Warnings for everyone
This medicine is suitable for most people, but a few people should not use it:
Do not take this medicine if:
- You have ever had a bad reaction to any of the ingredients.
- You are under 18 years for an IBS patient (or under 12 years for short-term diarrhoea).
- You have severe diarrhoea after taking antibiotics.
- You are having a flare-up of an inflammatory bowel condition like ulcerative colitis.
- You are constipated, or your stomach appears swollen (especially in children with severe dehydration).
- You have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.
If any of these applies to you, talk to a doctor or pharmacist and do not take IMODIUM® SoftGels 2mg Capsules.
Talk to your doctor first if:
- You have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor.
- You suffer from liver disease.
- You have diarrhoea that lasts for more than 48 hours.
- You have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
- You are taking any other medicines, including: ritonavir (used to treat HIV), quinidine (used to treat abnormal heart rhythms or malaria), oral desmopressin (used to treat excessive urination), itraconazole or ketoconazole (used to treat fungal infections), gemfibrozil (used to treat high cholesterol).
If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.
Pregnancy or breast-feeding
- If you are pregnant, think you are pregnant or planning a pregnancy: ask your doctor or pharmacist for advice before taking this medicine.
- If you are breast-feeding: do not take this medicine. Small amounts may get into your milk. Talk to your doctor about a suitable treatment.
Special warnings about this medicine
- This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If you're affected do not drive or use machines.
- Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.
- Consult with a doctor if you have a history of drug abuse.
- Loperamide is a type of opioid that acts directly on the gut when used as recommended but can cause other opioid effects when misused at high doses. Addiction is observed with opioids as a class.
- Abuse and misuse of loperamide, the active ingredient in IMODIUM® SoftGels 2mg Capsules, have been reported. Do not take this product for anything other than its intended use and never take more than the recommended amount.
- Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in IMODIUM® SoftGels 2mg Capsules.
Some of the ingredients can cause problems
- IMODIUM® SoftGels 2mg Capsules contain soya lecithin. If you are allergic to soya or peanut, do not use this medicinal product.
- This medicine contains 115.31 mg Propylene Glycol in each capsule which is equivalent to 0.65 mg/mg.
- This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
Extra warnings for IBS patients
Use only if your doctor has previously diagnosed IBS. Check the following:
Do not take this medicine if:
Talk to your doctor first if:
- You are aged 40 or over and it is some time since your last IBS attack.
- You are aged 40 or over and your IBS symptoms are different this time.
- You have recently passed blood from the bowel.
- You suffer from severe constipation.
- You are feeling sick or vomiting.
- You have lost your appetite or lost weight.
- You have difficulty or pain passing urine.
- You have a fever.
- You have recently travelled abroad.
If any of these applies to you, talk to your doctor before taking IMODIUM® SoftGels 2mg Capsules.
Possible side effects
IMODIUM® SoftGels 2mg Capsules can have side effects, like all medicines, although these don't affect everyone and most are usually mild.
Get medical help at once (Rare: affects less than 1 in 1,000 but 1 or more in 10,000 people)
- Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat.
- Skin rashes, which may be severe and include blistering or peeling skin.
- Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), muscle stiffness and uncoordinated movements.
- Not known (frequency cannot be estimated from the available data): Upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
If you get any of these, stop using the medicine and get medical help at once.
Talk to a doctor as soon as possible (Uncommon: affects less than 1 in 100 but 1 or more in 1,000 people)
- Itchiness or hives.
- Stomach pain or swollen stomach.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people)
- Difficulties passing water.
- Severe constipation.
- Miosis (narrowing of the pupils of the eye).
- Hypertonia (muscle tension).
- Coordination abnormality (uncoordinated movements).
If you notice any of the above, stop using the medicine and talk to a doctor.
Other effects that may occur
Common: (affects less than 1 in 10 but 1 or more in 100 people)
Uncommon: (affects less than 1 in 100 but 1 or more in 1,000 people)
- Dizziness or drowsiness.
- Vomiting, indigestion.
- Dry mouth.
Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people)
Dietary soya-products are known to cause allergic reactions including severe anaphylaxis in persons with soya allergy. Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Storing this medicine
Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package to protect from moisture. Keep blister in the outer carton to protect from light. Do not use your medicine after the date shown as the expiry date on the packaging. 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.
