Salazopyrin Tablets

Customer:    Kemwell AB


Date:    01.07.2015

CCL order:

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= Glue

Dimensions:    46 x 157 mm

No. of leaves:    16

Winding direction:    Outside 4


46x157 (46x111 +6+16) mm 16 bl U4 653 Stans 24-10-96-8-19 Rene Binau



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Date: 24 Mar 2016 Time: 15:23

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101 mm

10 mm

111 mm

6mm 16mm

[ | Tab | |

111 mm

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| Page 32

| Glue |

Front page outside

Page 28

Page 5

[Each tablet contains 'sulfasalazine 500 mg. iUse as directed by a doctor, lOrai use.

|Store below 25°C,

|Read the leaflet before use.

[Keep out of the reach and sight lof children,

'MA holder: Pfizer Limited, Ramsgate Road, [Sandwich, Kent, CT13 9NJ, UK.

IPL 00057/1044

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16mm 6mm    111 mm

Tab/Glue    Page 2 (Front page inside)

Patient Information Leaflet

Salazopyrin® Tablets

500 mg


In this leaflet:

1.    What Salazopyrin Tablets are and what they are used for

2.    Before you take Salazopyrin Tablets

3.    How to take Salazopyrin Tablets

4.    Possible side effects

5.    How to store Salazopyrin Tablets

6.    Further information

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Tablets 500 mg

Sulfasalazine I pom

112 Tablets











may be removed with a solution of washing soda. Always test the effect of soda on a small piece of the fabric first. Then apply a mild acid such as white vinegar.

Sulfasalazine has caused permanent staining of extended wear soft contact lenses. Although this happens very rarely. Daily-wear soft contact lenses and gas permeable lenses respond to standard cleaning if this happens.

Where can I get more advice about Ulcerative Colitis and Crohn’s Disease?

The National Association for Colitis and Crohn’s Disease (NACC) has local groups which offer meetings, events and information for patients. They may be contacted at NACC, P.O. Box 205, St. Albans, Herts, AL1 1AB.

This leaflet was last revised in 03/2016    PIL SZ 11 _0 Tabs UK


/Ulcerative Colitis is an inflammatory disease which affects only the large bowel (colon land back passage). The lining of the bowel becomes inflamed (red and swollen)

]and symptoms include abdominal pain and diarrhoea (which may contain blood jand mucus). Salazopyrin Tablets are used to control the flare-ups of ulcerative colitis. They may also be used at lower doses to prevent more flare-ups of ulcerative colitis.

iCrohn’s disease is an inflammatory disease which may affect any part of the [digestive system from the mouth to the anus, but it most commonly affects the [last part of the small bowel and the first part of the large bowel. Symptoms 'include abdominal pain and diarrhoea (which may be bloody). Salazopyrin Tablets are used to control the flare-ups of Crohn’s Disease.


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2. Before you take Salazopyrin Tablets

Your doctor will perform complete blood counts and liver function tests before starting Salazopyrin and every second week during the first three months of therapy. During the second three months, the same tests should be done once monthly and thereafter once every three months, and as clinically indicated. Urine analysis and an assessment of kidney function should also be done periodically during treatment with Salazopyrin. Thereafter, monitoring will be performed as your doctor requires.

Do not use Salazopyrin Tablets if you

•    are allergic (hypersensitive) any of the ingredients of Salazopyrin Tablets.

•    are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic).


(Marketing Authorisation Holder and Manufacturer

[The marketing authorisation for Salazopyrin Tablets is held by: Pfizer Limited, [Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK.

'Salazopyrin Tablets are made by: Kemwell AB, 75182 Uppsala, Sweden.

'For any information about this medicinal product, please contact the local irepresentative of the Marketing Authorisation Holder:

General Advice

[Because the tablets are coloured yellow they may cause your urine or motions [to become a yellow/orange colour. This is normal and harmless but can stain 'fabric. Any Salazopyrin soiled fabric should be put in to soak. Difficult stains


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(Read all of this leaflet carefully before you take 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.

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6. Further information What Salazopyrin Tablets contain

The active substance is sulfasalazine. Each tablet contains 500mg of sulfasalazine.

Other ingredients are maize starch, PVP( povidone), magnesium stearate, colloidal silicon dioxide.

What Salazopyrin Tablets look like and contents of the pack

The tablets are yellow in colour, and are round. They have “KPh” imprinted on one side and “101”, on the other. The tablets are the colour of the medicine itself. They contain no artificial colouring. Salazopyrin is supplied in bottles. Each bottle contains 112 tablets.


(• have a disease known as porphyria (a rare blood pigment disorder). Your doctor will have already told you if you have this disease.

Salazopyrin Tablets are not to be used in children under 2 years of age.

