Patient Information Leaflet

Excedrin Extra, 500 mg + 65 mg, film-coated tablets
Paracetamolum + Coffeinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

Excedrin Extra contains two active substances: paracetamol and caffeine. The therapeutic effect of the medicine results from the combined action of these active ingredients.
Paracetamol has analgesic and antipyretic properties.
Caffeine has a stimulant effect on the central nervous system and enhances the analgesic effect of paracetamol.

Indications for Excedrin Extra:
The medicine provides analgesic relief for headaches, sore throat, migraines, toothaches, bone, joint, and muscle pain, as well as menstrual pain. Excedrin Extra may be used for colds and flu-like conditions. It also has antipyretic action.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Excedrin Extra

When not to take Excedrin Extra:

if the patient is allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6).
in case of alcohol-related disease, severe liver or kidney failure, heart rhythm disorders, or insomnia. Do not administer this medicine to children under 12 years of age.

Warnings and precautions
This medicine contains paracetamol.
Do not take more than the recommended dose, as paracetamol overdose may
lead to severe liver damage and even death.
This medicine should not be used simultaneously with other prescription or over-the-counter
medicines containing paracetamol, such as painkillers, antipyretics, medicines used to treat
symptoms of flu and colds, or sleep aids.
Read the leaflet carefully before using the medicine and follow the instructions provided.
Consult a doctor before using the medicine in the following cases:

liver or kidney failure,
deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
underweight or malnourished patients suffering from anorexia,
patients who regularly consume alcohol. It may be necessary to completely discontinue Excedrin Extra or reduce the dose.

Consult a doctor before using the medicine in the following cases:

severe infection,
underweight or malnourished patients suffering from anorexia,
patients who regularly consume alcohol, as this may increase the risk of liver failure and metabolic acidosis.

During treatment, immediately inform the doctor if the patient develops severe conditions, 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).
In these situations, patients have experienced a serious condition called metabolic acidosis (a blood and body fluid abnormality) while taking paracetamol at standard doses over a prolonged period, or while taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Symptoms of liver failure may include:

loss of appetite, diarrhoea, fever, skin rash
low blood pressure and rapid heartbeat
nausea, vomiting, bloating under the right ribs, jaundice, bleeding disorders (skin bruising), disturbances in consciousness
Seek immediate medical attention if the patient experiences any of the above symptoms simultaneously.

Excedrin Extra and other medicines
This medicine contains paracetamol. Due to the risk of overdose, do not use with other medicines
containing paracetamol.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Inform your doctor or pharmacist if the patient is taking:

flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2). Consult a doctor if taking the following medicines: metoclopramide, domperidone (used for nausea and vomiting), cholestyramine (used to reduce high blood cholesterol levels), anticoagulants (e.g. warfarin) if long-term pain relief is needed, sedatives, antiepileptics, antituberculosis medicines, MAO inhibitors (medicines used for depression), estrogens and progesterone (sex hormones), disulfiram (used, among others, in the treatment of alcoholism), nonsteroidal anti-inflammatory drugs (e.g. acetylsalicylic acid).
This medicine is not recommended for patients taking lithium salts (used, among others, in the treatment of depression and mania).
Paracetamol may cause false results in certain laboratory tests (e.g. blood glucose measurement).
Paracetamol taken together with MAO inhibitors may cause agitation and high fever.
Do not drink alcohol while taking this medicine, due to increased risk of liver damage. The risk of liver damage is particularly high in malnourished patients and those who regularly drink alcohol.
This medicine contains caffeine. While using this medicine, avoid excessive intake of caffeine (e.g. from coffee, tea, or certain beverages). Excessive caffeine intake may cause difficulty sleeping, tremors, and palpitations.

If symptoms persist, consult a doctor.
Excedrin Extra with food, drink, and alcohol
Do not drink alcohol while taking this medicine, due to increased risk of liver damage.
If Excedrin Extra, which contains caffeine, is taken at the recommended dose together with dietary sources of caffeine, this may intensify adverse effects related to increased total caffeine intake, such as: insomnia, restlessness, anxiety, irritability, headache, gastrointestinal disturbances, and palpitations.
Children
Do not give this medicine to children under 12 years of age.
Pregnancy, breastfeeding, and fertility
Do not use Excedrin Extra during pregnancy or breastfeeding.
Driving and operating machinery
Excedrin Extra has no effect or negligible effect on the ability to drive and operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Excedrin Extra

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.
Adults and adolescents aged 12 years and over
Orally, 1-2 tablets depending on the severity of symptoms, up to 4 times daily. Do not take the medicine more frequently than every 4 hours or exceed 4 doses (8 tablets) in 24 hours.
Do not take a higher dose than recommended.
Always use the lowest effective dose for the shortest possible duration.
Do not use this medicine regularly for more than 3 days without consulting a doctor.
If you feel the effect of this medicine is too strong or too weak, consult your doctor.
Children
Excedrin Extra must not be given to children under 12 years of age.
Taking more Excedrin Extra than recommended
Paracetamol overdose may cause liver damage, which can result in liver transplantation or death. Cases of acute pancreatitis have also been observed, usually associated with liver function disorders and liver damage.
If you take more than the recommended dose, seek immediate medical advice even if you feel well, because life-threatening liver damage may occur, which can lead to liver transplantation or death. If less than one hour has passed since ingestion, induce vomiting. Alternatively, 60–100 g of activated charcoal may be taken orally, preferably mixed with water.
If you forget to take Excedrin Extra
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking the medicine immediately and consult a doctor if any of the following occur:

allergic (hypersensitivity) reactions such as skin rash or skin itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat or face,
skin rash or severe skin reaction manifesting as acute generalized blistering rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing large subcutaneous blisters, extensive skin erosions, peeling of large skin sheets, and fever,
breathing difficulties, particularly if similar problems occurred previously during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
unexplained bruising or bleeding,
liver function disorders. The above reactions occur very rarely, i.e. in less than 1 in 10,000 patients.

Other adverse reactions:

dizziness, headache, palpitations, insomnia, motor restlessness, anxiety, irritability, nervousness, gastrointestinal disturbances. A serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2). The frequency of the above reactions is unknown (cannot be estimated from available data).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, please inform your doctor, pharmacist or nurse.
Adverse reactions may also be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Excedrin Extra

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.

6. Contents of the pack and other information

What Excedrin Extra contains

The active substances in Excedrin Extra are paracetamol and caffeine. Each coated tablet contains 500 mg of paracetamol and 65 mg of caffeine.
The other ingredients are: gelatinized starch, maize starch, povidone (K 25), potassium sorbate, talc, stearic acid, sodium croscarmellose. The coating contains: hydroxypropylmethylcellulose, triacetin.

What Excedrin Extra looks like and contents of the pack
Excedrin Extra is a white, capsule-shaped, film-coated tablet with straight edges. One side is embossed with a triangle and a "+" sign, the other side is smooth.
The pack contains 8, 10, 12 or 24 film-coated tablets.

Marketing Authorization Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer
Haleon Ireland Dungarvan Limited
Knockbrack, Lisfennel,
Dungarvan,
Co. Waterford,
X35 RY76,
Ireland

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.