DULCOLAX PICO LIQUID 5 MG / 5 ML ORAL SOLUTION
Active substance: SODIUM PICOSULFATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
5mg / 5ml oral solution sodium picosulfate
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. You need to take DULCOLAX PICO Liquid as instructed in this leaflet to get the best results from it. Keep this leaflet. You may need to read it again Ask your pharmacist if you need more information or advice You must contact your pharmacist or doctor if your symptoms worsen or do not improve after five days treatment If a side effect occurs and gets troublesome, or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor In this leaflet: 1. What DULCOLAX PICO Liquid is and what it is used for 2. Before you take DULCOLAX PICO Liquid 3. How to take DULCOLAX PICO Liquid 4. Possible side effects 5. How to store DULCOLAX PICO Liquid 6. Further information 1.WHAT DULCOLAX PICO LIQUID IS AND WHAT IT IS USED FOR DULCOLAX PICO Liquid contains a medicine called sodium picosulfate. This belongs to a group of medicines called laxatives. DULCOLAX PICO Liquid is used for relief of constipation. DULCOLAX PICO Liquid gently stimulates the muscles of the bowel (large intestine). This brings predictable, overnight relief from constipation, helping to return the body to its natural rhythm. What is constipation? Normal and regular bowel movement is important for most people. However, what is normal and regular 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 2.BEFORE YOU TAKE DULCOLAX PICO LIQUID Do not take DULCOLAX PICO Liquid if: You are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients in the product (listed in Section 6: Further information) You have severe dehydration You have a bowel condition called ileus (blockage in the intestine) You have a serious abdominal condition such as appendicitis You have severe abdominal pain with nausea and vomiting You have a blocked bowel (intestinal obstruction) You have inflammation of the bowel (small and large intestine) Do not take DULCOLAX PICO Liquid if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking this medicine. Taking other medicines Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because DULCOLAX PICO Liquid can affect the way some other medicines work. Also, some other medicines can affect the way DULCOLAX PICO Liquid works. In particular, tell your doctor or pharmacist if you are taking: Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide) Steroid medicines such as prednisolone Antibiotics used for infections If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking DULCOLAX PICO Liquid. Pregnancy and breast-feeding Talk to your pharmacist or doctor before taking DULCOLAX PICO Liquid if you are pregnant, planning to become pregnant or are breastfeeding.
437716/GB/19
Dulcolax Pico Liquid
ABCD
Important information about some of the ingredients in DULCOLAX PICO Liquid DULCOLAX PICO Liquid contains 5.9% ethanol (alcohol), which is up to 480 mg per dose. This is equivalent to 12 ml beer or 5 ml wine per dose. This may be harmful for people with a drink problem (alcoholism). This should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as those with liver disease or epilepsy. DULCOLAX PICO Liquid contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate and the colouring agent sunset yellow (E110). These ingredients may cause allergic reactions, which may not happen after the first dose. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems. 3.HOW TO TAKE DULCOLAX PICO LIQUID If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask your pharmacist or doctor. As with all laxatives, DULCOLAX PICO Liquid should not be taken every day for long periods. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor. How much to take Adults and children over 10 years One to two 5 ml spoonfuls at night When your bowel regularity has returned to normal, the dose can usually be stopped Children aged between 4 and 10 years DULCOLAX PICO Liquid should only be given to children under 10 if recommended by a doctor. The usual dose for a child is: Half to one 5 ml spoonful at night Children under 4 years The dose will depend on the weight of your child: 0.25 ml for each kilogram of the childs body weight. If you take more DULCOLAX PICO Liquid than you should If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you; this is so the doctor knows what you have taken. If you have any questions on the use of this product, ask your pharmacist or doctor. 4.POSSIBLE SIDE EFFECTS Like all medicines, DULCOLAX PICO Liquid can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Isolated events (some side effects are so rare that it is not known how many people may be affected) Syncope (feeling faint) Allergic reaction If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems.
