300 mg and 400 mg film-coated tablet
Dexibuprofen
What Tradil is and what it is used for
Dexibuprofen, the active ingredient in Tradil, belongs to a group of medicines called non-steroidal anti-inflammatory/anti-rheumatic agents ( NSAIDs ). NSAID preparations such as dexibuprofen are used to relieve pain and inflammation. They work by reducing the number of prostaglandins (substances that control inflammation and pain) produced in the body.
What is Tradil used for
Tradil is used in adults to relieve:
- pain and inflammation caused by osteoarthritis (tissue-destroying joint disease)
- menstrual pains
- mild to moderate pain, such as muscle and joint pain and toothache.
The dexibuprofen found in Tradil may also be approved to treat 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 using Tradil
Do not use Tradil
- if you are allergic to dexibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid or other pain relievers (such allergy can cause breathing difficulties, asthma, runny nose, skin rash, or facial swelling); if you previously had bleeding or perforation (hole) in the gastrointestinal tract caused by NSAID treatment;
- if you have or have had recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea may be a sign of bleeding in the stomach or intestines);
- if you have had brain bleeding ( cerebrovascular bleeding) or another active bleeding;
- if you have recently had a flare-up of symptoms of inflammatory bowel disease ( ulcerative colitis, Crohn’s disease );
- if you suffer from severe dehydration (e.g. caused by vomiting, diarrhea, or insufficient fluid intake);
- if you have severe heart failure or severe liver or kidney disease;
- if you are a woman who is pregnant in the last trimester of pregnancy;
- if you suffer from a condition of unknown origin that results in the abnormal formation of blood cells.
Warnings and precautions
Talk to your doctor or pharmacist before using Tradil:
- if you have ever had a stomach or duodenal ulcer;
- if you have had ulcerative colitis, ulcerative colitis, or Crohn’s disease;
- if you have liver or kidney disease or if you are dependent on alcohol;
- if you have a disease that affects the clotting ability of the blood (see also the section “Other medicines and Tradil”);
- if you have edema (accumulation of fluid in the body’s tissues );
- if you have heart disease or high blood pressure;
- if you suffer from systemic lupus erythematosus, SLE (a disease that affects the joints, muscles, and skin) or from mixed collagenosis (a collagen disease that attacks the connective tissue) or
- if you have problems getting pregnant;
- if you have or have had asthma or allergic diseases, as shortness of breath may occur;
- if you suffer from hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. The allergic reactions can manifest as asthma attacks (so-called analgesic asthma ), Quincke’s edema (swelling mainly in the face, lips, eyelids, or genitals), or hives;
- if you have recently had major surgery;
- if you have certain hereditary blood formation disorders (eg acute intermittent porphyria );
- if you have an infection – see the heading “Infections” below.
Bleeding, ulcers, or holes (perforations) in the gastrointestinal tract, which can be life-threatening, have been reported with all NSAIDs. This has occurred at any time during treatment, with or without warning symptoms or previous occurrence of serious gastrointestinal side effects. When bleeding or ulceration of the gastrointestinal tract occurs, treatment should be discontinued immediately. The risk of bleeding, ulceration or perforation in the gastrointestinal tract increases with high NSAID doses, in patients who have previously had peptic ulcers, especially in more severe cases with bleeding or perforation (see section 2), and in the elderly. These patients should start treatment with the lowest possible dose. Combination treatment with agents that have a protective effect (e.g. misoprostol or proton pump inhibitors ) should be considered for these patients, and also for patients who simultaneously need low-dose aspirin or other drugs that are likely to increase the risk of side effects in the gastrointestinal tract.
If you have previously had side effects in the gastrointestinal tract, especially if you are older, you should report any unusual stomach symptoms to your doctor (especially bleeding in the gastrointestinal tract), especially if it occurs at the beginning of treatment.
Anti-inflammatory/pain-relieving drugs such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with a doctor or pharmacist before taking Tradil if you:
– have heart problems including heart failure, angina (chest pains) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked blood vessels), or any type of stroke (including “mini-stroke” ” or transient ischemic attack ( TIA )).
– have high blood pressure, diabetes, high cholesterol, a history of heart disease or stroke in the family, or if you are a smoker.
Severe acute hypersensitivity reactions (eg anaphylactic shock with symptoms such as shortness of breath, wheezing, and drop in blood pressure) have been observed very rarely. Stop treatment immediately at the first signs of a hypersensitivity reaction after taking Tradil and talk to your doctor immediately.
You may get a headache if you take high doses of pain relievers for a long time (beyond recommended use). If so, ask your doctor for advice; you should not take more Tradil for the headache.
In general, the habitual use of pain-relieving drugs, especially in combinations of more than one pain-relieving active substance, can lead to permanent kidney damage with the risk of kidney failure ( analgesic nephropathy ).
