500 mg enteric tablet er
Sulfasalazine
What Sulfasalazine medac is and what it is used for
Sulfasalazine medac is used in the treatment of
- active rheumatoid arthritis ( rheumatoid arthritis ) in adults.
- active juvenile idiopathic arthritis (joint rheumatism in children and adolescents – JIA) in children from the age of 6 where standard treatment has not been sufficiently effective.
Rheumatoid arthritis (or joint rheumatism ) is a chronic disease characterized by inflammation of the membranes of the joints. The membranes sit on the inside of the joint capsules and produce a fluid that acts as a lubricant for many joints. Inflammation causes the membranes to thicken and the joints to swell.
Juvenile arthritis affects children and young people under the age of 16. The variant that affects 4 or fewer joints during the first 6 months of the disease is called oligoarthritic, while the one that affects 5 or more joints during the first 6 months of the disease is called polyarthritic.
Sulfasalazine medac prevents joint damage and slowly reduces swelling and stiffness in the joints.
The doctor may have prescribed a different use. Always follow your doctor’s instructions.
Sulfasalazine, found in Sulfasalazine medac, may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Sulfasalazine medac
Do not take Sulfasalazine medac
- if you are allergic to sulfasalazine, the substances formed when sulfasalazine is broken down in the body, sulphonamides (eg sulphonamide antibiotics) or salicylates (eg acetylsalicylic acid ), or any other ingredient of this medicine (listed in section 6).
- if you currently have or have previously had, an acute skin reaction with redness and a ring-like rash (erythema exudative multiforme).
- if you suffer from a rare blood disorder called porphyria.
- if you currently have changes in your blood status such as a reduced number of white blood cells or platelets.
- if you suffer from constipation.
- if you have severe liver or kidney failure.
- if you have glucose -6-phosphate dehydrogenase deficiency (a rare enzyme deficiency disease).
- if you are being treated with methenamine (used to prevent urinary tract infections).
Sulfasalazine medac must not be used for the treatment of systemic forms (with fever) of juvenile idiopathic arthritis.
Sulfasalazine medac should not be given to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sulfasalazine medac.
Potentially life-threatening skin rash
Potentially life-threatening skin rashes ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) have been reported with the use of Sulfasalazine medac. The first signs of these reactions include reddish target-like spots or circular spots, often with central blisters on the trunk. Additional signs to look out for are sores in the mouth, throat, nose, genitals, and red and swollen eyes ( conjunctivitis ). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or scaling of the skin. You are most at risk of developing these severe skin reactions in the first weeks of treatment with Sulfasalazine medac. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using Sulfasalazine medac, you must never, ever be put on Sulfasalazine medac again. If you develop a skin rash or these skin symptoms, consult a doctor immediately and tell him/her that you are taking Sulfasalazine medac.
Take extra care with Sulfasalazine medac
- if you tend to be hypersensitive (allergic) or asthma.
- if you are allergic to sulfonylureas.
- if you have slightly impaired liver or kidney function.
Your doctor will monitor you during treatment with Sulfasalazine medac. Before and during treatment with Sulfasalazine medac, your blood count (including counting the number of blood platelets ) and white blood cells, as well as liver and kidney function, should be checked regularly. During the first 3 months of treatment, checks are recommended every fortnight, once a month during months 4 to 6 and then every quarter or when side effects occur.
Male patients trying to conceive should stop taking Sulfasalazine medac after consulting a doctor, as sperm production may decrease. No birth defects have been reported as a result of this temporarily reduced sperm production.
You should drink plenty during treatment with Sulfasalazine medac to avoid the formation of kidney stones.
Your skin and body fluids may turn yellow, and even soft contact lenses may become discolored.
Talk to your doctor if you develop a sore throat, fever, paleness, bleeding into the skin (purpura), or yellowing of the skin and eyes (jaundice) during treatment.
Tell your doctor if you are taking or have recently taken Sulfasalazine medac, or any other medicines containing sulfasalazine, as they may affect blood and urine test results.
If you know that you are a so-called slow acetylator (NAT2 polymorphism), you may experience more side effects and the doctor may need to adjust your dose.
Children
Treatment with Sulfasalazine medac in children should only be initiated and supervised by a physician experienced in treating juvenile idiopathic arthritis.
Other medicines and Sulfasalazine medac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This applies in particular to:
- Antibiotics (against a bacterial infection).
- Iron.
- Calcium.
- Folic acid ( vitamin used for supplemental treatment during pregnancy or to reduce the side effects of methotrexate).
- Medicines that are highly bound to blood proteins, such as methotrexate (used to treat autoimmune diseases ( allergy to the body’s substances) or cancer), phenylbutazone (for joint inflammation and pain), and sulfinpyrazone (for gout ).
