200 mg and 400 mg film-coated tablets Ibuprofen
What Ibuprofen Apofri is and what it is used for
Ibuprofen Apofri is used for temporary mild to moderate pain conditions, such as headaches, toothaches, muscle and joint pain, back problems, menstrual cramps and fever in colds.
Ibuprofen contained in Ibuprofen Apofri 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.
Ibuprofen Apofri belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Ibuprofen Apofri has analgesic, antipyretic and anti-inflammatory properties . Power is usually obtained within 30 minutes and maximum power is reached within 1-2 hours.
What you need to know before you use Ibuprofen Apofri
Do not use Ibuprofen Apofri
- 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 stomach ulcers or duodenal ulcers , or have previously had stomach ulcers or duodenal ulcers during treatment with Ibuprofen Apofri or similar preparations.
- if you have had recurrent stomach ulcers or duodenal ulcers .
- 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 Apofri.
The lowest dose and 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 Apofri 200 mg is not given to children under 6 years of age.
Ibuprofen Apofri 400 mg is not given to children under 12 years of age.
Before treatment with Ibuprofen Apofri you should consult a doctor if you have or have had the following diseases or symptoms:
- SLE or other connective tissue diseases
- impaired renal or hepatic function
- mild to moderate heart failure
- asthma or allergic diseases
- inflammatory bowel diseases
- previous stomach ulcers or other increased tendency to bleed
Elderly people should be aware of the increased risk of side effects that exist in old age.
Infection is
Ibuprofen Apofri can hide signs of infection such as fever and pain. Therefore, Ibuprofen Apofri 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 an infection persist or worsen, you should 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.
For chickenpox, Ibuprofen Apofri should not be used.
Ibuprofen Apofri, like other anti-inflammatory drugs, can mask the signs of infection .
If you have previously had problems with the gastrointestinal tract, you should contact a doctor if you have symptoms from the abdomen. Contact with a doctor is especially important if the symptoms occur at the beginning of treatment and in elderly patients.
Serious skin reactions have been reported with Ibuprofen Apofri. You should immediately stop taking Ibuprofen Apofri 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
Stop using Ibuprofen Apofri 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
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 (3 days for fever and 5 days for pain).
You should discuss your treatment with a doctor or pharmacist before using Ibuprofen Apofri 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 )).
- high blood pressure , diabetes , high cholesterol, a history of heart disease or stroke in the family or if you are a smoker.
There is a risk of impaired kidney function in children and adolescents who are dehydrated.
Ibuprofen Apofri can affect your chances of getting pregnant, see the section Pregnancy and breast-feeding for more information.
Other medicines and Ibuprofen Apofri
Do not use different types of painkillers at the same time without a doctor’s prescription.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ibuprofen Apofri may affect or be affected by treatment with certain medicines for:
- anticoagulants (ie blood thinners, eg acetylsalicylic acid , warfarin , ticlopidine)
- drugs that lower high blood pressure ( ACE inhibitors eg captopril , beta-blocker eg atenolol, angiotensin -II receptor antagonists eg losartan )
- inflammation ( corticosteroids are)
- irregular heartbeat ( digoxin )
- manic depressive illness (lithium)
- tumors and disorders of the immune system (eg methotrexate)
- certain immunosuppressive agents against rejection of transplanted organs (eg cyclosporine, tacrolimus)
- depression (so-called SSRIs )
- fungal infections (eg fluconazole , voriconazole)
- diabetes (sulphonylureas)
Some other medicines may also affect or be affected by treatment with Ibuprofen Apofri. You should therefore always consult your doctor or pharmacist before using Ibuprofen Apofri with other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
Pregnant women should not use Ibuprofen Apofri during the last three months of pregnancy. Taking Ibuprofen Apofri should be avoided by women planning a pregnancy or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription .
Breast-feeding
Ibuprofen Apofri passes into breast milk, but is unlikely to affect the breast-fed baby. Talk to your doctor if you are taking Ibuprofen Apofri more than temporarily while breast-feeding.
Fertility
Ibuprofen Apofri, 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 Apofri 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.
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.
Ibuprofen Apofri contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose , ie essentially ‘sodium – free’ . is next to “sodium free”
How to use Ibuprofen Apofri
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).
- 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.
Ibuprofen Apofri 200 mg tablets
Temporary mild to moderate pain and fever in colds
Adults and adolescents over 12 years (≥40 kg) : 1-2 tablets (200-400 mg) as a single dose or as needed 3-4 times a day with 4- 6 hour intervals. The maximum daily dose should not exceed 6 tablets (1,200 mg). More than 2 tablets (400 mg) at a time does not provide a better analgesic effect.
Children 6-12 years (≥20 kg) : 1 tablet (200 mg) 1-3 times a day if needed at 4-6 hour intervals. The maximum daily dose should not exceed 3 tablets (600 mg).
