Tablet 500 mg
Deregistration date: 2020-12-31(White, round, biconvex tablets, 12 mm in diameter, and a cross on one side.)
What Acetylsalicylic Acid Apofri is and what it is used for
Acetylsalicylic acid Apofri contains acetylsalicylic acid and is analgesic and antipyretic. The analgesic effect is due to the fact that acetylsalicylic acid counteracts the formation in the tissue of one of the special substances ( prostaglandins ) that increases pain sensitivity. The decrease in fever is due to the fact that acetylsalicylic acid increases the body’s heat release.
Acetylsalicylic acid Apofri is used for temporary mild to moderate pain conditions, e.g. for headaches, toothaches, muscle, and joint pain, menstrual cramps, and fever in colds.
Temporary pain in children. Fever in children and adolescents under 18 years of age only after contact with a doctor.
Acetylsalicylic acid contained in Acetylsalicylic acid Apofri may also be authorized 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 Acetylsalicylic acid Apofri
Do not use Acetylsalicylic acid Apofri
- if you are allergic to acetylsalicylic acid, salicylates, or any of the other ingredients of this medicine (listed in section 6)
- if you have an increased tendency to bleed
- if you have hemophilia
- if you have reduced platelet counts ( platelets )
- if you have stomach ulcers or ulcers in the intestinal tract
- if you have severe heart failure
- if you have severe kidney disease
- if you have cirrhosis of the liver
- if you have previously had symptoms of asthma, runny nose, or rash while taking acetylsalicylic acid or other anti-inflammatory drugs ( NSAIDs, such as ibuprofen).
- during the last three months of pregnancy (for more information see section Pregnancy, breast-feeding, and fertility below).
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.
Talk to your doctor, pharmacist, or nurse before taking Acetylsalicylic acid Apofri:
- if you have mild to moderate heart failure, kidney or liver disease, especially if you are being treated with diuretics ( diuretics ) at the same time. There is a risk of fluid retention and impaired kidney function.
- if you have asthma, chronic lung disease, hay fever or nasal polyps. People with these symptoms have an increased risk of hypersensitivity reactions.
- if you are taking medicines to prevent the formation of blood clots
- if you have any gastrointestinal disease or have had a stomach ulcer in the past
- if you have a severe deficiency of glucose -6-phosphate dehydrogenase (a hereditary disease), as Acetylsalicylic acid Apofri may reduce the number of red blood cells.
- if you have an increased risk of having gout attacks.
- if you are going to have surgery (including dental surgery) because Acetylsalicylic acid Apofri reduces the body’s ability to stop bleeding.
If you use Acetylsalicylic acid Apofri for a long time (more than 3 months), there is a risk that you may develop a headache or that the headache will get worse. If you think your headache is due to this, you should not increase your dose of Acetylsalicylic acid Apofri but consult your doctor.
Children and young people
Medicines containing acetylsalicylic acid should not be given to people under 18 years of age without a fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.
Acetylsalicylic acid Apofri should not be given to children under 10 years of age.
Other medicines and Acetylsalicylic acid Apofri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or other natural products.
Always tell your doctor before taking Acetylsalicylic acid Apofri if:
- you are taking medicines that prevent the formation of blood clots
- you are taking diuretics ( diuretics )
The effect of Acetylsalicylic acid Apofri may affect or be affected if taken concomitantly with certain other medicines for:
- blood clots (eg warfarin )
- organ rejection after transplantation (cyclosporine, tacrolimus)
- high blood pressure (eg diuretics, ACE inhibitors, alpha-blockers, or beta-blockers)
- pain and inflammation (eg corticosteroids and NSAIDs )
- pain and fever (metamizole)
- depression (selective serotonin reuptake inhibitors ( SSRIs ))
- gout (probenecid)
- cancer and rheumatoid arthritis (methotrexate)
- arrhythmias in the heart ( digoxin )
- manic depressive illness (lithium)
- epilepsy ( phenytoin, valproic acid )
- type II diabetes ( insulin or sulphonylureas)
- high blood fats ( nicotinic acid )
- glaucoma also called glaucoma (acetazolamide)
Acetylsalicylic acid Apofri with food, drink, and alcohol
Acetylsalicylic acid Apofri in combination with alcohol may increase the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, 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 Acetylsalicylic acid Apofri during the last three months of pregnancy. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Breast-feeding
Acetylsalicylic acid Apofri passes into breast milk but is unlikely to affect breastfed infants. However, consult your doctor if you use Acetylsalicylic Acid Apofri more than temporarily while you are breast-feeding.
Fertility
Treatment with acetylsalicylic acid Apofri may affect your ability to conceive. This effect is temporary and ceases if the medication is stopped. Acetylsalicylic acid Apofri is not recommended for women who want to become pregnant.
Driving and using machines
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.
How to use Acetylsalicylic acid Apofri
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 tablets are swallowed together with liquid and are preferably taken after a meal.
The recommended dose, unless your doctor prescribes otherwise, is:
Adults and adolescents over 14 years (over 50 kg) :
1-2 tablets 1-3 times a day at 4-8 hour intervals or as prescribed by a doctor, maximum 6 tablets (3 g) per day.
More than 2 tablets at a time do not provide a better analgesic effect. Higher doses can lead to serious risks. 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.
Use for children and adolescents:
Bodyweight should be used when calculating dose one (age indication is approximate).
