Imodium Instant Melts Imodium Instant Melts

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. ¦ If it is for a child aged under 12 (or under 18 for an IBS patient). ¦ If you have severe diarrhoea after taking antibiotics. ¦ If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis. ¦ If you are constipated, or your stomach appears swollen (especially in children with severe dehydration). ¦ If 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®. Talk to your doctor first… ¦ If you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor. ¦ If you suffer from liver disease. ¦ If you have diarrhoea that lasts for more than 48 hours. ¦ If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal. ¦ If 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. ¦ Do not take this product for anything other than its intended use and never take more than the recommended amount (see section 3). 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® Instant Melts. Some of the ingredients can cause problems ¦ This medicine contains 0.750 mg of Aspartame (E951) which is equivalent to 0.055 mg/mg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. ¦ Mint flavour contains traces of sulphites. This may rarely cause severe hypersensitivity reactions and bronchospasm. ¦ This medicine contains less than 0.00003 mg of alcohol (ethanol) in each tablet. The small amount of alcohol in this medicine will not have any noticeable effects. ¦ This medicine contains 0.00066 mg benzyl alcohol in each dose (2 mg) which is equivalent to 0.00033 mg/mg. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, or if pregnant or breast feeding. This is because large amounts of benzyl alcohol can buildup in your body and may cause side effects (called “metabolic acidosis”). ¦ This medicine contains less than 1 mmol sodium (23 mg) per tablet, 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 you are aged under 18. Talk to your doctor first… ¦ If you are aged 40 or over and it is some time since your last IBS attack. ¦ If you are aged 40 or over and your IBS symptoms are different this time. ¦ If you have recently passed blood from the bowel. ¦ If you suffer from severe constipation. ¦ If you are feeling sick or vomiting. ¦ If you have lost your appetite or lost weight. ¦ If you have difficulty or pain passing urine. ¦ If you have a fever. ¦ If you have recently travelled abroad. If any of these applies to you, talk to your doctor before taking IMODIUM®

IMODIUM® 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), uncoordinated movements. 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. ¦ Burning or prickling sensation of the tongue. ¦ Miosis (narrowing of the pupils of the eye). 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) ¦ Feeling sick, constipation or wind. ¦ Headache.

 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) ¦ Tiredness.

 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Short-term diarrhoea:

• Adults and children over 12 years: Take 2 tablets to start treatment. Take 1 tablet after each loose bowel movement, up to a maximum of 6 tablets per day.
• If your diarrhoea lasts for more than 48 hours, consult your doctor.
• Not recommended for children under 12 years.

IBS diarrhoea, previously diagnosed by a doctor:

• Adults aged 18 years and over: Take 2 tablets to start treatment. Take 1 tablet after each loose bowel movement, or as previously advised by a doctor, up to a maximum of 6 tablets per day.
• You can use this medicine for up to 2 weeks for repeated attacks, but do not take for any one attack lasting longer than 48 hours. If your symptoms change, worsen or are not improved after 2 weeks, consult your doctor.

Please read the enclosed leaflet carefully before use.

The active ingredient in IMODIUM® Instant Melts is: Loperamide hydrochloride 2 mg per tablet.

 Other ingredients are: Gelatin, mannitol, aspartame, mint flavour and sodium hydrogen carbonate.