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BISACODYL 5 MG TABLETS

Active substance(s): BISACODYL

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3. How to take SOVOLAX

GBR 724-7711-APIL
Package leaflet: Information for the user

SOVOLAX 5 mg Tablets
Bisacodyl

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

2. What you need to know before you take
SOVOLAX

This medicine is available without prescription. You need to take
SOVOLAX as instructed in this leaflet 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 your pharmacist or doctor if your symptoms
worsen or do not improve after five days treatment
• 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.

Do not take this medicine and tell your doctor:
• if you are allergic to bisacodyl or any of the other ingredients
in the medicine (listed in Section 6).
• if you are intolerant to or cannot digest some sugars (as the
tablet contains a small amount of lactose)
• if you have severe dehydration
• if you have a bowel condition called “ileus” (blockage in the
intestine)
• if you have a serious abdominal condition such as
appendicitis
• if you have severe abdominal pain with nausea and vomiting
• if you have a blocked bowel (intestinal obstruction)
• if you have inflammation of the bowel (small or large
intestine)
Do not take this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
SOVOLAX.

What is in this leaflet
1. What SOVOLAX is and what it is used for
2. What you need to know before you take SOVOLAX
3. How to take SOVOLAX
4. Possible side effects
5. How to store SOVOLAX
6. Contents of the pack and other information

1. What SOVOLAX is and what it is used for
• SOVOLAX contains a medicine called bisacodyl. This belongs
to a group of medicines called laxatives
• SOVOLAX is used for the short term relief of constipation
• SOVOLAX stimulates the muscles of the bowel (large
intestine). This brings about overnight relief from constipation.
SOVOLAX does not help with weight loss.
What is constipation?
Normal and regular bowel movement is important for most
people. However, what is “normal and regular” varies from
person to person. Some may have a bowel movement every day,
others less often. Whatever it is like for you, it is best that your
bowel movement has a regular pattern.
• Constipation is an occasional problem for some people. For
others, it may happen more often
• It happens when the normal muscle actions in the bowel
(large intestine) slow down. This can mean that material is not
easily eliminated from the body
The cause of constipation is often not known. It can be associated
with:
• Sudden change of diet
• A diet with not enough fibre
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise
Whatever the cause, constipation can be uncomfortable. It may
make you feel bloated and heavy or generally “off colour”.
Sometimes it causes headaches.
These healthy tips are recommended to try to prevent
constipation happening:
• Eat a balanced diet including fresh fruit and vegetables
• Drink enough water so that you do not become dehydrated
• Keep up your exercise and stay fit
• Make time to empty your bowels when your body tells you

Warnings and precautions
As with all laxatives, SOVOLAX should not be taken every day for
more than five days. If you need laxatives every day, or if you
have abdominal pain which does not go away, you should see
your doctor.
Other medicines and SOVOLAX
Please tell your pharmacist or doctor if you are taking or have
recently taken any other medicines,
including medicines obtained without a
prescription. This includes herbal
medicines. This is because SOVOLAX can
affect the way some other medicines work.
Also, some other medicines can affect the
way SOVOLAX works.
In particular, tell your doctor or pharmacist
if you are taking:
• Water tablets (diuretics) such as bendrofluazide or furosemide
(frusemide)
• Steroid medicines such as prednisolone
If you are not sure if any of the above applies to you, talk to your
pharmacist or doctor before taking SOVOLAX.
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.
Driving and using machines
Some people may feel dizzy or faint while taking this medicine. If
this happens to you, wait until these feelings go away before
driving or using machines.
SOVOLAX contains lactose and tartrazine (E102)
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
SOVOLAX also contains tartrazine (E102), which may cause
allergic reactions.

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.
Received Date:
04/08/2016
Taking this medicine
CDLthe
JOB
No. : whole with
57539
• Swallow
tablets
water. Do not crush or chew
Required By :
05/08/2016
the tablets.
• Milk-containing products or antacids should not be taken
within one hour before or after taking SOVOLAX. This is
because they will stop SOVOLAX from working properly
The recommended dose is:
Adults and children over 10 years
• Take one or two tablets (5 or 10 mg) daily before bedtime
• If you have not taken SOVOLAX before, start with one tablet
and increase to two if necessary
5 mgtoTablets
• When PRODUCT
your bowelNAME:
regularity Sovolax
has returned
normal, the dose
can usually
be stopped
PIP CODE:
GBR 724-7711-APIL
COMPONENT:
Leaflet
Use in children
SIZE: between 4 and 10150x220
Children aged
years mm
Great
Britain
SOVOLAX MARKET:
should only be given to
children
between the ages of 4
and 10 if recommended
by a doctor.
PRODUCT SITE:
TBC The usual dose for children
is: One tablet
(5 mg) daily before100%
bedtime
SCALE:
COLOURS:
Black
Children under
4 years
SOVOLAX is not recommended for
children under 4 years.
Cutter
DATE:
05/08/2016
If you take more SOVOLAX than you should.
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It may be harmful to:
• take too many SOVOLAX tablets or
• take SOVOLAX 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
REGULATORY
AUTHORITY
relaxed. This
means that bowel
emptying happens less often.
APPROVAL
CONFIRMATION
This can lead to long-term constipation;
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• imbalance
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• low levels
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This can make you tired, dizzy, make your muscles weak and
cause Accept
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• dehydration, making you thirsty, feel faint and giving you
headaches. It can also mean you cannot pass enough urine.
Reject Artwork ..................................................................

