipation or flatulence;
-   if you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with IMODIUM:
-   Although IMODIUM helps control diarrhoea, it does not cure its cause. If possible, the cause of diarrhoea should be treated as well.
-   At the time of diarrhoea, you lose a lot of fluid. You must drink a lot to replace the lost fluid. You can purchase a special powder containing sugar and salts from a pharmacy. If you add it to
water, it also makes up for the salts lost during diarrhoea. The solution is especially suitable for children.
-   As a result of taking IMODIUM, acute diarrhoea usually disappears within 48 hours. If there is no effect, stop using the medicine and talk to your doctor.
-   Patients with AIDS who have been treated with IMODIUM due to diarrhoea should stop using IMODIUM immediately if flatulence occurs. Single cases of toxic megacolon have been reported in AIDS patients, whose diarrhoea with viral or bacterial origins was treated with loperamide hydrochloride.

Additional warnings and precautions for patients with irritable bowel syndrome

•   you have severe constipation;
•   you are experiencing weight loss;
•   your symptoms are worsening or changing, you have new symptoms or if diarrhoea episodes last longer than two weeks.
If any of the above applies to you, talk to your doctor before taking IMODIUM.
Abuse and misuse of loperamide (active substance in IMODIUM) has been reported. Do not use this medicine for any other reasons than it is meant for (see section 1) and never take more than a recommended dose (see section 3).

Children

IMODIUM must not be administered to children under the age of 12 without talking to a doctor first and without a doctor’s supervision.

Pregnancy

If you are pregnant or think you may be pregnant, tell your doctor about it. Your doctor will decide if you are allowed to take IMODIUM.

Breast-feeding

IMODIUM is not recommended for using during breast-feeding, as it is excreted in breast milk in small quantities.

Driving and using machines

Take special care if you experience fatigue, dizziness or drowsiness.

Other medicines and IMODIUM

Please tell your doctor if you are taking medicines that slow down digestion (such as anticholinergic drugs), as these medicines may strengthen the effect of IMODIUM.
Quinidine and ritonavir may also strengthen the effect of IMODIUM. Colestyramine may weaken the effect of IMODIUM.

Abnormal hepatic function

Please tell your doctor if you have a liver disease. During treatment with IMODIUM, you may need careful medical supervision, as side effects may occur more frequently in the case of hepatic impairment.
IMODIUM contains lactose as an excipient. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use IMODIUM

Take IMODIUM as described in the instructions. If necessary, ask a doctor or pharmacist for advice. IMODIUM is available as orally administered capsules.
You may take IMODIUM at any time of the day.
Swallow the capsules with water.

Acute non-specific diarrhoea

Adults and children above the age of 12
-   In the case of acute diarrhoea, take 2 capsules (4 mg) at once, then 1 capsule (2 mg) after every defecation of loose stools, but not earlier than 2-3 hours after the initial dose. If the faeces become solid or if you develop constipation or if bowel movement has not occurred within 24 hours, do not take any more capsules.
Attention! Do not take more than 6 capsules (12 mg) within 24 hours!
Children under the age of 12:
IMODIUM should not be given to children under the age of 12 without a doctor’s prescription and medical supervision.
At the time of diarrhoea, you lose a lot of fluid. You must drink a lot to replace the lost fluid.
Check with your doctor or pharmacist if you are not sure.
Discontinue treatment with IMODIUM if the faeces become normal or if bowel movement has not occurred within 12 hours.

If you take more IMODIUM capsules than you should

If you have taken too much IMODIUM, talk to a doctor immediately or go to a hospital, especially if you develop the following symptoms: increased heart rate, irregular heartbeat, change in heartbeat (these symptoms might have serious, fatal consequences), muscle rigidity, coordination disorders, drowsiness or respiratory depression.
Children are more sensitive to an overdose than adults. If a child ingests too much IMODIUM or if the listed symptoms occur, talk to a doctor immediately.
Information for the doctor in the ease of an overdose
-   Start ECG monitoring.
-   Inject naloxone.
-   If necessary, continue administering naloxone in    1-3 hours.
-   It is necessary to observe the patient within at    least 48 hours.

4. Possible side effects

Like all medicines, IMODIUM can cause side effects, although not everybody gets them.
-   In general, IMODIUM is tolerated well and side effects occur rarely if it is used according to the instructions.
-   Constipation and flatulence may occur. In this case, stop taking IMODIUM. If these side effects are severe, talk to a doctor.
-   In very rare cases, hypersensitivity has developed to IMODIUM. The hypersensitivity reactions include skin rash, itching, breathlessness and swelling of the face. If these symptoms occur, talk to a doctor.
-   In very rare cases, stomach pain, ileus, nausea, vomiting, megacolon, incl. toxic megacolon, have occured, as well as flatulence and indigestion, drowsiness, loss of consciousness, impaired consciousness and dizziness.
-   Single cases of skin reactions have been reported. If you develop these, talk to a doctor immediately. Urinary retention has developed in single cases.
Some of the reported side effects may be symptoms caused by diarrhoea (stomach pain / abdominal
dicomfort, nausea, vomiting, dryness of the mouth, fatigue, drowsiness, dizziness, constipation and
flatulence). These symptoms are very difficult to be distinguished from side effects of the medicine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. 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.
Do not store at a temperature higher than 30 °C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.>

6. Contents of the pack and other information

What IMODIUM contains

Active substance is loperamide hydrochloride.
Excipients are:
Capsule content: lactose monohydrate, maize starch, talc, magnesium stearate.
Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), indigotin (E132), gelatin, black iron oxide (E172), erythrosine (E127).

What IMODIUM looks like and contents of the pack

IMODIUM is manufactured in capsules; the shell of the capsule (size 4) containing white powder is dark grey and the lid is green. The pack contains 6 capsules.

Marketing Authorisation Holder:

McNeil Products Ltd. c/o Johnson & Johnson Limited Foundation Park, Roxborough Way Maidenhead, Berkshire, SL6 3UG United Kingdom

Manufacturer:

Janssen-Cilag Domaine de Maigremont 27100 Val de Reuil France

This leaflet was last revised January 2017