2 mg orodispersible tablets
loperamide hydrochloride
1. What Imodium is and what it is used for
Imodium normalizes bowel movements, counteracts fluid loss, and increases the ability to hold stools.
Imodium is used for temporary ( acute ) diarrhea. Can also be prescribed by a doctor for other uses such as prolonged ( chronic ) diarrhea and in the “bag on the stomach” ( stoma ) after certain gastrointestinal surgeries or in the event of inability to hold the stool (feces incontinence).
Imodium orodispersible tablet is placed on the tongue. The tablet has a mint taste and dissolves quickly in the mouth, and can be swallowed without water.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
2. What you need to know before taking Imodium
Do not take Imodium
- if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
- in the case of blood in the stool or in case of high fever (intestinal infection caused by bacteria such as Salmonella , Shigella and Campylobacter ).
- in inflammation of the colon (eg ulcerative colitis or pseudomembranous colitis caused by antibiotics ).
- if the passage of food through the intestine is already slow, for example if you are constipated or bothered by a tense stomach.
Imodium should not be given to children under 12 years of age.
Warnings and cautions
- Treatment with Imodium relieves symptoms but does not cure the cause. Before long-term treatment, therefore, the underlying disease must be investigated and treatment against it put in the first place.
- If temporary diarrhea has not stopped after two days of treatment, stop treatment and consult a doctor.
- In case of signs of constipation or other signs of impaired bowel passage, stop treatment and consult a doctor.
- If you have impaired liver function, you should consult a doctor before starting treatment with Imodium.
- With diarrhea, you lose a lot of fluid. It is therefore important that you compensate for the fluid loss by drinking a lot.
- If you have AIDS , stop taking Imodium at the first sign of a tummy tuck.
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.
Children
Imodium should not be given to children under 12 years of age.
Other medicines and Imodium
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can affect or be affected by treatment with Imodium if taken at the same time. Examples of such drugs are:
- cholestyramine and gemfibrozil (lipid lowering)
- quinidine (for heart rhythm disorders and malaria )
- ritonavir (for HIV / AIDS)
- cyclosporine (inhibits the immune system)
- verapamil (lowering blood pressure)
- erythromycin and clarithromycin ( antibiotics )
- itraconazole and ketoconazole ( antifungal agents)
- oral desmopressin (agents used to control thirst and urine output in patients with diabetes insipidus and bedwetting in children and nocturnal urination in adults)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Limited experience of use during pregnancy. Ask your doctor for advice before taking Imodium if you are pregnant or think you may be pregnant.
Breast-feeding
Imodium is not recommended if you are breastfeeding as small amounts of the medicine may pass into breast milk.
Driving and using machines
Fatigue, dizziness, and drowsiness may occur during treatment with Imodium.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Imodium contains aspartame, sulphite, alcohol (ethanol), benzyl alcohol and sodium
Imodium orodispersible tablets contain 0.75 mg aspartame per tablet. Aspartame is a source of phenylalanine. It can be harmful to people with phenylketonuria (PKU), a rare inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
The flavoring substance (mint) may contain small amounts of sulphite, which in rare cases can cause severe hypersensitivity reactions and cramps in the trachea. The flavoring (mint) also contains 0.03 micrograms of alcohol ( ethanol ) in each tablet. The low amount of alcohol in this medicine does not produce any noticeable effects. In addition, the flavoring (mint) contains 0.66 micrograms of benzyl alcohol per tablet. Benzyl alcohol can cause allergic reactions. If you have 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 orodispersible tablet, ie it is essentially ‘sodium-free ‘.
3. How to take Imodium
Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
In case of temporary diarrhea:
The usual dose for adults and adolescents from 12 years of age: Start with 2 tablets. If diarrhea has not stopped within 2-3 hours, take 1 tablet at a time after each loose stool. Take a maximum of 8 tablets per day. Take Imodium for a maximum of 2 days straight. Doctors may prescribe another dosage.
In case of chronic diarrhea: Dose one is determined by the doctor who adjusts it individually for you.
The usual dose for adults and adolescents from 12 years: 1-8 tablets/day. Take a maximum of 8 tablets per day.
The tablet is placed on the tongue. The tablet dissolves in the mouth and can be swallowed without water. The tablets break easily and should therefore be handled with care.
The antidiarrheal effect is achieved within one hour after taking 2 tablets (4 mg).
- Fold up the foil edge
- Peel off the foil completely.
- Push up the tablet.
- Lift the tablet.
Do not push the tablet through the foil. It may damage the tablet as it is brittle.
If you take more Imodium than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you take more Imodium than 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.
Children react more strongly than adults to large amounts of Imodium. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.
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 Imodium and contact your doctor immediately if you get any of the following rare symptoms:
- swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing. This is a sign of angioedema .
- extreme fatigue, coordination problems and loss of consciousness or loss of consciousness.
- severe abdominal pain and / or swollen stomach which may be a sign of blocked or enlarged bowel.
- Lyellas syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (dermal detachment of the epidermis and superficial mucous membranes).
- Stevens-Johnson syndrome: An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.
The following side effects have been reported:
Common (may affect up to 1 in 10 people): constipation, nausea, flatulence/gas, headache, and dizziness.
Uncommon (may affect up to 1 in 100 people): drowsiness, abdominal pain or discomfort, dry mouth, vomiting, indigestion, and rash.
Rare (may affect up to 1 in 1,000 people): Hypersensitivity reactions (such as anaphylactic shock ), muscle stiffness, small pupils, tongue pain, itching, hives, and difficulty urinating.
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
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
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 substance is loperamide hydrochloride 2 mg.
- The other ingredients are gelatin, mannitol (E421), aspartame (E951), flavoring (mint) and sodium bicarbonate.
What the medicine looks like and contents of the pack
White to off-white, round tablet.
Blister with 2, 3, 4, 6, 12, 18, 24 tablets.
Not all pack sizes may be marketed.