2 mg /125 mg tablets
loperamide hydrochloride, dimethicone
1. What Imodium Plus is and what it is used for
The tablets contain two active substances:
- Loperamide hydrochloride, which reduces diarrhea by normalizing excessive bowel movements and which also facilitates the absorption of water and salts from the intestine.
- Dimethicone, which dissolves the gas bubbles in the gastrointestinal tract that cause stomach cramps and bloating.
Imodium Plus tablets are used in adults and adolescents over the age of 12, to treat temporary diarrhea when the diarrhea is associated with stomach cramps, bloating, and flatulence.
2. What you need to know before using Imodium Plus
Do not use Imodium Plus
- to children under 12 years.
- if you are allergic (hypersensitive) to loperamide hydrochloride, dimethicone or any of the other ingredients of the tablets (see section 6).
- if you have a fever (above 38 ° C) or blood in your stools.
- if you have a relapse of an inflammatory bowel disease such as ulcerative colitis .
- if you have severe diarrhea after using antibiotics .
- if you are constipated or if your stomach appears to be swollen.
Warnings and cautions
Talk to your doctor or pharmacist before taking Imodium Plus.
- Imodium Plus only treats the symptoms of diarrhea. In some cases, the cause of your diarrhea may require treatment. If symptoms persist or worsen, consult your doctor. If you have severe diarrhea, your body loses more fluid, sugar and salts than normal. You need to compensate for the fluid loss by drinking more than you normally do. Ask the pharmacy staff about preparations that replace sugar and salts.
- If you have AIDS and your stomach swells, stop taking the tablets immediately and contact a doctor.
- If you have liver disease, you should consult your doctor before starting treatment with the tablets. Some of the side effects can be more troublesome.
Do not take this medicine for anything other than its intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (with symptoms such as fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active substance in Imodium Plus.
In case of temporary diarrhea, the symptoms usually stop within 2 days. If symptoms persist after that period, discontinue treatment and consult a physician.
Important information about some of the ingredients of Imodium Plus
Each Imodium Plus tablet contains less than 0.026 mg of benzyl alcohol. Benzyl alcohol can cause allergic reactions. If you have or have had liver or kidney problems or if you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
This medicine contains less than 0.00044 mg of alcohol ( ethanol ) in each tablet. The low amount of alcohol in this medicine does not produce any noticeable effects.
This medicine contains maltodextrin which contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Children
Children under 12 years of age should not take Imodium Plus.
Other medicines and Imodium Plus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including:
- quinidine (used to treat heart rhythm disorders and malaria )
- itraconazole or ketoconazole ( antifungal )
- gemfibrozil (used to treat high cholesterol )
- ritonavir (used to treat HIV – infection and AIDS )
- desmopressin (used to control thirst and urine output in patients with diabetes insipidus ).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as Imodium Plus may interact with them.
Pregnancy and breastfeeding
Pregnancy: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding: Imodium Plus is not recommended if you are breastfeeding. Small amounts of the drug may pass into breast milk.
Driving and using machines
This medicine may make you feel dizzy, tired, or drowsy. If you experience these symptoms, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Imodium Plus
Always use this medicine exactly as described in this leaflet or according to the instructions of your pharmacist. If you are not sure, talk to a pharmacist.
- Swallow the tablets whole with water.
- For oral use only .
- Do not use more than the recommended dose .
Use for adults over 18 years
Swallow 2 tablets to begin with. Then take 1 tablet after each loose stool (bowel movement). Take a maximum of 4 tablets per day. If the symptoms do not stop after 2 days, stop taking the tablets and consult a doctor.
Use for children and adolescents between 12 and 18 years
Swallow 1 tablet to begin with. Then take 1 tablet after each loose stool (bowel movement). Take a maximum of 4 tablets per day. If the symptoms do not stop after 2 days, stop taking the tablets and consult a doctor.
Use for children and adolescents under 12 years of age
Do not give Imodium Plus tablets to children under 12 years of age.
If you take more Imodium Plus than you should
If you take more Imodium Plus then you should contact your doctor or hospital immediately for advice. Symptoms may include increased heart rate, irregular heartbeat, changes in a heartbeat (these symptoms can potentially have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or poor breathing. You may become dry in the mouth or have reduced pupils. You may have a stomach ache, feel sick or vomit or become constipated.
Children react more strongly than adults to large amounts of Imodium Plus. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.
If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Imodium Plus
Take one tablet after the next loose stool (bowel movement). Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and see a doctor immediately if you get any of the following
Allergic reactions including swelling of the face, tongue, or throat, difficulty swallowing, inexplicable wheezing when breathing, shortness of breath that may be accompanied by skin rash or hives.
Stop taking this medicine and talk to your doctor if you get any of the following
- Difficulty throwing water.
- Severe abdominal pain, bulging or swollen stomach or fever which may be a sign of blocked or enlarged bowel.
- Severe constipation.
The following side effects may also occur:
Common side effects (may affect up to 1 in 10 people):
Headache, nausea, taste changes.
Uncommon side effects (may affect up to 1 in 100 people):
Drowsiness, dizziness, weakness, constipation, vomiting, indigestion, flatulence, dry mouth, rash.
Rare side effects (may affect up to 1 in 1,000 people):
Unconsciousness or decreased level of consciousness, small pupils, a skin rash that can lead to severe blistering and skin detachment, hives, itching, fatigue.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imodium Plus
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 blister and carton. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are loperamide hydrochloride (2 mg per tablet) and simethicone (measured as 125 mg dimethicone per tablet).
- The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, acesulfame potassium, synthetic vanilla flavor (containing propylene glycol, maltodextrin, ethanol and benzyl alcohol), sodium starch glycolate (Type A) and stearic acid.
What the medicine looks like and contents of the pack
The tablets are white, capsule-shaped, and marked with “IMO” on one side, the other side is marked with “2” and “125” with a line in between.
Each pack contains: 6, 8, 10, 12, 15, 16, 18 or 20 tablets in blister cards.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
Janssen-Cilag SPA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
or
Janssen-Cilag – Val de Reuil, Domaine de Maigremont, 27100 Val de Reuil, France.