Excedrin Extra

Leaflet attached to the packaging: information for the user

Excedrin Extra, 500 mg + 65 mg, coated 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 a 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Excedrin Extracontains two active substances: paracetamol and caffeine. The therapeutic effect of the preparation is the result of the combined action of the active substances.
Paracetamol has analgesic and antipyretic effects.
Caffeine has a stimulating effect on the central nervous system and enhances the analgesic effect of paracetamol.

Indications for use of Excedrin Extra:

The medicine has an analgesic effect in headaches, throat pain, migraines, toothaches, bone, joint, and muscle pain, as well as menstrual pain. Excedrin Extra can be used in colds and flu-like conditions. It has an antipyretic effect.
If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

2. Important information before taking 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 alcoholism, severe liver or kidney failure, heart rhythm disorders, insomnia. The medicine should not be given to children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol.

Do not take a higher dose than recommended, asparacetamol overdose can lead to severe liver damage and even death.
The medicine should not be taken simultaneously with other medicines available without a prescription or on a doctor's prescription that contain paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms, or sleep aids.
You should read the leaflet before taking the medicine and follow the instructions contained in it.

Before taking the medicine, you should consult a doctor in the following cases:

• liver or kidney failure,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• patients with low body weight or malnourished, suffering from anorexia,
• patients who regularly consume alcohol. It may be necessary to completely stop taking Excedrin Extra or reduce its dose.

Before taking the medicine, you should consult a doctor in the following cases:

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

While taking the medicine, you should immediately inform your doctor if the patient experiences severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and fluid disorder), when they took paracetamol in standard doses for a longer period or took paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Symptoms of liver failure include:

• loss of appetite, diarrhea, fever, skin rash
• low blood pressure and rapid heart rate
• nausea, vomiting, abdominal pain on the right side, jaundice, blood clotting disorders (bruises on the skin), impaired consciousness. You should immediately contact a doctor if the patient experiences any of the above symptoms at the same time.

Excedrin Extra and other medicines

The medicine contains paracetamol. Due to the risk of overdose, do not take with other medicines that contain paracetamol.

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
You should inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2). You should consult a doctor when taking the following medicines: metoclopramide, domperidone (used against nausea and vomiting), cholestyramine (used to reduce high cholesterol levels in the blood), anticoagulant medicines (e.g., warfarin) in case of a need for long-term use of a painkiller, sedatives, antiepileptics, anti-tuberculosis medicines, MAO inhibitors (medicines used in depression), estrogens and progesterone (sex hormones), disulfiram (used in the treatment of alcoholism), non-steroidal anti-inflammatory medicines (e.g., acetylsalicylic acid).

This medicine is not recommended for people taking lithium salts (used in the treatment of depression, mania).
Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Paracetamol taken with MAO inhibitors may cause a state of excitement and high fever.
While taking the medicine, you should not drink alcohol due to the increased risk of liver damage. There is a special risk of liver damage in malnourished patients and those who regularly drink alcohol.
The medicine contains caffeine. During treatment with the medicine, you should avoid excessive consumption of caffeine (e.g., contained in coffee, tea, or some drinks). Excessive caffeine consumption may cause difficulty sleeping, trembling, and unpleasant feelings in the chest due to heart palpitations.
If symptoms persist, you should consult a doctor.

Excedrin Extra with food, drink, and alcohol

While taking the product, you should not drink alcohol due to the increased risk of liver damage.
In case the Excedrin Extra medicine containing, among other things, caffeine is administered in the recommended dosage in combination with caffeine contained in food, it is possible to intensify the side effects associated with the increase in the total caffeine dose, such as: insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disorders, heart palpitations.

Children

Do not give the medicine to children under 12 years of age.

Pregnancy, breastfeeding, and fertility

Do not take Excedrin Extra during pregnancy and breastfeeding.

Driving and using machines

Excedrin Extra has no influence or negligible influence on the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Excedrin Extra

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, you should consult a doctor, pharmacist, or nurse.
For oral use only.

Adults and adolescents over 12 years of age

Orally, depending on the severity of the symptoms, 1-2 tablets, up to 4 times a day. Do not take the medicine more often than every 4 hours or take more than 4 doses (8 tablets) in 24 hours.
Do not take a higher dose than recommended.
Always take the lowest effective dose of the medicine for the shortest possible time.

Without consulting a doctor, the medicine should not be taken regularly for more than 3 days.

If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.
Children
Excedrin Extra should not be given to children under 12 years of age.

Taking a higher dose of Excedrin Extra than recommended

Paracetamol overdose can cause liver damage, which may result in liver transplantation or death. There have also been cases of acute pancreatitis associated with liver damage and liver disorders.
In case of taking a higher dose than recommended, you should immediately seek medical advice, even if the patient's condition is good, as it may lead to life-threatening liver damage, which may result in liver transplantation or death. If it has been less than an hour since ingestion, you can induce vomiting. You can also take 60-100 g of activated charcoal orally, preferably mixed with water.

Missing a dose of Excedrin Extra

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately stop taking the medicine and consult a doctor if you experience:

• an allergic reaction (hypersensitivity) such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, in the mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, extensive erosions on the skin, and fever,
• breathing problems, in case similar problems occurred in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory medicines,
• bruises or bleeding of unknown cause,
• liver function disorders. The above reactions occur very rarely, i.e., in less than 1 in 10,000 patients.

Other side effects:

• dizziness, headache, heart palpitations, insomnia, restlessness, anxiety, irritability, nervousness, gastrointestinal disorders. A serious condition that can cause acidification of the blood (so-called metabolic acidosis) in patients with severe disease, taking paracetamol (see section 2). The above reactions occur with an unknown frequency (cannot be determined based on available data).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

5. How to store Excedrin Extra

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The medicine should be stored 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 month stated.
Store below 25°C.

6. Contents of the packaging and other information

What Excedrin Extra contains

• The active substances of the medicine are paracetamol and caffeine. Each coated tablet contains 500 mg of paracetamol and 65 mg of caffeine.
• The other ingredients are: gelatin starch, corn starch, povidone (K 25), potassium sorbate, talc, stearic acid, sodium croscarmellose. The coating contains: hypromellose, triacetin.

What Excedrin Extra looks like and what the packaging contains

Excedrin Extra is a white, coated, capsule-shaped tablet with a smooth edge, with a triangular embossing and a "+" sign on one side, and a smooth surface on the other.
The packaging contains 8, 10, 12, or 24 coated tablets.

Marketing authorization holder

Haleon Poland Sp. z o.o.
Rzymowskiego 53
02-697 Warsaw
phone: 800 702 849

Manufacturer

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

Date of last revision of the leaflet:

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