Biolax Tablets
|
Bisacodyl Product: 5 mg Tablets MA Holder: Chelonia |
Printing Colours: | Black |
Non-Printing Colours: |
Chelonia HEALTHCARE Final Preparation Date For Submission: 09/01/2015 |
|
PL No.: 33414/0139 |
Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000 | ||
|
Pack Size: All Packs |
Dimensions: 148 x 297 mm | ||
|
Livery: Chelonia |
Created By: DTawde | ||
|
Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: CL0139/G/PIL/CL2 |
Print Proof Approval: 00/00/0000 | |
|
Bar Code: - | |||
|
Font Type: Arial Narrow Font Size: 9.56 pt | |||
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISACODYL 5 mg TABLETS
r \
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 doctor or pharmacist has 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 5 days.
THIS LEAFLET CONTAINS
1. What Bisacodyl is for
2. Before you take Bisacodyl
3. How to take Bisacodyl
4. Possible side effects
5. How to store Bisacodyl
6. Further information
1. WHAT BISACODYL IS FOR
Bisacodyl tablets belong to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Bisacodyl tablets are used for the short-term relief of constipation.
Bisacodyl tablets do not help with weight loss.
2. BEFORE YOU TAKE BISACODYL
Do not take Bisacodyl and tell your pharmacist or doctor if you:
• are allergic to bisacodyl or any of the other ingredients in the tablets (see section 6 of this leaflet)
• have in the past been told not to use laxatives
• are severely dehydrated
• have a bowel condition called ileus or intestinal obstruction (blockage of the small or large intestine)
• have inflammation of the bowel (swelling of the small or large intestine)
• have a serious abdominal condition such as appendicitis (swelling of the appendix)
• have severe abdominal pain (aches and pains in the stomach area) with nausea and vomiting
Do not take this medicine if any of the above apply to you. If you are not sure, check with your pharmacist or doctor before taking Bisacodyl.
Warnings and precautions
Bisacodyl should not be used every day for more than 5 days, unless your pharmacist or doctor tells you to.
If you need laxatives every day, then you should see your doctor to find the cause of your constipation.
Other medicines and Bisacodyl
Tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Bisacodyl can affect the way some medicines work. Also some medicines can affect the way Bisacodyl works.
In particular, tell your pharmacist or doctor if you are taking any of the following:
• antacids (used to treat indigestion). Antacids should not be taken one hour before or after taking Bisacodyl, as they can make the medicine less effective
• diuretics (water tablets) such as bendroflumethiazide or furosemide (used to treat high blood pressure or a build-up of excess fluid in the body)
• steroids such as prednisolone (used to treat inflammatory conditions and allergies)
• cardiac glycosides such as digoxin (medicines used to treat heart failure or irregular heartbeats).
If you are not sure if any of the above apply to you, talk to your pharmacist or doctor before taking Bisacodyl.
Taking Bisacodyl with food and drink
Milk or milk products should not be taken one hour before or after taking Bisacodyl, as they can make the medicine less effective.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, talk to your pharmacist or doctor before taking Bisacodyl.
Driving and using machines
Some people may feel dizzy or faint whilst taking this medicine. If this happens to you, wait until these feelings go away before driving or using machines.
Important information about some of the ingredients of Bisacodyl tablets
This medicine contains lactose and sucrose (types of sugars). If you know you have an intolerance to some sugars contact your pharmacist or doctor before taking Bisacodyl.
3. HOW TO TAKE BISACODYL
Follow the instructions provided in this leaflet. If you are not sure how much you need to take talk to your pharmacist or doctor.
Taking this medicine
• Swallow the tablets whole with water
• The tablets should not be chewed or crushed
• Antacids, milk, or milk products or proton-pump inhibitors, (medicines which reduce stomach acid, e.g. omeprazole), should not be taken one hour before or after taking Bisacodyl, as they can make the medicine less effective.
Length of treatment
Bisacodyl should not be used every day for more than 5 days, unless your pharmacist or doctor tells you to.
Dosage
For constipation:
Adults (including the elderly) and children over 10 years: 1 to 2 tablets (5 to 10 mg) daily before bedtime.
When your bowel movements have returned to normal, the dose can usually be stopped.
Children under 10 years: Please consult your pharmacist or doctor before giving this medicine to children under 10 years old.
If you take more Bisacodyl than you should
If you or your child accidentally takes too many tablets, tell a doctor or go to a hospital casualty department immediately. Take this leaflet and the medicine pack with you so that the doctor knows what has been taken.
It may be harmful to
• Take too much of Bisacodyl or
• Take Bisacodyl 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.
If you forget to take Bisacodyl
If you forget to take Bisacodyl, skip the missed dose then go on as before. Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
If you have any further questions on the use of this medicine, ask your pharmacist or doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bisacodyl can cause side effects, although not everybody gets them.
STOP TAKING this medicine and see a doctor or go to a hospital straight away if you notice any of the following side effects:
• an allergic reaction. The signs may include a rash, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse.
Tell your pharmacist or doctor if any of the following side effects last longer than a few days:
Common (affects less than 1 in 10 people)
• pains or cramps in the stomach area
• feeling sick (nausea)
• diarrhoea
Uncommon (affects less than 1 in 100 people)
• dizziness
• being sick (vomiting)
• blood in the stools
• discomfort in the stomach area
• discomfort inside and around the back passage
Rare (affects less than 1 in 1000 people)
• dehydration
• fainting
• inflammation of the large intestine (colitis), which may cause aches and pain in the stomach area, diarrhoea, tiredness, fever, joint pain or weight loss
Reporting of side effects
If you get any side effects talk to your pharmacist or doctor.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.
5. HOW TO STORE BISACODYL
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use the tablets after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.
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 Bisacodyl tablets contain
The active ingredient (the ingredient which makes this medicine work) is bisacodyl. Each tablet contains 5 mg of bisacodyl.
The tablets also contain lactose, maize starch, magnesium stearate, pregelatinised maize starch, cellulose acetate phthalate, diethyl phthalate, sucrose, talc, povidone, titanium dioxide (E171) and quinoline yellow (E104).
What Bisacodyl tablets look like and contents of the pack
Bisacodyl tablets are round, yellow, sugar-coated gastro-resistant tablets which come in blister packs of 10 tablets.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9jQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2015.
CL0139/G/PIL/CL2