Paracetamol Krka 1000 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Krka 1 000 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Paracetamol Krka relieves mild to moderate pain and reduces fever.

This medicine can be used for various types of pain, such as headache, menstrual pain, dental pain, muscle and joint pain, and during febrile conditions, for example in colds.

2. What you need to know before taking Paracetamol Krka

Do not take Paracetamol Krka

• if you are allergic to paracetamol or to 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.

Exceeding the recommended dose may lead to potentially fatal poisoning. If overdose is suspected, contact your doctor immediately. There is a risk of overdose if you take other medicines that also contain paracetamol.

Caution is required in debilitated and exhausted patients, as well as in patients who are alcoholics.

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 might be in any way damaged.
• you have high fever, symptoms of infection (such as sore throat), or if your pain lasts longer than 3 days.
• you have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you take several different types of painkillers over a longer period, you may experience kidney damage with risk of kidney failure. 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 inform your doctor when blood and urine tests are being performed that you are taking paracetamol. This may affect your test results.

Children and adolescents

Paracetamol Krka is not recommended for children under 9 years of age.

Other medicines and Paracetamol Krka

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

Consult your doctor if you are taking:

• Medication for epilepsy (such as phenytoin, carbamazepine, and phenobarbital).
• Medication found in some herbal medicines (St. John's wort (Hypericum perforatum)).
• Medication for the treatment of gout (probenecid). A dose adjustment may be necessary.
• Anticoagulant medication (such as warfarin). You may experience bleeding if you take paracetamol regularly and for a long period of time.
• Medication to regulate intestinal motility (metoclopramide).
• Medication to prevent nausea and vomiting (domperidone).
• Medication for the treatment of tuberculosis (rifampicin).
• Medication for treating bacterial infections (chloramphenicol).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

If you are taking medication for high cholesterol (cholestyramine), you should take Paracetamol Krka at least 1 hour before or 4–6 hours after taking this medicine.

Taking Paracetamol Krka with food and drink

While taking this medicine, you should not drink alcohol.

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

You should take paracetamol tablets with a glass of water.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

You may breastfeed while taking paracetamol.

Driving and using machines

The effect of paracetamol on the ability to drive and use machines is none or negligible.

Paracetamol Krka contains sodium

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

3. How to take Paracetamol Krka

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

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

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

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

Doses should be spaced at least 4 hours apart.

Method of administration

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

Children under 9 years (< 30 kg body weight)

This medicine must not be given to children under 9 years of age.

Patients with renal impairment

Consult your doctor if you have kidney problems. A dose adjustment may be necessary.

Patients with hepatic impairment

• Consult your doctor if you have liver problems such as hepatic insufficiency, Gilbert's syndrome (familial non-hemolytic jaundice), or chronic alcohol consumption. A dose adjustment may be necessary, and the daily dose must not exceed 2 g in these situations.

Elderly patients

No dose adjustment is required in elderly patients.

If you take more Paracetamol Krka than you should

You must consult your doctor or pharmacist immediately.

Taking a higher dose of paracetamol than recommended is dangerous and may cause long-term harm. It can damage the liver and, in some cases, also the kidneys, pancreas, and bone marrow. You may not experience any symptoms immediately (they usually appear only after a few days). Even if you feel no symptoms, there may be a risk of severe liver damage. It is important 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Krka

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

If you stop taking Paracetamol Krka

You can safely stop taking this medicine once it is no longer needed.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• sudden skin rash, breathing difficulties and fainting (within minutes to hours) due to hypersensitivity reactions (anaphylactic reaction, allergic dermatitis);
• angioedema with symptoms such as swelling of the face, lips, throat or tongue;
• extensive peeling and shedding of the skin (toxic epidermal necrolysis);
• breathing difficulties (bronchospasm). This is more likely if you have previously experienced this when taking other painkillers such as ibuprofen and aspirin;
• bleeding into the skin and mucous membranes and bruising due to blood changes (insufficient platelets (thrombocytopenia));
• general malaise, increased susceptibility to infections, especially throat infections and fever, due to changes in the blood (insufficient white blood cells);
• anemia with jaundice due to breakdown of blood cells (hemolytic anemia);
• extensive skin rash, fever and skin inflammation, especially in 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. This can be serious. If you experience yellowing of the eyes (jaundice), contact your doctor.
• With long-term treatment, the risk of kidney damage cannot be excluded.

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

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis), in patients with serious illness who are using paracetamol (see section 2).

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Krka

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

Do not use this medicine after the expiry date stated on the carton, blister pack, or label of the bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Krka

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

Appearance of the product and contents of the pack

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

Paracetamol Krka is available in packs containing 8, 10, 15, 16, 18, 20, 30, 32, 40, 50, 60, 90, 100 and 105 tablets in blisters, and 100 and 105 tablets in HDPE bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

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

For further information about this medicinal product, please contact 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 European Economic Area member states under the following names:

Date of the last revision of this leaflet: April 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/