ALMUS LAXATIVE 5 MG GASTRO-RESISTANT TABLETS, BISACODYL LAXATIVE TABLETS 12+ YEARS, ENTROLAX CONSTIPATION RELIEF 5 MG TABLETS 12+ YEARS - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER Entrolax Constipation Relief 5mg Tablets 12+ years

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.

• – 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 five days.

What is in this leaflet :

• 1. What Entrolax is and what it is used for

• 2. What you need to know before you take Entrolax

• 3. How to take Entrolax

• 4. Possible side effects

• 5. How to store Entrolax

• 6. Contents of the pack and other information

1. What Entrolax is and what it is used for

Bisacodyl belongs to a group of medicines known as stimulant laxatives. Stimulant laxatives increase bowel movements. Entrolax is used for the short-term relief of occasional constipation. Entrolax does 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
• Not drinking enough fluids
• 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.

It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These 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 entrolax

Do not take Entrolax if you:

• are allergic (hypersensitive) to Bisacodyl or to any of the ingredients 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. Do not use in children under the age of 12 years. If you are not sure talk to your doctor or pharmacist before taking this medicine.

Does this help with weight loss?

Stimulant laxatives (including bisacodyl) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Overuse of laxatives must be avoided as it may harm the intestinal function.

Other medicines and Entrolax

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 Entrolax can affect the way some other medicines work. Also, some other medicines can affect the way Entrolax works.

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
• Other laxative medicines.

If you are not sure if any of the above applies to you, talk to your pharmacist or doctor before taking Entrolax.

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.

Entrolax contain lactose and sucrose

The tablets contain both lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take entrolax

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.

As with all laxatives, Entrolax 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 to find the cause of your constipation. Overuse can be harmful.

Taking this medicine

• 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 Entrolax. This is because they will stop the Entrolax Tablets from working properly.
• Take one or two tablets (5 to 10mg) daily
• If you have not taken Entrolax before, start with one tablet and increase to two if necessary
• When the bowel regularity has returned to normal, the dose should be reduced and stopped.

Children under 12 years

Entrolax are not recommended for children under 12 years.

If you take more Entrolax than you should

It may be harmful to:

• Take too much Entrolax
• Take Entrolax 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 including ischaemic colitis (inflammation of the large intestine which causes abdominal pain and diarrhoea)
• Dehydration
• Allergic reactions which may cause a skin rash
• Fainting
• Blood in the stools
• Vomiting
• Abdominal discomfort
• Discomfort inside and around the back passage
• Dizziness
• 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 at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store entrolax

• Keep this medicine out of the sight and reach of children
• Do not take Entrolax 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.

6. contents of the pack and other information

What Entrolax contains

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

Entrolax are round, yellow, sugar-coated tablets.

They are packed in cartons containing blister strips of 8, 10, 20, 28, 30, 40, 50, 56, 60, 84 or 100 tablets.

Not all pack sizes may be marketed.

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) Ltd.

6 Riverview Road, Beverley

East Yorkshire, HU17 0LD