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Dulco - 100 mg Capsules - - sodium - - Package Leaflet: - Information for the user

Read all of this leaflet carefully before you What is ? start taking this medicine because it Normal and regular bowel movement is contains important information for you. important for most people. However, what is Always take this medicine exactly as described 'normal and regular' varies from person to in this leaflet or as your doctor or pharmacist person. Some may have a bowel movement has told you. every day, others less often. Whatever it is like • Keep this leaflet. You may need to read it for you, it is best that your bowel movement again has a regular pattern. • Ask your pharmacist if you need more • Constipation is an occasional problem for information or advice some people - for others, it may happen • If you get any side effects, talk to your more often doctor or pharmacist. This includes any • Constipation happens when the normal possible side effects not listed in this leaflet. muscle actions in the bowel slow down See section 4 The cause of constipation is often not known. • You must talk to a doctor or pharmacist if It can be linked with: you do not feel better or you feel worse • Pregnancy • The full name of your medicine is DulcoEase • Lack of exercise 100 mg Capsules. In this leaflet the shorter • Sudden change of diet name DulcoEase is used • A diet with not enough fibre What is in this leaflet: • Having to stay in bed for a long time 1. What DulcoEase Capsules is and what it is • Medicines such as morphine or codeine used for • Loss of 'tone' of the bowel muscles in older 2. What you need to know before you take people DulcoEase Capsules Whatever the cause, constipation can be 3. How to take DulcoEase Capsules uncomfortable. It may make you feel bloated 4. Possible side effects and heavy or generally 'off colour'. Sometimes 5. How to store DulcoEase Capsules it causes headaches. 6. Contents of the pack and other information Try these healthy tips to help prevent -constipation happening: 1. What DulcoEase Capsules is and what • Eat a balanced diet including fresh fruit and it is used for vegetables What DulcoEase is • Drink enough water so that you do not become dehydrated DulcoEase contains the active substance • Keep up your exercise and stay fit docusate sodium. This medicine is a . • Make time to empty your bowels when your It belongs to a group of medicines called 'stool softeners'. body tells you • DulcoEase is used to treat constipation in 2. What you need to know before you take adults and children 12 years and over DulcoEase Capsules How DulcoEase works Do not take DulcoEase if: DulcoEase softens the stools (faeces). • It does this by increasing the amount of • You have stomach pains • You feel sick or have been sick in the last water within the stools (faeces) • This makes your bowel movements easier 24 hours • You have a blockage in your intestine It helps you when: (intestinal obstruction) • You are constipated • You are allergic to docusate sodium or any • You have piles of the other ingredients of this medicine • You have a tear in the lining of your anus (listed in Section 6) (anal fissure) • You are intolerant to any sugars such as fructose or . DulcoEase contains a small amount of sorbitol • You are taking a laxative such as liquid paraffin Do not take this medicine if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking this medicine. Warnings and precautions 4. Possible side effects As with all , do not take DulcoEase Like all medicines, DulcoEase can cause side every day for a long time. effects, although not everybody gets them. Talk to your pharmacist or doctor if: The following side effects may occur rarely • You end up taking DulcoEase every day with this medicine: • You get stomach pain which does not go Talk to your doctor or pharmacist if you get away any of the side effects listed below: If any of the above applies to you (or you are • Feeling sick (nausea) not sure), talk to your pharmacist or doctor. • Diarrhoea Other medicines and DulcoEase • Stomach cramps Tell your pharmacist or doctor if you are • Skin rash taking, have recently taken or might take any Talk to your doctor or pharmacist if you get other medicines. any of the side effects listed above. Do not take DulcoEase together with a mineral Reporting of side effects oil laxative such as liquid paraffin. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side Pregnancy and breast feeding effects not listed in this leaflet. You can also If you are pregnant or breast feeding, think report side effects directly via the Yellow Card you may be pregnant or are planning to have a Scheme at www.mhra.gov.uklyellowcard. By baby, ask your pharmacist or doctor for advice reporting side effects you can help provide before taking this medicine. · more information on the safety of this medicine. DulcoEase contains Sorbitol and Sunset Yellow E110 5. How to store DulcoEase Capsules • Do not take DulcoEase if you are intolerant to any sugars such as fructose or sorbitol. • Keep this medicine out of the sight and reach This medicine contains a small amount of of children sorbitol • Do not use this medicine after the expiry • DulcoEase contains the colouring Sunset date which is stated on the carton and blister Yellow E110. This may cause an allergic label after EXP . The expiry date refers to the reaction last date of that month • Do not store above 25°C 3. How to take DulcoEase Capsules • Store in the original package in order to protect from moisture Always take this medicine exactly as described • Do not throw away any medicines via waste in this leaflet or as your pharmacist or doctor water or household waste. Ask your has told you. Check with your pharmacist or pharmacist how to throw away medicines doctor if you are not sure. you no longer use. These measures will help How much to take protect the environment Adults and children 12 years and over • The recommended dose is to start with one 6. Contents of the pack and other information capsule 3 times a day. Then take more or less What DulcoEase contains if you need to • The active substance is docusate sodium. Each • Do not take more than one capsule 5 times capsule contains 100 mg of docusate sodium a day • The other ingredients are: macrogol400, Do not give DulcoEase to children under 12 propylene glycol, gelatin, , sorbitol years of age. (E420), titanium dioxide (E171), water, sunset yellow (E110}, and quinoline yellow (E104) You should feel more comfortable within 1 to 2 days of treatment. What DulcoEase Capsules look like and contents of the pack Talk to your pharmacist or doctQr if you end up DulcoEase 100 mg Capsules are yellow and taking DulcoEase every day. white coloured soft, oval capsules. They are How to take available in blister packs of 30 capsules. Swallow each capsule whole with water. The Marketing Authorisation is held by: If you take more DulcoEase than you should Boehringer lngelheim Limited, If you take more DulcoEase than you should, Consumer Healthcare, Ellesfield Avenue, drink lots of water. Then see a doctor or go to Bracknell, Berkshire, RG12 SYS, United Kingdom. the nearest hospital casualty cfepartment Dii'lCoEase CapsUles are manufactured at: straight away. Patheon Softgels B.V. De Posthoornstraat 7 5048 AS Tilburg, Netherlands.

This leaflet was revised in january 2016.

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