Patient Information Leaflet

Panacit Extra, 500 mg + 65 mg, tablets
Paracetamolum + Coffeinum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of Contents

What Panacit Extra is and what it is used for
Important information before taking Panacit Extra
How to take Panacit Extra
Possible side effects
How to store Panacit Extra
Contents of the pack and other information

1. What Panacit Extra is and what it is used for

Panacit Extra contains a combination of two active substances: paracetamol and caffeine, which
effectively relieve pain and fever.
Paracetamol has analgesic and antipyretic effects, reducing pain and lowering elevated body temperature. Caffeine enhances the analgesic effect of paracetamol, reduces fatigue, and mildly supports respiration and blood circulation during fever.
Panacit Extra does not irritate the stomach.
Panacit Extra is indicated for the relief of mild to moderate pain, such as headache, migraine, back pain, toothache, and menstrual pain. Panacit Extra also helps alleviate the discomfort associated with influenza and colds, such as muscle or joint pain and sore throat, and reduces fever.
After consultation with a doctor, Panacit Extra may be used in rheumatic conditions, such as joint inflammation (osteoarthritis) and neuralgias (nerve-related pain).
Panacit Extra can be used by adults and adolescents over 12 years of age.
Consult your doctor if your symptoms do not improve or worsen after 3 days of treatment.

2. Important information before using Panacit Extra

When not to use Panacit Extra:

if the patient is allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6),
if the patient has severe liver failure or acute hepatitis (liver inflammation),
if the patient has severe haemolytic anaemia (abnormal premature breakdown of red blood cells).

Warnings and precautions
Do not take Panacit Extra if the patient is taking other medicines containing paracetamol.
If the patient is unsure whether a medicine contains paracetamol, consult a doctor or
pharmacist.
Taking higher than recommended doses of this medicine may increase the risk of developing
severe liver failure.
Consult a doctor or pharmacist before using Panacit Extra:

if the patient has a low number of red blood cells (haemolytic anaemia),
if the patient lacks the enzyme called glucose-6-phosphate dehydrogenase (an inherited disorder causing changes in blood morphology),
if the patient has been diagnosed with liver or kidney disease (including alcoholic liver disease),
if the patient has problems related to excessive alcohol consumption. Long-term consumption of excessive amounts of alcohol significantly increases the risk of paracetamol-induced toxic liver failure; this risk is highest in patients who have recently abstained from alcohol (within the past 12 hours).

During treatment with Panacit Extra, inform the doctor immediately:
If the patient has severe illnesses, including severe kidney dysfunction or sepsis
(when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition,
chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (an abnormality in blood and
body fluids) have been reported in patients who take paracetamol regularly over a long
period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may
include: severe breathing difficulties, including rapid deep breathing, drowsiness,
nausea and vomiting.

Children and adolescents
Panacit Extra is not recommended for children under 12 years of age.

Panacit Extra and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Before starting treatment with Panacit Extra, inform the doctor if the patient is
taking any medicines, especially:

metoclopramide, domperidone, or propanteline (used for nausea, vomiting, stomach ulcers),
cholestyramine (to lower blood cholesterol levels),
warfarin or other anticoagulant (blood-thinning) medicines,
medicines used to treat epilepsy (glutethimide, phenobarbital, phenytoin, carbamazepine, or lamotrigine),
certain antibiotics or tuberculosis medicines (chloramphenicol, rifampicin, isoniazid),
zidovudine (for treatment of HIV and AIDS),
acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (salicylamide),
medicines used to treat depression (monoamine oxidase inhibitors, tricyclic antidepressants such as amitriptyline, nortriptyline, doxepin, imipramine, clomipramine),
medicines used to treat psychiatric conditions such as schizophrenia (clozapine),
medicines used for sedation or anaesthesia (barbiturates),
medicines used to treat gout (probenecid),
herbal remedies and supplements containing St John's wort (Hypericum perforatum - for depression, sleep problems),
other medicines that may have a toxic effect on the liver,
flucloxacillin (antibiotic), due to a serious risk of blood and body fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

Panacit Extra with food, drink and alcohol
Do not consume alcohol while taking this medicine. Long-term alcohol consumption
significantly increases the risk of liver failure. If the patient abuses alcohol, consult a doctor before
starting treatment.
Panacit Extra contains caffeine. During treatment, avoid excessive consumption of
caffeine-containing beverages (e.g. coffee or other caffeinated drinks). Consuming large amounts of caffeine
may cause difficulty sleeping, restlessness, anxiety, irritability, headache, gastrointestinal irritation, and discomfort in the chest (due to increased heart rate).
Panacit Extra can be taken independently of meals. Taking it after a meal may
reduce the effectiveness of paracetamol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
Panacit Extra is not recommended during pregnancy and breastfeeding due to
its caffeine content.
Caffeine may cause spontaneous abortion during pregnancy. Caffeine in breast milk may
have a stimulating effect on the breastfed infant.