- Methenamine (to prevent urinary tract infection) should not be given at the same time as Sulfasalazine medac (see Do not take Sulfasalazine medac ).
Additional medicines that affect or are affected by Sulfasalazine medac:
- Digoxin (in heart failure ).
- Certain medicines for the treatment of elevated blood lipids (so-called anion exchangers).
- Anticoagulants (to thin the blood).
- Medicines that inhibit blood cell production in the bone marrow a.
- Cyclosporine (to suppress the immune system in autoimmune diseases or organ transplantation).
- Live typhoid vaccine.
- Hepatotoxic drugs (drugs that cause liver damage).
- Sulfonylurea (to treat diabetes ).
- Azathioprine (to suppress the immune system in autoimmune diseases or organ transplantation).
Sulfasalazine medac with food, drink, and alcohol
Take the tablets at least 1 hour before a meal, together with plenty of water. Swallow the tablets whole.
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 using this medicine.
Pregnancy
Talk to the doctor if you are pregnant or become pregnant during treatment.
The doctor will prescribe sulfasalazine with caution if you are pregnant. Available data have not shown that treatment with sulfasalazine during pregnancy entails risks either for the pregnancy, the fetus, or the newborn baby. Treatment with sulfasalazine can lead to folic acid deficiency, which in turn can cause congenital malformations. Therefore, women of childbearing age and pregnant women during the first three months of pregnancy should take extra folic acid during simultaneous treatment with sulfasalazine.
Breast-feeding
Consult a doctor before taking any medicine. Sulfasalazine and its metabolite are excreted in breast milk. Caution is recommended when breastfeeding premature babies or babies with neonatal icterus (jaundice).
Driving ability and use of machinery
Responsiveness may be impaired in some patients. If you experience dizziness or other disturbances in the central nervous system such as sleepiness or reduced ability to concentrate while taking sulfasalazine, you should not drive a car, operate machinery, or perform any other activity that may be dangerous when attention is reduced.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Sulfasalazine medac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. it is almost ‘sodium-free’.
How to take Sulfasalazine medac
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
Dosage
Your doctor will prescribe the dose you should take. Usually, you can start with a low dose, e.g. 500 mg (one tablet a day), and the doctor will tell you how to increase the dose gradually. This is usually done over about 4 weeks:
| 1st week | 2nd week | 3rd week | 4th week and following weeks | |
| morning/daily dose | ——— | 1 tablet | 1 tablet | 2 tablets |
| evening/daily dose | 1 tablet | 1 tablet | 2 tablets | 2 tablets |
After 3 months, the daily dose can be increased to 2 tablets 3 times a day if the doctor considers that 2 tablets 2 times a day is not enough. Do not take more than 8 tablets per day.
For children from the age of 6, the recommended daily dose is 50 mg/kg body weight divided into two partial doses. The maximum daily dose should not exceed 2 g. To reduce side effects from the gastrointestinal tract, treatment should be initiated with a quarter to a third of the planned maintenance dose and increased weekly until the maintenance dose is reached after four weeks.
How to take the medicine
Take the tablets at least 1 hour before a meal, together with plenty of liquid. The tablet should not be split or crushed but swallowed whole.
Treatment with Sulfasalazine usually has an effect within 1–3 months. It may therefore be necessary to take additional pain-relieving or anti-inflammatory medicines, at least until Sulfasalazine medac starts to take effect.
Sulfasalazine medac is usually used for long-term treatment. The drug can be taken for many years if it works and is well tolerated.
If you have taken too much Sulfasalazine medac
Symptoms of overdose may include nausea, vomiting, stomach upset, and abdominal pain. In more severe cases, you may experience symptoms from the central nervous system (brain and spinal cord) such as drowsiness and convulsions. If you experience any of the above symptoms, contact a doctor or hospital immediately for information on the necessary measures.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Sulfasalazine medac
Do not take a double dose to make up for a missed dose. Inform the doctor and continue taking the prescribed dose.
If you stop taking Sulfasalazine medac
The treatment as well as the additional treatment takes place on a doctor’s prescription and is supervised by your doctor. You should not stop treatment without consulting a doctor, as the symptoms may return.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, Sulfasalazine medac can cause side effects, although not everybody gets them.
Many side effects are dose-dependent and can be reduced by lowering the dose.
If you experience severe poisoning or hypersensitivity reaction (e.g. severe skin reaction, shortness of breath), stop treatment with Sulfasalazine medac immediately and contact your doctor.
In case of dose-dependent side effects, treatment with Sulfasalazine medac must stop for 1 week. If the doctor decides to continue the treatment, Sulfasalazine medac can be given again in small doses that should be increased slowly, preferably under clinical supervision.
