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Senna Laxative Tablets

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Document: leaflet MAH BRAND_PL 00289-1750 change

Package leaflet: Information for the user

SENNA LAXATIVE TABLETS

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 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.

What is in this leaflet

1.    What Senna Laxative Tablets are and what they are used for

2.    What you need to know before you take Senna Laxative Tablets

3.    How to take Senna Laxative Tablets

4.    Possible side effects

5.    How to store Senna Laxative Tablets

6.    Contents of the pack and other information

1. WHAT SENNA LAXATIVE TABLETS ARE AND WHAT THEY ARE USED FOR

Senna Laxative Tablets are effective laxative for the short term relief of occasional constipation. Senna Laxative Tablets do not help with weight loss.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SENNA LAXATIVE TABLETS Do not take if you have:

•    an allergy (hypersensitivity) to Senna or any of the ingredients of Senna Laxative Tablets (see Section 6)

•    been told by your doctor not to take laxatives

•    a blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

•    paralysis or weakness in bowel muscle tone (atony)

•    persistent or undiagnosed abdominal complaints e.g. pain or discomfort, nausea or vomiting

•    appendicitis, diverticulitis, diarrhoea, inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis)

•    severe dehydration with water and loss of body salts (hypokalaemia)

•    faecal impaction or rectal bleeding for which you don’t know the cause, or blood in your stools

•    already taken a laxative and you are still constipated

•    a sudden change in bowel habit that has lasted for more than 2 weeks

•    kidney or heart failure

Pregnancy and breast-feeding

You should not use this medicine if you are pregnant, planning to become pregnant or breastfeeding

Talk to your pharmacist or doctor:

If you suffer from kidney problems

Other medicines and Senna Laxative Tablets

Before you take these tablets make sure you tell your pharmacist or doctor about any other medicines that you are using at the same time, particularly the following:

L Medicines for heart problems or heart rhythm problems (e.g. cardiac glycosides, antiarrhythmic medicines such as quinidine)

L Medicines which may cause changes to your heart beat (e.g. medicines for QT prolongation)

L Water tablets (diuretics)

L Corticosteriods (used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems)

L Liquorice root preparations

If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and any medicine you have bought yourself, including herbal and homeopathic remedies.

Other important information

Try to use changes in diet and bulk forming medicines to control your constipation before using this medicine. Then only use this medicine for a few days.

When administering this product to incontinent adults, pads should be changed more frequently to prevent extended contact with faeces.

3. HOW TO TAKE SENNA LAXATIVE 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.

Check the foil is not broken before use. If it is, do not take that tablet. Take the amount listed in the table below.

For oral use only

DOASGE:

How many to take

How often to take

Age

Adults, the elderly and children

Two

Once a day, at bedtime

of 12 years and over

Children of 6 to 11 years

One

Once a day, at bedtime

Normally it is sufficient to take this product up to 2 to 3 times a week.

Swallow the tablets with a drink of water.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

If you have no bowel movements after 3 days of taking this medicine, or if stomach pain persists or if you need a laxative every day, talk to your doctor.

If symptoms get worse or do not go away, talk to your doctor.

Do not take this medicine for more than 1 -2 weeks unless your doctor tells you to.

If you forget to take Senna Laxative Tablets

If you miss a dose, take your next dose at the usual time. Do not take a double dose to make up for the missed dose. Consult your doctor or pharmacist if you need further advice.

If you take too many Senna Laxative Tablets

It may be harmful to

o Take too many Senna Laxative Tablets or o Take Senna Laxative Tablets for too long

This is because taking too many 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.

Talk to a doctor straight away.

4. POSSIBLE SIDE EFFECTS

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

If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

□ Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

L Severe raised, red, itchy skin that may affect all parts of the body

If you get any of the following side effects see your pharmacist or doctor:

L Stomach pain, cramps, diarrhoea (if you get these side effects you should reduce the amount of tablets you are taking). These effects may occur particularly in patients with irritable bowel L Urine may appear yellow or red-brown during treatment which is harmless L Chronic use may lead to:

-    Protein in the urine or blood in the urine (known as albuminuria and haematuria)

-    Colouration of the lining of the gut which usually goes away when the medicine is no longer taken

The frequency of these effects occurring are not known.

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: 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 SENNA LAXATIVE TABLETS KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 25°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton.

If you need more advice ask your pharmacist.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Each tablet contains powdered Alexandrian Senna fruit (pods) (Cassia senna L. (C. acutifolia Delile) ) equivalent to 7.5mg hydroxyanthracene glycosides, calculated as Sennoside B. Also contains: maize starch, tricalcium phosphate, magnesium stearate.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva UK Limited, Eastbourne, BN22 9AG

Manufactured by Famar SA Anthoussa, Attiki 15344, Greece.

This leaflet was last revised: November 2015 PL 00289/1750