PANACIT 500 mg/65 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Panacit Extra, 500 mg + 65 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Panacit Extra and what is it used for
   1. Panacit Extra can be used by adults and adolescents over 12 years old.
4. Important information before taking Panacit Extra
   1. When not to take Panacit Extra:
   2. Warnings and precautions
   3. Children and adolescents
   4. Panacit Extra and other medicines
   5. Panacit Extra with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Panacit Extra is not recommended during pregnancy and breastfeeding due to its caffeine content.
   8. Driving and using machines
   9. Panacit Extra contains sodium
5. How to take Panacit Extra
   1. Adults and adolescents over 15 years old
   2. Use in children and adolescents (12-15 years old)
   3. Do not give Panacit Extra to children under 12 years old.
   4. Patients with liver or kidney function disorders
   5. Taking a higher dose of Panacit Extra than recommended
   6. In case of overdose or accidental ingestion by a child, you should
   7. Missing a dose of Panacit Extra
6. Possible side effects
   1. You should stop taking Panacit Extra and immediately contact a doctor if
   2. Reporting side effects
7. How to store Panacit Extra
8. Contents of the packaging and other information
   1. What Panacit Extra contains
   2. What Panacit Extra looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 03/2025

Leaflet attached to the packaging: patient information

Panacit Extra, 500 mg + 65 mg, tablets

Paracetamol+ Caffeine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or feel worse after 3 days, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Panacit Extra and what is it used for
• 2. Important information before taking Panacit Extra
• 3. How to take Panacit Extra
• 4. Possible side effects
• 5. How to store Panacit Extra
• 6. Contents of the packaging and other information

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

Panacit Extra contains a combination of two active substances: paracetamol and caffeine, which effectively combat pain and fever.
Paracetamol acts as a pain reliever and reduces elevated body temperature. Caffeine enhances the pain-relieving effect of paracetamol, reduces fatigue, and slightly supports breathing and blood circulation in a feverish state.
Panacit Extra does not irritate the stomach.
Panacit Extra is indicated for relieving mild to moderate pain, such as headache, migraine, back pain, toothache, and menstrual pain. Panacit Extra also relieves unpleasant symptoms of flu and colds, such as muscle or joint pain, sore throat, and reduces fever.
After consulting a doctor, Panacit Extra may be used in rheumatic diseases, such as arthritis (degenerative joint disease) and neuralgia (pain localized in nerve fibers).

Panacit Extra can be used by adults and adolescents over 12 years old.

You should consult a doctor if your condition does not change or worsens after 3 days of treatment.

2. Important information before taking Panacit Extra

When not to take Panacit Extra:

• if you are allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver failure, acute liver inflammation (hepatitis),
• if you have severe hemolytic anemia (abnormal premature breakdown of red blood cells).

Warnings and precautions

You should not take Panacit Extra if you are taking other medicines containing paracetamol.
If you are not sure if a medicine contains paracetamol, you should consult a doctor or pharmacist.
Taking higher doses of the medicine than recommended may lead to an increased risk of severe liver failure.
You should consult a doctor or pharmacist before taking Panacit Extra:

• if you have a low red blood cell count (hemolytic anemia),
• if you have a lack of an enzyme called glucose-6-phosphate dehydrogenase (a hereditary disorder that causes changes in blood morphology),
• if you have been diagnosed with liver or kidney disease (including alcoholic liver disease),
• if you have a problem related to excessive alcohol consumption. Long-term excessive alcohol consumption significantly increases the risk of toxic liver failure due to paracetamol, and this risk is highest in patients who have undergone short-term abstinence (12 hours).

While taking Panacit Extra, you should immediately inform your doctor:
If you have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic).
There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol in regular doses for a longer period or who have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Children and adolescents

Panacit Extra is not recommended for children under 12 years old.

