Package leaflet: Information for the patient

Senna 7.5 mg Tablets

Senna Leaf

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 has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your doctor or a pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor or a 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 3 days.

What is in this Leaflet

1.    What Senna 7.5 mg Tablets are and what they are used for

2.    What you need to know before you take Senna 7.5 mg Tablets

3.    How to take Senna 7.5 mg Tablets

4.    Possible side effects

5.    How to store Senna 7.5 mg Tablets

6.    Contents of the pack and other information

1.    What Senna 7.5 mg Tablets are and what they are used for

Senna 7.5 mg Tablets contain Senna leaf, a herbal ingredient with laxative effects. It is used for the short term relief of occasional constipation.

Senna 7.5 mg Tablets do not help with weight loss.

2.    What you need to know before you take Senna 7.5 mg Tablets

As with all medicines, Senna 7.5 mg Tablets may not be suitable for some people.

Do not take Senna 7.5 mg Tablets

-    If you are allergic to Senna Leaf or any of the other ingredients of this medicine (listed in section 6)

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

-    If you have paralysis or lack of muscle tone in the bowel (atony)

-    If you have appendicitis, inflammatory bowel disease such as Crohn’s disease or ulcerative colitis

-    If you have severe dehydration

-    If you have persistent or undiagnosed abdominal complaints e.g. pain, nausea or Vomiting

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

-    If you have already taken a laxative and you are still constipated

-    If you have had a sudden change in bowel habit that has lasted for more than 2 weeks

-    If you are under 12 years of age

-    If you have kidney or heart failure

Warnings and precautions

Talk to your doctor or pharmacist before taking Senna 7.5 mg Tablets if:

-    you suffer from kidney disorders.

When Senna leaf preparations are administered to incontinent adults then pads should be changed more frequently to prevent extended skin contact with faeces.

Children

The product is not recommended for use in children under 12 years.

Other medicines and Senna 7.5 mg Tablets

Tell your doctor or pharmacist before taking this medicine if you:

-    are taking medicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic medicinal products e.g. quinidine) and medicinal products inducing QT-prolongation.

-    are taking diuretics, adrenocorticosteroids or liquorice root preparations.

-    have recently taken or might take any other medicines.

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.

You should not use Senna 7.5mg Tablets if you are pregnant or breast feeding.

Driving and using machines

None known.

3.    How to take Senna 7.5 mg 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.

This medicine is intended for oral use only.

Adults, elderly and children over the age of 12 years:

The recommended dose is two tablets at night. The tablets should be taken with a glass of water. Senna 7.5 mg Tablets usually act within 8-12 hours.

Do not exceed the stated dose. Use for more than 1 - 2 weeks requires medical supervision.

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 more Senna 7.5mg Tablets than you should

If you accidentally take too many Senna 7.5 mg Tablets, consult your doctor or pharmacist for advice.

It may be harmful to take too much of Senna 7.5mg Tablets or take Senna 7.5 mg Tablets 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 'hypokalaemia'). 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 Senna 7.5mg Tablets

If you miss a dose, take your next dose when it’s due. Do not take a double dose to make up for a forgotten dose. Always consult your doctor or pharmacist if you need further advice.

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.

If any of the following or other side effects occur, stop taking this product and consult your doctor or pharmacist.

•    the product may produce abdominal pain, spasms and diarrhoea, in particular in patients with irritable colon

•    chronic use may lead to albuminuria and haematuria which is albumin 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

•    yellow or red-brown discolouration of urine may occur during the treatment, but is harmless

•    allergic reactions such as local or more widespread skin rash, hives (skin bumps) or itchiness around the anus. The frequency is 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 Yellow Card Scheme. Website: 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 your Senna 7.5 mg Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Senna 7.5 mg Tablets contains

-    The active substance is Senna leaf. Each tablet contains 203 mg of Senna leaf (Cassia senna L. (C. acutifolia Delile) or Cassia angustifolia Vahl) corresponding to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B.

-    The other ingredients (excipients) are maize starch, croscarmellose and magnesium stearate.

What Senna 7.5 mg Tablets looks like and contents of the pack

Senna 7.5 mg Tablets are greenish - brown biconvex tablets available in a polypropylene container with a polyethylene tamper evident closure in pack sizes of 20, 50, 60, 100, 200, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Chanelle Medical, Loughrea, Co. Galway, Ireland.

Manufacturer

Chanelle Medical, Loughrea, Co. Galway, Ireland.

Distributed by Chanelle Medical U.K. Ltd., Obeden Barn, Smarden, Kent TN27 8PR, UK This leaflet was last revised in May 2015    LB3136

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