Very common (may affect more than 1 in 10 users)
- Headache
- Nausea, vomiting, abdominal pain
- Itching, rash
- Loss of appetite
- Weakness, fatigue
- Decreased sperm production in men, temporarily impaired fertility
Common (may affect up to 1 in 10 users)
- Reduced number of red blood cells caused by folic acid deficiency with large blood cells as a result, as well as reduced number of white blood cells, and elevated liver enzymes.
- Drowsiness, dizziness, difficulty concentrating, difficulty sleeping
- Hives increased sensitivity to light
- Fever
Uncommon (may affect up to 1 in 100 users)
- The heartbeat is felt (palpitations), increased pulse
- Severe decrease in the number of white blood cells, decreased number of all blood cells, decreased number of red blood cells caused by the breakdown of the cells, decreased ability of the red blood cells to transport oxygen, decreased number of platelets, a reaction similar to viral infection with fever, sore throat, swollen glands and fatigue (mononucleosis-like reaction)
- Disorders in the peripheral nervous system (nerves that conduct signals from the brain and spinal cord to the body, they also conduct signals from the body to the brain) can cause changes in sensation, pain or muscle weakness, crawling, tingling, or numbness in the skin, changes in taste/smell
- Red irritated eyes
- Ringing in the ears ( tinnitus )
- Allergic pneumonia, cough, asthma, shortness of breath
- Flatulence, diarrhea, inflammation of the pancreas
- Bluish skin, rapid swelling of the face and throat
- Muscle weakness, joint pain, autoimmune reaction with joint pain, sore muscles, fever, and red rash on the face (lupus erythematosus)
- Increased blood pressure
- Reaction with fever, rash, and joint pain (disorder similar to serum sickness)
- Impaired liver function, reduced number of antibodies, presence of antibodies against the body’s cells, tissues, or organs
- Depression
Rare (may affect up to 1 in 1,000 users)
- Decreased blood cell production in the bone marrow, excess of certain immune cells in the blood (plasmacytosis), severe reduction of blood cells due to disturbances in blood cell formation
- Metallic taste
- In a single case, yellowing of soft contact lenses was reported
- Inflammation in the alveoli (alveoli) and scarring of the connective tissue between the lungs (fibrosing alveolitis)
- Inflammation of the oral mucosa ( stomatitis )
- Blood in the urine, crystals in the urine, yellow-orange discoloration of the urine
- Inflammatory skin reaction, yellow-orange discoloration of the skin, hair loss
- Muscle pain
- Acute attacks of porphyria (a disorder of hemoglobin formation)
- Skin reaction with abnormal white blood cell count ( eosinophilia ), fever and involvement of internal organs (DRESS syndrome), severe allergic reaction
- Liver inflammation
Very rare (may affect up to 1 in 10,000 users)
- Myocarditis, pericarditis
- Inflammation of protective membranes covering the brain and spinal cord, brain disease leading to an altered mental state ( encephalopathy ), inflammation of the spinal cord
- Inflammation in the finest branching of the tracheal tree (bronchioles) in the lungs
- Worsened recurrent inflammatory bowel disease
- Nephritis, a kidney disease that causes water to accumulate in the body ( nephrotic syndrome ), protein in the urine
- Potentially life-threatening skin rash ( Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), see section 2
- Impaired blood cell formation due to bone marrow disease ( myelodysplastic syndrome )
- Impaired blood circulation in toes and fingers
- Severe inflammation of the liver (potentially fatal)
- Psychosis
Has been reported (occurring in an unknown number of users)
- Lung complications with shortness of breath (called interstitial lung disease)
- Prolonged, often severely itchy skin with small angular flat nodules. Often ulcers in the oral mucosa. In rare cases, it can occur on the scalp, which can cause scarring with hairless patches ( lichen planus).
How to store Sulfasalazine medac
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 °C.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is sulfasalazine. One tablet contains 500 mg.
- Other ingredients are crospovidone, stearic acid, povidone, anhydrous colloidal silicon dioxide, purified water, magnesium stearate, titanium dioxide, talc, carmellose sodium, sodium citrate, macrogol, propylene glycol, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%.
Appearance and package sizes of the medicine
Sulfasalazine medac are white, coated, oval tablets. The enteric coating protects the tablet from dissolving in the stomach. Therefore, the active substance is not released until the tablet has reached the intestine.
Pack sizes: 100 /300 tablets in a white plastic jar closed with a white plastic screw cap.
Not all pack sizes may be marketed.
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 4103 8006-0
Fax: +49 4103 8006-100
Additional information is provided by:
medac GmbH, branch
Box 120
432 23 Varberg
Phone: 0340-64 54 70
Fax: 0340-64 54 79
This medicine is approved in the European Economic Area under the names:
Denmark: Sulfasalazine “medac”, 500 mg enteric tablet
Germany: Sulfasalazine medac 500 mg gastro-resistant film-coated tablet