Panacit Extra and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Before starting Panacit Extra, you should inform your doctor if you are taking any medicines, in particular:

• metoclopramide, domperidone, or propanteline (used for nausea, vomiting, stomach ulcers),
• cholestyramine (to lower blood cholesterol levels),
• warfarin or other blood-thinning medicines,
• medicines used to treat epilepsy (glutethimide, phenobarbital, phenytoin, carbamazepine, or lamotrigine),
• certain antibiotics or anti-tuberculosis medicines (chloramphenicol, rifampicin, isoniazid),
• zidovudine (HIV and AIDS treatment),
• acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (salicylamide),
• medicines used to treat depression (monoamine oxidase inhibitors, tricyclic antidepressants, such as amitriptyline, nortriptyline, doxepin, imipramine, clomipramine),
• medicines used to treat mental illnesses, such as schizophrenia (clozapine),
• medicines used for sedation, anesthesia (barbiturates),
• medicines used to treat gout (probenecid),
• medicines 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 (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

Panacit Extra with food, drink, and alcohol

You should not consume alcohol while taking this medicine. Long-term alcohol consumption significantly increases the risk of liver failure. If you abuse alcohol, you should consult a doctor before starting treatment.
Panacit Extra contains caffeine. During treatment, you should avoid excessive consumption of caffeine-containing beverages (e.g., coffee or other caffeinated beverages). Consuming large amounts of caffeine can cause sleep problems, nervousness, anxiety, irritability, headaches, gastrointestinal upset, and discomfort in the chest (caused by rapid heartbeat).
Panacit Extra can be taken independently of meals. Taking it after a meal may lead to reduced effectiveness of paracetamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking 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 a breastfed child.

Driving and using machines

Panacit Extra has no or negligible influence on the ability to drive and use machines.

Panacit Extra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Panacit Extra

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.

Adults and adolescents over 15 years old

1-2 tablets up to 4 times a day as needed, but not more often than every 4 hours. One tablet is suitable for patients with a body weight of 34 to 60 kg; two tablets may be taken by patients with a body weight over 60 kg. The maximum single dose is two tablets. You should not take more than 8 tablets in 24 hours.

Use in children and adolescents (12-15 years old)

1 tablet 3 times a day as needed, but not more often than every 6 hours. The maximum single dose is one tablet. You should not take more than 3 tablets in 24 hours.

Do not give Panacit Extra to children under 12 years old.

Patients with liver or kidney function disorders

Before use, you should consult a doctor about adjusting the dosage. After considering the patient's health conditions, the doctor may recommend a lower dose or extend the interval between doses to more than 4 hours.
You should not take more than the recommended daily dose.
Tablets should be swallowed with a sufficient amount of liquid.
You should not take other medicines containing paracetamol.
Without consulting a doctor, you should not take Panacit Extra for more than 7 days. If you do not feel better or feel worse after 3 days, you should consult a doctor.

Taking a higher dose of Panacit Extra than recommended

In case of overdose or accidental ingestion by a child, you should

immediately go to a doctor or the nearest hospitaland provide the exact amount of Panacit Extra taken. You should show the packaging and this leaflet.
Overdose of paracetamol may lead to severe liver damage or liver failure. In case of overdose, you should immediately go to a doctor, even if symptoms of overdose are not present.
High doses of caffeine may cause headache, tremors, nervousness, and irritability.

Missing a dose of Panacit Extra

You should not take a double dose to make up for a missed dose.
A missed dose should be taken as soon as you remember, but you should also remember to maintain a 4-hour interval between doses.
If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Panacit Extra can cause side effects, although not everybody gets them.

You should stop taking Panacit Extra and immediately contact a doctor if

you experienceallergic reactions, such as skin rash, hives, itching, sweating, sometimes with swelling of the mouth or face, and shortness of breath. These reactions are rare (may occur in 1 to 10 out of 10,000 patients).
Paracetamol side effects
Rare(may occur in 1 to 10 out of 10,000 patients)

• blood morphology changes
• hemolytic anemia (abnormal premature breakdown of red blood cells)
• edema
• vision disorders
• abdominal pain
• nausea
• vomiting
• diarrhea
• bleeding
• headache
• depression
• disorientation
• hallucinations
• tremors
• allergic reactions
• liver function disorders
• liver failure
• liver necrosis
• jaundice
• itching
• rash
• sweating
• purpura
• deep skin edema caused by fluid accumulation (angioedema)
• hives
• Stevens-Johnson syndrome (a rare but severe drug reaction characterized by blistering of the skin)
• toxic epidermal necrolysis
• acute generalized exanthematous pustulosis
• dizziness
• fever
• drug-induced sedation
• bronchospasm in patients sensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory medicines (NSAIDs).

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

• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Caffeine side effects
Frequency not known(cannot be estimated from the available information)

• nervousness
• dizziness

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Panacit Extra

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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 cornstarch, 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, packaged in PVC/PVDC/Aluminum blisters and a cardboard box.
Tablets are available in packs of 10, 12, 20, 24, and 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 03/2025