1200 mg enteral depot tablet
mesalazine
What Mezavant is and what it is used for
Mesalazine contained in Mezavant 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.
Pharmacotherapeutic group: aminosalicylic acid and similar agents.
Mezavant is an enteric-coated tablet containing the active substance mesalazine, which is an anti-inflammatory drug used to treat ulcerative colitis.
Ulcerative colitis is a disease of the colon (colon) and rectum (rectum), which makes the intestinal mucosa swollen and red (inflamed), leading to frequent and bloody stools along with stomach cramps.
When Mezavant is given in an acute stage of ulcerative colitis, it acts throughout the colon and rectum to treat inflammation and relieve symptoms. The tablets can also be used to prevent the recurrence of ulcerative colitis.
What you need to know before you take Mezavant
Do not take Mezavant
- if you are allergic (hypersensitive) to a group of medicines called salicylates (which include acetylsalicylic acid )
- if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (listed in section 6 of this data)
- if you have severe kidney or liver problems
Warnings and cautions
Talk to your doctor before using Mezavant
- if you have kidney or liver problems
- if you have a history of heart inflammation (which may be caused by a heart infection)
- if you have ever developed severe rash or dandruff, blistering and / or sores in your mouth after using Mezavant
- if you have previously had an allergic reaction to sulfasalazine (another medicine used to treat ulcerative colitis )
- if you have a narrowing or blockage in your stomach or intestines
- if you have lung problems
Before and regularly during treatment, your doctor may take urine and blood samples to check that your kidneys are working well and that your blood is normal.
Kidney stones can be formed when using Mezavant. Symptoms may include pain in the sides of the abdomen and blood in the urine. Be sure to drink enough fluids during treatment with Mezavant.
Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with Mezavant. Stop using Mezavant and seek medical attention immediately if you experience any of the symptoms of these severe skin reactions described in section 4.
Children and young people
Mezavant is not recommended for use in children and adolescents weighing 50 kg or less and not for children under 10 years of age due to insufficient data on safety and efficacy (see section 3).
Other medicines and Mezavant
Studies have shown that Mezavant does not affect the following antibiotics, which are used to treat infections: amoxicillin, metronidazole, or sulfamethoxazole.
However, me Avant may affect some other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Mesalazine or sulfasalazine (taken to treat ulcerative colitis )
- Non-steroidal anti-inflammatory drugs (for example, medicines containing acetylsalicylic acid , ibuprofen or diclofenac )
- Azathioprine or 6-mercaptopurine or other drugs that are known to affect the function of bone marrow (so-called “immunosuppressive” drugs which reduce the activity of the body’s immune system). Bone marrow is the tissue in the skeleton that produces blood cells .
- Coumarin -type anticoagulants (drugs that prolong blood clotting time) e.g. warfarin
Mezavant with food and drink
Mezavant should be taken with food and at the same time each day. The tablets should be swallowed whole and must not be crushed or chewed.
Pregnancy and breastfeeding
As mesalazine passes into the fetus during pregnancy and is excreted in small amounts in breast milk, you should only use Mezavant during pregnancy and breastfeeding if your doctor tells you to. Adverse outcomes (including low blood cell counts ( white blood cells, red blood cells, and platelets )) were reported in infants of mothers who took Mezavant during pregnancy. Diarrhea has been reported in infants who were breastfed by mothers who used Mezavant.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Impact on laboratory tests
If you are going to take urine samples, you must tell your doctor or nurse that you are taking or have recently taken this medicine, as it may affect some results.
Driving and using machines
Mezavant is unlikely to affect your 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 sharpened attention. 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. The description 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.
Mezavant contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per recommended maximum dose (4 tablets), ie is essential ‘sodium-free’.
How to take Mezavant
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults is 2.4 g to 4.8 g (two to four tablets) taken once daily in an acute phase of ulcerative colitis. The maximum daily dose of 4.8 g should not be taken for more than 8 weeks. Once your symptoms have subsided, and to prevent recurrent attacks, your doctor should instruct you to take 2.4 g (two tablets) daily.
In the acute phase of ulcerative colitis (the first 8 weeks of treatment), the recommended dose for children and adolescents weighing more than 50 kg and aged 10 years or older is 2.4 g to 4.8 g (two to four tablets) once daily.
To prevent recurrent episodes of ulcerative colitis in children and adolescents weighing more than 50 kg and aged 10 years or older, the recommended dose is 2.4 g (two tablets) once daily.
Remember to take your tablets at the same time each day with food. The tablets should be swallowed whole and must not be crushed or chewed.
When taking this medicine, be sure to drink fluids to maintain a good fluid balance, especially after severe or prolonged vomiting and/or diarrhea, high fever, or heavy sweating.
Mezavant is not recommended for use in children and adolescents weighing 50 kg or less, and not for children under 10 years of age due to insufficient data on safety and efficacy.