Skin reactions
Serious skin reactions have been reported in connection with Tradil treatment. You should stop taking Tradil and contact your doctor immediately if you develop a rash, sores on the mucous membranes, blisters, or other signs of allergy as these may be the first signs of a very serious skin reaction (see section 4).
Infection you
Tradil can mask signs of infection such as fever and pain. Therefore, Tradil can cause the appropriate treatment of infection to be delayed and the risk of complications to increase. This has been seen in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of infection persist or worsen, contact your doctor immediately.
You should avoid taking Tradil if you have chickenpox or shingles.
Other medicines and Tradil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tradil can affect or be affected by certain other medicines. For example:
– anticoagulant medicines (ie blood thinners, eg aspirin, warfarin, ticlopidine, rivaroxaban, apixaban, or dabigatran) may prolong bleeding time.
– medicines that lower high blood pressure ( ACE inhibitors eg captopril, beta-blockers eg atenolol, angiotensin -II receptor antagonists eg losartan ).
– voriconazole and fluconazole (CYP2C9 inhibitors), are used in fungal infections, as the effect of dexibuprofen may be increased.
Certain other medicines can also affect or be affected by treatment with Tradil. You should therefore always consult a doctor or pharmacist before using Tradil with other medicines. You must tell your doctor or pharmacist if, in addition to the medicines mentioned above, you also use any of the following medicines:
You should not take the following medicines together with Tradil unless you are under close medical supervision:
- Non-steroidal anti-inflammatory/anti-rheumatic agents, NSAIDs (agents for pain, fever and inflammation ). There is an increased risk of ulcers and bleeding in the gastrointestinal tract if you take Tradil together with other NSAIDs or acetylsalicylic acid as pain-relieving treatment.
You can take the following medicines, but for safety reasons, you must inform your doctor about them:
- Lithium is used to treat certain mental conditions where the mood is affected. Tradil may increase the effect of lithium.
- Methotrexate (a medicine for cancer or rheumatism). Tradil can increase the side effects of methotrexate. Diuretics ( diuretics ) because dexibuprofen can reduce the effect of these drugs.
- Corticosteroids: The risk of ulcers and bleeding in the gastrointestinal tract may increase.
- Some antidepressants (selective serotonin reuptake inhibitors) can increase the risk of bleeding in the gastrointestinal tract.
- Digoxin (a heart medicine). Tradil can increase the side effects of digoxin.
- Immunosuppressants (such as cyclosporin, tacrolimus, sirolimus) sulphonylureas (type of oral anti-diabetic medicine), and antibiotic aminoglycosides (medicines to treat infection ) – kidney damage may occur.
- Quinolone antibiotics, as the risk of convulsions, may increase.
- Potassium-sparing diuretics, as can lead to high potassium levels in the blood.
- Phenytoin is used to treat epilepsy. Tradil can increase the side effects of phenytoin.
- Pemetrexed (used to treat certain cancers)
- Zidovudine (agent for treating HIV/AIDS); Dexibuprofen can lead to an increased risk of bleeding in a joint or bleeding that leads to swelling.
- Baclofen (muscle relaxant): side effects of baclofen can develop after taking dexibuprofen.
- Sulfinpyrazone, probenecid (medicine against gout ), as excretion of dexibuprofen may be delayed.
Tradil with food, drink, and alcohol
Tradil can be taken without food, but taking it with a meal is better because it can help avoid stomach upset. This applies especially if the treatment continues for a long time.
You should avoid or limit your alcohol intake while using Tradil as this could worsen gastrointestinal problems.
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. You should not use Tradil during the last three months of pregnancy, as it may harm your unborn baby, even at very low doses. During the first 6 months of pregnancy, you should use Tradil only after consulting your doctor.
You should also not use Tradil if you are planning to become pregnant, as this medicine can make it more difficult to get pregnant.
In rare cases, drugs such as Tradil can affect a woman’s fertility. Your fertility will return to normal when you stop taking Tradil.
Only small amounts of Tradil pass into breast milk. If you are breastfeeding, however, you should not use Tradil for a long time or in high doses.
Driving ability and use of machinery
If you experience side effects such as dizziness, fatigue, vertigo or if you experience visual disturbances after taking Tradil, you should avoid driving a car or using machines that may pose a danger (see section 4 “Possible side effects”).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. A 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.
How to use Tradil
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
You should take Tradil with a glass of water or another liquid. Tradil has a faster effect if you take it without food. However, it is recommended to take the medicine with food, as it can help to avoid stomach upsets, especially if the treatment lasts for a long time.
300 mg
Do not take more than 1 tablet of Tradil 300 mg as a single dose.
