Scheduling Status
S2
Product Name
IMODIUM® MELT 2 mg TABLETS
Active Ingredient
Each tablet contains 2 mg loperamide hydrochloride.
Sweetener and Other Information
IMODIUM® MELT TABLETS contains:
| Ingredient information | Detail |
|---|---|
| Sweetener | Each tablet contains 0,75 mg aspartame |
| Other relevant ingredient | Contains mannitol |
| Sugar content | Sugar free |
Read Before Taking IMODIUM® MELT TABLETS
IMODIUM® MELT TABLETS is available without a doctor’s prescription for the treatment of a mild illness. It should still be taken carefully to get the best results.
Keep this information for future reference. Do not share IMODIUM® MELT TABLETS with another person. Ask a healthcare provider or pharmacist if more information or advice is needed.
A doctor should be consulted if symptoms worsen or do not improve after 48 hours.
What Is in This Article
- What IMODIUM® MELT TABLETS is and what it is used for
- What you need to know before you take IMODIUM® MELT TABLETS
- How to take IMODIUM® MELT TABLETS
- Possible side effects
- How to store IMODIUM® MELT TABLETS
- Contents of the pack and other information
1. What IMODIUM® MELT TABLETS Is and What It Is Used For
IMODIUM® MELT TABLETS is used to treat diarrhoea in adults and children 6 years and older.
It contains loperamide hydrochloride, which helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost during diarrhoea to be absorbed by the body.
2. What You Need to Know Before You Take IMODIUM® MELT TABLETS
Do Not Take IMODIUM® MELT TABLETS
Do not take IMODIUM® MELT TABLETS in the following situations:
| Do not take IMODIUM® MELT TABLETS if | Details |
|---|---|
| You or your child are allergic to loperamide hydrochloride | This includes allergy to the active ingredient or any other ingredient in the medicine |
| You or your child have acute dysentery | Symptoms may include blood in the stools and fever |
| You have a flare-up of an inflammatory bowel condition | This includes ulcerative colitis |
| You have bowel inflammation caused by bacterial infection | IMODIUM® MELT TABLETS may not be suitable |
| You or your child have severe diarrhoea after taking antibiotics | Medical advice is needed |
| You or your child are constipated | IMODIUM® MELT TABLETS should not be used |
| The stomach appears swollen | This is especially important in children with severe dehydration |
| The child is younger than 6 years | IMODIUM® MELT TABLETS is contraindicated in children under 6 years |
Warnings and Precautions
Take special care with IMODIUM® MELT TABLETS in the following situations:
| Situation requiring care |
|---|
| You or your child have severe diarrhoea, because the body loses more fluid, sugars and salts than normal |
| You or your child have diarrhoea lasting longer than 48 hours |
| You or your child have acquired immunodeficiency syndrome, also known as AIDS, and the stomach becomes swollen |
| You or your child have liver disease |
| You have a history of substance abuse |
If a person with AIDS develops a swollen stomach while taking IMODIUM® MELT TABLETS, treatment should be stopped immediately and a doctor should be contacted.
Children and Adolescents
IMODIUM® MELT TABLETS is contraindicated for use in children under the age of 6 years.
Other Medicines and IMODIUM® MELT TABLETS
Always tell your healthcare provider if you or your child are taking any other medicine, including complementary or traditional medicines.
Tell your doctor or pharmacist if you or your child are using:
| Medicine | Use |
|---|---|
| Quinidine | Used to treat malaria |
| Ritonavir | Used to treat HIV/AIDS |
| Itraconazole or ketoconazole | Used to treat fungal infections |
| Gemfibrozil | Used to treat high cholesterol or high levels of fat in the blood |
| Desmopressin | Used to control increased thirst and excessive urination |
| Other medicines used to treat diarrhoea | May interact or add to effects |
IMODIUM® MELT TABLETS With Food, Drink and Alcohol
Refer to the dosing and administration section for instructions on how to take IMODIUM® MELT TABLETS.
Pregnancy, Breastfeeding and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult a doctor, pharmacist, or other healthcare provider before taking IMODIUM® MELT TABLETS.
The safety of IMODIUM® MELT TABLETS during pregnancy has not been established. Small amounts may pass into breast milk.
Do not use IMODIUM® MELT TABLETS if you are pregnant or breastfeeding your baby.
Driving and Using Machines
Tiredness, dizziness, or drowsiness may occur when you have diarrhoea and are taking IMODIUM® MELT TABLETS.
Do not drive, operate machinery, or perform tasks requiring attention until you know how IMODIUM® MELT TABLETS affects you.
IMODIUM® MELT TABLETS Contains Aspartame
Aspartame is a source of phenylalanine. It may be harmful to people with phenylketonuria, also known as PKU, a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3. How to Take IMODIUM® MELT TABLETS
Do not share medicines with any other person.
IMODIUM® MELT TABLETS is contraindicated in children under the age of 6 years.
Always take IMODIUM® MELT TABLETS exactly as described in the patient information or as directed by a doctor or pharmacist. Check with a doctor or pharmacist if unsure.
Short-Term Diarrhoea
Adults
The usual starting dose is 2 tablets, followed by 1 tablet after each subsequent loose stool.
Children 6 to 12 Years
The usual starting dose is 1 tablet, followed by 1 tablet after each subsequent loose stool.
Maximum Daily Dosage for Children
Do not exceed the following maximum daily doses:
| Weight in kilograms | Maximum daily dose |
|---|---|
| From 14 kg | 2 tablets, equal to 4 mg |
| From 20 kg | 3 tablets, equal to 6 mg |
| From 27 kg | 4 tablets, equal to 8 mg |
| From 34 kg | 5 tablets, equal to 10 mg |
| From 40 kg | 6 tablets, equal to 12 mg |
| From 47 kg | 7 tablets, equal to 14 mg |
| From 54 kg | 8 tablets, equal to 16 mg |
IMODIUM® MELT TABLETS should be stopped as soon as the diarrhoea is under control.
