Package leaflet: Information for users. Imodium 2 mg orodispersible tablets Loperamide hydrochloride

Transcription

1 MARKETING AUTHORISATION NO. 7810/2015/ Annex 1 Package leaflet Package leaflet: Information for users Imodium 2 mg orodispersible tablets Loperamide hydrochloride Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. - You must talk to a doctor if you do not feel better or if you feel worse after two days. What is in this package leaflet: 1. What Imodium is and what it is used for 2. What you need to know before using Imodium 3. How to use Imodium 4. Possible side effects 5. How to store Imodium 6. Contents of the pack and other information 1. What Imodium is and what it is used for Imodium is indicated for the control of the symptoms of acute and chronic diarrhea. Imodium is one of a group of antidiuretic, antiinflammatory/antiseptic intestinal medicines and is an antipropulsive. In the case of diarrhea, Imodium makes the stools more consistent and less frequent. Imodium may also be recommended to you if you have had part of your intestine removed as this can cause frequent diarrhea. 2. What you need to know before using Imodium Imodium should not be administered to children under the age of six. Do not use Imodium: - If you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine; - if there is blood in your stools or you have a fever; - if you have an inflammation of the lower abdomen (for example ulcerative colitis or pseudomembranous colitis as a result of the use of antibiotics); 1

2 - If your doctor has told you that you need to avoid any slowing of your intestinal activity, for example if you are constipated or your abdomen is distended; - if you have bacterial enterocolitis caused by aggressive microorganisms such as Salmonella, Shigella or Campylobacter. If you have any concerns, ask your doctor or pharmacist for advice. Warnings and precautions Talk to your doctor or pharmacist before taking Imodium. - Although Imodium stops diarrhea, it does not treat the cause of this. Whenever possible, the cause of diarrhea must also be treated; - When you have diarrhea, you lose a lot of liquid. You therefore need to replace the liquid you have lost (drink more liquid). This is important for young children in particular. Your pharmacist will be able to offer you a special powder which contains sugar and mineral salts. When this is added to water, it will replace the salts you lost during an episode of diarrhea. The solution is indicated for children in particular; - In the case of a sudden (acute) attack of diarrhea, Imodium will generally stop the symptoms within 48 hours. If this does not happen, stop treatment and contact your doctor; - If you have AIDS and are treated with Imodium for diarrhea, if you have any signs of bloating or swelling of the abdomen stop treatment with Imodium immediately and tell your doctor; - Tell your doctor if you have any liver problems; you may need careful medical care while you are taking Imodium. Other medicines and Imodium Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including non-prescription medicines. Tell your doctor if you are using medicines which slow the activity of the stomach or intestinal peristalsis (such as anticholinergics) as these may intensify the effect of Imodium. Food and drink and Imodium The tablet dissolves and is swallowed with the saliva. You do not need to take orodispersible tablets with liquid. Pregnancy and breast-feeding Contact your doctor or pharmacist for advice before taking any medicines. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Imodium. It is recommended that you do not use Imodium if you are breast-feeding because small amounts of Imodium may get into your breast milk. Driving and using machines Imodium has no effect on the ability to drive or use machines. Tiredness, dizziness and sleepiness can accompany diarrhea, so it is recommended that you take precautions when driving or using machines. Important information on some of the other ingredients of this medicine It contains aspartame (E 951), a source of phenylalanine. This may harm people with phenylketonuria. 2

3 3. How to use Imodium The dose of Imodium you should take depends on your age and the type of diarrhea. The orodispersible tablet should be placed on the tongue. Orodispersible tablets are fragile and should not be pushed through the blister as this may damage them. To remove the orodispersible tablets from the blister: lift up the edge of the foil remove the foil completely push to press out the tablet remove the tablet Adults and elderly patients for acute diarrhea (a sudden episode), take two orodispersible Imodium tablets (4 mg loperamide hydrochloride) once, then take 1 Imodium tablet (2 mg loperamide hydrochloride) after each stool. If you have a solid or hard stool or if more than 24 hours pass without a stool, stop treatment. for long-lasting diarrhea (chronic), the exact dose will be determined together with your doctor. But do not administer more than 8 orodispersible Imodium tablets (16 mg loperamide hydrochloride) within 24 hours! Children over the age of six for acute diarrhea (a sudden episode of diarrhea), take one orodispersible Imodium tablet (2 mg loperamide hydrochloride) then continue with 1 orodispersible Imodium tablet (2 mg loperamide hydrochloride) for each stool. If the child has a solid or hard stool or if more than 24 hours pass without a stool, stop treatment. for chronic diarrhea (long-lasting), the exact dose will be determined together with your doctor. But never administer more than the recommended dose per day and per kilogram of body weight of your child! Child's body weight in kilograms (kg) From 14 kg From 20 kg From 27 kg From 34 kg From 40 kg From 47 kg From 54 kg Maximum number of Imodium tablets per day Never more than 2 orodispersible Imodium tablets Never more than 3 orodispersible Imodium tablets Never more than 4 orodispersible Imodium tablets Never more than 5 orodispersible Imodium tablets Never more than 6 orodispersible Imodium tablets Never more than 7 orodispersible Imodium tablets Never more than 8 orodispersible Imodium tablets If the stools become normal or if a stool is not passed for 12 hours, stop the administration of Imodium. 3

