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PACKAGE LEAFLET: INFORMATION FOR THE USER


BIOLAX TABLETS 5 mg

BISACODYL

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to take Biolax carefully to

get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist you need more information or advice.

-    You must contact your pharmacist or doctor if your symptoms worsen or do not improve after 5 days treatment.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

t this LEAFLET CONTAIN^

1.    What Biolax is for

2.    Before you take Biolax

3.    How to take Biolax

4.    Possible side effects

5.    How to store Biolax

6.    Further information


V-WHAT BIOLAX IS FOR


Biolax tablets contain a medicine called bisacodyl. This belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements.


Biolax tablets are used for recent or long term constipation. They can also be used in a hospital to clear your bowels before surgery, labour or radiological investigation.



Do not take Biolax 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 Biolax.


Continued daily use of Biolax over a long period of time can lead to:

•    'lazy bowels' (atonic non-functioning colon) a

condition in which bowel emptying occurs infrequently

   fluid and electrolyte (e.g. calcium, magnesium, sodium) imbalance

•    low blood levels of potassium (hypokalaemia), which can cause tiredness, dizziness and muscle weakness.

Taking other medicines

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 Biolax can affect the way some medicines work. Also some medicines can affect the way Biolax 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 Biolax, 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 Biolax.

Taking Biolax with food and drink Milk or milk products should not be taken one hour before or after taking Biolax, 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 Biolax.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Important information about some of the ingredients of Biolax 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 Biolax.



If this medicine is from your pharmacist or doctor, do exactly as they have told you to. Otherwise, follow the instructions provided in this leaflet. If you are not sure how much you need to take talk to your pharmacist or doctor.


Take special care with Biolax

Biolax should not be used every day for more

than 5 days, unless your pharmacist or doctor tells

you to. Laxatives do not help long-term weight loss.

If you need laxatives every day, then you should

see your doctor to find the cause of your

constipation.


Taking this medicine

•    Swallow the tablets whole with water

•    The tablets should not be chewed or crushed

   Antacids, milk, milk products or proton-pump inhibitors, (medicines which reduce stomach acid, e.g. omeprazole), should not be taken one hour before or after taking Biolax, as they can make the medicine less effective.


Length of treatment

Biolax 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 4-10 years: Please consult your pharmacist or doctor before giving this medicine to children 4 to 10 years old. The usual dose is 1 tablet (5 mg) daily before bedtime.

In preparation for radiological investigation or surgical procedure:

Adults (including the elderly) and children over 10 years: 2 tablets (10 mg) in the morning, and 2 tablets (10 mg) in the evening on the day before the investigation or operation. The following morning the doctor may give you a bisacodyl suppository via the back passage.

Children 4-10 years: 1 tablet (5 mg) in the evening on the day before the investigation or operation. The following morning the doctor may give the child a bisacodyl suppository via the back passage.

Children under 4 years: Biolax tablets should not

be given to children under 4 years old.

If you take more Biolax 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.

If you forget to take Biolax

If you forget to take Biolax, 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.

ffOSSIBSE^FECT^

Like all medicines, Biolax 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)

•    being sick (vomiting)

•    blood in the stools

•    discomfort or cramps in the stomach area

•    discomfort inside and around the back passage

Other side effects

•    dehydration

•    inflammation of the large intestine (colitis), which may cause aches and pain in the stomach area, diarrhoea, tiredness, fever, joint pain or weight loss

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

o^^STOSOA^

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use the tablets after the expiry date, which is stated on the package or container. 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.

What Biolax 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 Biolax tablets look like and contents of the pack

Biolax tablets are round, yellow, sugar-coated gastro-resistant tablets which come in blister packs and containers of 8, 10, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chatfield Pharmaceuticals Limited,

Kramer Mews,

London SW5 9JL

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 03/2012

BLX0028/0005E/LEA004P


PACKAGE LEAFLET: INFORMATION FOR THE USER


BIOLAX TABLETS 5 mg

BISACODYL

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to take Biolax carefully

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 5 days treatment.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

: this LEAFLET CONTAIN^

1.    What Biolax is for

2.    Before you take Biolax

3.    How to take Biolax

4.    Possible side effects

5.    How to store Biolax

6.    Further information


(1- WHAT BIOLAX IS FoR


Biolax tablets contain a medicine called bisacodyl. This belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Biolax tablets are used for recent or long term constipation.


<2. BEFORE YOU TAKE BIOLAX»


Do not take Biolax 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 Biolax.


If you need laxatives every day, then you should see your doctor to find the cause of your constipation.

Continued daily use of Biolax over a long period of time can lead to:

•    'lazy bowels' (atonic non-functioning colon)

a condition in which bowel emptying occurs infrequently

   fluid and electrolyte (e.g. calcium, magnesium, sodium) imbalance

•    low blood levels of potassium (hypokalaemia), which can cause tiredness, dizziness and muscle weakness.

Taking other medicines

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 Biolax can affect the way some medicines work. Also some medicines can affect the way Biolax 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 Biolax, 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 Biolax.

Taking Biolax with food and drink Milk or milk products should not be taken one hour before or after taking Biolax, 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 Biolax.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Important information about some of the ingredients of Biolax 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 Biolax.


Follow the instructions provided in this leaflet. If you are not sure how much you need to take talk to your pharmacist or doctor.


Take special care with Biolax Biolax should not be used every day for more than 5 days, unless your pharmacist or doctor tells you to.

Laxatives do not help long-term weight loss.


Taking this medicine

• Swallow the tablets whole with water


•    The tablets should not be chewed or crushed

   Antacids, milk, milk products or proton-pump inhibitors, (medicines which reduce stomach acid, e.g. omeprazole), should not be taken one hour before or after taking Biolax, as they can make the medicine less effective.

Length of treatment

Biolax 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 Biolax 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.

If you forget to take Biolax

If you forget to take Biolax, 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.

2^bS?CT2

Like all medicines, Biolax 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)

•    being sick (vomiting)

•    blood in the stools

•    discomfort or cramps in the stomach area

•    discomfort inside and around the back passage


Other side effects

•    dehydration

•    inflammation of the large intestine (colitis), which may cause aches and pain in the stomach area, diarrhoea, tiredness, fever, joint pain or weight loss

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

Keep out of the reach and sight 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 Biolax 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 Biolax tablets look like and contents of the pack

Biolax tablets are round, yellow, sugar-coated gastro-resistant tablets which come in blister packs of 10 tablets.


Marketing Authorisation Holder

Chatfield Pharmaceuticals Limited, Kramer Mews,

London SW5 9JL


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 03/2012

BLX0028/0005E/LEA004GSL