What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL08637/0027 .

Salofalk 1g gastro resistant tablets

Package leaflet: Information for the user

Salofalk® 1g gastro-resistant tablets

mesalazine

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

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • 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.

What is in this leaflet

1. What Salofalk 1g tablets are and what they are used for
2. What you need to know before you take Salofalk 1g tablets
3. How to take Salofalk 1g tablets
4. Possible side effects
5. How to store Salofalk 1g tablets
6. Contents of the pack and other information

1. What Salofalk 1g tablets are and what they are used for

Salofalk 1g tablets contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 1g tablets are used for the treatment of acute episodes of mild to moderate forms of an inflammatory disease of the large intestine (colon), called ulcerative colitis.

2. What you need to know before you take Salofalk 1g tablets

Do not take Salofalk 1g tablets:

  • If you are allergic to mesalazine, salicylic acid, salicylates such as aspirin or to any of the other ingredients of this medicine (listed in section 6).
  • If you have a serious liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Salofalk 1g tablets:

  • If you have a history of problems with your lungs, particularly if you suffer from bronchial asthma.
  • If you have a history of allergy to sulphasalazine, which is a substance related to mesalazine.
  • If you have liver problems.
  • If you have kidney problems.

During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests.

In patients who have undergone certain types of bowel surgery, Salofalk 1g tablets may be excreted undissolved in the stool. If you notice this, please inform your doctor.

Other medicines and Salofalk 1g tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Salofalk 1g tablets can affect the way some other medicines work. Also, some other medicines can affect the way Salofalk 1g tablets work.

In particular, tell your doctor or pharmacist if you are taking:

  • Azathioprine, 6-mercaptopurine or thioguanine (medicines used to treat immune disorders)
  • Certain medicines that prevent blood clotting (medicines for thrombosis or to thin your blood, e.g. warfarin)

You may still be able to use Salofalk 1g tablets and your doctor will decide what is suitable for you.

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 only use Salofalk 1g tablets during pregnancy if instructed by your doctor.

You should only use Salofalk 1g tablets during breast-feeding if instructed by your doctor, as this medicine may pass into breast milk.

Driving and using machines

Salofalk 1g tablets have no influence on your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Salofalk 1g tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Take one Salofalk 1g tablet three times a day (morning, midday and evening), or as instructed by your doctor.

Method of administration

Salofalk 1g tablets are for oral use only.

Take the tablets 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid.

Use in children

There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older

Ask your doctor about the precise dosage of Salofalk 1g tablets for your child. The dosage depends on how severe the condition is and on your child’s body weight.

The dose should be determined individually, starting with 30-50 mg mesalazine per kg body weight per day that should be given in divided doses. The maximum dose is 75 mg mesalazine per kg body weight per day. The total dose should not exceed the maximum adult dose.

It is generally recommended that half the adult dose should be given to children up to a body weight of 40 kg and the normal adult dose to those above 40 kg.

Due to the size of Salofalk 1g tablets and the dosage recommendations, preparations of lower strengths should be used in children (e.g. Salofalk 500 mg gastro-resistant tablets or Salofalk 500 mg gastro-resistant prolonged-release granules).

Duration of treatment

The length of treatment will depend upon your condition. Your doctor will decide how long you are to continue the medication.

You should take Salofalk 1g tablets regularly and consistently during the acute episode of inflammation so the desired therapeutic effect can be achieved.

If you think that the effect of Salofalk 1g tablets is too strong or too weak, talk to your doctor.

If you take more Salofalk 1g tablets than you should

Contact your doctor if you are in doubt as they can decide what to do.

If you take too many Salofalk 1g tablets on one occasion, take your next dose as prescribed. Do not use a smaller amount.

If you forget to take Salofalk 1g tablets

If you miss a dose, continue your treatment at the prescribed dosage. Do not take a double dose to make up for the forgotten one.

If you stop taking Salofalk 1g tablets

Do not stop taking this product before having spoken to your doctor.

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.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, stop taking it and contact your doctor immediately:

  • Allergic skin rash
  • Fever
  • Breathing difficulties.

If you experience a marked worsening of your general health, especially if accompanied by fever and/or a sore throat and mouth, stop using Salofalk 1g tablets and contact a doctor immediately.

These symptoms can, very rarely, be due to a fall in the number of white cells in your blood (a condition called agranulocytosis), which may make you more prone to developing a serious infection. A blood test can confirm whether your symptoms are due to an effect of this medicine on your blood.

The following side effects have also been reported by patients using medicines containing mesalazine, the active substance in Salofalk 1g tablets:

Common side effects (may affect up to 1 in 10 people):

  • Headache

Uncommon side effects (may affect up to 1 in 100 people):

  • Abdominal pain, diarrhoea, dyspepsia, wind (flatulence), nausea and vomiting
  • Severe abdominal pain because of acute inflammation of the pancreas
  • Changes in liver function parameters, changes in pancreatic enzymes.
  • Changes in the number of white blood cells

Rare side effects (may affect up to 1 in 1,000 people):

  • Dizziness
  • Chest pain, breathlessness or swollen limbs because of an effect on your heart
  • Jaundice or abdominal pain because of liver and bile flow disorders
  • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)
  • Joint pain
  • Feeling weak or tired

Very rare side effects (may affect up to 1 in 10,000 people):

  • Changes in kidney function, sometimes with swollen limbs or flank pain
  • Fever, sore throat or malaise, due to blood count changes
  • Shortness of breath, cough, wheezing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions
  • Severe diarrhoea and abdominal pain because of an allergic reaction to this medicine within the bowel
  • Skin rash or inflammation, allergic reaction which causes joint pain, skin rashes and fever
  • Muscle pain
  • Hair loss and the development of baldness
  • Numbness and tingling in the hands and feet (peripheral neuropathy)
  • Reversible decrease in semen production

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 Website: 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.

5. How to store Salofalk 1g 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 blister and the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via 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 Salofalk 1g tablets contain

The active substance is mesalazine. Each Salofalk 1g tablet contains 1g of mesalazine.

The other ingredients are:

Microcrystalline cellulose, povidone K 25, croscarmellose sodium, methacrylic acid methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acid methyl methacrylate copolymer (1:2) (Eudragit S 100), calcium stearate [herbal origin], talc, Macrogol 6000, hypromellose, colloidal anhydrous silica, iron oxide yellow (E172), titanium dioxide (E171).

What Salofalk 1g tablets look like and contents of the pack

Salofalk 1g tablets are yellow to ochre yellow, oblong, biconvex, rounded edges gastro-resistant tablets with a smooth surface.

Salofalk 1g tablets are available in packs of 20, 50, 60, 90, 100 and 150 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel: +49 (0) 761 / 1514-0
Fax: +49(0) 761 / 1514-321
E-mail: zentrale@drfalkpharma.de
Website: www.drfalkpharma.de

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany, Greece, Hungary, Spain and United Kingdom: Salofalk

This leaflet was last revised in June 2018

Marketing Authorisation No.: PL08637/0027