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1ST BAR 1ST BAR >> READ DIRECTION >> READ DIRECTION 100 mg Capsules sodium

LAST BAR LAST BAR Package Leaflet: Information for the user

Read all of this leaflet carefully before you • is an occasional problem for start taking this medicine because it some people - for others, it may happen contains important information for you. more often Always take this medicine exactly as described • Constipation happens when the normal in this leaflet or as your doctor or pharmacist muscle actions in the bowel slow down has told you. The cause of constipation is often not known. • Keep this leaflet. You may need to read it It can be linked with: again • • Ask your pharmacist if you need more • Lack of exercise information or advice • Sudden change of diet • If you get any side effects, talk to your • A diet with not enough fibre doctor or pharmacist. This includes any • Having to stay in bed for a long time possible side effects not listed in this leaflet. • Medicines such as morphine or codeine See section 4 • Loss of ‘tone’ of the bowel muscles in older • You must talk to a doctor or pharmacist if people you do not feel better or you feel worse • The full name of your medicine is DulcoEase Whatever the cause, constipation can be 100 mg Capsules. In this leaflet the shorter uncomfortable. It may make you feel bloated name DulcoEase is used and heavy or generally ‘off colour’. Sometimes it causes headaches. What is in this leaflet: Try these healthy tips to help prevent 1. What DulcoEase Capsules is and what it is constipation happening: used for • Eat a balanced diet including fresh fruit and 2. What you need to know before you take vegetables DulcoEase Capsules • Drink enough water so that you do not 3. How to take DulcoEase Capsules become dehydrated 4. Possible side effects • Keep up your exercise and stay fit 5. How to store DulcoEase Capsules • Make time to empty your bowels when your 6. Contents of the pack and other information body tells you

1. What DulcoEase Capsules is and what 2. What you need to know before you take it is used for DulcoEase Capsules What DulcoEase is Do not take DulcoEase if: DulcoEase contains the active substance • You have pains docusate sodium. This medicine is a . • You feel sick or have been sick in the last It belongs to a group of medicines called 24 hours ‘stool softeners’. • You have a blockage in your intestine • DulcoEase is used to treat constipation in (intestinal obstruction) adults and children 12 years and over • You are allergic to docusate sodium or any How DulcoEase works of the other ingredients of this medicine DulcoEase softens the stools (faeces). (listed in Section 6) • It does this by increasing the amount of • You are intolerant to any sugars such as water within the stools (faeces) fructose or . DulcoEase contains a • This makes your bowel movements easier small amount of sorbitol • You are taking a mineral laxative such as It helps you when: • You are constipated Do not take this medicine if any of the above • You have piles applies to you. If you are not sure, talk to your • You have a tear in the lining of your anus pharmacist or doctor before taking this () medicine.

What is constipation? Warnings and precautions Normal and regular bowel movement is As with all , do not take DulcoEase important for most people. However, what is every day for a long time. ‘normal and regular’ varies from person to person. Some may have a bowel movement Talk to your pharmacist or doctor if: every day, others less often. Whatever it is like • You end up taking DulcoEase every day for you, it is best that your bowel movement • You get stomach pain which does not go has a regular pattern. away If any of the above applies to you (or you are not sure), talk to your pharmacist or doctor.

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Technical colors Diecut-Legendcase Free area Glue points Other medicines and DulcoEase Talk to your doctor or pharmacist if you get Tell your pharmacist or doctor if you are any of the side effects listed below: taking, have recently taken or might take any Rare: affects fewer than 1 in 1,000 people other medicines. • Feeling sick (nausea) Do not take DulcoEase together with a mineral • Diarrhoea oil laxative such as liquid paraffin. • Stomach Pregnancy and breast feeding Not known: frequency cannot be estimated If you are pregnant or breast feeding, think from the available data you may be pregnant or are planning to have a • Skin rash baby, ask your pharmacist or doctor for advice • Pruritus (itching) before taking this medicine. Talk to your doctor or pharmacist if you get DulcoEase contains Sorbitol, Sunset any of the side effects listed above. Yellow (E110), Propylene glycol and Sodium Reporting of side effects • This medicine contains approximately 19.3 mg If you get any side effects, talk to your doctor of sorbitol in each 100mg which is or pharmacist. This includes any possible side equivalent to 1.38mg/kg. Sorbitol is a source effects not listed in this leaflet. You can also of fructose. If your doctor has told you that report side effects directly via the Yellow Card you (or your child) have an intolerance to Scheme at www.mhra.gov.uk/yellowcard or some sugars or if you have been diagnosed search for MHRA Yellow Card in the Google with hereditary fructose intolerance (HFI), Play or Apple App store. By reporting side a rare genetic disorder in which a person effects you can help provide more information cannot break down fructose, talk to your on the safety of this medicine. doctor before you (or your child) take or receive this medicine. 5. How to store DulcoEase Capsules • DulcoEase contains the colouring Sunset Yellow E110. This may cause an allergic • Keep this medicine out of the sight and reach reaction of children • This medicine contains 11.5 mg propylene • Do not use this medicine after the expiry glycol in each capsule which is equivalent to date which is stated on the carton and blister 0.49mg/kg. label after EXP. The expiry date refers to the • This medicine contains less than 1mmol last date of that month sodium per capsule, that is to say essentially • Do not store above 25°C ‘sodium free’. • Store in the original package in order to protect from moisture 3. How to take DulcoEase Capsules • Do not throw away any medicines via waste water or household waste. Ask your Always take this medicine exactly as described pharmacist how to throw away medicines in this leaflet or as your pharmacist or doctor you no longer use. These measures will help has told you. Check with your pharmacist or protect the environment doctor if you are not sure. How much to take 6. Contents of the pack and other information Adults and children 12 years and over What DulcoEase contains • The recommended dose is to start with one • The active substance is docusate sodium. Each capsule 3 times a day. Then take more or less capsule contains 100 mg of docusate sodium if you need to • The other ingredients are: 400, • Do not take more than one capsule 5 times propylene glycol, gelatin, , sorbitol a day (E420), titanium dioxide (E171), water, sunset Do not give DulcoEase to children under 12 yellow (E110), and quinoline yellow (E104) years of age. What DulcoEase Capsules look like and You should feel more comfortable within contents of the pack 1 to 2 days of treatment. DulcoEase 100 mg Capsules are yellow and white coloured soft, oval capsules. They are Talk to your pharmacist or doctor if you end up available in blister packs of 10, 30 and taking DulcoEase every day. 60 capsules. How to take The Marketing Authorisation is held by: Swallow each capsule whole with water. Sanofi If you take more DulcoEase than you should 410 Thames Valley Park Drive, If you take more DulcoEase than you should, Reading, Berkshire, RG6 1PT, drink lots of water. Then see a doctor or go to United Kingdom the nearest hospital casualty department Tel:0800 035 2525 straight away. Email: [email protected] DulcoEase Capsules are manufactured at: 4. Possible side effects Patheon Softgels B.V. Like all medicines, DulcoEase can cause side De Posthoornstraat 7 effects, although not everybody gets them. 5048 AS Tilburg, Netherlands. The following side effects may occur with this medicine: This leaflet was revised in October 2020

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