Paracetamol Accord

Leaflet attached to the packaging: patient information

Paracetamol Accord, 500 mg, tablets

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Paracetamol Accord and what is it used for
• 2. Important information before taking Paracetamol Accord
• 3. How to take Paracetamol Accord
• 4. Possible side effects
• 5. How to store Paracetamol Accord
• 6. Contents of the pack and other information

1. What is Paracetamol Accord and what is it used for

The active substance of Paracetamol Accord is paracetamol, which belongs to a group of pain-relieving medicines.
Paracetamol Accord is used to relieve pain and reduce fever. The tablets can be used to treat mild and moderate pain and/or fever.
Paracetamol Accord can be used in adults and adolescents, but it is not suitable for children under 6 years of age.

2. Important information before taking Paracetamol Accord

When not to take Paracetamol Accord

Warnings and precautions

Before starting to take Paracetamol Accord, the patient should discuss it with their doctor, pharmacist, or nurse:

During treatment with Paracetamol Accord, the patient should immediately inform their doctor:

In case of high fever, symptoms of secondary infection, or persistence of symptoms for more than three days, the patient should consult their doctor or pharmacist.

• Headaches caused by overuse of painkillers should not be treated by increasing the dose. In these cases, the patient should consult their doctor before taking painkillers.

Children and adolescents

Paracetamol Accord should not be used in children under 6 years of age.

Paracetamol Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.

Paracetamol Accord should not be used in combination with other medicines containing paracetamol.

The patient should discuss with their doctor before starting to take paracetamol if they are taking one of the following medicines:

• metoclopramide or domperidone (medicines used to treat nausea and vomiting)
• cholestyramine (used to lower cholesterol levels)
• warfarin and other coumarin derivatives (medicines used to thin the blood), especially if it is necessary to take paracetamol every day for a longer period
• salicylamide (a pain reliever)
• probenecid (used to treat gout)
• isoniazid and rifampicin (used to treat tuberculosis)
• lamotrigine or phenytoin (used to treat epilepsy)
• barbiturates or carbamazepine (medicines that cause relaxation and drowsiness)
• St. John's Wort (used to treat depression)
• chloramphenicol (an antibiotic)
• zidovudine (used to treat AIDS)
• flucloxacillin (an antibiotic), due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

If the patient plans to have any laboratory tests (blood tests, urine analysis, skin tests, etc.), they should inform their doctor about taking this medicine, as it may affect the results of these tests.

Paracetamol Accord with food and drink

The patient should not consume large amounts of alcohol while taking Paracetamol Accord.

Pregnancy, breastfeeding, and fertility

Pregnancy
Paracetamol Accord can be given to pregnant women if necessary. The patient should use the lowest effective dose for the shortest possible time. If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.
Before taking any medicine, the patient should consult their doctor or pharmacist.
Breastfeeding
Although paracetamol passes into breast milk in small amounts, there are no adverse effects on the breastfed child. Pregnant women can take paracetamol but in doses not exceeding the recommended ones. With prolonged use, caution should be exercised.
Fertility
There is no known harmful effect of the medicine on fertility during normal use of paracetamol.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Paracetamol does not affect the ability to drive and use machines.

3. How to take Paracetamol Accord

This medicine should always be taken exactly as described in the patient leaflet or as advised by
a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

Recommended dosage:

Adults and adolescents over 15 years old (> 55 kg body weight):
1 or 2 tablets (500-1000 mg paracetamol), if necessary, can be repeated every 4 to 6 hours, up to 6 tablets (3000 mg paracetamol) in 24 hours.
Children from 6 to 9 years old (22-30 kg body weight):
Half a tablet (250 mg paracetamol), up to 4-6 times in 24 hours.
The tablet can be divided into equal doses.
Children from 9 to 12 years old (30-40 kg body weight):
1 tablet (500 mg paracetamol), up to 3-4 times in 24 hours.
Children from 12 to 15 years old (40-55 kg body weight):
1 tablet (500 mg paracetamol), up to 4-6 times in 24 hours.
The smallest number of doses per day is intended for younger children in the same group.
The tablet should be swallowed whole with a large amount of water. Alternatively, the tablet can be dissolved in a glass of water, well mixed, and drunk.

