1 g paracetamol tablets
What Paracetamol Krka is and what it is used for
Paracetamol Krka contains paracetamol which is analgesic and antipyretic.
Paracetamol Krka is used to treat fever and pain conditions, e.g. fever with cold, headache, toothache, menstrual pain, muscle, and joint pain.
Paracetamol contained in Paracetamol Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol Krka
Do not use Paracetamol Krka
- 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 Krka.
Never take more Paracetamol Krka than is stated in the dosing instructions. Higher doses than those recommended do not provide better pain relief but instead carry the risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor immediately if you have taken too large a dose, even if you are feeling well.
If you are taking other painkillers that contain paracetamol, do not use Paracetamol Krka without first talking to your doctor or pharmacist. If you are taking other medicines that contain paracetamol, there is a risk of overdose.
Paracetamol should be used with caution in weak and debilitated patients. Do not use Paracetamol Krka without a doctor’s prescription if you have alcohol problems or liver damage, and do not use Paracetamol Krka with alcohol. The intoxicating effect of alcohol does not increase with the addition of Paracetamol Krka.
Talk to your doctor before taking Paracetamol Krka if:
- you have impaired liver function
- you have impaired kidney function
- you have poor nutritional status, e.g. due to alcohol abuse, decreased appetite ( anorexia ), or malnutrition
- you may need to take a lower dose because otherwise your liver may be damaged
- you have a high fever, signs of infection (eg sore throat), or if the pain lasts for more than 3 days
If you use several different types of painkillers for a long time, you may suffer from kidney damage with the risk of kidney failure. If you use Paracetamol Krka for headaches for a long time, the headaches may worsen or occur more frequently. Talk to your doctor if you have headaches often or daily. Always tell them that you are taking Paracetamol Krka if you have a blood or urine sample as this may affect the results.
Children and young people
Paracetamol Krka is not recommended for children under 9 years.
Other medicines and Paracetamol Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines, medicines bought abroad, herbal medicines, and vitamin and mineral supplements.
Tell your doctor if you are taking:
- medicines to treat epilepsy (eg phenytoin, carbamazepine, and phenobarbital)
- medicines in certain traditional herbal medicines ( St. John’s wort ( Hypericum perforatum ))
- drugs to treat gout (probenecid). It may be necessary to change dose one.
- blood-thinning drugs (eg warfarin ). You may experience bleeding if you use Paracetamol Krka regularly for a long time.
- drugs that affect the movement of the stomach (metoclopramide)
- medicines to prevent nausea and vomiting (domperidone)
- drugs to treat tuberculosis (rifampicin)
- drugs to treat bacterial infections (chloramphenicol).
If you are taking medicines for high cholesterol (cholestyramine), you should take Paracetamol Krka at least 1 hour before or 4-6 hours after taking the medicine.
Paracetamol Krka with food, drink, and alcohol
If you are taking Paracetamol Krka, do not drink alcohol.
Paracetamol Krka can be taken with food, but it is not necessary.
You should take Paracetamol Krka tablets with a glass of water.
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.
Pregnancy
If necessary, Paracetamol Krka can be used during pregnancy. However, you should use the lowest possible 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.
Breast-feeding
You can breastfeed even if you use Paracetamol Krka.
Driving and using machines
Paracetamol Krka does not affect your ability to drive or use machines.
Paracetamol Krka contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Paracetamol Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. You should not take more than the recommended dose.
Adults and adolescents 16 years and older (with a bodyweight 55 kg or over)
1 tablet (1 g) 3-4 times daily. The daily dose should not exceed 4 tablets (4 g) per day. In some cases, a tablet (500 mg) 3-4 times daily may be sufficient. At least 4 hours should elapse between two dosing sessions.
Children from 9 to 15 years (with bodyweight 30 to 55 kg)
| Age (bodyweight) | Dos Paracetamol Krka 1 g | Maximum daily dose |
| 9 to 12 years (30-40 kg) | ½ tablet (500 mg) up to 3 times daily | 1 tablet (1.5 g) |
| 12 to 15 years (40-55 kg) | ½ tablet (500 mg) up to 4 times daily | 2 tablets (2 g) |
Method of administration
The tablet can be divided into two equal doses. Swallow the tablet with liquid.
Children under 9 years (with bodyweight under 30 kg)
This medicine should not be given to children under 9 years of age.
Patients with renal insufficiency
Talk to your doctor if you have kidney problems. Your dose may need to be adjusted.
Patients with hepatic impairment
- Talk to your doctor if you have problems with your liver, e.g. hepatic insufficiency, Gilbert’s syndrome (familial non-hemolytic jaundice), or chronic alcohol consumption. Your dose may need to be adjusted and in these cases, the daily dose should not exceed 2 g.
Older
No dose adjustment is necessary for elderly patients.
If you use more Paracetamol Krka 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.
Higher paracetamol doses than recommended are dangerous and can cause long-term damage. It can destroy the liver and in some cases even the kidneys. You do not get any symptoms immediately (they usually come after a few days). Even if you do not experience any symptoms, there is a risk of serious liver damage. You must contact your healthcare provider as soon as possible after a suspected overdose, even if you feel well.
If you forget to use Paracetamol Krka
Do not take a double dose to make up for a forgotten tablet.
If you stop using Paracetamol Krka
When you no longer need the medicine, you can stop using it.
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 Krka and contact your doctor immediately if you experience any of the following:
Very rare (may affect up to 1 in 10,000 people):
- sudden rash, difficulty breathing, and fainting (within minutes to hours) due to hypersensitivity reaction ( anaphylactic reaction )
- angioedema with symptoms such as the swollen face, swollen lips, throat, or tongue
- severe peeling and skin rejection ( toxic epidermal necrolysis )
- respiratory distress ( bronchospasm ). This is more likely if you have previously experienced difficulty breathing when using other painkillers such as ibuprofen and acetylsalicylic acid
- bleeding from the skin and mucous membranes and bruising, due to changes in the blood (decreased number of platelets – thrombocytopenia )
- general lethargy, the tendency to inflammation ( infection ) especially sore throat and fever due to changes in the blood (decreased number of white blood cells )
- severe anemia with jaundice due to degradation of blood cells (hemolytic anemia )
- severe rash, fever, and inflammation of the skin, especially on the hands and feet and in and around the mouth ( Stevens-Johnson syndrome ).
Other side effects
Rare (may affect up to 1 in 1,000 people):
- increased levels of serum creatinine
- hives ( urticaria )
- increase in liver enzyme values
Very rare (may affect up to 1 in 10,000 people):
- hepatic impairment. Can get serious. If you experience yellowing of the eyes (jaundice), consult your doctor
- for long-term use, the risk of kidney damage can not be ruled out
How to store Paracetamol Krka
Keep this medicine out of the sight and reach of children and adolescents.
Do not use this medicine after the expiry date which is stated on the carton, blister, or label after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 tablet contains 1 g of paracetamol .
- The other ingredients (excipients) are sodium starch glycolate (type A), povidone, partially pregelatinized maize starch, and stearic acid. See section 2 “Paracetamol Krka contains sodium”.
What the medicine looks like and the contents of the pack
The tablet is white to off-white, capsule-shaped with a scoreline between engraving “10” and “00” on one side, and a scoreline between engraving “PA” and “RA” on the other side (21.4 mm long x 9.0 mm x 6.9 mm thick). The tablet can be divided into two equal doses.
Paracetamol Krka 1 g is available in packs containing 8, 10, 15, 16, 18, 20, 30, 32, 40, 50, 60, 90, 100, or 105 tablets in blister packs, as well as 100 or 105 tablets in an HDPE jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia