IMODIUM INSTANT 2MG MUTĒ DISPERĢĒJAMĀS TBL N6

ATC code: A07DA03 

Active substances: Loperamidum

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

IMODIUM INSTANT 2MG N6

Package leaflet: Information for the user

Imodium instant 2 mg orodispersible tablets

Loperamide hydrochloride

Read all of this leaflet carefully before you start 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 told you.
-   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 instant is and what it is used for
2.   What you need to know before you use Imodium instant
3.   How to use Imodium instant
4.   Possible side effects
5.   How to store Imodium instant
6.   Contents of the pack and other information

1. What Imodium instant is and what it is used for

Imodium instant is used for the symptomatic treatment of acute non-specific diarrhoea in adults and children above 12 years of age.
In case of diarrhoea, Imodium instant increases the solidity of excrement and decreases defecation times.

2. What you need to know before you use Imodium instant Do not use Imodium instant:

-   if you are allergic to loperamide or any of the other ingredient(s) of this medicine (listed in section 6);
-   if there is blood in the excrement or if you have a high fever;
-   if you have inflammation of the intestine (e.g. ulcerative colitis or pseudomembranous colitis occurring as a result of using antibiotics);
-   If your doctor has told you that you have a condition which requires you to prevent the intestinal activity from slowing down (e.g. constipation or flatulence).

Warnings and precautions

Although Imodium instant helps control diarrhoea, it does not cure its cause. If possible, the cause of diarrhoea should be treated as well.
With diarrhoea, you lose a lot of fluids. Therefore, drink plenty of liquid to make up for the lost fluids. 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 instant, acute diarrhoea usually disappears within 48 hours (2 days). If the symptoms do not improve within 2 days, stop using the medicine and talk to a doctor.
Patients with AIDS, who have been treated with Imodium instant due to diarrhoea, must stop using Imodium instant immediately if flatulence occurs. Single cases of toxic megacolon have been reported in patients with AIDS whose viral or bacterial diarrhoea was treated with loperamide hydrochloride.

Additional warnings and precautions to patients with irritable bowel syndrome

•   you have severe diarrhoea;
•   you experience weight loss;
•   your symptoms are worsening, you experience more symptoms, your symptoms are changing or if the diarrhoea episodes last for more than two weeks.
If any of the above applies to you, talk to your doctor before taking Imodium instant.
Loperamide (the active ingredient of Imodium instant) abuse and misuse has been described. Do not use this medicine for other reasons than it is indicated for (see section 1) and never take more than a recommended dose (see section 3).

Children

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

Hepatic function disorder

Tell your doctor if you have a liver disease. You may require careful medical supervision during treatment with Imodium instant.

Other medicines and Imodium instant

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Tell your doctor or pharmacist if you are taking the following medicines:
-   ritonavir (used to treat HIV);
-   quinidine (used to treat abnormal heart rhythm);
-   oral desmopressin (used to treat excessive urination);
-   itraconazole or ketoconazole (used to treat fungal infections);
-   gemfibrozil (used to lower high cholesterol).

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, ask your doctor for advice before taking Imodium instant.
It is not recommended to use Imodium instant during breast-feeding, as it is excreted in breast milk in small quantities.

Driving and using machines

Fatigue, dizziness or sleepiness may occur. For this reason, you must be careful when driving or using machines.
Imodium instant contains aspartame, a source of phenylalanine. As a result, the medicine may be harmful to patients with phenylketonuria.

3. How to use Imodium instant

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Imodium instant is an easily soluble tablet that must be placed on the tongue where it will quickly dissolve. Hence, there is no need to take the medicine with water. You can use Imodium instant at any time of the day.

Acute nonspecific diarrhoea

Adults and children over the age of 12
Take 2 tablets (4 mg) as a loading dose, then 1 tablet (2 mg) after each defecation of non-solid excrement.
If the symptoms do not recede in 2 days, the cause of the diarrhoea will require more thorough examination.
Maximum permitted daily dose is 6 tablets (12 mg).
Removing the tablet from the foil:

-   grab the edge of the foil;
-   completely remove the foil from the tablet;
-   carefully remove the tablet from the blister.
The tablets must not be pressed out of the blister, as the tablets are fragile and can be easily broken.

If you take more Imodium instant than you should

If you have taken too much Imodium instant, immediately talk to a doctor or turn to a hospital, especially if you get the following symptoms: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms might have severe, life-threatening consequences), muscle rigidity, coordination disorders, drowsiness, difficulties urinating or respiratory depression.
Children are more sensitive to an overdose than adults. If a child ingests more medicine than prescribed or if the listed symptoms occur, talk to a doctor immediately.
Information for the doctor in 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, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects is
Very common
Common
Uncommon
Rare
Very rare

reported as follows:
≥ 1/10
≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 ≥ 1/10,000 to < 1/1,000 1/10,000, including isolated reports

Immune system disorders

Rare   hypersensitivity reactions, anaphylactic reaction (including anaphylactic
shock) and anaphylactoid reaction

Nervous system disorders

Common   headache, dizziness
Uncommon   drowsiness
Rare   coordination disorders, clouding of consciousness, increased muscle tone, loss of
consciousness, limited response to   external irritants

Eye disorders

Rare   narrowing of the pupils

Gastrointestinal disorders

Common   constipation, nausea,    flatulence
Uncommon stomach ache, abdominal discomfort, dry mouth, upper abdominal pain, vomiting, indigestion
Rare   intestinal obstruction (incl. paralytic intestinal obstruction), dilated and flaccid colon
(incl. toxic colon dilation), tongue pain, bloating

Skin and subcutaneous tissue disorders:

Uncommon   rash
Rare   bullous rash (incl. Stevens-Johnson syndrome, toxic epidermal necrolysis, and
multiform redness), hives and itching

Renal and urinary disorders

Rare   urinary retention

General disorders and administration site reactions

Rare   fatigue

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 instant

Store in the original package in order to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after {EXP}. 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 instant contains

The active ingredient is loperamide hydrochloride. One orodispersible tablet contains 2 mg of loperamide hydrochloride.
The other ingredients are: gelatin, mannitol (E421), aspartame (E951), mint flavouring, sodium bicarbonate.

What Imodium instant looks like and contents of the pack

White to off-white, round, freeze-dried tablet with a diameter of approximately 9.5 mm.
6 or 10 tablets in an Al/Al blister pack, packaged in a carton.
The pack contains 6, 10, or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

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

Manufacturer:

Janssen-Cilag S.p.A.,
Via C. Janssen, Borgo S. Michele
IT-04010 Latina
Italy
or
Janssen-Cilag Domaine de Maigremont 27100 Val-De-Reuil France

This leaflet was last revised in April 2017