500 mg effervescent tablet is
paracetamol
What Paracetamol Accord is and what it is used for
Paracetamol Accord contains paracetamol which belongs to a group of medicines called analgesics and antipyretics. Paracetamol Accord is used to relieve mild to moderate pain and/or fever.
Paracetamol contained in the Paracetamol Accord 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 Paracetamol Accord
Do not take Paracetamol Accord
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Paracetamol Accord
- If you have liver problems.
- If you have asthma and at the same time are sensitive to acetylsalicylic acid.
- If you have Gilbert’s syndrome (mild jaundice).
- If you have kidney problems.
- If you have glucose ‑6 ‑ phosphate dehydrogenase deficiency (enzyme deficiency).
- If you have severe hepatic impairment.
- If you have hemolytic anemia (abnormal red blood cell breakdown ).
- If you are taking medicines that affect your liver function (see section Other medicines and Paracetamol Accord).
- If you are malnourished or dehydrated.
Do not use Paracetamol Accord if you have alcohol-related problems or liver damage and do not use Paracetamol Accord with alcohol. The intoxicating effect of alcohol is not increased by the addition of the Paracetamol Accord.
Do not take other medicines that contain paracetamol.
Do not take more Paracetamol Accord than the dose recommended in section 3 or as prescribed by your doctor.
Higher doses than the recommended doses do not provide better pain relief but instead carry the risk of very severe liver damage. Symptoms of liver damage usually do not appear until after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose, even if you feel well.
Laboratory samples
These tablets may affect the results of laboratory tests for uric acid in the blood and blood sugar. Check with your doctor before the tests.
Other medicines and Paracetamol Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Paracetamol Accord may affect or be affected by other medicines. Tell your doctor or pharmacist if you are taking:
- metoclopramide (used to treat nausea and vomiting)
- warfarin (used to thin the blood); there is a risk that the effect of warfarin may be increased
- probenecid (used for gout )
- phenytoin, phenobarbital, or carbamazepine (used to treat epilepsy )
- rifampicin (used to treat tuberculosis )
- cholestyramine (used to treat lipid disorders [dyslipidemia]); this medicine should be taken at least one hour before or after taking paracetamol
- chloramphenicol (used to treat bacterial infections); chloramphenicol used to treat eye infections and Paracetamol Accord can be used together.
- zidovudine (a medicine used to treat HIV infection )
- St. John’s wort (found in some (traditional) herbal medicines).
Paracetamol Accord with food and alcohol
Do not drink alcohol while taking Paracetamol Accord.
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 Accord can be used during pregnancy. However, you should use the lowest effective dose that relieves your pain and/or fever and use the medicine for the shortest possible time. Contact a doctor if the pain and/or fever do not decrease or if you need to take the medicine more often.
Paracetamol Accord passes into breast milk, but it is unlikely to affect breastfeeding infants. You should contact your doctor or pharmacist if you are taking paracetamol for a long time while you are breastfeeding.
Driving and using machines
Paracetamol Accord does not affect your ability to drive or use machines.
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.
Paracetamol Accord contains sodium and sorbitol
Consult your doctor or pharmacist if you need one or more effervescent tablets daily for a long time, especially if you have been prescribed a low-salt (sodium-poor) diet.
This medicine contains 418.5 mg sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 20.9% of the maximum recommended daily intake of 2 grams of sodium for adults and counts as “high” sodium intake.
This medicine contains 100 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare, inherited disease that prevents you from breaking down fructose, consult a doctor before you (or your child) use this medicine.
How to take Paracetamol Accord
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults and adolescents weighing more than 50 kg (over 15 years):
1‑2 tablets (500 mg ‑ 1 gram) every 4-6 hours as needed.
You usually do not need to take more than 3 grams of paracetamol per day (6 tablets per day).
The maximum dose is 8 tablets (4 grams) per day.
Children:
Dosage for children should be based on body weight and the appropriate dosage form should be used.
