PACKAGE LEAFLET: INFORMATION FOR THE USER ALEXANDRIAN SENNA PODS Alexandrian Senna Pods

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

This medicine is available without prescription. However, you still need to use Alexandrian Senna Pods 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

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

In this leaflet:

1.    What Alexandrian Senna Pods is and what it is used for

2.    Before you take Alexandrian Senna Pods

3.    How to take Alexandrian Senna Pods

4.    Possible side effects

5.    How to store Alexandrian Senna Pods

6.    Further information

1.    WHAT ALEXANDRIAN SENNA PODS IS AND WHAT IT IS USED FOR

The name of your medicine is Alexandrian Senna Pods. It contains the active ingredient Alexandrian Senna Pods. It is a herbal medicinal product used for the short term relief of occasional constipation.

Alexandrian Senna Pods do not help with weight loss.

2.    BEFORE YOU TAKE ALEXANDRIAN SENNA PODS Do not take Alexandrian Senna Pods if you:

•    are allergic (hypersensitive) to Alexandrian Senna Pods

•    have severe dehydration

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

•    have paralysis or lack of muscle tone in the bowel (atony)

•    have appendicitis, inflammatory bowel diseases (e.g. Crohn’s disease, ulcerative colitis)

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

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

•    have already taken a laxative and you are still constipated

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

•    have a kidney or heart condition

•    are pregnant or breast-feeding

•    are under 12 years of age.

Warnings and precautions

•    Patients with kidney disorders should be aware of possible electrolyte imbalance and should consult their doctor before taking this medicine.

•    If laxatives are needed every day the cause of the constipation should be investigated.

•    Long term use of laxatives should be avoided. This product should only be used if relief of constipation cannot be achieved by a change of diet or the administration of bulk forming agents (such as ispaghula husk which works in the same way as dietary fibre)

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

Taking other medicines

If you are taking medicines for a heart condition e.g. cardiac glycosides, antiarrhythmic medicinal products e.g. quinidine; medicinal products inducing QT- prolongation or diuretics, adrenocorticosteroids or liquorice root preparations, consult your doctor before taking this product.

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

Taking with food and drink

•    maintain an adequate fluid intake whilst taking this medicine. Drink plenty of water while you are being treated with this medicine. You should aim to drink at least eight large glasses of water a day.

•    to help prevent constipation it is important to eat a well-balanced diet containing fibre (whole grain breads and cereals, bran, fruit and green leafy vegetables) and to take daily exercise

•    drinks containing caffeine (tea, coffee) or alcohol can make constipation worse as they have a diuretic effect, which means they cause a loss of fluid from the body, causing dehydration.

Pregnancy and breast-feeding

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

3. HOW TO USE ALEXANDRIAN SENNA PODS

Follow the directions on this package leaflet or pack carefully, and ask your pharmacist to explain any part you do not understand.

For oral use

Adults and the Elderly:

Soak 6 to 8 Senna pods in a glass of cold water for about four hours; and drink at bed time. Children over 12 years of age:

Soak only three or four Senna pods and drink at bedtime. A little sugar may be added.

Not recommended for children under 12 years of age

Do not exceed the stated dose.

The correct individual dose is the smallest dose that produces a soft formed motion.

Use for more than 1 -2 weeks requires medical supervision

Normally it is sufficient to take this medicinal product up to two to three times a week.

Consult your doctor after taking this medicine:

-    If symptoms worsen or persist

-    - If there is no bowel movement after 3 days and laxatives are needed every day

-    If abdominal pain persists

If you take too much of Alexandrian Senna Pods

If you take more of this medicine than you should, please consult your doctor or pharmacist immediately.

It may be harmful to

-    Take too much of Alexandrian Senna Pods

-    Take Alexandrian Senna Pods 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 miss a dose

If you miss a dose, take your next dose at the usual time. Do not take double the dose to make up for a missed dose.

Consult your doctor or pharmacist if you need further advice.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Alexandrian Senna Pods may cause side-effects, although not everybody gets them.

This product may cause stomach pain, spasms and diarrhoea, in particular in patients with irritable colon.

Chronic use may lead to albuminaria and haematuria which is albumin or red blood cells in the urine. Yellow or red-brown discolouration of urine may occur during treatment but is harmless.

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

Allergic reactions such as local or widespread skin rash, hives (skin bumps) or itchiness around the anus may occur. The frequency is not known.

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 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 ALEXANDRIAN SENNA PODS

•    Keep out of the reach and sight of children.

•    Store in the original packaging.

•    Keep the carton closed.

•    Do not use Alexandrian Senna Pods after the expiry date which is stated on the pack. The expiry date refers to the last date of that month.

•    Alexandrian Senna Pods should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of this product when no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What this product contains

Alexandrian Senna pods (Cassia senna L. (C. acutifolia Delile) fruit).

What Alexandrian Senna Pods look like and content of the pack

Alexandrian Senna Pods are flattened reniform pods, green to greenish-brown and are available in a cardboard carton containing 25g Senna pods.

Marketing Authorisation Holder and Manufacturer:

Bristol Laboratories Limited, Unit-3, Canalside, Northbridge Road, Berkhamsted,

HP4 1EG, UK

Tel: 0044 (0)1442 200922,

Fax: 0044 (0)1442 873717 Email: info@bristol-labs.co.uk Alexandrian Senna Pods PL 17907/0381 This leaflet was last revised in May 2015

To request a copy of this leaflet in Braille, large print or audio format, please contact the Marketing Authorization holder at the address (or telephone, fax, email) above.