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Ex-Lax Senna

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Document: leaflet MAH BRAND_PL 44673-0167 change

Ex Lax Senna Pills - PL 44673/0167 - Leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

EX-LAX SENNA PILLS

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 Pills carefully to get the best results from them.

•    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 le afle t:

1.    What Ex-Lax Senna Pills are and what they are used for

2.    Before you take Ex-Lax Senna Pills

3.    How to take Ex-Lax Senna Pills

4.    Possible side effects

5.    How to store Ex-Lax Senna Pills

6.    Further information

1.    WHAT EX-LAX SENNA PILLS ARE AND WHAT THEY ARE USED FOR

Ex-Lax Senna Pills belong to a group of medicines known as laxatives, and are used to relieve constipation. Ex-Lax Senna Pills do not help with weight loss.

Each Ex-Lax Senna Pill contains the equivalent of 12 mg of refined extract of senna containing sennosides.

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

•    an allergy (hypersensitivity) to Senna or any of the ingredients of Ex-Lax Senna Pills (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 (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 mor e 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 Pills are not recommended for children aged under 12 years.

•    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 taken 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 Pills with food and drink

Ex-Lax Senna Pills can be taken with or without with 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 Pills can affect your ability to drive or operate machinery.

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

This medicine contains the sugars lactose, sucrose and glucose. 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 PILLS

For oral use only

Adults, elderly and children over 12years: Take one tablet before going to bed. A higher dose may be prescribed by a medical practitioner.

Children under 12years: Not recommended for children under 12.

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

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 Pills should not be used for more than 7 days without seeking medical advice.

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

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

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

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 Pills can cause side effects, although not everybody gets them.

STOP taking Ex-Lax Senna Pills 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 Pills 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 PILLS Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Ex-Lax Senna Pills after the expiry date (EXP) which is stated on the blister and 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.

6.    FURTHER INFORMATION What Ex-Lax Senna Pills contain

Each tablet contains sennosides, as calcium salts, equivalent to 12 mg hydroxyanthracene glycosides, calculated as sennoside B.

The other ingredients are: sucrose, lactose monohydrate, maize starch, talc, acacia, titanium dioxide, glucose, stearic acid, gelatin, silica colloidal anhydrous, red iron oxide and carnauba wax.

What Ex-Lax Senna Pills look like and contents of the pack

Ex-Lax Senna Pills are circular, biconvex, brownish red sugar-coated tablets of approximately 6 mm diameter.

Ex-Lax Senna Pills are available in blister packs of sizes: 6, 9, 10, 12, 18, 20, 24, 30, 36, 40 or 48 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford,

TW8 9GS,

UK

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

This leaflet was last revised in May 2016.