Package leaflet: Information for the patient. Pikopil druppels voor oraal gebruik, oplossing, 7.5 mg/ml. Sodium picosulfate

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1 Package leaflet: Information for the patient Pikopil druppels voor oraal gebruik, oplossing, 7.5 mg/ml Sodium picosulfate Read all of this leaflet carefully before you start taking 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 have 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 3 days. What is in this leaflet 1. What Pikopil is and what it is used for 2. What you need to know before you take Pikopil 3. How to take Pikopil 4. Possible side effects 5. How to store Pikopil 6. Contents of the pack and other information 1. What Pikopil is and what it is used for Pikopil contains an active substance called sodium picosulfate. Pikopil belongs to a group of medicines called laxatives. Pikopil works by stimulating your bowel movements. It also increases the amount of water in your bowel. Pikopil is used for short-term relief of prolonged or recurrent constipation. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. What you need to know before you take Pikopil Do not take Pikopil, if you are/have: - allergic to sodium picosulfate, other substances belonging to a group of triarylmethane (e.g., bisacodyl) or any of the other ingredients of this medicine (listed in section 6). - severe dehydration (i.e., lost too much water from your body) - a blocked bowel (intestinal obstruction) - a serious abdominal problem such as appendicitis - acute inflammatory bowel disease - severe abdominal pain whith makes you feel or be sick - sudden, severe abdominal pain just before intake - a bowel problem called ileus where your small intestine is blocked. Do not take Pikopil if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Pikopil. Warnings and precautions If you take Pikopil for a long time or in high doses, it may affect the amounts of fluids and salts in your body. In particular, you may get low levels of potassium (hypokalaemia), low levels of water (dehydration) or diarrhoea. 1

2 Dizziness and fainting may occur, usually by straining at stool or in conjunction with abdominal pain due to constipation. You should not take Pikopil every day or over a long period. If you find you need to take this medicine every day or if the symptoms persist or recur frequently, you should consult your doctor so that the cause of your constipation can be investigated. If you do not have a bowel movement after using Pikopil, stop taking this medicine. If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Pikopil. Children and adolescents Ask your doctor or pharmacist for advice before giving Pikopil to your child. Pikopil is less effective in children younger than 4 years. Other medicines and Pikopil Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Pikopil can affect the way some other medicines work. Also some other medicines can affect the way Pikopil works. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: prescribed medicines that may affect the amounts of fluids and salts in your body e.g.: water tablets (diuretics) such as bendrofluazide or furosemide (frusemide), steroid medicines such as prednisolone. certain medicines used to treat heart conditions (such as digoxin, digitoxin). Imbalance of the amounts of fluids and salts in your body may lead to increased sensitivity to the effect of these medicines. antibiotics (for infections). Concurrent administration of broad-spectrum antibiotics may reduce the effect of Pikopil. Pregnancy and breast-feeding 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 this medicine. You should not use Pikopil during pregnancy or breast-feeding unless your doctor decides it is necessary. Driving and using machines Dizziness and fainting may occur, usually by straining at stool or in conjunction with abdominal pain due to constipation. If you are affected in this way, use caution when you are driving a car or using machines. Pikopil contains sorbitol If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take Pikopil Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded. 2

3 Dosing for adults The recommended daily dose is 8 to 12 drops at once. You can take more or less drops, so that the dose is found that is most suitable for you. Use in children and adolescents Ask your doctor or pharmacist for advice before giving Pikopil to your child. For children younger than 4 years Pikopil is less effective. The recommended daily dose for children is: Children over 6 years: 8 to 12 drops at once Children aged 4 to 6 years: 6 drops at once. Method of administration Count drops onto a spoon to administer the oral solution. Hold the vial upside down with the dropper pointing down vertically and gently squeeze the vial. The dropping speed does not exceed 2 drops per second. If a drop contains air bubble, do not count it and release additional drop. Take Pikopil with or without additional liquid at bedtime. The effect usually occurs after about 6 to 12 hours, so it will not disrupt your sleep. While you are taking this medicine, drink plenty of water through the day. This is to stop you getting dehydrated. Duration of treatment Do not take Pikopil for more than 3 subsequent days. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. If you take more Pikopil than you should If you take more of this medicine than you should, contact your doctor or go to a nearest hospital immediately. Take the pack of this medicine with you. This is so the doctor knows what you have taken. Drink plenty of water. You may experience massive diarrhoea or severe abdominal cramps. Furthermore, failures occur in the concentrations of salts in the body (mainly a low potassium level) when a lot of moisture loss. In severe overdoses, there are reported cases of reduced blood flow to the intestinal mucosa. Laxatives can lead to chronic diarrhea, abdominal pain, low potassium levels in the blood, which in severe cases can cause muscle spasms or muscle weakness, and fatigue, poor kidney function and formation of kidney stones. If you forget to take Pikopil Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious. Stop taking this medicine and call your doctor or seek emergency medical attention at once if the following side effects occur: allergic reaction. The signs may include itching, rash, swelling of the lips, mouth, tongue, throat, difficulty in breathing. 3

4 The following side effects may also occur: Very common side effect (may effect more than 1 in 10 users): - diarrhea Common side effects (may effect up to 1 in 10 users): - abdominal cramping - abdominal pain - uncomfortable feeling in the stomach Occasional side effects (may effect up to 1 in 100 users): - dizziness * - fainting * - vomiting - nausea - skin reaction * Dizziness and fainting may occur, usually in conjunction with stools or abdominal pain due to constipation. Reporting of side effects Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pikopil 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 bottle label and carton, after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Shelf life after first opening: 1 year. 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 Pikopil contains - The active substance is sodium picosulfate. 1 ml contains sodium picosulfate monohydrate equivalent to 7.5 mg sodium picosulfate anhydrous (1 ml = 15 drops). - The other ingredients are sodium benzoate (E211), sorbitol (E420), citric acid monohydrate (E330), sodium citrate (E331), water for injections. What Pikopil looks like and contents of the pack Pikopil 7.5 mg/ml oral drops, solution is a clear colorless or yellowish solution. Pikopil is packed in white opaque polyethylene dropper container with green tamper-evident cap containing 15 ml or 30 ml oral drops, solution. Not all pack sizes may be marketed. 4

5 Marketing Authorisation Holder and Manufacturer Houder van de vergunning voor het in de handel brengen Vital Pharma GmbH Frankfurter Landstrasse 8 D Bad Homburg v.d.h Duitsland Fabrikant Biokanol Pharma GmbH Kehler Str. 7, D Rastatt, Duitsland Health-Med spółka z ograniczoną odpowiedzialnością sp.k. ul. Walewska 8 lok Warszawa Polen This medicinal product is authorised in the Member States of the EEA under the following names: Nederland: Pikopil druppels voor oraal gebruik, oplossing, 7.5 mg/ml Polen: Pikopil Deze bijsluiter is voor het laatst goedgekeurd in september 2016 General information for the user What is constipation? What is normal and regular bowel movement varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. Constipation is an occasional problem for some people. For others, it may happen more often. It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with: Sudden change of diet A diet with not enough fibre Loss of tone of the bowel muscles in older people Pregnancy Medicines such as morphine or codeine Having to stay in bed for a long time Lack of exercise Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally off colour. Sometimes it causes headaches. These healthy tips are recommended to try to prevent constipation happening: Eat a balanced diet including fresh fruit and vegetables Drink enough water so that you do not become dehydrated Keep up your exercise and stay fit Make time to empty your bowels when your body tells you 5