4 The maximum dose in the case of acute and chronic diarrhea is 8 tablets (16 mg) per day for adults; in the case of children the dose should correlate with the child's body weight (3 tablets/20 kg) but a maximum of 8 tablets per day should not be exceeded. If you have any concerns, ask your doctor or pharmacist for advice. If you use more Imodium than you should If you have taken too many Imodium 2 mg orodispersible tablets, contact your doctor, particularly if you have any of the following symptoms: dizziness, muscle rigidity, uncoordinated movements, sleepiness, superficial respiration or difficulty with micturition. Children react more strongly than adults to high doses of Imodium 2 mg orodispersible tablets. If a child has taken too much of the medicine or is any of the symptoms above occur, contact a doctor immediately. Information for the doctor in the case of an overdose: - Injectable naloxone is to be administered as an antidote. - The administration of naloxone can be repeated after 1-3 hours if necessary. - The patient should be monitored for at least 48 hours. If you forget to use Imodium Do not take a double dose to compensate for the dose you forgot. If you stop using Imodium Stopping treatment prematurely will not have a direct effect, but it is possible that the condition you were using Imodium to treat may improve more slowly. If you have any additional questions about this medicine contact your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them and the majority are moderate. You should seek urgent medical assistance if you experience any of the following: - Allergic reactions including inexplicable wheezing, shortness of breath, fainting or swelling of the face or throat. - Skin rash which may be severe and include vesicles or flaking of the skin - Loss of consciousness or low level of consciousness (fainting, feeling faint or less alert), uncoordinated movements Talk to your doctor as soon as possible if any of the following occur: - Itching or urticaria. - Stomach pain or bloated stomach. - Difficulty urinating. - Severe constipation. - Burning or prickling sensation in the tongue. - Miosis (narrowing of the pupils). If you notice any of the reactions above, stop taking this medicine and talk to a doctor. Other reactions which may occur include tiredness. Side effects which appeared during treatment for acute diarrhea: Common (affects less than 1 in 10 people): - Nausea, constipation or intestinal gas, - headaches 4

5 Uncommon (affects less than 1 in 100 people): - Dizziness - Vomiting, indigestion - Stomach pain - Dry throat - Itching Rare (affects less than 1 in 100 people): bloating of the stomach Side effects which appeared during treatment for chronic diarrhea: Common (affects less than 1 in 10 people): - Dizziness - Nausea, constipation or intestinal gas, Uncommon (affects less than 1 in 100 people): - headaches - Stomach pain - Dry throat - Indigestion If any of the side effects becomes serious or you notice any side effects which are not mentioned in this package leaflet, please tell your doctor or pharmacist. Side effects in children are expected to be similar to those described above which occur in adults. Reporting side effects If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system, the details of which are published on the website of the National Agency for Medicines and Medical Devices By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Imodium Keep this medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month. Store in the original packaging to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Imodium contains - The active substance is loperamide hydrochloride. One orodispersible tablet contains 2 mg of loperamide hydrochloride. - The other excipients are: gelatin, mannitol, mint flavoring, sodium hydrogen carbonate. 5

6 What Imodium looks like and contents of the pack Imodium is available as round white to nearly white tablets. Its is available in boxes containing 2, 3, or 4 PVC/OPA/Alu/OPA/PVC paper/plt/alu blister packs each with 6,12,18 or 24 orodispersible tablets. Not all pack sizes may be marketed. Marketing Authorization Holder Great Britain Manufacturer JANSSEN-CILAG S.P.A Via C. Janssen, Borgo San Michelle, Latina, Italy This package leaflet was approved in July