30-50 kg (approx. 10 -14 years): 1 tablet (500 mg) 1-3 times a day at least 4 hours apart, a maximum of 3 tablets (1500 mg) per day.
Do not use Acetylsalicylic acid Apofri for children for more than 2 consecutive days unless your doctor prescribes otherwise.
Acetylsalicylic acid Apofri should not be given to children under 10 years of age.
Warning: Do not give to people under 18 years of age with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.
Dizziness and tinnitus can be symptoms of overdose.
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.
Stop taking Acetylsalicylic acid Apofri and contact your doctor immediately if you get any of the following symptoms:
- Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ). Rare side effect (may affect less than 1 user in 1,000)
- Bleeding from the stomach or intestines. Uncommon side effect (may affect up to 1 in 100 people)
- Severe widespread damage to the skin or mucous membranes with blisters and skin detachment ( Lyell’s syndrome or toxic epidermal necrolysis ). Very rare side effect (may affect less than 1 in 10,000 people)
- Extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals (Steven-Johnson syndrome, SJS). Very rare side effect (may affect less than 1 in 10,000 people)
- Fever with severely deteriorating general condition or fever with eg sore throat/pharynx/mouth or difficulty urinating which may be a symptom of a lack of white blood cells ( agranulocytosis ). Very rare (may affect less than 1 in 10,000 people)
More than 1 in 10 taking acetylsalicylic acid is expected to have side effects. The most common are gastrointestinal problems. The side effects are generally related to the size of the dose and the length of treatment.
The following side effects have been observed with Acetylsalicylic acid Apofri treatment.
Very common (may affect more than 1 user in 10) :
- It takes longer for the blood to clot/clot.
- Stomach pain, heartburn, acid regurgitation.
Common (may affect up to 1 in 10 people):
- Increased risk of bleeding.
- Breathing problems in asthmatics.
- Nausea, irritation, pain, or discomfort in the upper part of the gastrointestinal tract.
- Headache, insomnia.
- Vomiting, diarrhea, hives.
Uncommon (may affect up to 1 in 100 people):
- Anaphylactic reactions (sudden hypersensitivity reactions within minutes to hours, such as skin rash, difficulty breathing, or fainting).
- Ulcers and bleeding in the upper part of the gastrointestinal tract.
- Black / bloody stools, bloody vomiting due to the above bleeding.
- Drowsiness, fraud.
- Dizziness, tinnitus.
- Skin rash, sweating.
- Nasal or nasal congestion, fatigue.
Rare (may affect up to 1 in 1,000 people):
- Cerebral hemorrhage (paralysis, difficulty speaking, impaired consciousness).
- Inflammation of the blood vessels due to an allergic reaction.
- People who have a hereditary deficiency of glucose -6-phosphate dehydrogenase have an increased risk of red blood cell dissolution ( hemolysis ) or increased red blood cell degradation ( hemolytic anemia ).
- Anemia after long-term treatment.
- Severe bleeding from the upper part of the gastrointestinal tract, ulcers on the gastrointestinal tract.
- Kidney dysfunction.
- Increased sensitivity to insulin, which increases the risk of low blood sugar.
- Temporary hearing loss.
- Asthma and shortness of breath.
Very rare (may affect up to 1 in 10,000 people):
- Lack of platelets (may cause bleeding from the skin, mucous membranes, or bruises) and lack of white blood cells (may cause general fatigue, the tendency to infection, especially throat infection and fever).
- Transient liver infection that can occur in connection with influenza A and B and chickenpox.
- Reye’s syndrome (fever, vomiting, unconsciousness in children).
- Inflammation of the colon.
- Inflammation of mouth, esophagus, stomach.
- Constrictions in the intestines.
- Ulcers in the lower part of the gastrointestinal tract.
- Exacerbation of pre-existing inflammatory bowel disease.
Has been reported (occurs in an unknown number of users): Acute renal failure(where symptoms may include nausea, vomiting, and stomach bleeding).
Liver damage can occur at high doses in patients with rheumatism (the damage goes back when you stop taking acetylsalicylic acid Apofri).
Acetylsalicylic acid Apofri can also cause side effects that you do not normally notice. This can be changed in some laboratory samples e.g. due to effects on the liver, kidneys, and changes in the blood.
People with known allergies or asthma are at increased risk of hypersensitivity reactions.
Minor blood loss can in some cases lead to anemia.
Additional side effects in children and adolescents
Acetylsalicylic acid increases the risk of Reye’s syndrome in children and adolescents in connection with viral diseases, especially chickenpox and influenza. The symptoms are signs of brain swelling and liver damage, sometimes with low blood sugar.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Acetylsalicylic acid Apofri
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C.
Do not use this medicine after the expiry date which is stated on the carton after the abbreviation “EXP”: and on blisters after “EXP”. The expiration date 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 acetylsalicylic acid 500 mg
- The other ingredients are microcrystalline cellulose and corn starch
What the medicine looks like and the contents of the pack
The tablet is white, round, biconvex, diameter 12 mm, and a cross on one side.
Blister packs: 2, 4, 6, 8, 10, 20, 30, 40, 50 and 60 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Apofri AB
Box 120
182 12 Danderyd
Tel. 08-544 960 30
Manufacturer:
Medicofarma SA
Ul. Tarnobrzeska 13
26-613 Radom
Poland