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 young people
Contact a doctor if children and adolescents need to use this medicine for more than 3 days, or if their symptoms worsen.
Menstrual pain
Adults and adolescents over 12 years (≥40 kg) : 2 tablets (400 mg) 1-3 times a day if necessary at 4-6 hour intervals. The maximum daily dose should not exceed 6 tablets (1,200 mg). Take the medicine as early as possible at the beginning of menstruation, then the effect will be better. More than 2 tablets (400 mg) at a time does not provide a better analgesic effect. Take the medicine as early as possible at the beginning of menstruation, then the effect will be better.
Ibuprofen Apofri tablets 400 mg
Temporary mild to moderate pain and fever in colds
Adults and adolescents over 12 years (≥40 kg) : 1 tablet (400 mg) as a single dose or, if necessary, 2-3 times a day at 4-6 hour intervals. The maximum daily dose should not exceed 3 tablets (1,200 mg). More than 1 tablet (400 mg) at a time does not provide a better analgesic effect.
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.
Young people
Contact a doctor if young people need to use this medicine for more than 3 days, or if their symptoms worsen
Menstrual pain
Adults and adolescents over 12 years (≥40 kg) : 1 tablet (400 mg) 1-3 times a day if needed at 4-6 hour intervals. The maximum daily dose should not exceed 3 tablets (1,200 mg). More than 1 tablet (400 mg) at a time does not provide a better analgesic effect. Take the medicine as early as possible at the beginning of menstruation, then the effect will be better.
If you use more Ibuprofen Apofri than you should
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly containing blood), headache, tinnitus (earring), confusion and uncontrolled eye movements. At high doses , drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills and breathing problems have been reported.
If you forget to use Ibuprofen Apofri
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.
4. Possible side effects
Like all medicines, Ibuprofen Apofri 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.
Common side effects (affects more than 1 user in 100) : gastrointestinal side effects (stomach pain, heartburn, nausea, vomiting, constipation, flatulence, bleeding from the stomach and intestines which may cause black stools or blood-mixed vomiting, diarrhea), fatigue, rash , headache.
Uncommon side effects (affects less than 1 in 100 people) : stomach ulcers , hepatitis , jaundice, kidney damage, hives , itching , slight bleeding in the skin and mucous membranes, inflammation of the gastric mucosa, swelling of the face, lips, tongue and throat, sometimes with shortness of breath or difficulty swallowing ( angioedema ), shortness of breath, bronchospasm, allergic rhinitis, asthma or worsening asthma , insomnia, mild anxiety, visual disturbances, photosensitivity, hearing damage.
Rare side effects (affects less than 1 in 1,000 people) : allergic reaction , fluid retention in the body, blood changes, ruptured stomach ulcers , liver damage, depression, confusion, skin and mucosal effects such as epidermal detachment and / or multiple skin redness (sometimes severe), non bacterial meningitis , visual impairment, tinnitus , dizziness.
No known frequency (can not be calculated from the available data): 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 treatment ( acute generalized exanthematous pustulosis ). Stop using Ibuprofen Apofri immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
Note that Ibuprofen Apofri may prolong the bleeding time.
High blood pressure and heart failure as well as aggravated ulcers in the colon and Crohn’s disease (intestinal disease) have been reported during treatment with painkillers ( NSAIDs ).
A severe skin reaction called DRESS (drug- related rash with eosinophilia and systemic symptoms) may occur. Symptoms of DRESS include skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell ).
In rare cases, serious side effects occur in connection with chickenpox.
Medicines such as Ibuprofen Apofri may cause a small increased risk of heart attack or stroke .
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 Apofri
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine 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 and 400 mg.
- The other ingredients are maize starch, pregelatinised maize starch, sodium starch glycolate (type A), magnesium stearate, talc, hypromellose, macrogol, titanium dioxide (dye E171)
What the medicine looks like and contents of the pack
200 mg
White, round, biconvex, film-coated tablet, diameter 10 mm.
Blister pack (PVC / Al) 1, 2, 3, 4, 5, 6, 7, 8, 9 and 30 tablets.
400 mg
White, oval, biconvex film-coated tablet with a notch on both sides, 18.5 mm x 8 mm.
The tablet can be divided into two equal parts.
Blister pack (PVC / Al) 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 30 tablets.
Marketing Authorization Holder and Manufacturer
Holder of approval for sale:
Apofri AB
Box 120
182 12 Danderyd
Tel .: 08-544 960 30
Manufacturer:
Dr. Pfleger Arznemittel GmbH
Dr.-Robert-Pfleger-Str. 12
D-96052 Bamberg
Germany
Evolan Pharma AB
Svärdvägen 19
182 33 Danderyd