Imodium ® 2 mg Tablets

IMODIUM ® 2 mg is used to treat diarrhoea in adults and children 6 years and older. It contains loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by your body. In children under the age of 6 years IMODIUM ® 2 mg is used to slow down an overactive bowel. IMODIUM ® 2 mg is not indicated for use in children under the age of 2 years and is not suitable for use in children under 6 years of age. It should only be given to children under the age of 6 years with a prescription and under the supervision of a doctor.

Do not take IMODIUM ® 2 mg:

• if you or your child are hypersensitive (allergic) to loperamide hydrochloride or any of the other ingredients of IMODIUM ® 2 mg (see What IMODIUM ® 2 mg contains);
• if you or your child have acute dysentery (symptoms may include blood in your stools and fever);
• if you have a flare - up of an inflammatory bowel condition like ulcerative colitis or if you have inflammation of your bowels caused by bacterial infections;
• if you or your child have severe diarrhoea after taking antibiotics;
• if you or your child are constipated, or your stomach appears swollen (especially in children with severe dehydration).

IMODIUM ® 2 mg is contraindicated for use in children under the age of 2 years.

Warnings and precautions

Take special care with IMODIUM ® 2 mg:

• if you or your child have severe diarrhoea as your body loses more fluid, sugars and salts than normal. IMODIUM ® 2 mg should only be given to children under the age of 6 years with a prescription and under the supervision of a doctor;
• if you or your child have diarrhoea that lasts for more than 48 hours;
• if you or your child have acquired immunodeficiency syndrome (AIDS) and you suffer from severe constipation or your stomach becomes swollen, stop taking IMODIUM ® 2 mg immediately and contact your doctor;
• if you or your child suffer from any liver disease;
• if you have a history of substance abuse.

Children and adolescents

IMODIUM ® 2 mg is contraindicated for use in children under the age of 2 years and is not suitable for use in children under 6 years of age. It should only be given to children under the age of 6 years with a prescription and under the supervision of a doctor.

Other medicines and IMODIUM ® 2 mg

Always tell your health care provider if you or your child are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you or your child are currently using:

• quinidine (used to treat malaria);
• ritonavir (used to treat HIV/AIDS);
• itraconazole or ketoconazole (used to treat fungal infections);
• gemfibrozil (used to treat cholesterol (high levels of fat in your blood));
• desmopressin (used to control increased thirst and too much urination);
• any other medicines used to treat diarrhoea.

IMODIUM ® 2 mg with food, drink and alcohol See section 3.

Do not share medicines with any other person. IMODIUM ® 2 mg is contraindicated in children under the age of 2 years. The tablets are not suited for children under 6 years of age and should only be given to children under the age of 6 years under medical prescription or supervision.

Short - term diarrhoea:

Adults: The usual dose is 2 tablets as an initial dose, followed by 1 tablet after each subsequent loose stool.

Children (older than 6 years): The usual dose is 1 tablet as an initial dose followed by 1 tablet after each subsequent loose stool.

Do not exceed the following maximum daily dosages:

Always take IMODIUM ® 2 mg exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. It is important that you stop taking IMODIUM ® 2 mg as soon as your or your child’s diarrhoea is under control. Do not take for attacks that last longer than 48 hours. If your diarrhoea does not get better, you must contact your doctor.

Long - lasting diarrhoea (as per consultation with your doctor)

Adults: The usual dose is 2 tablets daily. Children (older than 6 years): The usual dose is 1 tablet daily.

Instructions for use:

Swallow the tablets with a drink of water. If you have the impression that the effect of IMODIUM ® 2 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more IMODIUM ® 2 mg than you should In the event of an overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining IMODIUM ® 2 mg with you so the doctor will know what you have taken.

If you forget to take IMODIUM ® 2 mg You should only take IMODIUM ® 2 mg as you need it. If you forget to take a dose, take your next dose after your next loose stool. Do not take a double dose to make up for forgotten individual doses.

IMODIUM ® 2 mg can have side effects. Not all side effects reported for IMODIUM ® 2 mg are included in this leaflet. Should your or your child’s general health worsen or if you or your child experience any untoward effects while taking IMODIUM ® 2 mg, please consult your health care provider for advice.

If any of the following happens, stop taking or giving IMODIUM ® 2 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you or your child may have had a serious allergic reaction to IMODIUM ® 2 mg. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Side effects occurring less frequently:

• lack of bowel movements causing severe constipation;
• severe stomach pain or swelling including inflammation of your pancreas known as pancreatitis (pain of the stomach area that radiates to your back, tenderness when touching your abdomen, fever, rapid pulse, nausea, vomiting);
• severe, painful skin rash causing blistering or peeling of the skin, also known as Stevens - Johnson syndrome, toxic epidermal necrolysis or erythema multiforme;
• difficulty urinating.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• headache;
• dizziness;
• constipation, dry mouth, flatulence (excessive wind), cramping or pain in your stomach area, nausea (feeling sick), vomiting (being sick), colic.

Side effects occurring less frequently:

• swelling or discomfort of your stomach area, indigestion;
• drowsiness;
• abnormal coordination, stiffness (difficulty moving);
• reduced level of consciousness or loss of consciousness (passing out, feeling faint or less alert);
• constriction of your pupils;
• tiredness.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of IMODIUM ® 2 mg. For further information, please contact the Johnson and Johnson call centre on 0860 410032 (landline).

• Store at or below 25 °C.

• Protect from light.

• Keep in the original container until required for use.

• Store all medicines out of reach of children.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).