200 mg Film-coated tablet
ibuprofen
What Ibuprofen Orifarm is and what it is used for
Ibuprofen Orifarm belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines). Ibuprofen Orifarm has analgesic, antipyretic and anti-inflammatory properties . Power is usually obtained within 30 minutes and maximum power is reached within 1-2 hours.
Ibuprofen Orifarm is used for temporary mild to moderate pain conditions, e.g. headaches, including migraine headaches, toothaches, backaches, muscle and joint pain, fever in colds, and menstrual cramps.
Ibuprofen Orifarm 200 mg is not recommended for use in children below 6 years of age.
Ibuprofen contained in Ibuprofen Orifarm may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Ibuprofen Orifarm
Do not use Ibuprofen Orifarm
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
- during the last three months of pregnancy.
- if you have any disease with an increased tendency to bleed.
- if you have or have had stomach ulcers , duodenal ulcers or bleeding during treatment with Ibuprofen Orifarm or similar medicines.
- if you have ever had bleeding or perforation (holes) in your stomach or intestines after taking NSAIDs .
- if you have severe liver or kidney disease.
- if you have severe heart failure .
- if you have had allergic symptoms (eg difficulty breathing, nasal congestion, rash) while taking acetylsalicylic acid or similar anti- inflammatory drugs .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Ibuprofen Orifarm:
- if you have certain disorders of the immune system (various connective tissue disorders, systemic lupus erythematosus ( SLE ), conditions where the immune system affects the connective tissue resulting in joint pain, skin changes and disorders of other organs) as it may increase the risk of non-bacterial meningitis
- if you have impaired kidney or liver function
- if you have heart problems including heart failure , angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked blood vessels) or any kind of stroke (including “mini-” stroke ”or transient ischemic attack ( TIA ))
- if you have high blood pressure , diabetes , high cholesterol, a history of heart disease or stroke in the family or if you are a smoker.
- if you have asthma , chronic rhinitis (chronic stuffy and runny nose) or allergic diseases as Ibuprofen Orifarm may cause difficulty breathing, rash or a severe allergic reaction when you have any of these conditions
- if you have inflammatory bowel disease, have previously had stomach ulcers or other tendencies to increase bleeding.
The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects.
Higher doses than those recommended can lead to serious risks. Do not use different types of painkillers at the same time without a doctor’s prescription.
Ibuprofen Orifarm 200 mg should not be given to children under 6 years of age.
If you use painkillers for a long time, this can cause headaches which should not be treated with more painkillers. If you think this is true for you, talk to a doctor or pharmacist.
If you have previously had problems with the gastrointestinal tract, you should contact a doctor if you have symptoms from the abdomen, especially bleeding in the gastrointestinal tract). Contact with a doctor is especially important if the symptoms occur at the beginning of treatment and in the elderly.
Elderly people should be aware of the increased risk of side effects, especially bleeding and perforation (holes) in the gastrointestinal tract, which can be life-threatening.
Treatment must be stopped and a doctor consulted when gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen Orifarm.
Anti-inflammatory/analgesic drugs such as ibuprofen 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 treatment time.
Ibuprofen Orifarm may affect your chances of getting pregnant, see the section Pregnancy and breastfeeding for more information.
Infection is
Ibuprofen Orifarm can hide signs of infection such as fever and pain. Therefore, Ibuprofen Orifarm may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of infection persist or worsen, contact your doctor:
- Adults: Contact a doctor if the symptoms worsen or do not improve within 3 days in case of fever and within 5 days in case of pain.
- Children and adolescents: Contact a doctor if children and adolescents need to use this medicine for more than 3 days, or if their symptoms worsen.
Stop using Ibuprofen Orifarm and contact your 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
Serious skin reactions have been reported with ibuprofen. You should immediately stop taking Ibuprofen Orifarm and seek medical attention if you develop any rash, mucous membrane ulcers, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
There may also be serious infection with destruction ( necrosis ) of the skin, subcutaneous tissue, and muscles.
Ibuprofen Orifarm may in rare cases affect the white blood cells so that the defense against infection deteriorates. 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 have information about your medication.
Caution should be exercised in dehydrated patients as there is a risk of renal impairment, especially in dehydrated children, adolescents, and the elderly.
Children and young people
There is a risk of impaired kidney function in children and adolescents who are dehydrated.
Ibuprofen Orifarm 200 mg tablets should not be taken by children under 6 years of age.
