Paracetamol Apofri 500 mg effervescent paracetamol tablet
What Paracetamol Apofri Is And What Paracetamol Apofri Used For
Paracetamol Apofri is used to treat temporary fever and pain conditions of a mild nature, such as
- Fever in colds
- Headaches
- Toothaches
- Menstrual cramps
- Muscle and joint pain
Paracetamol contained in Paracetamol Apofri may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before You Use Paracetamol Apofri
Do Not Take Paracetamol Apofri
- If you are allergic to paracetamol or any other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Paracetamol Apofri should be used with caution if you
- Have liver problems, including liver problems due to alcohol abuse
- Have Gilbert’s syndrome (mild jaundice)
- Have kidney problems
- Is dehydrated and chronically malnourished
- Is on long-term treatment with a higher dose of paracetamol
- Has asthma and is sensitive to acetylsalicylic acid (aspirin)
- Take other medicines that contain paracetamol
- Have a fever even though you are using paracetamol
- Has a deficiency of glucose -6-phosphate dehydrogenase (a hereditary condition that leads to low red blood cell count ).
- Have hemolytic anemia (abnormal red blood cell breakdown )
Never take more Paracetamol Apofri than is stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but carry the risk of serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.
Do not use Paracetamol Apofri without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Apofri with alcohol. The intoxicating effect of alcohol is not increased by the addition of Paracetamol apofri.
Other Medicines And Paracetamol Apofri
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Paracetamol Apofri may affect or be affected by certain medicines;
- Metoclopramide, domperidone (medicines for nausea and vomiting).
- Warfarin (blood-thinning drug). Contact your treating physician if you take more than 2 effervescent tablets of Paracetamol Apofri (500 mg) daily for 5 consecutive days. There is a risk that the effect of warfarin will be affected.
- Probenecid (medicine for gout ).
- Certain medicines for epilepsy: phenytoin, phenobarbital, and carbamazepine.
- Rifampicin, isoniazid (a medicine used to treat tuberculosis ).
- Cholestyramine (medicine for high blood fats). The medication should be taken at least one hour apart.
- Chloramphenicol for injection (medicine for bacterial infections). (However, chloramphenicol can be used simultaneously against infection in your eye and Paracetamol Apofri.)
- St. John’s wort extract (included in some herbal remedies).
Paracetamol may affect laboratory values in uric acid and blood glucose tests. If you are taking other painkillers that contain paracetamol, do not use Paracetamol Apofri without first talking to your doctor or pharmacist.
Paracetamol Apofri With Food, Drink, And Alcohol
Concomitant use of paracetamol and alcohol consumption should be avoided.
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.
If necessary, Paracetamol Apofri can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and fever and use the medicine for the shortest possible time. Contact a doctor or midwife if the pain and fever do not decrease or if you need to take medicine more often.
Paracetamol passes into breast milk. However, regular doses of paracetamol can be taken during breastfeeding.
Driving And Using Machines
Paracetamol Apofri does not affect your ability to drive and use machines.
Paracetamol Apofri Contains Sodium And Sorbitol
Sodium
This medicine contains 503 mg of sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 25% of adults’ recommended daily sodium intake. Consult your doctor or pharmacist if you need 1 or more effervescent tablets daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
Sorbitol
This medicine contains 131 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If you (or your child) cannot tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary
Fructose intolerance is a rare, inherited disease that prevents you from breaking down fructose. Talk to your doctor before using this medicine.
How To Use Paracetamol Apofri
Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Note! Higher doses than those recommended carry a risk of very serious liver damage.
Adults
The usual dose for adults is 1-2 tablets of 500 mg. The treatment can be repeated 4-6 hours later, but not more than 8 tablets (4 g) per day.
Maximum daily dose
- The maximum daily dose of paracetamol must not exceed 8 tablets (4 g).
- A maximum of 2 effervescent tablets (1 g) of paracetamol may be taken simultaneously.
Use children and adolescents.
- Children under 12 years: Not recommended for children under 12 years.
- Adolescents 12-15 years weigh 41-50 kg: one tablet (500 mg) per dose. If necessary, treatment can be repeated after 4-6 hours, but not more than 4 tablets (2 g) per day.
- Adolescents 16-18 years weighed over 50 kg: the same dosage as adults.
