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Package leaflet: Information for the patient

Paracetamol Krka 500 mg tablets

paracetamol

Read this leaflet carefully before you start taking this medicine as it contains important
information.
- Save the leaflet. You may need to read it again.
- Ask the doctor or pharmacist if there is more you want to know.
- The doctor has prescribed this medicine for you personally. Therefore, stop giving
the medicine to others. It can be harmful to others, even if they have the same symptoms as you.

- Contact the doctor or pharmacist if you experience side effects, including side effects such as
are not mentioned in this leaflet. See point 4.

See the latest package insert at www.indlaegsseddel.dk.

Overview of the package

insert Effect
1. and use 2. What
you need to know before you start taking Paracetamol Krka 3. How to
take Paracetamol Krka 4.
Side effects
5. Storage
Package sizes and further information 6.

1. Effect and application

Paracetamol Krka relieves mild to moderate pain and has a fever-reducing effect.

You can use Paracetamol Krka against various types of pain, such as headache, menstrual
pain, toothache, muscle and joint pain, and to reduce fever, e.g. in case of a cold.

2. What you need to know before you start taking Paracetamol Krka

The doctor may have prescribed a different use or dosage than indicated in this information. Always follow
your doctor's instructions and the information on the dosage label.

Do not take Paracetamol Krka

- if you are allergic to paracetamol or one of the other ingredients in Paracetamol Krka (listed in point 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Krka.

If the recommended dose is exceeded, life-threatening poisoning can occur. If an overdose is suspected,
you should seek medical attention immediately. If you take other medicines that also contain paracetamol,
there is a risk of overdose.

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Caution must be exercised in weak and debilitated patients and alcoholics.

Talk to your doctor before taking Paracetamol Krka: if

- you have reduced liver function. if you have
-
reduced kidney function. if you have poor
-
nutritional status, e.g. due to alcohol abuse, lack of appetite (anorexia) or malnutrition. it may be necessary for
you to take a lower dose, otherwise your liver may be damaged. if you have a high fever, signs of an infection
-
(e.g. sore throat) or if the pain lasts more than 3 days.
-

If you take several different types of painkillers at the same time over a long period, you can get kidney damage and there
may be a risk of kidney failure. If you take Paracetamol Krka for headaches for a long time, your headaches may get worse
and occur more frequently. Contact your doctor if you have frequent or daily headache attacks. If you need to have a blood
or urine sample taken, you must always tell them that you are taking Paracetamol Krka. Paracetamol Krka can affect the
results of such tests.

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

Using other medicines with Paracetamol Krka Always tell your doctor
or pharmacist if you are taking other medicines, have recently taken other medicines or plan to take other medicines.
This also applies to over-the-counter medicines, medicines bought abroad, herbal medicines and strong vitamins and
minerals.

Contact your doctor if you are

-
taking: Medicines to treat epilepsy (eg phenytoin, carbamazepine and phenobarbital).
-
Drugs sometimes present in traditional herbal remedies (St. John's wort (Hypericum perforatum)).

-
Medicines for the treatment of gout (probenecid). It may be necessary to change the dose.

-
Blood-thinning medicines (eg warfarin). You may experience bleeding if you take Paracetamol Krka regularly
and over a long period of time.
-
Medicines to regulate bowel movements (domperidone).
-
Medicines to prevent nausea and vomiting (metoclopramide).
-
Medicines to treat tuberculosis (rifampicin).
-
Medicines to treat infections caused by bacteria (chloramphenicol).
-
Flucloxacillin (antibiotics) due to a serious risk of blood and fluid disturbances (metabolic acidosis with
high anion gap) which must be treated immediately and which can occur especially in cases of severely
impaired kidney function, septicemia (where bacteria and their toxins circulate in the blood and causes organ
damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.

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

Using Paracetamol Krka with food and drink If you take Paracetamol
Krka, you should not drink alcohol.
You can take Paracetamol Krka with a meal, but it is not necessary.
You should take Paracetamol Krka tablets with a glass of water.

Pregnancy and breast-

feeding If you are pregnant or breast-feeding, suspect that you are pregnant or are planning to become pregnant, ask
your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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You can take Paracetamol Krka during pregnancy if necessary. You should take the lowest possible dose that relieves your
pain and/or your fever for as short a time as possible. Contact your doctor if your pain and/or fever is not relieved, or if you
need to take the medicine more often.

Breastfeeding You can take Paracetamol Krka while breastfeeding.

Traffic and occupational safety

Paracetamol Krka does not affect the ability to drive a motor vehicle or operate machinery.

Paracetamol Krka contains sodium This

medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially sodium free.

3. How to take Paracetamol Krka

Always take the medicine exactly as directed by your doctor or pharmacist. If you are in doubt, ask your doctor or pharmacist.
You should not exceed the recommended dose.

Adults and young people aged 16 and over (body weight ÿ 55 kg)
The usual dose for adults and adolescents aged 16 and over is 1-2 tablets (500 mg-1,000 mg) 3-4 times daily, but no
more than 8 tablets (4,000 mg) daily. In some cases, 1 tablet (500 mg) 3-4 times a day is sufficient. A minimum of 4
hours should elapse between each dose.

