PACKAGE LEAFLET: INFORMATION FOR THE USER

Galpharm Constipation Relief 5mg Tablets

(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, p 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 Galpharm Constipation Relief 5mg Tablets are and what they are used for |2. What you need to know before you take Galpharm Constipation Relief 5mg Tablets ,3. How to take Galpharm Constipation Relief 5mg Tablets

4.    Possible side effects

5.    How to store Galpharm Constipation Relief 5mg Tablets

6.    Contents of the pack and other information

WHAT GALPHARM CONSTIPATION RELIEF 5MG TABLETS ARE AND WHAT THEY ARE USED FOR

Bisacodyl belongs to a group of medicines known ias stimulant laxatives. Stimulant laxatives increase bowel movements. Galpharm Constipation Relief 5mg Tablets is used for the short term relief of bonstipation. Galpharm Constipation Relief 5mg Tablets does not help with weight loss.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALPHARM CONSTIPATION RELIEF 5MG TABLETS

Do not take Galpharm Constipation Relief 5mg Tablets if you

!• are allergic (hypersensitive) to bisacodyl or to any of the ingredients of this medicine (listed in section 6)

|» 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)

» have a serious abdominal condition such as appendicitis

•    have severe abdominal pain with nausea and vomiting

,• have a blocked bowel (intestinal obstruction)

•    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.

Other medicines and Galpharm Constipation Relief 5mg 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 Galpharm Constipation Relief 5mg Tablets can affect the way some other medicines work. Also, some other medicines can affect the way Galpharml Constipation Relief 5mg 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 Galpharm Constipation Relief 5mg Tablets.

Pregnancy and breast feeding

Talk to your pharmacist or doctor before taking Galpharm Constipation Relief 5mg Tablets 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.

Galpharm Constipation Relief 5mg Tablets 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-galactosel 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.

□ HOW TO TAKE GALPHARM

CONSTIPATION RELIEF 5MG TABLETS

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 Galpharm Constipation Relief 5mg Tablets. This is because they will stop the Galpharm Constipation Relief 5mg Tablets 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 Galpharm Constipation Relief 5mg Tablets than you should

It may be harmful to

•    Take too much Galpharm Constipation Relief 5mg Tablets or

•    Take Galpharm Constipation Relief 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.

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

Q POSSIBLE SIDE EFFECTS

Like all medicines, Galpharm Constipation Relief 5mg Tablets can cause side effects although 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.

_ _ _ _ _ _ _ _

Common side effects (affect less than 1 in 101 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.aov.uk/vellowcard.

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

□ HOW TO STORE GALPHARM

CONSTIPATION RELIEF 5MG TABLETS

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

• Do not take Galpharm Constipation Relief 5mg Tablets 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 Galpharm Constipation Relief 5mg Tablets 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

Galpharm Constipation Relief 5mg Tablets 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 January 2016

Galpharm Constipation Relief 5mg Tablets PL 08553/0199

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