An effervescent tablet is dissolved in a full glass of water before ingestion.
Contact a doctor if the symptoms worsen or do not improve within 3 days in case of fever and 5 days in case of pain.
The tube lid contains a desiccant, which must not be swallowed.
Paracetamol Apofri can be taken with or without food and drink.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Use For Children And Adolescents
This medicine should only be used by adults and adolescents over 12.
If You Use More Paracetamol Apofri Than You Should
If you have ingested too much medicine or if, e.g., a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. There is a risk of future serious liver damage, even if you feel well.
If You Forget To Use Paracetamol Apofri
If you forget to take a dose, take it as soon as you remember unless it is time to take the next dose. Remember that there should be at least 4 hours between doses. Never take a double dose to make up for a forgotten dose.
Possible Paracetamol Apofri Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop taking Paracetamol Apofri and contact a doctor immediately if you get any of the following symptoms ( angioedema )
Very rare side effects (may affect up to 1 in 10,000 people) :
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing.
Very rare cases of severe skin reactions have been reported.
Epidermal necrolysis (life-threatening skin disease), Stevens-Johnson syndrome (severe life-threatening skin disease), and erythema multiforme ( allergic reaction or infection of the skin). Has been reported (to occur in an unknown number of users).
Other side effects are:
Rare: (affects less than 1 user in 1,000)
| Anemia (decreased number of red blood cells ), decreased number of white blood cells ( leukopenia ), decreased number of neutrophils in the blood ( neutropenia ), decreased number of platelets ( thrombocytopenia ), abnormal red blood cell breakdown ( hemolytic anemia ) |
| Tremors, Headache |
| Visual disturbances |
| Abdominal pain, Diarrhea, Nausea, Vomiting, and Bleeding in the gastrointestinal tract |
| Liver failure, Abnormal liver function, Liver necrosis (liver cell death), Jaundice |
| Overdose and poisoning |
Very rare: (affects less than 1 user in 10,000)
| Low blood sugar (hypoglycemia) |
| Fluid accumulation in the larynx |
| Damage to the liver due to chemicals (liver toxicity), liver effects |
| Cloudy urine and disorders of renal function, Blood in the urine ( hematuria ), Inability to urinate (manures), severe renal impairment |
| Urticaria, Hypersensitivity reaction, Difficulty breathing, Wheezing |
How To Store Paracetamol Apofri
- Keep this medicine out of sight and reach of children and adolescents.
- Do not use this medicine after the expiry date stated on the carton after EXP. Date. The expiration date is the last day of the specified month.
- Do not store above 30 ° C. Close the polypropylene pipe tightly. Store in the original package. Moisture sensitive. Sensitive to light.
- Do not take medicine if there are visible signs of destruction, e.g., brown or black spots or bulges on the tablets or if they are discolored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
- The other ingredients are anhydrous citric acid, sodium bicarbonate, sorbitol (E420), anhydrous sodium carbonate, povidone (E1201), simethicone, saccharin sodium, citrus flavor (containing corn maltodextrin, alpha-tocopherol (E307)), macrogol.
What The Medicine Looks Like And The Contents Of The Pack
- Paracetamol Apofri effervescent tablets are white to off-white, round and flat tablets with beveled edges, smooth on both sides, and have a 25 mm ± 0.2 mm diameter.
- Paracetamol Apofri effervescent tablets are packaged in white, opaque, smooth polypropylene tubes with a white, opaque, guarantee-sealed polyethylene cap with desiccant.
- Pack size:
- 10 effervescent tablets are. One carton contains 1 tube of 10 effervescent tablets
- 16 effervescent tablets are. One carton contains 2 tubes of 8 effervescent tablets.
- 20 effervescent tablets are. One carton contains 1 tube of 20 effervescent tablets.
- 10 effervescent tablets are. 1 tube of 10 effervescent tablets.
- 20 effervescent tablets are. 1 tube of 20 effervescent tablets.
- Not all pack sizes may be marketed.
CAUTION: The lid contains a desiccant that must not be swallowed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Apofri AB
Box 120
182 12 Danderyd
Manufacturer
RosenPharma as, no. of descriptive 265, 664 81 Veverské Knínice, Czech Republic