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Bisacodyl 5mg Tablets

Document: leaflet MAH GENERIC_PL 06464-0186 change

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Medical


GBR 724-7729-APIL

Package leaflet: Information for the user 1 SOVEREIGN

Size 150 x 220 mm


BISACODYL 5 mg TABLETS


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. You need to take Bisacodyl 5 mg Tablets 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 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

1.    What Bisacodyl 5 mg Tablets are and what they are used for

2.    What you need to know before you take Bisacodyl 5 mg Tablets

3.    How to take Bisacodyl 5 mg Tablets

4.    Possible side effects

5.    How to store Bisacodyl 5 mg Tablets

6.    Contents of the pack and other information

1. What Bisacodyl 5 mg Tablets are and what they are used for

•    Bisacodyl 5 mg Tablets contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives

•    Bisacodyl 5 mg Tablets are used for the short term relief of constipation

•    Bisacodyl 5 mg Tablets can also be used in a hospital to empty a person's bowel before child birth, surgery or radiological investigations

•    Bisacodyl 5 mg Tablets stimulate the muscles of the bowel (large intestine). This brings about overnight relief from constipation.

Bisacodyl 5 mg Tablets do not help with weight loss.

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.

hese 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. What you need to know before you take Bisacodyl 5 mg Tablets

Do not take this medicine and tell your doctor:

•    if you are allergic to bisacodyl or any of the other ingredients in the medicine (listed in Section 6).

•    if you are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose)

•    if you have severe dehydration

•    if you have a bowel condition called “ileus” (blockage in the intestine)

•    if you have a serious abdominal condition such as appendicitis

•    if you have severe abdominal pain with nausea and vomiting

•    if you have a blocked bowel (intestinal obstruction)

•    if you 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 doctor or pharmacist before taking Bisacodyl 5 mg Tablets.

Warnings and precautions

As with all laxatives, Bisacodyl 5 mg Tablets should not be taken every day for more than five days. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor.

Other medicines and Bisacodyl 5 mg Tablets

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 Bisacodyl 5 mg Tablets can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl 5 mg Tablets 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 Bisacodyl 5 mg Tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Bisacodyl 5 mg Tablets contains lactose and tartrazine (E102)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Bisacodyl 5 mg Tablets also contain tartrazine (E102), which may cause allergic reactions.

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3.    How to take Bisacodyl 5 mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow the tablets whole with water. Do not crush or chew the tablets.

•    Milk-containing products or antacids should not be taken within one hour before or after taking Bisacodyl 5 mg Tablets. This is because they will stop the Bisacodyl 5 mg Tablets from working properly

The recommended dose is:

dults and children over 10 years

•    Take one or two tablets (5 or 10 mg) daily before bedtime

•    If you have not taken Bisacodyl 5 mg Tablets before, start with one tablet and increase to two if necessary

•    When your bowel regularity has returned to normal, the dose can usually be stopped

Use in children

Children aged between 4 and 10 years Bisacodyl 5 mg Tablets should only be given to children between the ages of 4 and 10 if recommended by a doctor. The usual dose for children is: One tablet (5 mg) daily before bedtime

Children under 4 years

Bisacodyl 5 mg Tablets are not recommended for children under 4 years.

If you take more Bisacodyl 5 mg Tablets 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 your medicine and this leaflet with you. This is so the doctor knows what you have taken. It may be harmful to:

•    take too many Bisacodyl 5 mg Tablets or

•    take Bisacodyl 5 mg Tablets 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 your medicine

If you forget to take your tablets, just take the next dose at the usual time, DO NOT take a double dose to make up for the forgotten dose.

If you have any further questions on the use of this product, ask your pharmacist or doctor.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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•    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

Common side effects (affect less than 1 in 10 people)

•    Abdominal cramps or pain

•    Diarrhoea

•    Nausea

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 5 mg Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or container and on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

Blister packs: Store in the original package in order to protect from moisture.

Securitainers: Keep the container tightly closed. Store in the original container in order to protect from moisture.

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.

6.    Contents of the pack and other information

What Bisacodyl 5 mg Tablets contain

The active substance is bisacodyl.

Bisacodyl 5 mg gastro-resistant tablets contain 5 mg of bisacodyl. The other ingredients are lactose, maize starch, liquid paraffin, magnesium stearate, polyvinyl acetate phthalate, stearic acid, Opadry® (contains hypromellose, titanium dioxide, polyethylene glycol and tartrazine (E102)) and Carnauba Wax.

What Bisacodyl 5 mg Tablets look like and the contents of the pack

Bisacodyl 5 mg Tablets are yellow, shiny, round tablets with no markings.

They are available in foil blister packs of 60 tablets, 100 tablets and in a securitainer pack of 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Sovereign Medical, Sovereign House,

Miles Gray Road, Basildon,

Essex, SS14 3FR, UK.

Manufacturer

Waymade Plc, Sovereign House,

Miles Gray Road, Basildon,

Essex SS14 3FR, UK

This leaflet was last revised in: August 2016