Very common side effects (affects 1 in 10 people or more) Diarrhoea Common side effects (affects less than 1 in 10 people) Abdominal discomfort, cramps or pain Uncommon side effects (affects less than 1 in 100 people) Nausea Vomiting Dizziness If a side effect occurs and gets troublesome or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor. 5.HOW TO STORE DULCOLAX PICO LIQUID Keep this medicine out of the sight and reach of children Do not take DULCOLAX PICO Liquid after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month Keep the bottle within the outer carton Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment 6.FURTHER INFORMATION What DULCOLAX PICO Liquid contains Each 5 ml contains 5 mg of sodium picosulfate (present as sodium picosulfate monohydrate) as the active ingredient The other ingredients are: carmellose sodium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, aroma tutti frutti (flavouring), saccharin sodium, colouring sunset yellow (E110), ethanol, sodium hydroxide (for pH adjustment) and water What DULCOLAX PICO Liquid looks like and contents of the pack DULCOLAX PICO Liquid is a clear, yellowishorange, slightly viscous fruit flavoured solution. It is available in packs of 100 ml and 300 ml. The Marketing Authorisation is held by: Boehringer Ingelheim Limited, Self-Medication Division, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom. DULCOLAX PICO Liquid is manufactured at: Istituto De Angeli. S.r.l. Localit Prulli di Sotto n. 103/C 50066 Regello (FI) Italy This leaflet was revised in January 2012
Registered trade mark
Copyright Boehringer Ingelheim Limited 2012
437716/GB/19
20110318
5mg / 5ml oral solution sodium picosulfate
Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. You need to take DULCOLAX PICO Liquid as instructed in this leaflet to get the best results from it. Keep this leaflet. You may need to read it again Ask your pharmacist if you need more information or advice You must contact your pharmacist or doctor if your symptoms worsen or do not improve after five days treatment If a side effect occurs and gets troublesome, or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor In this leaflet: 1. What DULCOLAX PICO Liquid is and what it is used for 2. Before you take DULCOLAX PICO Liquid 3. How to take DULCOLAX PICO Liquid 4. Possible side effects 5. How to store DULCOLAX PICO Liquid 6. Further information 1.WHAT DULCOLAX PICO LIQUID IS AND WHAT IT IS USED FOR DULCOLAX PICO Liquid contains a medicine called sodium picosulfate. This belongs to a group of medicines called laxatives. DULCOLAX PICO Liquid is used for relief of constipation. DULCOLAX PICO Liquid gently stimulates the muscles of the bowel (large intestine). This brings predictable, overnight relief from constipation, helping to return the body to its natural rhythm. What is constipation? Normal and regular bowel movement is important for most people. However, what is normal and regular 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 2.BEFORE YOU TAKE DULCOLAX PICO LIQUID Do not take DULCOLAX PICO Liquid if: You are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients in the product (listed in Section 6: Further information) You have severe dehydration You have a bowel condition called ileus (blockage in the intestine) You have a serious abdominal condition such as appendicitis You have severe abdominal pain with nausea and vomiting You have a blocked bowel (intestinal obstruction) You have inflammation of the bowel (small and large intestine) Do not take DULCOLAX PICO Liquid if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking this medicine. Taking other medicines Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because DULCOLAX PICO Liquid can affect the way some other medicines work. Also, some other medicines can affect the way DULCOLAX PICO Liquid works. In particular, tell your doctor or pharmacist if you are taking: Water tablets (diuretics) such as bendrofluazide or furosemide (frusemide) Steroid medicines such as prednisolone Antibiotics used for infections If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking DULCOLAX PICO Liquid. Pregnancy and breast-feeding Talk to your pharmacist or doctor before taking DULCOLAX PICO Liquid if you are pregnant, planning to become pregnant or are breastfeeding.
437716/GB/19
Dulcolax Pico Liquid
ABCD
Important information about some of the ingredients in DULCOLAX PICO Liquid DULCOLAX PICO Liquid contains 5.9% ethanol (alcohol), which is up to 480 mg per dose. This is equivalent to 12 ml beer or 5 ml wine per dose. This may be harmful for people with a drink problem (alcoholism). This should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as those with liver disease or epilepsy. DULCOLAX PICO Liquid contains the preservatives methyl parahydroxybenzoate, propyl parahydroxybenzoate and the colouring agent sunset yellow (E110). These ingredients may cause allergic reactions, which may not happen after the first dose. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems. 3.HOW TO TAKE DULCOLAX PICO LIQUID If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. If you do not understand the instructions, or you are not sure, ask your pharmacist or doctor. As with all laxatives, DULCOLAX PICO Liquid should not be taken every day for long periods. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor. How much to take Adults and children over 10 years One to two 5 ml spoonfuls at night When your bowel regularity has returned to normal, the dose can usually be stopped Children aged between 4 and 10 years DULCOLAX PICO Liquid should only be given to children under 10 if recommended by a doctor. The usual dose for a child is: Half to one 5 ml spoonful at night Children under 4 years The dose will depend on the weight of your child: 0.25 ml for each kilogram of the childs body weight. If you take more DULCOLAX PICO Liquid than you should If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you; this is so the doctor knows what you have taken. If you have any questions on the use of this product, ask your pharmacist or doctor. 4.POSSIBLE SIDE EFFECTS Like all medicines, DULCOLAX PICO Liquid can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Isolated events (some side effects are so rare that it is not known how many people may be affected) Syncope (feeling faint) Allergic reaction If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include: a rash, swelling of your skin, mouth and face which may cause swallowing or breathing problems.
Very common side effects (affects 1 in 10 people or more) Diarrhoea Common side effects (affects less than 1 in 10 people) Abdominal discomfort, cramps or pain Uncommon side effects (affects less than 1 in 100 people) Nausea Vomiting Dizziness If a side effect occurs and gets troublesome or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor. 5.HOW TO STORE DULCOLAX PICO LIQUID Keep this medicine out of the sight and reach of children Do not take DULCOLAX PICO Liquid after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month Keep the bottle within the outer carton Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment 6.FURTHER INFORMATION What DULCOLAX PICO Liquid contains Each 5 ml contains 5 mg of sodium picosulfate (present as sodium picosulfate monohydrate) as the active ingredient The other ingredients are: carmellose sodium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), glycerol, aroma tutti frutti (flavouring), saccharin sodium, colouring sunset yellow (E110), ethanol, sodium hydroxide (for pH adjustment) and water What DULCOLAX PICO Liquid looks like and contents of the pack DULCOLAX PICO Liquid is a clear, yellowishorange, slightly viscous fruit flavoured solution. It is available in packs of 100 ml and 300 ml. The Marketing Authorisation is held by: Boehringer Ingelheim Limited, Self-Medication Division, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom. DULCOLAX PICO Liquid is manufactured at: Istituto De Angeli. S.r.l. Localit Prulli di Sotto n. 103/C 50066 Regello (FI) Italy This leaflet was revised in January 2012
Registered trade mark
Copyright Boehringer Ingelheim Limited 2012
437716/GB/19
20110318
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
