Numark Constipation Relief
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Entrolax®
(Bisacodyl)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:
Always take 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. I* 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.
What is in this leaflet:
n . What Entrolax is and what it is used for 2. What you need to know before you take Entrolax
0. How to take Entrolax
4. Possible side effects
|5. How to store Entrolax
6. Contents of the pack and other information
WHAT ENTROLAX IS AND WHAT IT IS USED FOR
iBisacodyl belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Entrolax is used for the short term relief of constipation. Entrolax do not help with weight loss.
B| WHAT YOU NEED TO KNOW BEFORE LJ YOU TAKE ENTROLAX
Do not take Entrolax if you ,• are allergic (hypersensitive) to bisacodyl or to any of the ingredients of this medicine (listed in section 6)
p are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and sucrose)
• have severe dehydration
• have a bowel condition called “ileus” (blockage in the intestine)
p have a serious abdominal condition such as appendicitis
p have severe abdominal pain with nausea and vomiting
• have a blocked bowel (intestinal obstruction) p have inflammation of the bowel (small or
large intestine)
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.
L _ _ _ _ _ _ _
Other medicines and Entrolax
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 Entrolax can affect the way some other medicines work. Also, some other medicines can affect the way Entrolax work.
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.
If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking Entrolax.
Pregnancy and breast feeding
Talk to your pharmacist or doctor before taking Entrolax if you are pregnant, planning to become pregnant or are breast feeding.
Driving and using machines
Some people may feel dizzy or faint while taking this medicine. If this happens to you, wait until these feelings go away before driving or using machines.
Entrolax contain lactose and sucrose
The tablets contain a small amount of lactose and sucrose in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
FI HOW TO TAKE ENTROLAX
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your pharmacist if you are not sure.
• Swallow the tablets whole with water. The tablets should not be chewed or crushed.
• Milk, antacids or proton pump inhibitors (medicines which reduce stomach acid) should not be taken within one hour before or after taking Entrolax. This is because they will stop the Entrolax from working properly.
Doses
For constipation:
Adults (including the elderly) and children over 10 years: 1 to 2 tablets at night.
Continued over page
Length of treatment
These tablets should not be used every day for more than 5 days. If you need laxatives every day, then you should see your doctor to find the cause of your constipation.
If you take more Entrolax than you should
It may be harmful to
|» Take too much of Entrolax or
» Take Entrolax for too long
This is because taking too much for too long
|may lead to:
- A 'lazy bowel', where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.
- Imbalance of fluid and salts in the body.
This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.
- Low levels of potassium in the blood (called 'hypo-kalaemia'). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.
- Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass enough urine.
|lf 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.
ilf you have any questions on the use of this product, ask your pharmacist or doctor.
FI POSSIBLE SIDE EFFECTS
Like all medicines, Entrolax can cause side effects ^though not everybody gets them. The following side effects may happen with this medicine:
Rare side effects (affect less than 1 in 1000 people)
• Severe allergic reactions which may cause swelling of the face or throat and difficulty in breathing or dizziness. If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away.
• Colitis (inflammation of the large intestine which causes abdominal pain and diarrhoea)
• Dehydration
• Allergic reactions which may cause a skin rash |» Fainting
Uncommon side effects (affect less than 1 in 100 people)
» Blood in the stools
• Vomiting
• Abdominal discomfort
• Discomfort inside and around the back passage ^ Dizziness
Xommon side effects (affect less tharn in 10 people)
• Abdominal cramps or pain
• Diarrhoea
• Nausea
Reporting of side effects
If you get any 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
jjj HOW TO STORE ENTROLAX
• Keep this medicine out of the sight and reach of children
• Do not take Entrolax after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month
• Do not store above 25°C
• Keep the blister within the outer carton
• 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.
□ CONTENTS OF THE PACK AND OTHER INFORMATION
What Entrolax contain
The active ingredient (the ingredient which makes this medicine work) is bisacodyl. Each tablet contains 5mg of bisacodyl.
The tablets also contain: lactose, maize starch, cellulose acetate phthalate, diethyl phthalate, sucrose, povidone, magnesium stearate, pregelatinised maize starch, talc, E171 (titanium dioxide) and E104 (quinoline yellow).
What your tablets look like and the contents of the pack
Entrolax are round yellow, sugar-coated tablets. They are packed in cylindrical plastic containers or cartons containing blister strips.
Both pack types contain 8, 10, 20 or 40 tablets. If you want to know more about your medicine, ask your doctor or pharmacist who can give you| more information.
Marketing authorisation holder and manufacturer
Dr. Reddy's Laboratories (UK) Limited 6 Riverview Road, Beverley East Yorkshire, HU17 OLD
This leaflet was revised in December 2014
Entrolax
PL 08553/0199 4nns737