Children under 12 years (under 40 kg)
Contact a doctor before using Ibuprofen Orifarm if:
- the child is difficult to carry or has abdominal pain, neck stiffness or back pain.
- the child has severe problems with ears, throat or trachea.
If the child has a fever contact a doctor if:
- the child has not drunk any fluid or lost a large amount of fluid due to persistent vomiting or diarrhea.
- the treatment did not have any effect on the pain or fever after the first day.
- new symptoms appear or stomach pain / stomach upset is stored or lasts a long time.
Other medicines and Ibuprofen Orifarm
Do not use different types of painkillers at the same time without a doctor’s prescription.
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Ibuprofen Orifarm may affect or be affected by certain other medicines. For example:
- anticoagulants (ie blood thinners, eg acetylsalicylic acid , warfarin , ticlopidine)
- drugs that lower high blood pressure ( ACE inhibitors eg captopril , beta blockers eg atenolol, angiotensin II receptor antagonists eg losartan )
- anti- inflammatory drugs ( corticosteroids )
- drugs for irregular heartbeat ( digoxin )
- drugs for manic-depressive illness (lithium)
- anti- tumor drugs and disorders of the immune system (eg methotrexate)
- certain immunosuppressive agents against rejection of transplanted organs (eg cyclosporine, tacrolimus)
- antidepressants (so-called SSRIs – selective serotonin reuptake inhibitors)
- drugs for bacterial infections (certain antibiotics including aminoglycosides )
- medicines for fungal infections (eg fluconazole , voriconazole)
- drugs against diabetes (sulfonylureas)
- drugs for high cholesterol (cholestyramine)
- drugs against HIV – infection (zidovudine)
- diuretics (eg furosemide )
Some other medicines may also affect or be affected by treatment with Ibuprofen Orifarm. You should therefore always consult your doctor or pharmacist before using Ibuprofen Orifarm with other medicines.
Ibuprofen Orifarm with food, drink and alcohol
Ibuprofen Orifarm can be taken with food and drink. Ibuprofen Orifarm works faster if the tablet is taken on an empty stomach. If Ibuprofen Orifarm is taken with alcohol, the side effects may increase.
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.
Pregnancy
Pregnant women should not use Ibuprofen Orifarm during the last three months of pregnancy.
Taking Ibuprofen Orifarm should be avoided by women planning a pregnancy or who are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Breast-feeding
Ibuprofen Orifarm passes into breast milk but is unlikely to affect the breast-fed baby. Talk to your doctor if you need more than temporary use of Ibuprofen Orifarm during breastfeeding.
Fertility
Ibuprofen Orifarm, like many anti-inflammatory drugs, can impair the chances of getting pregnant and is therefore not recommended for women trying to conceive. The effect is temporary and ceases when you stop using this type of medicine.
Driving and using machines
Ibuprofen Orifarm may impair the ability of some people to react, e.g. due to side effects such as visual disturbances, dizziness, or drowsiness. This should be borne in mind at times when sharper attention is required, e.g. while driving, and applies to a greater extent to combination with alcohol.
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. 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.
Ibuprofen Orifarm contains lactose
Ibuprofen Orifarm contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Ibuprofen Orifarm
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor immediately if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2):
- Adults : Contact a doctor if symptoms worsen or do not improve within 3 days in case of fever and within 5 days in case of pain.
- Children and adolescents : Contact a doctor if children and adolescents need to use this medicine for more than 3 days or if symptoms worsen.
The recommended dose is:
Occasional mild to moderate pain and fever in colds.
Adults and adolescents over 12 years (over 40 kg):
1 tablet if needed 1-4 times a day or 2 tablets if needed 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets (1200 mg). More than 2 tablets at a time do not provide a better analgesic effect.
Children 6–9 years (20-29 kg):
1 tablet if necessary 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 3 tablets (600 mg).
Children 10-12 years (30-40 kg):
1 tablet if needed 1-4 times a day at least 4-6 hours apart.
The maximum daily dose should not exceed 4 tablets (800 mg).
Migraine headache
Adults and adolescents over 12 years (over 40 kg):
2 tablets if needed 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets (1200 mg). More than 2 tablets at a time do not provide a better analgesic effect.
Contact a doctor if the symptoms worsen or do not improve within 3 days in case of migraine headache.
Menstrual cramps.
Adults and adolescents over 12 years (over 40 kg):
2 tablets if needed 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets (1200 mg). More than 2 tablets at a time do not provide a better analgesic effect. Take the medicine as early as possible at the beginning of menstruation, then the effect will be better.