Take special care with Salazopyrin Tablets

If the answer is YES to any of these questions tell you doctor or pharmacist

'before taking this medicine:

'• Have you ever had any problems with your liver or kidneys?

[• Have you been told by your doctor that you have an inherited condition in which the body doesn’t have enough of an enzyme known as glucose-6-dehydrogenase which helps red blood cells function normally?


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Supplier N°


Printing Non-Printing

Perigord N°


Proof N°






Label Leaflet


Barcode N°

As Supplied

Pharma Code




1. What Salazopyrin Tablets are and what they are used for

The active substance in Salazopyrin Tablets is sulfasalazine which is an anti-inflammatory drug and belongs to a group of medicines called aminosalicylates.

Your doctor may give you Salazopyrin Tablets to treat and manage inflammatory bowel disease.

Smallest BODY TEXT Size

Body Text: 7 pt; Cover: 5.5 pt I

Drawing N°



46x157 mm

The main forms of inflammatory bowel disease are Ulcerative Colitis and Crohn’s disease. Although the diseases have some features in common, there are some important differences.

•    Have you ever had asthma?

•    If you are a child and have arthritis?

Tests on your blood, kidneys, liver and urine

Your doctor will be taking blood tests to check your blood, your kidneys before you start treatment and regularly during treatment. They will also measure substances produced by your liver known as enzymes (liver function tests) before you start treatment and at regular intervals. They may also test your urine for protein and blood.

Taking other medicines

Tell your doctor or pharmacist if you are taking the following medicines as they may interact with Salazopyrin tablets:


(5. How to store Salazopyrin Tablets

'Keep out of the reach and sight of children.

[Do not use Salazopyrin Tablets after the expiry date which is stated on the [bottle. The expiry date refers to the last day of that month.

[Store your tablets below 25°C in a dry place.

[Medicines should not be disposed of via wastewater or household waste. 'Ask your pharmacist how to dispose of medicines no longer required. These imeasures will help to protect the environment.


PAR Number


| Perigordpremedia

Perigord House, Damastown Industrial Park, Dublin 15, Ireland

Telephone +353 (0)1 440322 - -

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Total of label / Braille placement only - CCL work area

24 mm    111 mm

16 mm Tab

•    Urine or motions may become a yellow/orange colour which is normal and harmless. (See section 6 General Advice for further information)

•    Temporary infertility in men. Fertility returns when treatment is stopped. Normal contraception should still be used.

Very rarely sulfasalazine has caused permanent staining of extended wear soft contact lenses. (See section 6 General Advice for further information).

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.

(• any medicine for high blood sugar/diabetes,

!• methenamine, an antibiotic for treating urinary tract infections,

]• digoxin, used to treat heart failure,

]• folate, sometimes taken during the first few weeks of pregnancy to reduce the risk of neural tube defects, e.g. Spina Bifida,

!• azathioprine and mercaptopurine, drugs used to help to suppress your bodies immune response in organ transplantation and certain chronic inflammations (e.g. rheumatoid arthritis).

* methotrexate, used to treat rheumatoid arthritis

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

•    Abdominal pains

•    Diarrhoea

•    Being sick

•    Ringing in the ears

•    Blood shot eyes

•    Inflamed mouth (stomatitis)

•    Cough

•    Itching of the skin

•    Joint pain

•    Protein in urine

•    Fever


(Crohn’s Disease

Adults and the Elderly

•    Severe Flare-Ups

2-4 tablets four times a day, with other medicines such as steroids.

Do not leave more than 8 hours between the evening and following morning dose.

•    Mild/Moderate Flare-Up

2-4 tablets four times a day, but not always with other medicines.

Children 2 years of age and over

jYour doctor will tell you what dose your child will need to use. This will be based on your child’s weight.    12

Each tablet contains sulfasalazine 500 mg.

Use a^ir^fted b" a doctor, q Orakise. •

Stoif below 25°(?

Read tjje Ij^flet l^f ore ype. # Keejioiit of the rtpch aid sight • of children.    •

MA holder: Pfizer Limited, Ramsgate Road, Sandwich Ke*t, CT13 9NA UK. •

PL 0005^1044 9 • •

• • • • •


. Tablets 500 mg

• •

• Sdfesalazine |pqm|

• •

•112 Tablets




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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 for advice before taking this medicine You should avoid breast-feeding while taking this medicine.

There have been reports of diarrhoea or blood in the stools of babies of breast-feeding mothers taking Salazopyrin tabs.

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

Driving and using machines

Salazopyrin tablets are unlikely to affect your ability to drive or use machinery.

