Ibuprofen ABECE 200 mg and 400 mg film-coated ibuprofen tablets
1. What Ibuprofen ABECE Is And What It Is Used For
Ibuprofen Abece belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Ibuprofen Abece has analgesic, antipyretic and anti-inflammatory properties. Power is usually obtained within 30 minutes and maximum power is reached within 1-2 hours.
Ibuprofen Abece is used for temporary mild to moderate pain conditions, such as
- Headaches
- Toothaches
- Muscle, and joint pain
- Back problems
- Menstrual cramps
- Fever in colds
Ibuprofen contained in Ibuprofen Abece 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 Using Ibuprofen ABECE
Do Not Use Ibuprofen ABECE
- If you are allergic to ibuprofen or any of the other ingredients of ibuprofen abece (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 Abece 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 Abece.
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 Abece 200 mg is not given to children under 6 years of age.
- Ibuprofen Abece 400 mg is not given to children under 12 years of age.
Before treatment with Ibuprofen Abece 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 Abece 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 ibuprofen abece while you have an infection and the symptoms of 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 ibuprofen abece for more than 3 days, or if their symptoms worsen.
- For chickenpox, Ibuprofen Abece should not be used.
- 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 Abece. You should immediately stop taking Ibuprofen Abece 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.
- Stop using Ibuprofen Abece and contact your doctor immediately if you experience 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 Abece 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)
- 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 Abece may affect your chances of getting pregnant, see the section Pregnancy and breastfeeding for more information.
Other Medicines And Ibuprofen ABECE
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 Abece 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
- 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
- Ciclosporin
- 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 Abece. You should therefore always consult your doctor or pharmacist before using Ibuprofen Abece with other medicines.
Pregnancy, Breastfeeding And Fertility
Pregnancy
Pregnant women should not use Ibuprofen Abece during the last three months of pregnancy.
Taking Ibuprofen Abece 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 Abece passes into breast milk but is unlikely to affect the breast-fed baby. Consult a physician if you are taking Ibuprofen Abece more than temporarily while breastfeeding.
Fertility
Ibuprofen Abece, 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 Abece may impair the ability of some people to react, e.g. due to side effects such as
- Visual disturbances
- Dizziness
- 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 ABECE 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 ABECE
Ibuprofen abece uses
Always use ibuprofen abece 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 ibuprofen abece uses for more than 3 days, or if their symptoms worsen.
Ibuprofen ABECE tablets 200 mg
Occasional mild to moderate pain and fever in colds
Adults and adolescents over 12 years of age (≥40 kg): 1-2 tablets (200-400 mg) as a single dose or, if necessary, 3-4 times a day at 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 the 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 ibuprofen abece uses for more than 3 days, or if their symptoms worsen.
- Menstrual cramps
Adults and adolescents over 12 years of age (≥40 kg): 2 tablets (400 mg) 1-3 times a day if needed at 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. Take the medicine as early as possible at the beginning of menstruation, then the effect will be better.
Ibuprofen ABECE 400 mg tablet
Occasional mild to moderate pain and fever in colds
Adults and adolescents over 12 years of age (≥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 the 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 ibuprofen abece uses for more than 3 days, or if their symptoms worsen
Menstrual cramps
Adults and adolescents over 12 years of age (≥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 (ibuprofen abece 400 mg dosage) 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 ABECE Than You Should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms of ibuprofen abece overdose may include
- Nausea
- Stomach pain
- Vomiting (possibly containing blood)
- Headache
- Tinnitus (earring)
- Confusion and uncontrolled eye movements
- Drowsiness
- Chest pain
- Palpitations
- Unconsciousness
- Seizures (mainly in children)
- Weakness
- Blood in the urine
- Chills and breathing problems have been reported
If You Forget To Use Ibuprofen ABECE
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 Ibuprofen Abece Side Effects
Like all medicines, Ibuprofen Abece 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 ibuprofen abece side effects (affects more than 1 user in 100) :
- Gastrointestinal
- 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 ibuprofen abece side effects (affects less than 1 user in 100):
- 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 ibuprofen abece 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 Abece immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
- Note that Ibuprofen Abece may prolong 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 ibuprofen abece side effects occur in connection with chickenpox.
Medicines such as Ibuprofen Abece 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 ABECE
- Keep out of sight and reach of children.
- Do not use ibuprofen abece 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
Marketing Authorisation Holder:
Evolan Pharma AB
Box 120
182 12 Danderyd
Tel .: 08-544 960 30
Manufacturer:
Dr Pfleger Chemische Fabrik GmbH
Dr. Robert Pfleger Page 12
D-96052 Bamberg
Germany
Evolan Pharma AB
Svärdvägen 19
182 33 Danderyd