Do not take more than 4 tablets of Tradil 300 mg per day.
400 mg
Do not take more than 1 tablet of Tradil 400 mg as a single dose.
Do not take more than 3 tablets of Tradil 400 mg per day.
In the case of osteoarthritis
300 mg
The recommended dose is 1 tablet of Tradil 300 mg 2 to 3 times per day. In case of acute symptoms, your doctor can increase the dose by one to 4 tablets of Tradil 300 mg per day.
400 mg
The recommended dose is 1 tablet of Tradil 400 mg 2 times a day (1 in the morning and 1 in the evening). In case of acute symptoms, your doctor can increase the dose by one to 3 tablets of Tradil 400 mg per day.
In case of menstrual pains
300 mg
The recommended dose is 1 tablet of Tradil 300 mg 2 to 3 times per day.
400 mg
The recommended dose is 1 tablet of Tradil 400 mg 2 times a day.
For mild to moderate pain
300 mg
The recommended dose is 1 tablet of Tradil 300 mg 2 times per day. If a higher dose is needed, your doctor can prescribe up to 4 tablets of Tradil 300 mg per day.
400 mg
The recommended dose is 200 mg Tradil (half a 400 mg tablet) 3 times a day. If a higher dose is needed, your doctor can prescribe up to 3 tablets of Tradil 400 mg per day. Depending on your symptoms, your doctor may also prescribe lower-strength Tradil tablets (300 mg). The break on the tablets (see the section “Appearance of the medicine”) allows them to be divided into two equal doses.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact your doctor immediately if you have an infection and symptoms (such as fever and pain) persist or worsen (see section 2).
The 400 mg tablet can be divided into two equal doses. To split the tablet, place it on a hard surface and press down with your index fingers or thumbs.
Patients with liver or kidney disease: Your doctor may have prescribed Tradil at a lower dose than normal. You should not increase the dose prescribed by your doctor.
Elderly patients: If you are over 60 years of age, your doctor may have prescribed a lower dose than normal. If you do not have any problems using Tradil, your doctor may increase the dose for you.
Children and adolescents: As there is not enough experience in the treatment of children and adolescents, Tradil should not be used in people younger than 18 years.
If you think the effect of Tradil is too strong or too weak, consult a doctor or pharmacist.
If you have taken too much Tradil
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.
Symptoms may include nausea, stomach pain, vomiting (may contain some blood), headache, ringing in the ears, lack of coordination, confusion, and jerky eye movements. At high doses, drowsiness, chest pain, palpitations, unconsciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, low blood pressure, freezing, and breathing problems have been reported.
If you forget to take Tradil
Do not take a double dose to make up for a missed tablet. Take the next tablet as usual.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by taking the lowest dose for the shortest possible time to relieve symptoms. Elderly people who use this medicine have an increased risk of side effects. Side effects are mostly dose dependent and vary from patient to patient. The risk of side effects in the gastrointestinal tract is particularly dependent on the dose and duration of treatment.
Stop using Tradil and seek immediate medical attention
- if you get severe stomach pain, especially when you start taking Tradil.
- if you have black stools, bloody diarrhea, or vomit blood.
- if you get a rash, severe blistering or peeling of the skin, mucosal lesions, or any signs of hypersensitivity.
- if you get symptoms such as fever, sore throat, and mouth, flu-like symptoms, feeling tired, and nose and skin bleeding. These symptoms can be caused by a decrease in white blood cells ( agranulocytosis ).
- if you get severe or persistent headaches.
- if you develop yellowing of the skin and whites of the eyes (jaundice).
- if you develop swelling of the face, tongue, or throat, difficulty swallowing or breathing ( angioedema ), or a worsening of asthma.
- if you urinate less than normal, have swelling, cloudy urine, or generally feel unwell these may be the first signs of kidney damage or kidney failure.
Very common side effects ( may affect more than 1 in 10 users):
- Problems in the gastrointestinal tract, such as stomach pain, nausea, indigestion, diarrhea, gas formation ( flatulence ), constipation, heartburn, vomiting, and small blood losses in the stomach and/or intestine which in exceptional cases can cause anemia.
Common side effects ( may affect up to 1 in 10 users):
- Ulcers of the gastrointestinal tract, sometimes with bleeding and perforation (see section 2), black stools (melena), blood-stained vomit (hematemesis), mouth ulcers and inflammation (ulcerative stomatitis ), inflammation of the large intestine ( colitis ), worsening of inflammatory bowel disease, complications associated with bulges of the large intestine (hole in the intestinal wall or fistula ).
- Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or sleepiness (drowsiness), dizziness, and fatigue.