To avoid a transient burning sensation in the throat or mouth, the tablets should be swallowed whole and rinsed with at least half a glass of water. For faster effect, Ibuprofen Orifarm can be taken on an empty stomach. Take ibuprofen with food if you have a sensitive stomach.
If you use more Ibuprofen Orifarm 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, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms of overdose are main symptoms of the gastrointestinal tract such as nausea, stomach pain, vomiting (may be blood mixed), headache, ringing in the ears, confusion, and jerky involuntary eye movements. At high doses, drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, frostbite, and difficulty breathing have been reported.
If you forget to take Ibuprofen Orifarm
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, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common are side effects from the gastrointestinal tract, which occur in 10 to 30% of all users.
Serious side effects are
The following side effects are very serious and may require immediate treatment. Stop taking Ibuprofen Orifarm and contact your doctor immediately if the following serious side effects occur:
- ( angioedema , a less common side effect)
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
- Ibuprofen Orifarm may cause a decrease in the number of white blood cells ( agranulocytosis ) with decreased resistance to infection as a result (a less common side effect ). You should contact your doctor immediately if you get an infection with symptoms such as fever and severe general malaise, or fever with local infection symptoms such as sore throat / pharynx / mouth or difficulty urinating. It is important that you inform your doctor about your medicines.
- Severe changes in the skin and mucous membranes such as epidermal necrolysis and / or erythema multiforme have been reported (a very rare side effect ). Stop taking Ibuprofen Orifarm and consult a doctor if you get a rash or ulcer in the mucous membranes. The severe rashes can include blisters on the skin, especially on the legs, arms, hands and feet, and can also involve the face and lips. This can also become even more serious as the blisters can become larger and spread and parts of the skin can fall off ( toxic epidermal necrolysis ). There may also be severe infection with destruction ( necrosis ) of the skin, subcutaneously tissue and muscles.
- A severe skin reaction known as DRESS syndrome may occur (has been reported, occurs in an unknown number of users). Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell ).
- Widespread red, scaly rash with bumps under the skin and blisters mainly in the folds of the skin, on the torso and arms together with fever at the beginning of the treatment ( acute generalized exanthematous pustulosis ). Stop using Ibuprofen Orifarm immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
Other side effects are
Common (may affect up to 1 in 10 people) :
- gastrointestinal side effects (indigestion, diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence, bleeding from the stomach and intestines which may cause black stools or blood-mixed vomiting)
- fatigue
- rash
- headache and dizziness.
Uncommon (may affect up to 1 in 100 people) :
- allergic rhinitis
- gastric ulcer , intestinal ulcer, inflammation of the gastric mucosa, ulcers of the oral mucosa
- inflammation of the liver ( hepatitis ), jaundice
- hives
- itching , slight bleeding in the skin and mucous membranes
- photosensitivity
- renal impairment
- blood count changes
- anemia (a decrease in the number of red blood cells or hemoglobin which may make the skin pale and may lead to weakness)
- hypersensitivity
- ant crawls
- drowsiness, excessive fatigue
- shortness of breath, convulsions in the trachea
- asthma
- insomnia, anxiety
- visual disturbances
- hearing damage.
- tingling or numbness in the skin.
Rare (may affect up to 1 in 1,000 people) :
- allergic reaction , fluid accumulation in the body
- liver damage
- depression, confusion
- visual impairment, tinnitus (ringing in the ears), dizziness.
- non-bacterial meningitis .
Very rare (may affect up to 1 in 10,000 users) :
- inflammation of the pancreas, impaired liver function.
Has been reported (occurs in an unknown number of users):
- worsening of ulcers in the colon ( colitis ) and Crohn’s disease (intestinal disease)
- high blood pressure
- heart failure
- myocardial infarction.
Note that Ibuprofen Orifarm may prolong bleeding time.
- In rare cases, serious side effects occur in connection with chickenpox.
- Medicines such as Ibuprofen Orifarm may cause a small increased risk of heart attack or stroke .
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ibuprofen Orifarm
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. Issue / EXP 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is ibuprofen , 200 mg.
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, povidone , maize starch, anhydrous colloidal silica , sodium lauryl sulphate, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol, titanium dioxide (dye E 171).
What the medicine looks like and contents of the pack
Ibuprofen Orifarm 200 mg is a white, round tablet.
Blister packs: 7, 10, 14, 20, 20×1 (single dose), 21, 28, 29 and 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com