•    Bluish tint to skin due to poor circulation

•    Lung complications with breathlessness

•    Inflammation of the salivary glands on either side of the face

•    Kidney inflammation and kidney pain,

•    Liver disease (hepatitis)

•    Yellowing of the skin or whites of the eyes (jaundice)

•    Inflammation of pancreas, which causes severe pain in the abdomen and face

•    Rash, reddening or blistering of the skin, eczema,

•    Tingling, numbness, pain in hands and feet

•    Blood in urine

How long should you use these tablets?

Flow long you use these tablets depends on how well the tablets suit you.

For Ulcerative Colitis and Crohn’s Disease

•    The tablets should start to work in a few days.

•    If they work well, you may be using them for some time because inflammatory bowel disease may be a life long condition.

•    Don’t stop using the tablets just because you feel better without talking to your doctor.

Ensure that you drink adequate fluids whilst you are taking this medicine. This is to avoid problems with your kidneys.


(Other side effects that may occur are:

Very common side-effects which may affect more than 1 person in 10 are listed below:

]• Indigestion, heartburn

*    Feeling sick (nausea)

Common side-effects which may affect more than 1 person in 100 are listed below:

]• Dizziness ]• Difficulty sleeping

*    Fleadache

!• Changes in taste


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( Since introduction to the market the following side-effects have been reported:

•    Inflammation of the lining of the brain

•    Severe diarrhoea

•    Other blood disorders including anaemia, enlarged glands (lymph nodes)

•    Blood vessel inflammation

•    Loss of appetite

•    Hallucinations

•    Changes in mental state

•    Changes in smell

•    Inflammation of the sac surrounding the heart (pericarditis)

•    Inflammation of the heart muscle (myocarditis)

3. How to take Salazopyrin Tablets

The tablets should be taken with a glass of water and should be swallowed Iwhole. Do not crush or chew the tablets.

jUnless your doctor has told you otherwise, the usual doses for the following jconditions are:

Ulcerative Colitis Adults and the Elderly • Severe Flare-Ups

2-4 tablets four times a day, with other medicines such as steroids.Do not leave more than 8 hours between the evening and following morning dose.

•    If you are breast feeding stop taking this medicine, once you notice blood in stools or diarrhoea in newborn.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine as they will stop treatment in these cases:

•    If you notice any unexplained bleeding.

•    If you notice bruising, fever, rash, pallor (paleness), a severe sore throat or tiredness. These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets. Your doctor may take regular blood samples to test for these effects.

Discontinue treatment with Salazopyrin while awaiting the results of

blood tests


If you take more Salazopyrin Tablets than you should

Contact your nearest hospital casualty department or tell your doctor immediately, if you have taken too many tablets (an overdose) or if a child has taken your medicine.

Please take this leaflet and these tablets with you to the hospital casualty department or to your doctor.

If you miss a dose of Salazopyrin Tablets

If you forget to take a dose, just take the next dose as usual. Do not double dose the next dose to make up for a missed one.


[Each tablet contains sulfasalazine 500 mg. jUse as directed by a doctor.

'Oral use.

'Store below 25°C.

Read the leaflet before use.

Keep out of the reach and sight of children.

iMA holder: Pfizer Limited, Ramsgate Road, iSandwich, Kent, CT13 9NJ, UK.

|PL 00057/1044


Tablets 500 mg


112 Tablets


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•    Mild/Moderate Flare-Up

2-4 tablets four times a day, but not always with other medicines.

•    Maintenance dose to control your flare ups

Once the flare-up is controlled the dose is slowly reduced to 4 tablets each day. Your doctor will tell you how to reduce your dose. This lower dose may be continued for some time to help stop other flare-ups.

Children 2 years of age and over

Your doctor will tell you what dose your child will need to use. This will be based on your child’s weight.

(Uncommon side-effects which may affect more than 1 person in 1000 are listed below:

]• Depression

'• Fits, jerky, uncontrolled movements

*    Loss of balance

!• Shortness of breath ]• Flair loss ]• Flives

*    Puffiness around the eyes and face

4. Possible side effects

Like all medicines, Salazopyrin Tablets can cause side effects, although not everybody gets them.

Stop taking Salazopyrin Tablets and tell your doctor immediately if you

experience any of the following symptoms after taking this medicine.

Although they are very rare, these symptoms can be serious.

• An allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

(• If you develop a severe skin rash that causes blistering, (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome, or toxic epidermal necrolysis (TEN). Your doctor will stop your treatment in these cases.

* If you have a serious skin condition with a rash (sometimes confined to the cheeks and bridge of the nose) peeling skin or blistering. It may be triggered or aggravated by sunlight. Should this occur, stop taking this medicine, avoid strong sunlight and contact your doctor promptly.

]• If you are generally feeling unwell, have a fever, have pains in your joints, hives, swollen glands, rash and itching. These may be signs of a condition known as serum sickness. Your doctor will stop your treatment in these cases.