500 mg enteric tablet is
sulfasalazine
What Salazopyrin EN is and what it is used for
Salazopyrin EN has an anti-inflammatory and antibacterial effect and inhibits inflammation, especially in the intestinal mucosa.
Salazopyrin EN is a gastric juice-resistant tablet specially designed for patients with active rheumatoid arthritis and patients experiencing gastrointestinal side effects from Salazopyrin tablets.
Salazopyrin EN is used in the treatment of rheumatoid arthritis and inflammatory bowel diseases ( ulcerative colitis, Crohn’s disease ).
Salazopyrin EN is also used in the treatment of the skin disease pyoderma gangrenous , which is sometimes seen in patients with ulcerative colitis.
What you need to know before you use Salazopyrin EN
Do not use Salazopyrin EN
- if you are allergic to sulfasalazine, its metabolites, sulfa ( sulfonamides ) or acetylsalicylic acid (included in some medicines for fever and pain), or any of the other ingredients of this medicine (listed in section 6).
- if you have acute intermittent porphyria (liver porphyria, increased presence of certain blood dyes caused by enzyme deficiency).
Warnings and cautions
Talk to your doctor or pharmacist before taking Salazopyrin EN
- if you have recurrent or chronic infection
- if you have impaired kidney or liver function
- if you have severe allergies or asthma
- if you have glucose -6- phosphate -dehydrogenase deficiency, you should inform your doctor before starting treatment.
- if you are a man trying to have children because Salazopyrin EN may reduce sperm production (normalizes if medication is stopped)
- if you are taking or have recently taken Salazopyrin EN or any other medicines that contain sulfasalazine, as they may affect your blood and urine test results.
Contact your doctor immediately if you develop a new infection during your treatment with Salazopyrin EN. Your doctor may stop treatment.
Blood count, and renal and hepatic function should be checked before starting treatment and at the beginning of treatment. Thereafter, the treating physician should be contacted for regular check-ups.
Contact your doctor immediately if you get symptoms such as sore throat, fever, pallor, get a reddish or yellowish color in the skin. This may indicate liver problems, as well as blood count changes and treatment, may need to be stopped.
Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with sulfasalazine. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso. Additional signs to be aware of are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes). The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas of skin detachment. The risk of serious skin reactions is greatest during the first weeks of treatment. If you suffer from Stevens-Johnson syndrome or toxic epidermal necrolysisWhen you have used sulfasalazine contained in Salazopyrin EN, you must never use medicines containing sulfasalazine again. If you get a rash or signs of these skin reactions, stop taking Salazopyrin EN immediately, and contact your doctor immediately and tell them that you are taking this medicine.
Hypersensitivity reactions, which may be life-threatening (such as drug-induced skin rash (DRESS)), have been reported with the use of sulfasalazine. Early signs of hypersensitivity may be rash, fever, or swollen lymph nodes. If you get symptoms of a hypersensitivity reaction, contact your doctor immediately and tell them you are taking this medicine.
During treatment with sulfasalazine, it is important to drink properly to prevent the formation of crystals in the urine and kidney stones.
Other medicines and Salazopyrin EN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. The treatment effect may be affected if Salazopyrin EN is taken at the same time as certain other medicines. If you are taking any of the following medicines, a dose of Salazopyrin EN or the other medicine may need to be changed or other precautions may need to be taken.
- Digoxin for heart disease
- Folic acid for anemia
- Rifampicin for tuberculosis
- Mercaptopurine or azathioprine for leukopenia or transplantation and immunological diseases
Salazopyrin EN with food, drink, and alcohol
The enteric tablets should be taken with a meal and distributed as evenly as possible during the day. The tablets are coated so that they do not dissolve until they reach the intestine. It is therefore important that they are swallowed whole so that the surface layer (coating) is not damaged.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Treatment with Salazopyrin EN may lead to folic acid deficiency.
The concentration of the drug can be expected to be the same in the mother and the fetus and thus there is a risk of side effects in the fetus as well. However, animal studies do not indicate any risk of birth defects, but risks associated with use during pregnancy can not be completely ruled out. During pregnancy, Salazopyrin EN should be given only after special medical consideration.