Driving and operating machinery
Panacit Extra has no effect or negligible effect on the ability to drive and
operate machinery.

Panacit Extra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning this medicine is considered "sodium-free".

3. How to use Panacit Extra

This medicine should always be used according to the recommendations of a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults and adolescents aged over 15 years
1-2 tablets up to 4 times daily as needed, no more frequently than every 4 hours. A single
tablet is appropriate for patients weighing 34 to 60 kg; two tablets may be used by
patients weighing over 60 kg. The maximum single dose is two tablets. Do not take
more than 8 tablets within 24 hours.
Use in children and adolescents (aged 12–15 years)
1 tablet 3 times daily as needed, no more frequently than every 6 hours. The maximum
single dose is one tablet. Do not take more than 3 tablets within 24 hours.
Do not give Panacit Extra to children under 12 years of age.
Patients with impaired liver or kidney function
Before use, consult a doctor regarding dose adjustment. After considering the patient's health
condition, the doctor may recommend a lower dose or extend the interval between doses to longer
than 4 hours.
Do not exceed the recommended daily dose.
Tablets should be swallowed with sufficient fluid.
Do not take other medicines containing paracetamol.
Without consulting a doctor, do not use Panacit Extra for longer than 7 days. If there is no improvement
or the condition worsens after 3 days, consult a doctor.
Taking more than the recommended dose of Panacit Extra
In case of overdose or accidental ingestion by a child, seek immediate medical attention at a doctor's office or the nearest hospital
and provide the exact amount of Panacit Extra taken. Bring the packaging and this leaflet with you.
Paracetamol overdose may lead to severe liver damage or liver failure. In case of overdose, seek immediate medical attention,
even if symptoms of overdose are not present.
Large doses of caffeine may cause headache, tremor, nervousness, and irritability.
Missing a dose of Panacit Extra
Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as you remember, but remember to maintain a 4-hour interval between consecutive doses.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking Panacit Extra and contact your doctor immediately if allergic reactions occur, such as skin rash, urticaria, itching, sweating, sometimes with swelling of the lips or face, and shortness of breath. These reactions are rare (may occur in 1 to 10 out of 10,000 patients).

Adverse effects of paracetamol
Rare (may occur in 1 to 10 out of 10,000 patients)

blood count abnormalities
haemolytic anaemia (abnormal premature breakdown of red blood cells)
oedema
visual disturbances
abdominal pain
nausea
vomiting
diarrhoea
bleeding
headache
depression
disorientation
hallucinations
tremor
allergic reactions
liver function disturbances
liver failure
hepatic necrosis
jaundice
itching
rash
sweating
purpura
swelling of deeper layers of skin due to fluid accumulation (angioedema)
urticaria
Stevens-Johnson syndrome (a rare but serious drug reaction characterised by the formation of blisters on the skin that may rupture)
toxic epidermal necrolysis
acute generalised exanthematous pustulosis
dizziness
fever
sedation
bronchospasm in patients sensitive to acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs).

Frequency unknown (cannot be estimated from the available data)

severe condition causing blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Adverse effects of caffeine
Frequency unknown (cannot be estimated from the available data)

nervousness
dizziness

If the medicine is combined with caffeine in food, the frequency of caffeine-related adverse effects increases, such as insomnia, restlessness, anxiety, irritability, headache, gastrointestinal irritation (nausea), and palpitations.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Panacit Extra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Panacit Extra contains

The active substances are paracetamol 500 mg and caffeine 65 mg in one tablet.
The other ingredients are: maize starch gelatinised, povidone K 25, sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Panacit Extra looks like and contents of the pack
Panacit Extra is a white or almost white elongated tablet, 16 mm in length, packed in PVC/PVDC/Aluminium blisters and cardboard boxes.
Tablets are available in packs containing 10, 12, 20, 24, and 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic Parapyrex Combi
Poland Panacit Extra
Slovak Republic Parapyrex Combi 500 mg/65 mg
Romania Panacit Extra 500 mg/65 mg tablets