PARACETAMOL-GRINDEKS TBL 500MG N10

ATC code: N02BE01 

Active substances: Paracetamolum

 Made in Latvia. 
Vendor, principal: Grindeks A/s. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PARACETAMOL ACCORD 500MG N10

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Paracetamol Accord 500 mg tablets

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.
•   Keep this leaflet. You may need to read it again.
•   Ask your pharmacist if you need more information or advice.
•   If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
•   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1.   What Paracetamol Accord is and what is it used for
2.   What you need to know before you take 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 Paracetamol Accord is and what it is used for

Paracetamol Accord contains active substance paracetamol which belongs to a group of medicines called analgesics (painkillers).
Paracetamol Accord is used to relieve pain and help reduce fever. The tablets can treat mild to moderate pain and/or fever.
Paracetamol Accord may be used in adults and adolescents but is not suitable for use in children below 6 years.

2. 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).
-   If you are below 6 years of age.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Paracetamol Accord
-   if you are taking other paracetamol containing medicines, as it may severely damage the liver.
-   if you have kidney or liver disease (including Glibert’s syndrome or acute hepatitis)
-   if you have a deficiency of a certain enzyme called glucose-6-phosphatase
-   if you have haemolytic anaemia (abnormal breakdown of red blood cells).
-   if you regularly take large amounts of alcohol. Never take more than 4 tablets a day.
-   if you are asthmatic sensitive to acetylsalicylic acid.
-   in case of dehydration or chronic malnutrition
In cases of high fever, signs of a secondary infection, or persistence of your symptoms for more than three days, consult your doctor or pharmacist.
-   Headaches caused by overuse of analgesics should not be handled by increasing the dose. In those cases, the use of analgesics should be taken after consulting a doctor.

Children and adolescents

Paracetamol Accord should not be given to children under 6 years. .

Other medicines and Paracetamol Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not use Paracetamol Accord in combination with other paracetamol-containing medicines.

Please talk to your doctor before you take paracetamol in case you use one of the following medicines:
-   metoclopramide or domperidone (medicines used to treat nausea and vomiting)
-   cholestyramine (used to lower your    cholesterol);
-   warfarin and other coumarin derivatives (medicines to thin the blood), particularly in case you need to take paracetamol on a daily basis over a long period of time.
-   salicylamide (a pain killer)
-   probenecide (a medicine used to treat gout)
-   isoniazid or rifampicin (a medicine used to treat tuberculosis)
-   lamotrigine or phenytoin (a medicine used to treat epilepsy)
-   barbiturates or carbamazepines (medicines that cause relaxation and sleepiness)
-   St. John’s Wort (a medicine used to treat depression)
-   chloramphenicol (an antibiotic)
-   zidovudine (a medicine used to treat    AIDS)
If you are going to have any laboratory tests (such as a blood test, urine analysis, skin allergy test, etc.), you should tell your doctor that you are taking this medicine as it could affect the results of these tests.

Paracetamol Accord with food and drink and alcohol

It is advised not to drink large amounts of alcohol when taking Paracetamol Accord

Pregnancy and breast-feeding and fertility

Pregnancy
Studies with paracetamol do not indicate that there are adverse effects on the pregnancy or on the health of the unborn child. You may take paracetamol in the recommended doses during pregnancy.
During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other medicinal products.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Although paracetamol is excreted in the breast milk in small amounts it has no unwanted effects on the child that is breast fed. Paracetamol may be used by breastfeeding women as
long as the recommended dosage is not exceeded. In case of long term use caution should be exercised.
Fertility
No detrimental effects on fertility upon normal use of paracetamol are known.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Paracetamol Accord is not expected to impair your ability to drive or to operate machinery.

3. How to take Paracetamol Accord

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

The recommended dose is:

Adults and children over 15 years (> 55 kg body weight):
1 to 2 tablets (500-1000 mg) at a time, if necessary, repeat every 4 to 6 hours, up to 6 tablets (3000 mg) per 24 hours.
Children aged 6 to 9 years (22-30 kg body weight):
Half tablet at a time, up to 4 to 6 times per 24 hours.
Children aged 9 to 12 years (30-40 kg body weight):
One tablet at a time, up to 3 to 4 times per 24 hours.
Children 12 to 15 years (40-55 kg body weight):
One tablet at a time (500 mg), maximum 4-6 times per 24 hours.
The least number of administrations per day is intended for the younger children in a particular group.
The tablet should be swallowed whole with plenty of water. Optionally, the tablet into a large amount of water to disintegrate, stir well and drink.
-   Paracetamol Accord is not suitable for children below 6 years.
-   Between two intakes should be at least 4 hours.
-   Do not use in combination with other paracetamol-containing preparations.
-   Do not exceed the stated dose.
-   If your symptoms of pain and/or fever return, you may repeat the treatment with Paracetamol Accord.
-   Paracetamol Accord scored for easy breaking for use in Children.
-   If the pain persists for more than 5 days or the fever lasts for more than 3 days exists or gets worse or other symptoms appear, you should stop the treatment and consult a doctor.
The effective daily dose should not exceed 60 mg / kg / day (up to 2 g / day) in the following situations:
-   adults weighing less than 50 kg
-   mild to moderate hepatic insufficiency, Gilbert’s syndrome (familial non-haemolytic jaundice)
-   dehydration
-   chronic malnutrition
Follow these instructions unless your doctor has given you different advice.
If you feel that_Paracetamol Accord too strong or too weak, talk to your doctor or pharmacist.
Method of administration:
Swallow the tablet with a glass of water or if desired, leave the tablet to dissolve in a glass of water and stir well before drinking.