Uncommon side effects ( may affect up to 1 in 100 users):
- Gastric catarrh
- Visual disturbances
- Hypersensitivity reactions, such as hives ( urticaria ), itching, purple bruises (purpura), and eczema as well as asthma attacks (possibly with a drop in blood pressure)
- Swelling of the face or neck ( angioedema )
- Anxiety
- Ringing in the ears ( tinnitus )
- Rhinitis ( rhinitis )
- Rash
- Development of edema, especially in patients with high blood pressure or with kidney problems including nephritis and kidney failure.
Rare side effects ( may affect up to 1 in 1,000 users):
- Psychotic reaction
- Vision loss (toxic amblyopia)
- Impaired hearing
- Kidney damage (papillary necrosis ), elevated urea concentration, and uric acid concentration in the blood
- Liver function problems (usually reversible )
- Depression, confusion, hallucination
Very rare side effects ( may affect up to 1 in 10,000 users):
- Difficulty breathing (mainly in patients with bronchial asthma )
- Inflammation of the esophagus or pancreas, formation of membrane-like strictures in the small and large intestine (membrane-like strictures in the intestine)
- Swelling ( edema ), high blood pressure, inflammation of the blood vessels, palpitations, heart failure
- Impaired liver function, liver damage, especially during long-term treatment, liver failure, acute liver inflammation ( hepatitis ), and jaundice
- Photosensitivity reactions
- Disorders in the production of blood cells ( anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis ) – the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose, and skin bleeding. In these cases, you must immediately stop treatment and consult a doctor. You must not treat these symptoms with painkillers or antipyretic drugs
- Exacerbation of infection-related inflammation (eg, necrotizing fasciitis) associated with the use of certain analgesics ( NSAIDs ) has been described. If signs of infection appear or worsen while using dexibuprofen, see a doctor without delay to determine if there is a need for anti-infective/ antibiotic treatment
- In exceptional cases, serious skin infections and soft tissue complications in the case as chicken pox infection (varicella)
- Symptoms of meningitis (aseptic meningitis ) with neck stiffness, headache, malaise, nausea, fever, or clouded consciousness have been observed with the use of dexibuprofen. Patients with autoimmune diseases ( SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs
- Serious types of skin reactions such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell’s syndrome ), hair loss ( alopecia )
- Severe generalized hypersensitivity reaction (swelling of the face, tongue, and larynx, shortness of breath, rapid heartbeat, low blood pressure, severe shock ), worsening of asthma
Has been reported (occurring in an unknown number of users):
- A serious skin reaction called DRESS may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell ).
- Red, widespread, scaly rash with bumps under the skin and blisters mainly in skin folds, on the upper body and arms, accompanied by fever at the beginning of treatment ( acute generalized exanthematous pustulosis ). If you develop these symptoms, stop taking Tradil and contact your doctor immediately (See section 2).
Medicines such as Tradil may be associated with a slightly increased risk of heart attack or stroke.
If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information.
How Tradil should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C.
Use before the expiry date which is stated on the carton and blister after “EXP:”. 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 dispose of 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 dexibuprofen. One film-coated tablet contains either 300 mg or 400 mg of dexibuprofen.
- Other ingredients are
Tablet core: hypromellose, microcrystalline cellulose, carmellose calcium, colloidal anhydrous silica, talc.
Film coating: hypromellose, titanium dioxide (E 171), triacetin, talc, macrogol 6000.
Appearance and package sizes of the medicine
300 mg
The 300 mg tablets are white and round.
Diameter: approx. 11.2 mm
Height: approx. 5.2 mm
Tradil 300 mg tablets are supplied in cartons of 10, 20, 30, 50, 60, 90, and 100 tablets in transparent, colorless PVC/PVDC/aluminum blisters.
400 mg
The 400 mg tablets are white with a score on both sides.
Length: approx. 18.2 mm
Width: approx. 8.2 mm
Height: approx. 5.9 mm
Tradil 400 mg tablets are supplied in cartons of 4, 10, 20, 30, 50, 60, 90, and 100 tablets in transparent, colorless PVC/PVDC/aluminum blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Nordic Drugs AB, Box 300 35, 200 61 Limhamn
Manufacturer
Gebro Pharma GmbH, 6391 Fieberbrunn, Austria
This medicine is approved in the European Economic Area under the names:
| Austria: | Dexibuprofen “Gebro” 300, 400 mg Film tablet |
| Portugal: | Seractil 300, 400 mg comprimidos revestidos |
| Sweden: | Tradil 300, 400 mg film-coated tablets |
| Denmark: | Selective 300, 400 mg film-coated tablets |
| Spain: | Seractil 400 mg comprimidos recubiertos con película |
| Greece: | Seractil 400 mg film-coated tablets |
| Germany: | Dolomagon 300, 400 mg Film tablet |
| Italy: | Seractil 300, 400 compresse rivestite con film |