If you take more Mezavant than you should
If you take more Mezavant than you should, you may experience one or more of the following symptoms: tinnitus (ringing in the ears), dizziness, headache, confusion, drowsiness, shortness of breath, increased fluid loss (associated with sweating, diarrhea, and vomiting), low blood sugar (which can cause dizziness), rapid breathing, altered blood levels, and increased body temperature.
If you forget to take Mezavant
You must take your Mezavant tablets every day, even when you have no symptoms of ulcerative colitis. Always complete the entire prescribed treatment.
If you forget to take your tablets, take them, as usual, the next day. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Tell your doctor immediately
- If you experience symptoms such as cramps, severe abdominal pain, bloody and increased bowel movements (diarrhea), fever, headache or rash. These symptoms may be signs of acute intolerance syndrome which may occur during an acute phase ( relapse ) of ulcerative colitis . This is a serious condition that rarely occurs, but requires your treatment to be stopped immediately.
- If you develop unexplained bruising (without injury), rash, anemia (feeling tired, weak and pale, especially on the lips, nails and inside of the eyelids), fever (high body temperature), sore throat or unusual bleeding (eg nosebleeds) .
- If you notice reddish, non-raised spots on the torso that resemble targets or are round, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms .
- If you develop an allergic swelling of the tongue, lips and around the eyes.
- If you develop increased pressure in the brain that causes headaches that can begin behind the eyes and worsen with eye movements, with blurred or blurred vision, double vision, that you see flashes, difficulty looking to the side and short-term or permanent vision loss. These may be accompanied by dizziness, nausea, vomiting and ringing in the ears.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects, occurring in less than 1 in 10 patients, are headache, changes in blood pressure, flatulence (flatulence), nausea, bloating or aching stomach, inflammation-causing abdominal pain or diarrhea, diarrhea, indigestion, vomiting, abnormal liver function, itching, joint pain, back pain, weakness, fatigue (extreme fatigue), fever.
Uncommon side effects, experienced by less than 1 in 100 patients, are decreased platelet count, which increases the risk of bleeding and bruising, dizziness, drowsiness or tiredness, tremors or tremors, earache, rapid heartbeat, sore throat, inflamed pancreas ( linked to pain in the upper abdomen and back and nausea), rectal polyp (a non-cancerous growth in the rectum which causes symptoms such as constipation and bleeding), acne, hair loss, muscle pain, hives, swollen face.
Rare side effects, experienced by less than 1 in 1,000 patients, are kidney failure, the sharp decrease in the number of white blood cells, which increases the risk of infection, increased skin sensitivity to sunlight and ultraviolet light ( photosensitivity ).
The following side effects have been reported, but it is not known exactly how often they occur:
Severe decrease in the number of blood cells, which may cause weakness or bruising, low number of blood cells, allergic reaction (hypersensitivity), severe allergic reaction that causes difficulty breathing or dizziness, severe disease with blisters on the skin
(which can cause the skin to be scary and painful, sore areas), or in
mouth, eyes, and genitals, allergic reaction causing rash, fever, and inflammation of internal organs, neuropathy (abnormal or damaged nerves leading to numbness and tingling), inflammation of the heart and surrounding tissue, pneumonia, difficulty breathing or wheezing, gallstones, hepatitis ( inflammation of the liver which causes flu-like symptoms and jaundice), liver toxicity (liver damage that may manifest as abnormal liver values), allergic swelling of the tongue, lips and around the eyes, reddening of the skin, especially rash on the face, skin more sensitive to sunlight along with joint pain, arthritis, fatigue and general malaise, kidney problems (such as inflammation and scarring of the kidneys), kidney stones and kidney pain (see also section 2), decreased reversible sperm production (which goes back).
How to store Mezavant
- Keep this medicine out of the sight and reach of children.
- Do not store above 25 ° C.
- Store in the original package. Moisture sensitive.
- Do not use this medicine after the expiry date which is stated on the carton after “EXP”. 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 pack and other information
Content declaration
The active substance is mesalazine 1200 mg.
The other ingredients are carmellose sodium, carnauba wax, stearic acid, colloidal hydrated silica, sodium starch glycolate (type A), talc, magnesium stearate, Methacrylic acid – methyl methacrylate copolymer (1: 1),
Methacrylic acid – methyl methacrylate copolymer (1: 2), triethyl citrate, titanium dioxide (E171), red iron oxide (E172), macrogol 6000.
What the medicine looks like and contents of the pack
Mezavant is supplied in blister packs of foil which are packed in a carton. The pack contains 60 or 120 tablets.
Not all pack sizes may be marketed.
The tablets are reddish-brown, oval (dimensions 20.5 × 9.5 × 7.5 mm), and embossed with S476.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation HolderShire Pharmaceuticals Ireland LimitedBlock 2 & 3 Miesian Plaza50 – 58 Baggot Street LowerDublin 2IrelandTel: +44 (0) 1256 894 959Email: medinfoEMEA@shire.com | ManufacturerCosmo SpAVia C. Colombo 120045 Lainate-MilanItaly |
| Local representativeTakeda Pharma ABBox 30143104 25 StockholmTel: 08-731 28 00Email: infosweden@takeda.com |