250 mg capsules 

User information

Please note that the doctor may have prescribed the medicine for another use and/or with a different dosage than that stated in the package leaflet. Always follow your doctor’s prescription and the instructions on the medicine pack.

What does the medicine contain?

One capsule contains: 
Active substance: olsalazine sodium 250 mg. 
Other substances: magnesium stearate 
Capsule shell: gelatin, sugar color (dye E 150), titanium dioxide (dye E 171) 
Capsule writing: shellac, iron oxide (dye E 172), propylene glycol. 
Beige gelatin capsule filled with yellow powder, marked “DIPENTUM® 250 mg”.

How does the drug work?

Dipentum has an anti-inflammatory effect in the treatment of the intestinal disease ulcerative colitis. The effect is exerted locally on the intestinal mucosa.

Marketing Authorisation Holder

Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK.

What is the medicine used for?

Dipentum is used to treat ulcerative colitis (an inflammatory disease of the colon that can cause severe diarrhea).

When should the medicine not be used?

Dipentum should not be used by people who are hypersensitive to olsalazine, other salicylates (a group of similar active substances that are included in certain medicines for fever and pain), or any of the other ingredients of Dipentum.

To think about before and when the medicine is used

People with any of the following conditions should consult their doctor before starting treatment with Dipentum: renal or hepatic impairment, severe allergy, or asthma.

Stop taking Dipentum and contact a doctor immediately if you get any of the following symptoms:

angioedema

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

hematotoxicity

  • fever, sore throat, sore mouth, bruising, or bleeding

Pregnancy and breastfeeding

Limited experience of use during pregnancy. Do not take Dipentum without first consulting your doctor if you are pregnant. 
May pass into breast milk. Do not take Dipentum without first consulting your doctor if you are breast-feeding.

Traffic warning

Dipentum has no known effect on the ability to drive or use machines. 
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

What to avoid when using this medicine

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

Dipentum may affect or be affected by certain medicines for:

  • cancer (mercaptopurine, thioguanine).
  • blood clots (such as heparin, warfarin )

If you are going to be vaccinated against chickenpox, you should consult your doctor about stopping the medication at the time of vaccination and a limited time thereafter.

Dosage instructions

Dose one is determined by the doctor, who adjusts it individually for you. 
Dipentum should be taken at regular intervals immediately after a meal. The capsules are swallowed whole. 
The usual dose for adults is 2 capsules twice daily, but at the beginning of treatment, a lower dose is often given.

What happens if you take too large a dose?

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

What side effects can the drug cause?

Like all medicines, Dipentum can cause side effects, although not everybody gets them. 
The most common side effect is diarrhea, which is usually transient in nature. In case of prolonged or severe diarrhea, the treating physician should be consulted.

Common (more than 1 in 100): Headache, diarrhea, nausea, rash, joint pain.

Uncommon (more than 1 in 1000 but less than 1 in 100): Decreased platelet count ( thrombocytopenia ), depression, dizziness, and crawling, rapid heartbeat ( tachycardia), shortness of breath, vomiting, indigestion, elevated liver enzyme levels, pruritus, hair loss, skin reactions caused by an increased hypersensitivity to light, hives, muscle pain, fever.

No known frequency (can not be calculated): Anemia, increased number of a certain type of white blood cell ( eosinophilia ), decreased number of a certain type of white blood cell ( neutropenia, leukopenia ), decrease in a total number of blood cells. Pericarditis, myocarditis, palpitations. Upper abdominal pain, inflammation of the pancreas. Hepatitis ( hepatitis ), elevated bilirubin (a red bile dye), allergic swelling ( edema ) of the skin and mucous membranes (so-called angioedema), see Thinking about before and when the medicine is used), kidney inflammation (interstitial nephritis), pneumonia (interstitial lung disease), abnormal sensations, affect of the small nerves mainly in the lower legs and feet usually sensory nerves which can give e.g. pertussis ( peripheral neuropathy ), blurred vision.

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.

Storage and durability

Do not store above 25 ° C. 
Keep out of sight and reach of children. 
Do not use this medicine after the expiry date which is stated on the label after EXP. dat. The expiration date is the last day of the specified month. 
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Muhammad Nadeem

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