Patient Information Leaflet

Paracetamol Krka 1000 mg Tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Paracetamol Krka relieves mild to moderate pain and reduces fever.

This medication can be used for various types of pain, such as headache, menstrual cramps, toothache, muscle and joint pain, and during feverish states, for example in the common cold.

Do not take Paracetamol Krka

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Krka.

If you exceed the recommended dose, it may lead to a potentially fatal overdose. If there is suspicion of overdose, you must contact your doctor immediately. If you take other medicines that also contain paracetamol, there is a risk of overdose.

Caution is required in weakened and exhausted patients and in alcoholic patients.

Consult your doctor before starting to take paracetamol if:

• you have liver problems.
• you have kidney problems.
• you suffer from malnutrition, for example due to alcohol abuse, loss of appetite (anorexia) or poor nutrition.
• you may need to take a lower dose if your liver is somehow damaged.
• you have high fever, symptoms of infection (such as sore throat) or if your pain lasts more than 3 days.

If you take several types of painkillers over a period of time, you may experience kidney damage with a risk of renal insufficiency. If you take paracetamol for headache over a longer period, your headache may worsen and become more frequent. Contact your doctor if you experience frequent or daily headaches. Always mention that you are taking paracetamol when having blood and urine tests. This may affect your results.

Children and adolescents

Paracetamol Krka is not recommended for children under 9 years.

Other medicines and Paracetamol Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes any medicine obtained without a prescription, medicines bought abroad, herbal remedies, as well as strong vitamins and minerals.

Consult your doctor if you take:

• Medicine to treat epilepsy (such as phenytoin, carbamazepine and phenobarbital).
• Medicine included in some herbal remedies (St. John's Wort (Hypericum perforatum)).
• Medicine for the treatment of gout (probencid). A dose change may be necessary.
• Anticoagulant medicine (such as warfarin). You may experience bleeding if you take paracetamol regularly and for a long period of time.
• Medicine to regulate intestinal motility (metoclopramide).
• Medicine to prevent nausea and vomiting (domperidone).
• Medicine to treat tuberculosis (rifapentine).
• Medicine to treat bacterial infections (chloramphenicol).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and which may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.

If you are taking medicines to lower cholesterol (cholestyramine), you must take Paracetamol Krka at least 1 hour before or 4-6 hours after this medicine.

Paracetamol Krka and food and drink

If you are taking this medicine, do not drink alcohol.

You can take paracetamol with food, but it is not necessary.

You must take the paracetamol tablets with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If necessary, you can take paracetamol during pregnancy. You should take the lowest dose of this medicine that reduces your pain and/or fever and for the shortest time possible. Consult your doctor if the pain and/or fever do not decrease or if you need to take the medicine more frequently.

Breastfeeding

You can breastfeed even if you are taking paracetamol.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Paracetamol Krka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Adults and adolescents 16 years and older (≥ 55 kg of body weight)

1 tablet of 1,000 mg 3-4 times a day, but no more than 4 tablets (4,000 mg) per day. In some cases, ½ tablet (500 mg) 3-4 times a day should be sufficient. Doses should be spaced at least 4 hours apart.

Children 9 to 15 years old (30-55 kg of body weight)

Doses should be spaced at least 4 hours apart.

Administration form

The tablet can be divided into equal doses. Swallow the tablet with liquid.

Children under 9 years (<30)

This medication should not be administered to children under 9 years old.

Patients with renal insufficiency

Consult your doctor if you have kidney problems. The dose may need to be adjusted.

Patients with liver insufficiency

• Consult your doctor if you have liver problems such as liver insufficiency, Gilbert syndrome (familial non-hemolytic jaundice) or chronic alcohol consumption. The dose may need to be adjusted and the daily dose should not exceed 2 g in these cases.

Older adults

No dose adjustment is required in older adults.

If you take moreParacetamol Krkathan you should

You should consult your doctor or pharmacist immediately.

A higher dose of paracetamol than recommended is hazardous and can cause long-term damage. It can destroy the liver and in some cases also the kidneys, pancreas, and bone marrow. You may not have immediate symptoms (usually they appear only after a few days). Even if you do not feel any symptoms, there may be a risk of severe liver damage. It is essential to seek medical advice as soon as possible in case of suspected overdose, even if you feel well.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeParacetamol Krka

Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Paracetamol Krka

You can stop taking this medication safely once you no longer need it.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rare (may affect up to 1 in 10,000 people):

• Sudden skin eruption, breathing difficulties, and fainting (from minutes to hours) due to hypersensitivity reactions (anaphylactic reaction, allergic dermatitis);
• Angioedema with symptoms such as facial, lip, throat, or tongue inflammation;
• Extensive skin peeling and rejection (toxic epidermal necrolysis);
• Respiratory difficulties (bronchospasm). This is more likely if you have experienced it before when taking other pain relievers like ibuprofen and aspirin;
• Bleeding in the skin and mucosa and bruising due to changes in the blood (insufficient platelets (thrombocytopenia));
• General discomfort, tendency to infections, especially throat infections and fever, due to changes in the blood (insufficient white blood cells);
• Anemia with jaundice due to red blood cell rupture (hemolytic anemia)
• Extensive skin eruption, fever, and skin inflammation, especially on the hands and feet, and around the mouth (Stevens-Johnson syndrome).

Other Adverse Effects

Rare (may affect up to 1 in 1,000 people):

• Increased serum creatinine;
• Urticaria;
• Increased liver enzymes.

Very rare (may affect up to 1 in 10,000 people):

• Reduced liver function. It can be severe. If you experience yellowing of the eyes (jaundice), contact your doctor.
• In long-term treatments, the risk of kidney damage cannot be ruled out.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, blister pack, or bottle label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Paracetamol Krka

• The active ingredient is paracetamol. Each tablet contains 1,000 mg of paracetamol.
• The other components (excipients) are sodium glycolate (type A) (from potato), povidone, partially pregelatinized cornstarch, and stearic acid. See section 2 “Paracetamol Krka contains sodium”.

Appearance of the product and contents of the package

The tablets are white to off-white, in capsule form, engraved with a line between “10” and “00” on one side and a line between “PA” and “RA” on the other side (21.4 mm in length x 9.0 mm x 6.9 mm in width).

Paracetamol Krka is available in packages containing8, 10, 15,16, 18, 20, 30, 32, 40, 50, 60, 90, 100, and 105 tablets in blisters, and 100 and 105 in HDPE bottles.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.

C/ Anabel Segura, 10, 28108, Alcobendas (Madrid), Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2022

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/