200 mg film-coated tablets
ibuprofen
What Ibuprofen Actavis is and what it is used for
Ibuprofen Actavis belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines) and has analgesic, anti-inflammatory, and antipyretic effects.
Ibuprofen Actavis 200 mg is used for temporary mild to moderate pain conditions, e.g. headaches, including migraine headaches, toothaches, muscle, and joint pain, back problems, menstrual cramps, and fever in colds.
Ibuprofen contained in Ibuprofen Actavis may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Ibuprofen Actavis
Do not take Ibuprofen Actavis
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
- if you have previously had an allergic reaction such as asthma , nasal congestion, itchy rash or swelling of the lips, face, tongue or throat after taking medicines containing acetylsalicylic acid or other medicines for pain and inflammation ( NSAIDs )
- if you have previously had ulcers or bleeding in the stomach or duodenum ( duodenum ) in connection with the use of painkillers and inflammation ( NSAIDs )
- if you have or have had recurrent ulcers or bleeding in the stomach or duodenum (two or more times)
- if you have severe liver, kidney or heart problems (including coronary heart disease)
- during the last 3 months of pregnancy
- if you are dehydrated (caused by vomiting, diarrhea or insufficient fluid intake)
- if you have any ongoing bleeding (including cerebral haemorrhage)
- if you have any disease that affects your blood cell formation
Ibuprofen Actavis 200 mg should not be given to children under 6 years of age.
Warnings and cautions
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.
Do not use if you have or have had stomach ulcers or if you are hypersensitive to acetylsalicylic acid. If you have asthma, you should consult a doctor before using Ibuprofen Actavis.
Talk to your doctor before taking Ibuprofen Actavis:
- if you have Systemic Lupus Erythematosus ( SLE ) or any other autoimmune disease
- if you have a hereditary disease ( porphyria ) that affects the pigment of the red blood cells ( hemoglobin )
- if you have a chronic inflammatory bowel disease such as ulcerative colitis , Crohn’s disease or other gastrointestinal diseases
- if you have disorders in the formation of blood cells
- if you have any disorder of the clotting function in the blood
- if you have allergies , hay fever, asthma , chronic swelling of the nasal mucosa or sinuses, adenoids or chronic obstructive pulmonary disease , as there is a greater risk that you will then have narrow airways ( bronchospasm ) with difficulty breathing
- if you have poor blood circulation in your arms or legs
- if you have liver, kidney or heart problems, or high blood pressure
- if you have recently undergone any major surgery
- during the first 6 months of pregnancy
- if you are breast-feeding
Older
If you are older, the risk of side effects increases, especially bleeding or perforation (holes) in the gastrointestinal wall. This can be life-threatening.
Sores, holes ( perforation ), and bleeding in the stomach or intestines
If you have a history of stomach or intestinal ulcers, especially if it is complicated by perforation or bleeding, you should be aware of abnormal symptoms from the stomach and contact a doctor immediately, especially if the symptoms occur at the beginning of treatment. The reason for this is that the risk of bleeding or ulcers in the gastrointestinal tract in such cases is increased, especially in elderly patients. If bleeding or ulcers occur, treatment should be discontinued.
Bleeding, ulceration, or perforation in the gastrointestinal wall may occur without prior signs, even in patients who have not had such problems before. These conditions can be life-threatening.
The risk of ulcers, holes ( perforation ), and bleeding in the gastrointestinal wall usually increases with a higher dose of ibuprofen. The risk may also increase if certain other medicines are used at the same time as ibuprofen (see section “Other medicines and Ibuprofen Actavis” below).
Skin reactions
Serious skin reactions have been reported with Ibuprofen Actavis. You should immediately stop taking Ibuprofen Actavis and seek medical attention if you develop any 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 is
Ibuprofen Actavis can hide signs of infection such as fever and pain. Therefore, Ibuprofen Actavis 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 symptoms worsen or do not improve within 3 days in case of fever and 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, the drug should not be used.
Impact on heart and brain
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 (For adults: 3 days for fever or migraine headache and after 5 days for pain, for children and adolescents: 3 days for fever and pain).
You should discuss your treatment with a doctor or pharmacist before taking Ibuprofen Actavis 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 )).
- have high blood pressure , diabetes , high cholesterol, a history of heart disease or stroke in the family or if you are a smoker.
Kidney impact
Ibuprofen can affect kidney function even in patients who have not had kidney problems before. This can cause swollen bones and also lead to heart failure or high blood pressure in sensitive individuals.
Ibuprofen can cause kidney damage, especially in patients who already have kidney, heart, or liver problems or who use diuretics ( diuretics ) or ACE inhibitors (antihypertensives) and in the elderly. Discontinuation of ibuprofen treatment usually leads to recovery.
Aseptic meningitis ( meningitis without bacterial infection )
During treatment with ibuprofen, some cases of meningitis have been reported (with symptoms such as neck stiffness, headache, nausea, vomiting, fever, and confusion). Although it is probably more likely to occur in patients with autoimmune diseases such as Systemic Lupus Erythematosus or a combination of connective tissue diseases, it has also been reported in patients without underlying chronic disease
Other precautions
During long-term treatment with high-dose painkillers, headaches may occur. This should not be treated with high doses of this medicine. Habitual use of painkillers can cause kidney damage and the risk of kidney failure.
Ibuprofen may temporarily prolong the bleeding time.
Ibuprofen Actavis may make it harder for you to get pregnant. Talk to your doctor if you are planning to become pregnant or if you have difficulty getting pregnant.
Children and young people
Not used for children under 6 years
Contact a doctor before using Ibuprofen Actavis 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 worsens or lasts a long time.
Ibuprofen can cause kidney problems in children and adolescents who are dehydrated.
Other medicines and Ibuprofen Actavis
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
The risk of side effects from Ibuprofen Actavis may increase with the concomitant use of certain other medicines. Ibuprofen Actavis may increase or decrease the effect of other medicines, or increase the risk of side effects when used concomitantly.
Ibuprofen Actavis may affect or be affected by certain other medicines. For example:
- other NSAIDs
- anticoagulants (ie blood thinners / anticoagulants, eg acetylsalicylic acid , warfarin , heparin , ticlopidine)
- platelet inhibitors (used to prevent clot formation) such as clopidgrel
- methotrexate (used to treat cancer and disorders of the immune system)
- digoxin (used to treat various types of heart disease)
- phenytoin (used to prevent epileptic seizures)
- lithium (used to treat depression and mania)
- diuretic drugs and potassium-sparing diuretic drugs
- drugs that lower high blood pressure ( ACE inhibitors eg captopril , beta blockers eg atenolol, angiotensin -II receptor antagonists eg losartan )
- cholestyramine (used to treat high cholesterol)
- aminoglycosides (used against a certain type of bacteria)
- SSRIs (used to treat depression) such as paroxetine , sertraline , citalopram
- moclobemide (RIMA – used to treat depressive illness or social phobia )
- ciclosporin, tacrolimus (used to suppress the immune system after organ transplantation)
- zidovudine or ritanovir (used to treat HIV patients )
- mifepristone
- probenecid or sulfinpyrazone (used to treat gout )
- quinolone antibiotics
- sulphonylurea (used to treat type 2 diabetes )
- corticosteroids (used to treat inflammation )
- bisphosphonates (used to treat osteoporosis, Paget’s disease and to reduce high calcium levels in the blood)
- oxpentifylline (pentoxifylline) is used to treat circulatory diseases affecting the blood vessels in the arms and legs)
- baclofen (muscle relaxant)
Some other medicines may also affect or be affected by treatment with Ibuprofen Actavis. You should therefore always consult your doctor or pharmacist before using Ibuprofen Actavis with other medicines.
Ibuprofen Actavis with food and drink
Ibuprofen Actavis should be swallowed with a glass of water during or after a meal.
Alcohol should be avoided as it may aggravate the side effects of Ibuprofen Actavis, especially in the stomach, intestines, or brain.
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.
Pregnant women should not use Ibuprofen Actavis during the last three months of pregnancy as it may cause major heart, lung, and kidney damage to the fetus. Use during the end of pregnancy can cause an increased tendency to bleed in both mother and child and weaken the force of the uterine contractions and thus delay the birth. Taking Ibuprofen Actavis 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.
Ibuprofen can make it difficult to get pregnant. Talk to your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant.
Ibuprofen passes into breast milk but is unlikely to affect the breast-fed baby. Small amounts of Ibuprofen Actavis pass into breast milk and breastfeeding usually does not need to be stopped during short-term treatment. However, when longer-term treatment is prescribed, early discontinuation of breastfeeding should be considered. Talk to your doctor if you need more than temporary use of Ibuprofen Actavis during breastfeeding.
Driving and using machines
Ibuprofen does not usually affect your ability to drive or use machines. However, high-dose treatment can cause side effects in the form of fatigue, decreased level of consciousness, dizziness (reported as common), and visual disturbances (reported as uncommon) that may affect the ability to drive and use machines in individuals. These effects are exacerbated by concomitant alcohol intake.
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. 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 Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
How to take Ibuprofen Actavis
Always take this medicine exactly as described in this leaflet or 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 symptoms worsen or do not improve within 3 days in case of fever and 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.
Occasional mild to moderate pain and fever in colds
Adults and adolescents over 12 years (over 40 kg):
The maximum daily dose should not exceed 6 tablets.
Dose and be taken as:
1 tablet if needed 1-4 times a day at least 4-6 hours apart.
or:
2 tablets if needed 1-3 times a day at least 4-6 hours apart.
More than 2 tablets at a time do not provide a better analgesic effect.
Children 6-9 years (20-29 kg): 1 tablet if needed 1-3 times a day at least 4-6 hours apart.
The maximum daily dose should not exceed 3 tablets.
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.
Migraine headache
Adults and adolescents over 12 years (over 40 kg): 2 tablets if necessary 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets. 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 pain
Adults and adolescents over 12 years (over 40 kg): 2 tablets if necessary 1-3 times a day at least 4-6 hours apart. The maximum daily dose should not exceed 6 tablets. 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.
The tablets should be swallowed with a glass of water during or after a meal. To facilitate swallowing or to adjust the dose, the tablets can be divided into two equal doses.
Older
Elderly people are at greater risk of side effects, especially bleeding and perforation in the gastrointestinal tract, which can be life-threatening. Consult a physician before starting treatment.
Impaired kidney or liver function
If you have impaired kidney or liver function, consult a doctor before starting treatment.
If you take more Ibuprofen Actavis than you should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms may include nausea, stomach pain, diarrhea, vomiting (may be bloody), headache, ringing in the ears, confusion and jerky involuntary eye movements. Bleeding in the stomach or intestines may also occur. At high doses and in more severe cases of overdose, drowsiness, chest pain, palpitations, unconsciousness, agitated state, confusion, coma , seizures (especially in children), weakness, dizziness, blurred vision and effects on the eyes, kidney failure , blood in the urine, liver damage , low blood pressure , chills and difficulty breathing, blue discoloration of the lips, tongue and fingers and increased bleeding tendency have been reported. Exacerbated asthma in asthmatics may also occur.
If you forget to take Ibuprofen Actavis
If you forget to take a dose , take it as soon as you can, unless there are less than 4 hours left until the next regular dose. Do not take a double dose to make up for a forgotten dose .
If you have any further questions on the use of this product, ask your doctor or pharmacist .
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are most likely at high doses and long treatment times.
Medicines such as Ibuprofen Actavis may cause a small increased risk of heart attack or stroke . Fluid retention ( edema ), high blood pressure and heart failure have been reported with NSAIDs .
The side effects are listed according to how common they are, as follows:
Very common: may affect more than 1 user in 10
Common: may affect up to 1 in 10 users
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Has been reported: occurs in an unknown number of users
The following side effects are important to note and require immediate action. You should stop taking Ibuprofen Actavis and contact your doctor immediately if the following symptoms occur:
Usual:
- Black, tar-like stools or blood-mixed vomiting (bleeding from ulcers in the gastrointestinal tract).
Very rare:
- Swelling of the face, tongue or throat that can cause very severe difficulty breathing ( angioedema ), rapid heartbeat, sharp drop in blood pressure or life-threatening shock .
- Sudden allergic reaction with shortness of breath, wheezing and drop in blood pressure.
- Severe rash with blisters on the skin, especially on arms, legs, hands and feet. Face and lips may also be involved (erythema multiforme, Stevens-Johnson syndrome ). This can become even more serious as the blisters become larger and spread and lead to loosening of the skin ( Lyell’s syndrome ). Severe infections can also occur with tissue death in the skin, subcutaneous tissue, connective tissue and muscles.
Has been reported:
- A severe skin reaction called DRESS syndrome can occur. 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 Actavis immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
You should stop taking the medicine and contact a doctor as soon as possible if the following side effects occur:
Very common:
- Heartburn, stomach pain, indigestion.
Uncommon:
- Blurred vision or other eye problems such as photosensitivity.
- Hypersensitivity reactions such as rash, itching , asthma attacks (sometimes accompanied by low blood pressure ).
- Your skin becomes more sensitive to light
Rare:
- Loss of vision.
Very rare:
- Acute accumulation of fluid in the lungs which causes difficulty breathing, high blood pressure , fluid retention and weight gain.
Other side effects that occur are:
Very common:
- Gastrointestinal disorders such as diarrhea, nausea, vomiting, gas in the stomach, constipation.
Usual:
- Ulcers in the gastrointestinal tract with or without perforation (holes in the gastrointestinal wall).
- Inflammation of the intestines and worsening inflammation of the colon ( colitis ) and digestive tract ( Crohn’s disease ). Complications associated with bulges on the colon (holes in the intestinal wall or fistula ).
- Not visible bleeding from the intestine which can lead to anemia (low blood count).
- Sores and inflammation in the mouth.
- Headache, drowsiness, dizziness, dizziness, fatigue, anxiety, insomnia and irritability.
Uncommon:
- Inflammation of the gastric mucosa.
- Kidney problems including development of edema (fluid retention), inflammation of the kidneys and kidney failure .
- Runny nose.
- Breathing difficulties ( bronchospasm ).
Rare:
- Depression, confusion, hallucinations.
- Lupus erythematosus syndrome.
- Increase in urea in the blood and other liver enzymes, decrease in hemoglobin and hematocrit values, effect on platelets and prolonged bleeding time, decreased calcium level and elevated serum uric acid level .
Very rare:
- Discomfort from palpitations, heart failure , heart attack and high blood pressure .
- Disorders of blood formation (with symptoms such as fever, sore throat, superficial sores in the mouth, flu-like symptoms , severe fatigue, nose and skin bleeding).
- Earring or tinnitus .
- Inflammation of the esophagus and pancreas .
- Constrictions in the intestine.
- Acute inflammation of the liver, yellowing of the skin and whites of the eyes, impaired liver function, liver damage, liver failure.
- Damage to kidney tissue
- Hair loss.
Has been reported:
- Knitting in hands and feet.
- Anxiety.
- Impaired hearing
- General malaise.
- Inflammation of the optic nerve one that can cause vision problems.
- Meningitis without bacterial infection (aseptic meningitis )
Ibuprofen Actavis can in rare cases affect the number of white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection 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 inform about your medication.
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 Actavis
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 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is ibuprofen . Each film-coated tablet contains 200 mg of ibuprofen .
- Other ingredients are:Tablet core: Microcrystalline cellulose, colloidal anhydrous silica, hydroxypropylcellulose, sodium lauryl sulfate, croscarmellose sodium, talc.Film coating (Opadry white 06B28499): Hypromellose, macrogol 400, titanium dioxide (E171).
What the medicine looks like and contents of the pack
Film-coated tablet.
White, oval, biconvex film-coated tablets with a score line on one side.
Pack sizes:
Blisters: 6, 10, 12, 20, 24, 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220-Hafnarfjordur
Iceland
Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa, 2600, Bulgaria
Balkanpharma-Razgrad AD, 68 April Blvd., Razgrad, 7200, Bulgaria