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Ex-Lax Senna

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Document: leaflet MAH BRAND_PL 00030-0131 change

PATIENT INFORMATION LEAFLET

EX-LAX SENNA

Senna Fruit

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, you still need to take Ex-Lax Senna carefully 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 a doctor if your symptoms worsen, or do not improve after 7 days.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ex-Lax Senna is and what is it used for

2.    Before you take Ex-Lax Senna

3.    How to take Ex-Lax Senna

4.    Possible side effects

5.    How to store Ex-Lax Senna

6.    Further information

1.    WHAT EX-LAX SENNA IS AND WHAT IT IS USED FOR

Ex-Lax Senna belongs to a group of medicines known as laxatives, and is used for the short term relief of occasional constipation. Ex-lax Senna does not help with weight loss.

Each Ex-Lax Senna chocolate tablet contains the equivalent of 15 mg of refined extract of senna containing sennosides.

2.    BEFORE YOU TAKE EX-LAX SENNA Do not take Ex-Lax Senna if you have:

•    an allergy (hypersensitive) to Senna or any of the ingredients of Ex-Lax Senna (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

•    have 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

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

•    kidney or heart failure

•    an ileostomy or colostomy (an operation in which your small intestine, or large intestine is routed to an opening in the surface of your abdomen called a stoma).

Ex-Lax Senna must not be given to children under 6 years old.

Talk to your doctor or pharmacist before taking Ex-lax Senna if you:

•    have recently had abdominal surgery,

•    have a kidney disorder

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Tell your doctor before taking this medicine if you are taking:

•    Medicines used to treat heart problems or heart rhythm problems (e.g. cardiac glycosides, antiarrhythmic medicines such as quinidine)

•    Medicines taken which may cause changes to your heart beat (medicines inducing QT prolongation)

•    Water tablets,

•    Liquorice root preparations

•    Corticosteroids (used to treat conditions such as pain, swelling, allergy, asthma,rheumatism).

Taking Ex-Lax Senna with food and drink

Ex-Lax Senna can be taken with or without food and drink.

Pregnancy and breast-feeding

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

Driving and using machines

There is no evidence that Ex-Lax Senna can affect your ability to drive or operate machinery.

Important information about some of the ingredients of Ex-Lax Senna.

This medicine contains sucrose. If you have an intolerance to some sugars, contact your doctor before taking this product.

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

It is recommended to use changes in diet and bulk forming medicines to control constipation.

3. HOW TO TAKE EX-LAX SENNA

For oral use only

Adults, elderly and children over 12 years: Chew one chocolate tablet at bedtime.

Children 6years and over: Chew half a chocolate tablet at bedtime.

Children under 6years: not recommended.

Drink plenty of liquids while you are taking Ex-Lax Senna.

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

Consult your doctor if:

•    there is no bowel movement after 3 days,

•    you need a laxative every day,

•    you have persistent abdominal pain, if symptoms worsen or persist.

Ex-Lax Senna should not be used for more than 7 days without seeking medical advice.

If you take more Ex-Lax Senna than you should

Taking too many tablets may cause diarrhoea, stomach cramps and dehydration^ If this happens, drink plenty of liquids to help replace the lost fluid.

If you accidentally take too many tablets, or you suspect that your child has accidentally taken any medicine, contact your doctor or pharmacist.

It may be harmful to take too much of Ex-Lax Senna or take Ex-Lax Senna 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 the 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 Ex-Lax Senna

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next dose at the correct scheduled time.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ex-Lax Senna can cause side effects, although not everybody gets them.

STOP taking Ex-Lax Senna and seek medical help immediately if you or your child has any of the following which may be signs of an allergic reaction:

•difficulty in breathing or swallowing • swelling of the face, lips, tongue or throat

•severe itching of the skin, with a red rash or raised bumps, which may be local or more widespread.

Ex-Lax Senna may produce abdominal pain, spasms and diarrhoea, in particular in patients with irritable colon.

If you experience persistent abdominal pain, nausea and diarrhoea with excessive loss of water, if the constipation continues or become worse when taking Ex-Lax, stop taking it and tell your doctor straight away.

Yellow or red-brown discolouration of urine may occur but is harmless.

Chronic use may lead to albuminuria and haematuria, which is protein or red blood cells in the urine.

Chronic use may cause pigmentation of the gastrointestinal tract which usually recedes when the product is no longer taken.

This medicine may cause other effects such as increase in the hormone aldosterone, dehydration, kidney problems, low blood pressure (hypotension), tiredness, muscle cramps, muscle weakness , a decrease in levels of body salts in the blood (e.g. calcium, magnesium, potassium and sodium), and abnormal enlarging/expansion of the colon.

Prolonged use may also lead to a tolerance of the medicine, meaning that larger doses will be required to produce the desired effect.

If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 the package 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 EX-LAX SENNA

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Do not use Ex-Lax Senna after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Ex-Lax Senna contains

Each tablet contains sennosides, as calcium salts, equivalent to 15 mg hydroxyanthracene glycosides, calculated as sennoside B.

The other ingredients are cocoa liquor, sucrose, cocoa butter, lecithin and vanilin.

What Ex-Lax Senna looks like and contents of the pack

Ex-Lax Senna are rectangular chocolate tablets wrapped in paper backed aluminium foil, or aluminium foil, and packed into cartons of 6, 9, 12, 18, 24, 36, or 48 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

For any information about this medicinal product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in September 2015