GALPHARM CONSTIPATION RELIEF 5 MG TABLETS - patient leaflet, side effects, dosage

Package Leaflet: information for the patient

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You should contact a doctor if your symptoms worsen or do not improve within 24 hours
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

WHAT IS IN THIS LEAFLET:

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

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

3. How to take the medicine

4. Possible side effects

• 5. Storing the medicine

6. Contents of the pack and other information

• 1. WHAT BISACODYL 5MG TABLETS ARE AND WHAT THEY ARE USED FOR Bisacodyl 5mg Tablets contain the active ingredient bisacodyl. Bisacodyl belongs to a group of medicines known as stimulant laxatives, which increase bowel movements. Bisacodyl 5mg Tablets are used for the short term relief of constipation. Bisacodyl 5mg Tablets do not help with weight loss.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISACODYL 5MG TABLETS

Do not take this medicine if:

• You are allergic to Bisacodyl or any of the ingredients listed in Section 6.
• You suffer from ileus (a condition where the intestine stops working properly which results in blockage, causing pain).
• You have a blockage in your intestinal tract, which will mean you have difficulty in passing a motion even after taking laxatives (e.g. Bisacodyl, Senna).
• You have severe dehydration.
• You are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and sucrose).
• You have inflammation of the bowel (small or large intestine).
• You have a severe abdominal condition such as appendicitis.
• You have severe abdominal pain with nausea and vomiting.

Warnings and precautions

• You are taking diuretics (water tablets) or antacids.
• You are taking Steroids medicines such as prednisolone.
• You are taking cardiac glycosides such as digoxin.

If laxatives are needed every day or you have persistent abdominal pain, consult your doctor. Prolonged use should be avoided.

Important information about some of the ingredients of this medicine:

• This medicine contains lactose. If you have been told by your doctor that you are intolerant to some sugars, please contact your doctor before taking this medicinal product.

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.

Do not give this medicine to children under the age of 10 years old.

Always use 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.

3. how to take the medicine

Adults, the elderly and children over 10 years

How to take:

Swallow the tablets whole with a drink of water.

Dose and how often to take:

1–2 tablets to be taken at night, usually just before going to bed.

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

• Do not give to children under 10 years of age.
• These tablets have a special coating, do not take antacids or milk products 1 hour before or after taking them.
• Do not take more than the recommended dose.
• As with all laxatives, this medicine should not be taken every day for more than five days. If you need laxatives every day, or you have abdominal pain that does not go away, you see your doctor.

If you take more tablets than you should

It may be harmful to

• Take too much of Bisacodyl 5mg Tablets or
• Take Bisacodyl 5mg 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 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.

4. possible side effects

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

Get medical help at once

• 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. The signs may include: a rash, swelling of the skin, mouth and face which may cause swallowing and breathing problems.
• Colitis (inflammation of the large intestine which causes abdominal pain and diarrhoea).

If you get any of these,

• Nausea
• Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)

• Vomiting
• Blood in stools
• Abdominal discomfort
• Discomfort inside and around the back passage
• Dizziness.

Rare side effects (may affect up to 1 in 1000 people)

• Dehydration.
• Allergic reactions which may cause a skin rash.
• Fainting.

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:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. STORING THE MEDICINE

Do not store above 25°C.

Do not use the tablets after the expiry date shown on the pack.

Keep out of the sight and reach of children.

6. contents of the pack and other information

What is in this medicine:

Bisacodyl 5mg.

The other ingredients are:

Lactose Monohydrate, Maize Starch, Light Liquid Paraffin and Magnesium Stearate.

The tablet coating consists of Opadry White YS-1–7027 (which contains Hypromellose, Titanium Dioxide (E171) and Triacetin) and Acryl-eze Yellow (which contains Methylacrylic Acid Copolymer, Talc, Titanium Dioxide (E171), Triethyl Citrate, Quinoline Yellow

(E104), Colloidal Anhydrous Silica, Sodium Bicarbonate and Sodium Lauryl Sulphate).

Contents of the pack:

This pack contains 10 or 20 round yellow tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer:

Galpharm International Ltd, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

This leaflet was revised in 06/2016