Do not take IMODIUM® MELT TABLETS for attacks lasting longer than 48 hours. If diarrhoea does not improve, contact a doctor.
Long-Lasting Diarrhoea
Long-lasting diarrhoea should be managed in consultation with a doctor.
Adults
The usual dose is 2 tablets daily.
Children Older Than 6 Years
The usual dose is 1 tablet daily.
Instructions for Use and Handling
To remove the tablet from the blister:
| Step | Instruction |
|---|---|
| 1 | Pull the edge of the foil |
| 2 | Tear the foil completely off |
| 3 | Press out the tablet |
| 4 | Remove the tablet |
The fast-dissolving tablets are fragile. They should not be pushed through the blister because this may damage them.
Place the IMODIUM® MELT TABLETS tablet on the tongue. The orodispersible tablet will dissolve and should be swallowed with saliva. No fluid intake is needed.
If the effect of IMODIUM® MELT TABLETS seems too strong or too weak, tell a doctor or pharmacist.
If You Take More IMODIUM® MELT TABLETS Than You Should
In the event of overdose, consult a doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
Take the patient information and the remaining IMODIUM® MELT TABLETS with you so the doctor will know what was taken.
If You Forget to Take IMODIUM® MELT TABLETS
IMODIUM® MELT TABLETS should only be taken as needed.
If a dose is forgotten, take the next dose after the next loose stool.
Do not take a double dose to make up for forgotten individual doses.
4. Possible Side Effects
IMODIUM® MELT TABLETS can have side effects.
Not all side effects reported for IMODIUM® MELT TABLETS are included here. If general health worsens or any unexpected effects occur while taking IMODIUM® MELT TABLETS, consult a healthcare provider.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Very serious allergic reactions | Swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing | Stop taking or giving IMODIUM® MELT TABLETS and tell a doctor immediately or go to the casualty department at the nearest hospital |
| Very serious allergic reactions | Rash or itching | Stop taking or giving IMODIUM® MELT TABLETS and seek urgent medical attention |
| Very serious allergic reactions | Fainting | Stop taking or giving IMODIUM® MELT TABLETS and seek urgent medical attention |
| Serious side effects occurring less frequently | Lack of bowel movements causing severe constipation | Tell a doctor immediately or go to the casualty department at the nearest hospital |
| Serious side effects occurring less frequently | Severe stomach pain or swelling | Tell a doctor immediately or go to the casualty department at the nearest hospital |
| Serious side effects occurring less frequently | Severe, painful skin rash causing blistering or peeling of the skin, also known as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme | Tell a doctor immediately or go to the casualty department at the nearest hospital |
| Serious side effects occurring less frequently | Difficulty urinating | Tell a doctor immediately or go to the casualty department at the nearest hospital |
| Side effects occurring frequently | Headache | Tell a doctor if noticed |
| Side effects occurring frequently | Dizziness | Tell a doctor if noticed |
| Side effects occurring frequently | Constipation, dry mouth, flatulence, stomach cramping or stomach pain, nausea, vomiting, colic | Tell a doctor if noticed |
| Side effects occurring less frequently | Swelling or discomfort of the stomach area, indigestion | Tell a doctor if noticed |
| Side effects occurring less frequently | Drowsiness | Tell a doctor if noticed |
| Side effects occurring less frequently | Abnormal coordination or stiffness, including difficulty moving | Tell a doctor if noticed |
| Side effects occurring less frequently | Reduced level of consciousness or loss of consciousness, including passing out, feeling faint, or feeling less alert | Tell a doctor if noticed |
| Side effects occurring less frequently | Constriction of the pupils | Tell a doctor if noticed |
| Side effects occurring less frequently | Tiredness | Tell a doctor if noticed |
| Side effects not listed | Any side effect not mentioned or any unexpected health change | Inform a doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to a doctor or pharmacist.
Reporting side effects helps provide more information on the safety of IMODIUM® MELT TABLETS.
For further product-related information, the Johnson & Johnson call centre may be contacted on 0860 410032.
5. How to Store IMODIUM® MELT TABLETS
Store IMODIUM® MELT TABLETS at or below 25 °C.
Protect from moisture.
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 unused medicine to a pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, including toilets.
6. Contents of the Pack and Other Information
What IMODIUM® MELT TABLETS Contains
Each tablet contains 2 mg loperamide hydrochloride.
The other ingredients are:
| Other ingredients |
|---|
| Aspartame, also known as E951 |
| Gelatine |
| Mannitol, also known as E421 |
| Mint flavour |
| Sodium hydrogen carbonate |
What IMODIUM® MELT TABLETS Looks Like and Contents of the Pack
IMODIUM® MELT TABLETS are white to off-white, circular, freeze-dried tablets.
They are supplied in a carton containing one aluminium blister with either 6 tablets or 10 tablets.
Holder of Certificate of Registration
Johnson & Johnson (Pty) Ltd.
241 Main Road
Retreat
7945
South Africa
This Leaflet Was Last Revised In
| Item | Date |
|---|---|
| Date of registration | 04 March 2005 |
| Date of revision | 10 March 2022 |
Registration Number
29/11.9/0213
Access to the Corresponding Professional Information
The latest electronic Professional Information may be found through SAHPRA resources or by contacting Johnson & Johnson directly.
Consumer Contact Centre
| Contact method | Detail |
|---|---|
| Telephone | 0860 410032 |
| SMS | SMS “jnj” and comment to +27 83 293 3273 |
| jnjza@its.jnj.com |
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist, or healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