• Paracetamol Accord is not suitable for children under 6 years of age.
• A minimum of 4 hours should be left between two consecutive doses.
• Do not take in combination with other preparations containing paracetamol.
• Do not exceed the recommended dose.
• If pain and/or fever return, treatment with Paracetamol Accord can be repeated.
• Paracetamol Accord has a dividing line to facilitate breaking the tablet when used in children.
• If pain persists for more than 5 days or if fever persists for more than 3 days, symptoms worsen, or other symptoms appear, treatment should be stopped, and the patient should consult their doctor.

The effective daily dose should not exceed 60 mg paracetamol/kg body weight/day (up to 2 g paracetamol/day) in the following cases:

• adults with a body weight of less than 50 kg,
• mild or moderate liver failure, Gilbert's syndrome (familial non-hemolytic jaundice),
• dehydration,
• prolonged malnutrition.

The patient should follow these instructions unless their doctor has advised otherwise.
If the patient feels that the effect of Paracetamol Accord is too strong or too weak, they should consult their doctor or pharmacist.
Method of administration:
The tablet should be swallowed whole with a large amount of water. Alternatively, the tablet can be dissolved in a glass of water, well mixed, and drunk.

Taking a higher dose of Paracetamol Accord than recommended

In
case of possible delayed, severe liver damage.

Missing a dose of Paracetamol Accord

A double dose should not be taken to make up for a missed tablet. Instead, the patient should take the next dose at the appropriate time.

Stopping treatment with Paracetamol Accord

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Accord can cause side effects, although not everybody gets them.
Possible side effects are listed below:
Rare side effects: occur in 1 to 10 patients out of 10,000

• Certain blood diseases, including: agranulocytosis, thrombocytopenia, purpura, hemolytic anemia, leukopenia, platelet disorders (coagulation disorders), and stem cell disorders (disorders of blood cell formation in the bone marrow).
• Allergic reactions.
• Depression, disorientation, hallucinations.
• Tremors, headaches.
• Visual disturbances.
• Edema (abnormal accumulation of fluid under the skin).
• Abdominal pain, gastrointestinal bleeding or stomach ulcers, diarrhea, nausea, vomiting.
• Liver function disorders, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), liver necrosis (death of liver cells).
• Rash, itching, excessive sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat, or tongue.
• Dizziness, malaise, fever, excessive sedation, drug interactions.
• Overdose and poisoning.

Very rare side effects: occur in less than 1 patient out of 10,000

• Pancytopenia (reduced number of blood cells).
• Allergic reactions, where treatment should be stopped, including angioedema, breathing difficulties, sweating, nausea, decreased blood pressure, shock, and anaphylaxis.
• Low blood sugar levels.
• Hepatotoxicity (liver damage caused by chemicals).
• Cloudy urine and kidney disorders.
• Bronchospasm (breathing difficulties) in patients allergic to acetylsalicylic acid and other anti-inflammatory medicines.
• Hematuria (blood in the urine).
• Anuria (inability to urinate).

Frequency not known (cannot be estimated from the available data)

• Acute generalized exanthematous pustulosis (a rash characterized by the presence of numerous, small, mainly non-pustular, sterile pustules).
• Severe skin rash or exfoliation.
• Stevens-Johnson syndrome (a severe, life-threatening skin disease).
• Redness of the skin, blisters, or rash caused by taking paracetamol.
• A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

After stopping the medicine, these symptoms should disappear. If any of these side effects worsen, the patient should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Paracetamol Accord

Keep out of the sight and reach of children.
Do not use Paracetamol Accord after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol Accord contains

• The active substance of the medicine is paracetamol. Each tablet contains 500 mg of paracetamol.
• Other ingredients of the medicine are: cornstarch, gelatin, colloidal silica, talc, sodium carboxymethylcellulose (type A), magnesium stearate.

What Paracetamol Accord looks like and what the pack contains

Paracetamol Accord is a white, uncoated capsule-shaped tablet with a dividing line and the marking "B" and "T" on one side and smooth on the other.
The length, width, and thickness of the tablet are: 16.50 ± 0.20 mm, 8.20 ± 0.20 mm, and 5.10 ± 0.30 mm, respectively.
Paracetamol Accord, 500 mg, tablets are packaged in PVC/Aluminum blisters in a cardboard box.
Pack sizes: 8, 10, 12, 16, 20, 24, 30, 32, 50, 56, 60, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: January 2025