Document: leaflet MAH BRAND_PL 08637-0019 change

• leaflet MAH BRAND_PL 08637-0019
• leaflet MAH BRAND_PLPI 15814-1079

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Salofalk® 500mg

gastro-resistant tablets

Mesalazine

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.

-    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.

In this leaflet:

1.    What Salofalk 500mg tablets are and what they are used for

2.    Before you take Salofalk 500mg tablets

3.    How to take Salofalk 500mg tablets

4.    Possible side effects

5.    How to store Salofalk 500mg tablets

6.    Further information

Salofalk 500mg tablets contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 500mg tablets are used for:

- the treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis.

Do not take Salofalk 500mg tablets:

-    If you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin® or to any of the other ingredients of Salofalk 500mg tablets (these are listed in section 6, Further information).

-    If you have a serious liver or kidney disease.

Take special care with Salofalk 500mg tablets. Before you start taking this medicine you should tell your doctor:

-    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, a substance related to mesalazine.

-    If you suffer with problems of your liver.

-    If you suffer with problems of your kidney.

Further precautions

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 rare cases, in patients who have undergone bowel resec-tion/bowel surgery in the ileo-coecal area with removal of the ileocoecal valve, it has been observed that Salofalk 500mg tablets are excreted undissolved in the stool, due to an excessively rapid passage through the bowel. If you notice this occurrence in your own case, please inform your doctor.

Using other medicines

Please tell your doctor if you take or use any of the medicines mentioned below as the effects of these medicines may change (interactions):

-    Certain medicines that affect blood clotting (medicines for thrombosis or to thin your blood, e.g., warfarin)

-    Azathioprine, 6-mercaptopurine or thioguanine

(medicines used to treat immune disorders)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It may still be all right for you to use Salofalk 500mg tablets and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should only use Salofalk 500mg tablets during pregnancy if your doctor tells you to.

You should also only use Salofalk 500mg tablets during breast-feeding if your doctor tells you to, as this the medicine may pass into breast milk.

Driving and using machines

There are no effects on the ability to drive and use machines.

Important information about some of the ingredients of Salofalk 500mg tablets

One Salofalk 500mg tablet contains 2.1 mmol (49 mg) sodium. If you need to be on a controlled sodium salt diet, you should take this into consideration.

Always take Salofalk 500mg tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Salofalk 500mg tablets are for oral use only.

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

Dosage

Children

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

Children 6 years of age and older

Please ask your doctor about the precise dosage of Salofalk 500mg tablets for your child.

In acute episodes: to 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.

To prevent a relapse: to be determined individually, starting with15-30 mg mesalazine per kg body weight per day that should be given in divided doses. The total dose should not exceed the recommended 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.

Duration of treatment

How long you will use the medicine depends upon your condition. Your doctor will decide how long you are to continue the medication.

You should follow the treatment with Salofalk 500mg tablets regularly and consistently both during the acute episode of inflammation and also as long-term treatment, because this is the only way to achieve the desired therapeutic effect.

If you think that the effect of Salofalk 500mg tablets is too strong or too weak, talk to your doctor.

If you take more Salofalk 500mg tablets than you should

Contact a doctor if you are in doubt, so he or she can decide what to do.

If you use too much Salofalk 500mg tablets on one occasion, just take your next dose as prescribed. Do not use a smaller amount.

If you forget to take Salofalk 500mg tablets

Do not take a larger than normal dose of Salofalk 500mg tablets next time, but continue treatment at the prescribed dosage.

If you stop taking Salofalk 500mg tablets

Do not stop taking this product until you have talked to your doctor.

If you have any further guestions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Salofalk 500mg tablets 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, you should contact your doctor immediately:

-    Allergic skin rash

-    Fever

-    Breathing difficulties

If you experience a marked reduction of your general health, especially if accompanied by fever, and/or a sore throat and mouth, stop using these tablets and contact your 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 mesalazine:

Rare side effects (that affect less than 1 in 1,000 patients):

-    Abdominal pain, diarrhoea, wind (flatulence), nausea and vomiting

-    Headache, dizziness

-    Chest pain, breathlessness or swollen limbs because of an effect on your heart.

Very rare side effects (that affect less than

1 in 10,000 patients):

-    Changes in kidney function, sometimes with swollen limbs or flank pain

-    Severe abdominal pain because of acute inflammation of the pancreas

-    Fever, sore throat or malaise because of 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

-    Muscle and joint pain

-    Jaundice or abdominal pain because of liver and bile flow disorders

-    Flair loss and the development of baldness

-    Numbness and tingling in the hands and feet (peripheral neuropathy)

-    Reversible decrease in semen production

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.

Keep out of the reach and sight of children.

Do not use Salofalk 500mg tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.

This medicinal product does not reguire any special storage conditions.

What Salofalk 500mg tablets look like and contents of the pack

Salofalk 500mg tablets are oval, light yellow to ochre, gastro-resistant tablets, matt with smooth surface; they are not scored.

Salofalk 500mg tablets are available in blister packs of 20, 45, 50, 90, 100 and 300 tablets.

Not all package 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

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

Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Great Britain, Greece, Flungary, Latvia, Lithuania, Malta, The Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia and Spain: Salofalk®

Belgium and Luxembourg: Colitofalk®

Finland and Norway: Mesasal®

This leaflet was last approved in 01/2012

What Salofalk 500mg tablets contain

The active substance in Salofalk 500mg tablets is mesalazine, and one tablet of Salofalk 500mg tablets contains 500 mg mesalazine.

The other ingredients are:

Calcium stearate; cellulose, microcrystalline; croscarmellose sodium; basic butylated methylacrylate copolymer (=Eudragit E); methacrylic acid-methyl methacrylate copolymer (1:1)

(=Eudragit L); glycine; silica, colloidal anhydrous; hypromel-lose; macrogol 6000; sodium carbonate, anhydrous; povidone K25; talc; colouring agents: titanium dioxide (E 171); iron oxide hydrate (E 172)