If you forget to take your medicine
If you forget to take your tablets, just take the next dose at the
usual time,Signature
DO NOT..........................................................................
take a double dose to make up for the
forgotten dose.
Name .................................................................................

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

4. Possible side effects

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

PAGE 1 OF 2

Rare side effects (affect less than 1 in 1000 people)
• Severe allergic reactions which may cause swelling of the
face or throat and difficulty in breathing or dizziness.
If you have a severe allergic reaction, stop taking this medicine
and see a doctor straight away.
• Colitis (inflammation of the large intestine which causes
abdominal pain and diarrhoea)
• Dehydration

3. How to take SOVOLAX
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.
Taking this medicine
• Swallow the tablets whole with water. Do not crush or chew
the tablets.
• Milk-containing products or antacids should not be taken
within one hour before or after taking SOVOLAX. This is
because they will stop SOVOLAX from working properly
The recommended dose is:
Adults and children over 10 years
• Take one or two tablets (5 or 10 mg) daily before bedtime
• If you have not taken SOVOLAX before, start with one tablet
and increase to two if necessary
• When your bowel regularity has returned to normal, the dose
can usually be stopped
Use in children
Children aged between 4 and 10 years
SOVOLAX should only be given to children between the ages of 4
and 10 if recommended by a doctor. The usual dose for children
is: One tablet (5 mg) daily before bedtime
Children under 4 years
SOVOLAX is not recommended for children under 4 years.
If you take more SOVOLAX than you should.
If you take more of this medicine than you should, talk to a doctor
or go to a hospital straight away. Take the medicine pack with
you; this is so the doctor knows what you have taken.
It may be harmful to:
• take too many SOVOLAX tablets or
• take SOVOLAX 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 ‘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 your medicine
If you forget to take your tablets, just take the next dose at the
usual time, DO NOT take a double dose to make up for the
forgotten dose.
If you have any further questions on the use of this medicine, ask
your pharmacist or doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Rare side effects (affect less than 1 in 1000 people)
• Severe allergic reactions which may cause swelling of the
face or throat and difficulty in breathing or dizziness.
If you have a severe allergic reaction, stop taking this medicine
and see a doctor straight away.
• Colitis (inflammation of the large intestine which causes
abdominal pain and diarrhoea)
• Dehydration

• Allergic reactions which may cause a skin rash
• Fainting
Uncommon side effects (affect less than 1 in 100 people)
• Blood in the stools
• Vomiting
• Abdominal discomfort
• Discomfort inside and around the back passage
• Dizziness

Received Date:
CDL JOB No. :
Required By :

04/08/2016
57539
05/08/2016

PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:

DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

Sovolax 5 mg Tablets
GBR 724-7711-APIL
Leaflet
150x220 mm
Great Britain
TBC
100%
Black
Cutter
05/08/2016
8 pt
9
CH
Sovereign Medical

Common side effects (affect less than 1 in 10 people)
• Abdominal cramps or pain
• Diarrhoea
• Nausea
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 SOVOLAX
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 blister and on the carton. The expiry date refers to the last day
of that month.
Do not store above 25ºC. Store in the original package in order to
protect from moisture.
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 SOVOLAX contains
The active substance is Bisacodyl.
SOVOLAX 5 mg gastro-resistant tablets contain 5 mg of bisacodyl.
The other ingredients are lactose, maize starch, liquid paraffin,
magnesium stearate, polyvinyl acetate phthalate, stearic acid,
Opadry® (contains hypromellose, titanium dioxide, polyethylene
glycol and tartrazine (E102)) and Carnauba Wax.
What SOVOLAX looks like and contents of the pack
SOVOLAX tablets are yellow, shiny, round tablets with no
markings.

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................

The tablets are supplied in blisters packed in cartons containing
10, 20 and 40 tablets.

Signature ..........................................................................

Not all pack sizes may be marketed.

Name .................................................................................

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon,
Essex, SS14 3FR, UK.
Manufacturer
Waymade Plc, Sovereign House,
Miles Gray Road, Basildon,
Essex SS14 3FR, UK
This leaflet was last revised in: August 2016

Date ...................................................................................

PAGE 2 OF 2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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