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

Age/body weight Dose (Paracetamol Krka 500 mg) Maximum daily dose 9 to
12 years (30-40 kg) 1 tablet (500 mg) up
mg)toup
3 times
to 4 times
dailydaily
3 tablets
4 tablets
(1,500
(2,000
mg) 12
mg)to 15 years (40-55 kg) 1 tablet (500

A minimum of 4 hours should elapse between each dose.

How to take the tablets Swallow the

tablet with liquid.

Children under 9 years (body weight < 30 kg)

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

Patients with kidney insufficiency

Contact the doctor if you have kidney problems. It may be necessary to adjust the dose.

Patients with impaired liver function Contact

the doctor if you have liver problems such as liver failure, Gilbert's syndrome (hereditary non-haemolytic jaundice) or
chronic alcohol intake. It may be necessary to adjust the dose and the daily dose should not exceed 2 gi in these situations.

Elderly
It is not necessary to adjust the dose in elderly patients.

If you have taken too much Paracetamol Krka Contact the

doctor, the emergency department or the pharmacist if you have taken more Paracetamol Krka than is stated in this
information, or more than the doctor has prescribed.

A larger dose of paracetamol than recommended is dangerous and can cause long-term damage. It can damage the
liver and in some cases also the kidneys, pancreas and bone marrow. The symptoms do not appear immediately (they
usually do not appear until a few days later). Even if you don't notice

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some symptoms, there may be a risk of serious liver damage. It is important that you see a doctor as soon
as possible if you suspect an overdose, even if you feel well.

If you forget to take Paracetamol Krka You must

not take a double dose to replace the forgotten tablet.

If you stop taking Paracetamol Krka You can safely stop

taking the medicine when you no longer need it.

Ask the doctor or pharmacist if there is anything you are unsure about.

4. Side effects

This medicine, like all medicines, can cause side effects, but not everyone gets side effects.
Stop taking the medicine and contact your doctor or hospital immediately if you get: Very rare
(may affect up to 1 in 10,000 people):
- Sudden skin rash, breathing problems and fainting (within minutes to hours) due to a hypersensitivity
reaction (anaphylactic reaction, allergic dermatitis).
- Angioedema with severe symptoms, such as swelling of the face, lips, throat or tongue.

- Severe peeling and rejection of the skin (toxic epidermal necrolysis).

- Breathing problems (bronchospasm). You are more likely to get such symptoms if you have
previously experienced them when taking other pain-relieving medicines such as ibuprofen and
aspirin.
- Bleeding from the skin and mucous membranes and bruising due to changes in the blood (too
few platelets) (thrombocytopenia)).
- General lethargy, tendency to infections, especially sore throat and fever, due to changes in the blood
(too few white blood cells).
- Anemia with jaundice (yellowing of the whites of the eyes and skin) caused by the breakdown of red blood
cells (haemolytic anaemia).
- Severe skin rash, fever or 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 serum

- creatinine (measure of kidney function).
- Hives.
- Elevated liver enzymes (liver count).

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

- Impaired liver function. Can be serious. If you experience yellowing of the eyes (jaundice), contact the
doctor.
- With long-term treatment, the risk of kidney damage cannot be ruled out.

Reporting side effects If you

experience side effects, you should talk to your doctor or pharmacist. This also applies to possible side effects
that are not included in this leaflet. You or your relatives can also report side effects directly to the Danish
Medicines Agency via:

The Danish Medicines

Agency Axel Heides
Gade 1 DK-2300
Copenhagen S Website: www.meldenbivirkning.dk

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By reporting side effects, you can help provide more information about the safety of this medicine.

5. Storage

Keep the medicine out of the reach of children.

Do not take the medicine after the expiry date which is stated on the box, blister or container label after EXP.
The expiration date is the last day of that month.

This medicinal product does not require any special storage precautions.

Ask the pharmacy staff how to dispose of leftover medicine. For the sake of the environment, you must not throw
medicine residues down the drain, toilet or rubbish bin.

6. Package sizes and additional information

Paracetamol Krka contains: Active

- substance: Paracetamol. Each tablet contains 500 mg of paracetamol. Other
- ingredients (excipients): Sodium starch glycolate (type A), povidone, partially pregelatinized corn
starch and stearic acid. See point 2 "Paracetamol Krka contains sodium".

Appearance and contents of the

pack Tablets are white, oblong, debossed with “500” on one side and smooth on the other side (17.5 mm long
x 7.3 mm x 5.7 mm thick).

Paracetamol Krka is available in packs of 30, 50, 60, 100, 105 and 120 tablets in blisters and 100 and 105
tablets in HDPE containers.

Not all pack sizes may be marketed.

Marketing Authorization Holder KRKA, dd,

Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Representative
KRKA Sweden AB, Göta Ark 175, 118 72 Stockholm, Sweden

Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is approved in the member states of the European Economic Area
Collaboration area under the following names:
Denmark, Belgium, Spain, Paracetamol Krka
Ireland, Portugal, Sweden
Slovenia Daleron

This leaflet was last changed 07/2022

Further information about this medicine can be found on the Danish Medicines Agency's website
www.dkma.dk