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OLSALAZINE SODIUM 250 MG CAPSULES

Active substance(s): OLSALAZINE SODIUM

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Patient Information Leaflet

Dipentum® 250 mg Capsules
Olsalazine Sodium
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
 In this leaflet, Dipentum 250 mg Capsules will be called Dipentum.
In this leaflet:
1. What Dipentum is for
2. Before you take Dipentum
3. How to take Dipentum
4. Possible side effects
5. How to store Dipentum
6. Further information.
1. What Dipentum is for
Dipentum belongs to a group of medicines called aminosalicylates.
Dipentum works by reducing pain and swelling (inflammation) in the intestine. It
reduces the actions of substances in the body that cause inflammation.
Dipentum is used to treat an inflammation of your large intestine (colon) called
ulcerative colitis. It is used for short-term (acute) attacks (called "flare-ups"), and at a
lower dose to maintain the improvement (maintenance treatment) and keep away
further "flare-ups".
If untreated, a severe attack of ulcerative colitis may cause death due to dehydration
and bursting of the colon (peritonitis).
2. Before you take Dipentum
Do not take if:
 You are allergic to olsalazine sodium or any of the other ingredients of Dipentum
(see section 6)
 You have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirincontaining products, including those bought over the counter)
 You have severe kidney disease
 You are a child under 12.
If any of the above apply to you talk to your doctor or pharmacist.
Take special care
Before you start taking Dipentum your doctor will do a blood test. This will be
repeated every three months for the first year, every six months for the next four
years and then once a year. This is to see how well your liver and kidneys are
functioning.
You should also check for signs of worsening of allergies such as asthma.
Tell your doctor immediately if you develop unexplained bruising or bleeding
accompanied with fever, dizziness, sore throat and mouth ulcers. You could have
developed a blood disorder.
Tell your doctor if you are taking any of the following medicines:
 Aspirin or any other aspirin-containing medicines or salicylates
 Other drugs to treat ulcerative colitis

 Blood thinning agents such as warfarin or heparin or heparinoids
 Drugs that treat irritable bowel syndrome and cancer such as thioguanine and 6
mercaptopurine
 If you have recently had chickenpox vaccination (taking Dipentum may cause a
greater risk of Reye's syndrome; a life threatening condition)
 Any other medicine, including medicines obtained without a prescription.
Taking Dipentum with food and drink
Always take Dipentum with a glass of water after food.
Pregnancy and breast-feeding
If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor
before taking Dipentum.
Driving and using machines
If you experience dizziness and/or blurred vision whilst taking Dipentum do not drive
or use machinery.
3. How to take Dipentum
Always use Dipentum exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown
clearly on the label that your pharmacist puts on your medicine. If it does not,
or you are not sure, ask your doctor or pharmacist.
Remember: Your medicine should always be taken after food.
Adults, children over 12 and the elderly
Acute “flare-ups”
 The usual starting dose is two capsules twice a day (two in the morning, two in the
evening at the end of a meal).
 Your doctor may increase your dose until your condition improves.
 You must not take more than twelve capsules a day or more than four capsules at
a time
 If a "flare-up" is severe you are likely to be given additional medicines.
Maintenance treatment
 Once the "flare-up" is controlled your doctor may gradually reduce your dose to
two capsules twice a day (two in the morning, two in the evening at the end of a
meal).
 This is to prevent further "flare-ups”
 You may remain on this treatment, provided it remains effective, for a long period
of time.
If you take more Dipentum than you should
Do not take more Dipentum than you should. If you have taken too much,
immediately go to the nearest hospital casualty department or your doctor. Take your
capsules and this leaflet with you.
Signs of taking too much Dipentum include nausea, vomiting and diarrhoea.
If you forget to take Dipentum
If you forget a dose take the next one as usual. Do not take a double dose to make
up for a missed dose.

If you stop taking Dipentum
Do not stop taking Dipentum without first talking to your doctor even if your
symptoms have improved.
If you have any further questions about the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines Dipentum can cause side effects, although not everybody gets
them.
Seek immediate medical help if you have any of the following symptoms (the
frequency of these side effects is unknown):
 Swelling of face, lips, tongue or throat which may cause difficulty in
swallowing/breathing
 Blood disorders (reduced number of blood cells) where you could have the
following symptoms: bruise or bleed easily, have a persistent sore throat, mouth
ulcers, dizziness and feeling tired and feverish
 Pancreatitis where you could have the following symptoms: severe stomach pain,
fever, feeling sick/being sick
 Liver disease where you could have the following symptoms: feeling sick/being
sick, loss of appetite, feeling generally unwell, itching and the whites of the eyes
may become yellow.
Other possible side effects:
Common (affects less than 1 in 10 people):
 Headache
 Diarrhoea. It does not usually last very long, but taking your medicine at the end of
a meal helps to reduce diarrhoea.
 Feeling sick
 Rash
 Joint pain
Uncommon (affects less than 1 in 100 people):
 Fever
 Being sick
 Indigestion
 Raised liver enzymes (tests your doctor may perform will show changed liver
function)
 Itching and/or hives, a nettle-like rash
 Unusual hair loss
 Light sensitivity.
 Increased heart rate
 Shortness of breath
 Muscle pain
 Pins and needles
 Depression
 Dizziness
The frequency of the following side effects is unknown:
 Altered breakdown of blood cells in the liver which could result in jaundice
(yellowing of skin/eyes)
 Stomach pain
 Inflammation of heart muscle








Awareness of your heartbeat
Inflammation of sac around heart muscle
Pain in passing urine or blood in the urine
Difficulty in breathing
Blurred vision
Loss of touch sensation/numbness

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.
5. How to store Dipentum
Keep out of the reach and sight of children.
Do not use Dipentum after the expiry date on the carton. The expiry date refers to the
last day of that month.
Store in a dry place.
Medicines should not be disposed of via wastewater or household waste. Return any
medicine you no longer need to your pharmacist.
6. Further information
What Dipentum contains
The active substance is Olsalazine Sodium 250 mg.
The other ingredients are:
Capsule contents: Magnesium stearate
Capsules shell: Gelatin, caramel (E150) and titanium dioxide (E171)
Printing ink: Shellac, iron oxide black (E172) and propylene glycol.
What Dipentum looks like
Dipentum are beige colour and marked Dipentum 250 mg.
Dipentum comes in plastic bottles containing 112 capsules.
Marketing Authorisation Holder
Atnahs Pharma UK Limited
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 updated on August 2014
If this leaflet is difficult to see or read or you would like it in a different format,
please contact
Atnahs Pharma UK Limited
Sovereign House,
Miles Gray Road,
Basildon, Essex,
SS14 3FR, UK.

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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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