Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Dipentum belongs to a group of medicines called aminosalicylates.
Dipentum Capsules works by reducing pain and swelling (inflammation) in the intestine. It reduces the actions of substances in the body that cause inflammation.
Dipentum Capsules 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).
Do not take Dipentum Capsules if you: • are allergic to olsalazine sodium or any of the other ingredients of this medicine (listed in section 6)
• have ever had an allergic reaction to any salicylates (e.g. aspirin and aspirin- containing products, including those bought over the counter)
• have severe kidney disease
If any of the above apply to you talk to your doctor or pharmacist.
Warning and precautions Before you start taking Dipentum Capsules your doctor will do a blood test. This will be repeated every three months for the first year, every six months for the next fouryears 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.
Children and adolescents Do not take Dipentum Capsules if you are under 12 years of age.
Other medicines and Dipentum Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might have taken 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 Olsalazine Sodium Capsules may cause a greater risk of Reye's syndrome; a life threatening condition)
• Any other medicine, including medicines obtained without a prescription.
Dipentum Capsules with food and drink Always take Olsalazine Sodium Capsules with a glass of water after food.
Pregnancy, breast-feeding and fertility If you are pregnant, or trying to become pregnant or breastfeeding, talk to your doctor before taking Dipentum Capsules.
Driving and using machines If you experience dizziness and/or blurred vision whilst taking Dipentum Capsules do not drive or use machinery.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
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 Capsules than you should Do not take more Dipentum Capsules 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 Capsules include nausea, vomiting and diarrhoea.
If you forget to take Dipentum Capsules Do not take a double dose to make up for a forgotten dose. If you forget a dose take the next one as usual.
If you stop taking Dipentum Capsules Do not stop taking Dipentum Capsules 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.
Like all medicines this medicine 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: may affect up to 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: may affect up to 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
Not known: frequency cannot be estimated from the available data :
• 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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton. The expiry date refers to the last day of that month.
Store in a dry place.
Do not throw away 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.
What Dipentum Capsules contains The active substance is Olsalazine Sodium 250 mg.
The other ingredients are:
Capsules contents: Magnesium stearate
Capsules shell: Gelatin, caramel (E150) and titanium dioxide (E171) Printing ink: Shellac, iron oxide black (E172) and propylene glycol.
What Dipentum Capsules looks like and content of the pack Dipentum Capsules are beige colour and marked Dipentum 250 mg. Dipentum Capsules 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
United Kingdom
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom
Coripharma ehf
Reykjavíkurvegur 78
IS-220 Hafnarfjörður
Iceland
This leaflet was last revised in July 2023
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
Atnahs Pharma UK Ltd
Address
Sovereign House, Miles Gray Road, Basildon, SS14 3FR
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www.pharmanovia.com
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Dipentum Capsules 250 mg comes as capsule containing 250 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dipentum Capsules 250 mg is olsalazine sodium.
Medicines with the same active substance include: Olsalazine Sodium 250 mg Capsules, Olsalazine Sodium 500 mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Dipentum Capsules 250 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ask anything about Dipentum Capsules 250 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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