Document: leaflet MAH BRAND_PLPI 33902-0472 change

• leaflet MAH BRAND_PL 10341-0004
• leaflet MAH BRAND_PLPI 33902-0472

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PACKAGE LEAFLET:

INFORMATION FOR THE USER

Salofalk® 250mg 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 250mg Tablets are and what they are used for

2.    What you need to know before you take Salofalk 250mg Tablets

3.    How to take Salofalk 250mg Tablets

4.    Possible side effects

5.    How to store Salofalk 250mg Tablets

6.    Contents of the pack and other information

Salofalk 250mg Tablets contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease.

Salofalk 250mg 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 250mg Tablets

•    If you are allergic to salicylic acid, to salicylates such as aspirin or to any of the other ingredients of Salofalk 250mg Tablets (listed in section 6).

•    If you have a serious liver or kidney disease.

Warnings and precautions

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.

S0472-100-RM-PIL-31.07.2015

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 resection/bowel surgery in the ileo-coecal area with removal of the ileocoecal valve, it has been observed that Salofalk 250mg 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.

Other medicines and Salofalk 250mg Tablets

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

•    Certain agents that inhibit blood clotting

(medicines for thrombosis or to thin your blood, e.g., warfarin)

•    Azathioprine, 6-mercaptopurine orthioguanine

(medicines used to treat immune disorders)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It may still be alright for you to use Salofalk 250mg Tablets and your doctor will be able to 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 250mg Tablets during pregnancy if your doctor tells you to.

You should only use Salofalk 250mg Tablets during breastfeeding if your doctor tells you to as this medicine may pass into breast milk.

Driving and using machines

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

Salofalk 250mg Tablets contain 48mg of sodium per tablet. To be taken into consideration by patients on a sodium controlled diet.

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

Method of administration

Salofalk 250mg 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.

Use in children and adolescents: 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 Salofak 250mg Tablets for your child. In acute episodes: to be determined individually, starting with 30 - 50 mg mesalazine per kg body weight per day to be given in divided doses. The maximum dose is 75mg 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 with 15-30 mg mesalazine per kg body weight per day to 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 40kg and the normal adult dose to those above 40kg. The daily dose may be divided into three portions, taken in the morning, at noon and at night

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 250mg 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 250mg Tablets is too strong or too weak, talk to your doctor.

If you take more Salofalk 250mg 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 250mg Tablets on one occasion, just take your next dose as prescribed. Do not use a smaller amount.

If you forget to take Salofalk 250mg Tablets

Do not take a double dose of Salofalk 250mg Tablets next time, but continue treatment at the prescribed dosage.

If you stop taking Salofalk 250mg Tablets

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

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

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, 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 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

•    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 national reporting system:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Salofalk 250mg Tablets after the expiry date which is stated on the carton and the blister pack. The expiry date refers to the last day of that month.

Do not store above 25°C, store in the original package.

Medicines 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.

If your medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.

6. Contents of the pack and other information

What Salofalk 250mg Tablets contain

The active substance is mesalazine.

Each gastro-resistant tablet contains 250mg Mesalazine.

The other ingredients are: polymethacrylate (Eudragit E), calcium stearate, yellow iron oxide (E172), colloidal anhydrous silica, hypromellose, polyethylene glycol, methacrylic acid copolymer, microcrystalline cellulose, talc, sodium carbonate anhydrous, povidone K25, titanium dioxide (E171) and glycine.

What Salofalk 250mg Tablets look like and contents of the pack

Salofalk 250mg Tablets are round, butter-yellow to ochre, gastro-resistant tablets, matt with smooth surface; they are not scored.

Salofalk 250mg Tablets are available in blister packs of 100 tablets.

Manufacturer:

Dr. Falk Pharma GmbH,

Leinenweperstrasse 5 Freiburg, D-79108 Germany

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon, London, NW9 6AQ. Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon,

London, NW9 6AQ.    _

PL No

Salofalk® is a registered trademark of Dr. Falk Pharma GmbH.

S0472-100-RM-PIL-31.07.2015