Information about the child’s age within each weight group listed below is for guidance only.
Children weighing more than 40 kg (over 12 years): 1 tablet (500 mg) every 4-6 hours, 3 to 4 times a day. The maximum dose is 5 tablets (2.5 grams) per day. The dosing interval should always be at least 4 hours.
The maximum daily dose should not be exceeded due to the risk of severe liver damage.
If you have severe kidney or liver problems, the dose should be reduced or the interval between doses increased. Consult your doctor.
Method of administration
Oral administration. Put the tablets in a glass of water and dissolve them completely before swallowing.
If you take more Paracetamol Accord than you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice. Do this even if you or your child are feeling well due to the risk of delayed, severe liver damage.
If you forget to take Paracetamol Accord
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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Paracetamol Accord and contact a doctor immediately or see a hospital if you experience any of these serious side effects:
- swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ) (rare side effects )
- severe allergic reaction or hypersensitivity reaction with fever, rash, swelling, and sometimes drop in blood pressure (very rare side effects )
- severe skin reactions ( toxic epidermal necrolysis and Stevens-Johnson syndrome) (reported)
- in rare cases, Paracetamol Accord may affect the white blood cells, damaging the immune system. If you get an infection with symptoms such as fever along with a very poor general condition or fever with local infectious symptoms such as the sore throat or difficulty urinating, you should contact a doctor immediately so that blood tests can be used to rule out white blood cell deficiency ( agranulocytosis). ). You must inform healthcare professionals about your medicine in connection with this.
Other possible side effects are
Rare (may affect up to 1 in 1,000 people)
- edema (abnormal accumulation of fluid under the skin)
- depression, confusion, hallucinations, visual disturbances
- headache, tremor (shaking)
- abdominal pain, diarrhea, gastrointestinal bleeding, nausea, vomiting
- abnormal liver function, hepatic impairment, liver necrosis (tissue death), jaundice
- reduction of certain blood cells ( red blood cells, platelets, and neutrophils), problems with blood clotting ( coagulation ), stem cell disorders (problems with the blood-forming cells in the bone marrow ), hemolytic anemia (abnormal degradation of red blood cells )
- fever, sedation, and sweating.
Very rare (may affect up to 1 in 10,000 people):
- severe respiratory distress with shortness of breath
- liver damage
- low blood sugar levels
- cloudy urine, kidney disease
- severe skin reactions
- dizziness (including vertigo), malaise.
Has been reported (occurs in an unknown number of users)
- erythema multiforme ( allergic reaction or infection of the skin)
- accumulation of fluid in the larynx (larynx)
- anemia (decreased number of red blood cells )
- kidney disease (severe renal impairment, interstitial kidney inflammation, blood in the urine, inability to urinate)
- liver disease and infection of the liver ( hepatitis )
- feeling unsteady (dizziness).
How to store Paracetamol Accord
Keep this medicine out of the sight and reach of children and adolescents.
Store below 30 o C.
Tube: Keep the tube tightly closed. Moisture sensitive.
Strip: Store in the original container. Moisture sensitive.
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.
Do not use this medicine if you notice clear signs of deterioration, such as brown or black spots on the tablets, dented tablets, or discolored tablets.
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.
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 (E330), sodium bicarbonate, sorbitol (E420), anhydrous sodium carbonate, povidone, simethicone, sodium saccharin, powdarome lemon premium (flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, acacia, acacia).
What the medicine looks like and the contents of the pack
Paracetamol Accord is white to off-white, round, flat tablets with beveled edges, smooth on both sides with a lemon scent.
Paracetamol Accord is packaged in a perforated unit dose strip (4 layers of paper / PE/aluminum / surlyn [copolymer of ethylene / methacrylic acid/zinc material]) and tablet container with a white opaque safety-sealed polyethylene lid with built-in packaging with desiccant.
Pack sizes: 6, 10, 12, 16, 20, 24, 30, 40, 60, 90, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Ltd.
Sage House, 319 Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice
Poland