500 mg enter depot granulate
mesalazine
What Salofalk is and what it is used for
Salofalk enter depot granules contain the active ingredient mesalazine, an anti-inflammatory substance used in the treatment of inflammatory bowel disease.
Salofalk is used for
- treatment of acute periods and prevention of additional periods (recurrence) of chronic colitis ( ulcerative colitis ).
Mesalazine contained in Salofalk may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Salofalk
Do not take Salofalk:
- if you are allergic to mesalazine, salicylic acid, salicylates such as acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6)
- if you have severe liver and/or kidney function.
Warnings and cautions
Talk to a doctor before taking Salofalk:
- if you have had problems with your lungs in the past, especially if you suffer from asthma
- if you have previously been hypersensitive to preparations containing sulfasalazine, a substance related to mesalazine
- if you have impaired liver function
- if you have impaired kidney function
- if you have ever developed severe skin rash or dandruff, blistering, and/or sores in your mouth after using mesalazine.
Additional precautions
During treatment, your doctor may want you under close medical supervision and you may need to take regular blood and urine tests.
Kidney stones can form when using mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Be sure to drink enough fluids during treatment with mesalazine.
Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with mesalazine treatment. Stop using mesalazine and seek medical attention immediately if you experience any of the symptoms of these severe skin reactions as described in section 4.
Other medicines and Salofalk
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular:
- azathioprine, 6-mercaptopurine, or thioguanine (medicines used to treat diseases of the immune system)
- certain agents that affect the blood’s ability to coagulate (medicines for blood clots or blood thinners such as warfarin )
- lactulose (a medicine used to treat constipation) or other preparations that may alter the acidity of your stool.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. After all, it can be good to use Salofalk and your doctor can assess what is right for you.
Pregnancy and breastfeeding
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.
You should only use Salofalk during your pregnancy if your doctor tells you to.
You should only use Salofalk during breastfeeding if your doctor tells you to, as the medicine is likely to pass into breast milk.
Driving and using machines
Salofalk has no or negligible effect on the ability to drive or use machines.
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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Salofalk contains aspartame, sucrose and sodium
This medicine contains 1 mg aspartame per sachet Salofalk and 500 mg enter depot granules Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, ie essentially ‘sodium-free’.
How to take Salofalk
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Method of administration
Salofalk is for oral use only.
Salofalk enter depot granules must not be chewed. Enterodepot granules are placed on the tongue and swallowed with plenty of fluid without chewing.
Dosage
| Age and body weight | A dose | Total daily dose |
| Adults, the elderly, and children weighing more than 40 kg | ||
| Treatment in acute periods | 1‑6 sachets Salofalk 500 mg | 1 × 3‑6 sachets or 3 × 1-2 sachets |
| Prevention against further periods | 1‑6 sachets Salofalk 500 mg | 3 × 1 sachet or 1 × 6 sachets (for patients at increased risk of recurrence) |
| Children 6 years and older | ||
| Treatment in acute periods | 30‑50 mg mesalazine/kg body weight/day once daily or divided into different doses | |
| Prevention against further periods | 15‑30 mg mesalazine/kg body weight/day divided into different dosing times |
Adults and the elderly
Unless your doctor prescribes otherwise, the normal dose for the treatment of acute periods of ulcerative colitis, depending on what is required in each case, is 3‑6 sachets of Salofalk 500 mg once daily (equivalent to 1.5‑3 g mesalazine daily) as preferably taken in the morning or 1‑2 sachets 3 times daily (morning, noon, evening).
To prevent the recurrence of ulcerative colitis
Normal dosages to prevent further periods of ulcerative colitis are:
1 sachet of Salofalk 500 mg three times daily (equivalent to 1.5 g mesalazine per day).
If your doctor has judged that you have an increased risk of recurrence, the dosage is one to prevent further episodes of ulcerative colitis:
6 sachets Salofalk 500 mg once daily, preferably taken in the morning (equivalent to 3 g mesalazine daily).
If possible, Salofalk 1000 mg, Salofalk 1500 mg, or Salofalk 3000 mg should generally be used for dose recommendations greater than 1.5 g mesalazine and up to 3 g mesalazine.
Use for children
There is only limited documentation regarding the effect on children (age 6‑18 years).
Children 6 years and older
Ask your doctor what the exact dose of Salofalk is for your child.
In acute periods
Determined individually and started with 30-50 mg of mesalazine per kg body weight and day which should be given once daily, preferably in the morning or at divided dosing times. 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 relapse
Determined individually, start with 15‑30 mg mesalazine per kg body weight and day to be given in divided doses. The total dose should not exceed the recommended adult dose.