If you take more Paracetamol Accord than you should:

SEEK IMMEDIATE MEDICAL ADVICE IN THE EVENT OF AN OVERDOSE, EVEN IF
YOU FEEL WELL, because of the risk of delayed, serious liver damage. Symptoms of paracetamol overdose are nausea, vomiting and reduced apetite. Unconsciousness does not usually occur.

If you forget to take Paracetamol Accord:

Do not take a double dose to make up for a forgotten tablet. Instead you should simply continue with the next dose when it is due.

If you stop taking Paracetamol Accord

If you have any further questions on the use of this medicine, ask your 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 and classified as:
Rare side effects (affects 1 to 10 users in 10,000)
-   Several blood disorders including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia leukopenia platelet disorders (clotting disorders) and stem cell disorders (disorders of the blood forming cells in bone marrow).
-   Allergic reactions.
-   Depression, confusion, hallucinations.
-   Tremor, headache.
-   Disturbed vision.
-   Oedema (abnormal accumulation of fluid under the skin).
-   Abdominal pain, stomach or intestinal bleeding, diarrhoea, nausea, vomiting.
-   Abnormal liver function, liver failure, jaundice (with symptoms like yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
-   Rash, itching, sweating, hives, red patches on skin, angioedema with symptoms like swollen face, lips, throat or tongue.
-   Dizziness, generally feeling unwell (malaise), fever, sedation, interactions with medicines.
-   Overdose and poisoning.
Very rare side effects (affects less than 1 user in 10,000):
-   Pancytopenia (reduction in the number of blood cells).
-   Allergic reactions where treatment should be stopped, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock, and anaphylaxis.
-   Low level of blood glucose in the blood.
-   Hepatotoxicity (damage caused to the liver due to chemicals).
-   Cloudy urine and kidney disorders.
-   Bronchospasm (difficulty in breathing) in patients sensitive to aspirin and other antiinflammatory medicines.
-   Haematuria (blood in urine).
-   Anuresis (inability to urinate).
Not Known (frequency cannot be estimated from the available data):
-   Acute generalised exanthemateus pustulosis (drug eruption characterized by numerous small, primarily non-follicular, sterile pustules) .
-   Severe skin rash or peeling of the skin.
-   Stevens-Johnson syndrome (a severe life-threatening skin disorder).
-   Reddening of skin, blisters or rash due to intake of Paracetamol.
Once you stop taking the medicine these side effects should go away. If any of the side effects gets serious, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5.   How to store Paracetamol Accord

-   Keep this medicine out of the sight and reach of children.
-   Do not use this medicine after the expiry date stated on the carton or container after "EXP." The expiry date refers to the last day of that month.
-   This medicinal product does not require any special temperature storage conditions
-   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.   Contents of the pack and other information

What Paracetamol Accord contains

•   The active substance is paracetamol. Each tablet contains 500 mg paracetamol.
•   The other ingredients are: Maize Starch, Gelatin (E441), Silica, Colloidal Anhydrous (E551), Talc (E553B), Sodium Starch Glycolate (Type A) (E468) and Magnesium Stearate (E572).

What Paracetamol Accord looks like and contents of the pack

Paracetamol Accord are White, uncoated capsule shape tablet marked with “B score T” on
one side and plain on the other side. The tablet can be divided into equal doses.
Dimension: Length, width and thickness of the tablet is 16.50±0.20 mm, 8.20±0.20 mm and
5.10±0.30 mm respectively.
Paracetamol Accord is packed in ALU-PVC blister packs of 8, 10, 12, 16, 20, 24, 30, 32, 50,
56, 60, 100 & 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Country
The Netherlands
Austria
Bulgaria
Cyprus
Estonia
Finland
France
Ireland
Latvia
Lithuania
Malta
Denmark
Poland

Invented Name

Paracetamol Accord 500 mg tabletten Paracetamol Accord 500 mg tabletten Paracetamol Accord 500 mg tablets Paracetamol Accord 500 mg tablets Paracetamol Accord Paracetamol Accord 500 mg tabletti Paracetamol Accord 500 mg comprime Paracetamol 500 mg tablets Paracetamol Accord 500 mg tabletes Paracetamol Accord 500 mg tabletes Paracetamol 500 mg tablets Paracetamol Accord 500 mg tabletter Paracetamol Accord

The leaflet was last approved in September 2015.