Sulfasalazine passes into breast milk in small amounts. Bloody stools and diarrhea have been reported in infants where the breastfeeding woman has been treated with sulfasalazine.
Driving and using machines
No effects were observed.
Salazopyrin EN contains propylene glycol
This medicine contains 5 mg of propylene glycol per tablet.
How to use Salazopyrin EN
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Dose one is individually tailored for you. Carefully follow the dosage stated on the pharmacy label!
In rheumatoid arthritis:
The usual dose, adults: 2 tablets twice daily.
In inflammatory bowel disease:
The usual dose, adults: 2-4 tablets 2-4 times daily.
The usual dose, children: dose one depends on the weight of the child.
If you use more Salazopyrin EN than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for risk assessment and advice.
If you forget to use Salazopyrin EN
Do not take a double dose to make up for a forgotten dose. Medication should be continued for as long as your doctor prescribes, otherwise the disease may worsen and return. As a rule, Salazopyrin EN should be taken for a long time.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In rare cases, hypersensitivity reactions may occur.
During treatment with Salazopyrin EN, any side effects usually occur during the first 3 months of treatment.
Common (affects more than 1 user in 100):
- decreased leukocyte count ( white blood cells )
- loss of appetite
- headache, dizziness, taste changes
- tinnitus
- cough
- nausea, abdominal pain, bloating, diarrhea, vomiting
- hives
- itching
- purple discoloration of the skin
- joint pain
- protein in the urine
- reduced sperm production ( reversible )
- fever
- transient increase in liver enzymes
Uncommon (affects less than 1 user in 100):
- decreased platelet count ( platelets )
- swelling of the face
- Depression,
- breathing difficulties
- hair loss
Rare (affects less than 1 user in 1,000):
- nail changes, skin reactions that can be life-threatening ( epidermal necrolysis and Stevens-Johnson syndrome )
- jaundice
Has been reported (occurs in an unknown number of users):
- pseudomembranous colitis (intestinal inflammation)
- mononucleosis-like syndrome (false glandular fever)
- effects on the blood picture with, for example, severe white blood cell deficiency ( agranulocytosis ) and severe anemia
- hypersensitivity reaction, angioedema (swelling of the lips, eyelids, face, tongue, and throat), serum sickness (delayed allergic reaction )
- deficiency of folic acid
- effects on the nervous system, meningitis, encephalopathy (brain disease), altered olfactory sensations, myocarditis
- pericarditis, decreased oxygenation of the blood leading to bluish discoloration of the skin, lips, and mucous membranes (cyanosis) and pallor
- different types of lung diseases (such as fibrous alveolitis), pain in the mouth and throat
- pancreatitis, worsening of ulcerative colitis
- hepatitis sometimes sudden onset, hepatic failure, narrowing of the bile ducts in the liver, and slower flow of bile in the gallbladder
- drug-induced rash (DRESS see also Warnings and precautions), skin rash, reddening of the skin, severe skin inflammation with dandruff (exfoliative dermatitis ), skin reactions to sun exposure
- SLE syndrome (autoimmune disease)
- kidney effects, blood in the urine, crystals in the urine, kidney stones
- yellowing of skin and body fluids (eg sweat, saliva, urine, and tear fluid) and thus also yellowing of soft contact lenses
- formation of antibodies directed against the body’s tissues (so-called autoantibodies)
If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat / mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.
Stop taking Salazopyrin EN 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
Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ) have been reported (see section Warnings and precautions).
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Salazopyrin EN
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 carton. The expiration date is the last day of the specified month.
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.
Contents of the packaging and other information
Content declaration
- The active substance is sulfasalazine. One tablet contains 500 mg sulfasalazine.
- The other ingredients are maize starch, magnesium stearate, povidone, colloidal silica, cellulose acetate phthalate, propylene glycol (E 1520) (see section 2 “Salazopyrin EN contains propylene glycol”), white beeswax, carnauba wax, glycerol monostearate, macrogol 20,000.
What the medicine looks like and the contents of the pack
Jar with screw caps made of HD polyethylene and polypropylene, 100 pcs and 300 pcs. The lid has a notch so that, for example, a pencil can simplify opening.
The tablet is yellow, arched, 10 × 18 mm with an engraved symbol.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Recipharm Uppsala AB
Björkgatan 30
751 82 Uppsala