Half the adult dose is recommended for children weighing up to 40 kg, and the normal adult dose for those weighing over 40 kg.
Processing time
Your doctor will decide how long you need to continue treatment with this medicine. This depends on your condition. To get the maximum benefit from the medicine, Salofalk should be used regularly and consistently both in the treatment of acute ulcerative colitis and in long-term treatment, by the instructions you have received.
Talk to your doctor if you think the effect of Salofalk is too strong or too weak.
If you take more Salofalk than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Contact a doctor if you are unsure so he or she can decide what to do. If you take more Salofalk granules at one time, continue to take the next dose as recommended. Do not take less.
If you forget to take Salofalk
Do not take a double dose to make up for a forgotten dose.
If you stop taking Salofalk
Do not stop taking this medicine before talking to your doctor.
If you have any further questions on the use of this product, 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, but severe allergic reactions are very rare. If you get any of the following symptoms after taking this medicine, you should contact a doctor immediately:
- Allergic skin rash
- Fever
- Breathing difficulties
If you experience a marked deterioration in your general health, especially if you also have a fever and/or sore throat and mouth, you should stop treatment immediately and consult a doctor.
In very rare cases, the symptoms may be due to a decrease in the number of white blood cells in your blood (a condition called agranulocytosis ), which may make you more likely to develop a serious infection. A blood test can confirm if the symptoms are due to the effect of the medicine on your blood.
Stop using mesalazine and seek medical attention immediately if you get any of the following symptoms:
- reddish, not raised, spots on the torso that resemble targets or are round, often with blisters in the middle, scaly skin, sores in the mouth, pharynx, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms.
The following side effects have also been reported in patients taking mesalazine:
Common (may affect up to 1 in 10 people)
- Headache
Uncommon (may affect up to 1 in 100 people)
- Abdominal pain, diarrhea, indigestion, flatulence, nausea, vomiting
- Severe abdominal pain due to acute inflammation of the pancreas
- Changes in liver values, changes in pancreatic enzymes
- Changes in the number of white blood cells
Rare (may affect up to 1 in 1,000 people)
- Dizziness
- Chest pain, shortness of breath, or swelling of the arms and legs due to your heart being affected
- Jaundice or abdominal pain due to liver disease or impaired bile flow
- Increased skin sensitivity to sunlight and ultraviolet light ( photosensitivity )
- Joint pain
- Feeling weak or tired
Very rare (may affect up to 1 in 10,000 people)
- Fever, sore throat, or malaise due to altered blood count.
- Skin rash or inflammation of the skin, allergic condition that causes joint pain, rash, and fever
- Severe diarrhea and abdominal pain due to an allergic reaction in the intestine caused by the drug
- Numbness and tingling in the hands and feet ( peripheral neuropathy )
- Shortness of breath, cough, wheezing, lung infiltrates on X-ray due to allergic and/or inflammatory lung conditions
- Hair loss and development of baldness
- Muscle aches
- Impaired renal function, sometimes with swollen arms and legs or pain in the side (between the lower rib and the iliac crest)
- Reversible reduction in semen production.
Has been reported (occurs in an unknown number of users)
- Kidney stones and pain from the kidneys (see also section 2)
How to store Salofalk
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 and sachet after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 mesalazine. Each Salofalk 500 mg sachet corresponds to 500 mg mesalazine.
The other ingredients are aspartame (E 951), carmellose sodium, microcrystalline cellulose, citric acid, anhydrous colloidal silica, hypromellose, magnesium stearate, methacrylic acid – methyl methacrylate copolymer (1: 1) (Eudragit L 100), methylcellulose, polyacrylate 40 Dissipation % nonoxynol 100), povidone K 25, simethicone, sorbic acid, talc, titanium dioxide (E 171), triethyl citrate and vanillin aroma (containing sucrose).
What the medicine looks like and the contents of the pack
Salofalk enter depot granules are oblong or round, grayish-white granules.
Each sachet contains 930 mg of granules .
Available pack sizes for Salofalk 500 mg are 50, 100, and 300 bags.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Finland, Greece, Ireland, Latvia, the Netherlands, Norway, Portugal, Slovakia, Slovenia, Spain, the United Kingdom, Sweden, the Czech Republic, Germany, and Hungary: Salofalk.
Belgium and Luxembourg: Colitofalk.
Austria: Mesagran.