Excedrin Sprint

Leaflet attached to the packaging: information for the user

Excedrin Sprint

500 mg, coated tablets

Paracetamol

Read the leaflet carefully 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 directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible 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 Sprint and what is it used for
• 2. Important information before taking Excedrin Sprint
• 3. How to take Excedrin Sprint
• 4. Possible side effects
• 5. How to store Excedrin Sprint
• 6. Package contents and other information

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

Excedrin Sprint contains paracetamol, which has analgesic and antipyretic effects.
Excedrin Sprint is indicated for headaches, migraines, tension headaches, toothaches, neuralgia,
back pain, bone, joint, and muscle pain, painful menstruation, sore throat,
symptomatic treatment of pain in mild arthritis. Excedrin Sprint has analgesic and antipyretic effects
during colds and flu-like conditions.
Excedrin Sprint has a special composition of excipients with a rapid disintegration effect (Optizorb™),
causing faster release compared to standard paracetamol tablets. Excedrin Sprint tablets start to disintegrate within 5
minutes of administration.

2. Important information before taking Excedrin Sprint

When not to take Excedrin Sprint

• If the patient is allergicto paracetamol or any of the other ingredients of this medicine (listed in section 6),
• In case of alcoholism,
• In case of severe liver or kidney failure.

Warnings and precautions

The medicine contains paracetamol.Do not take a dose higher than recommended. Overdose of paracetamol can lead to severe liver damage.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms or as a sleep aid.
Read the leaflet before taking the medicine and follow the recommendations contained therein.
Consult a doctor before taking the medicine in case of:

• liver or kidney failure,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• patients suffering from chronic headaches,
• patients who are underweight or malnourished, suffering from anorexia,
• patients who regularly consume alcohol (it may be necessary to completely stop taking this product or reduce the dose),
• severe infection (sepsis) that may increase the risk of metabolic acidosis. Symptoms of metabolic acidosis include:
• deep, rapid, and difficult breathing,
• nausea, vomiting, and loss of appetite, - general poor condition. You should immediately contact a doctor if the patient experiences the above symptoms simultaneously. Consult a doctor if the patient suffers from chronic headaches. There is a special risk of overdose leading to life-threatening liver damage in patients with alcoholism and those who are malnourished. Existing liver disease increases the risk of liver damage associated with paracetamol use. If symptoms persist, consult a doctor. Do not take a dose higher than recommended, do not take more frequently than every 4 hours. Before taking the medicine, consult a doctor if the patient suffers from mild arthritis and needs to take painkillers every day. Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

If symptoms persist, consult a doctor. Keep the medicine out of sight and reach of children.

Excedrin Sprint and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Do not take other medicines containing paracetamol at the same time.

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(such as warfarinor other coumarin derivatives) in case of a need for long-term use of a painkiller,
• medicines that increase liver metabolism, such as certain sleeping pills or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), rifampicin (an antitubercular antibiotic), St. John's Wort, which can lead to liver damage even when taking recommended doses of paracetamol,
• monoamine oxidase inhibitors (used to treat depression),
• salicylamide,
• nonsteroidal anti-inflammatory drugs (including acetylsalicylic acid).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Excedrin Sprint can be used during pregnancy if clinically justified. Take the lowest possible dose that reduces pain and (or) fever, for the shortest time and as infrequently as possible.
Consult a doctor if pain and (or) fever do not decrease or if you need to take the medicine more frequently. Like other medicines, this medicine should only be used during pregnancy if necessary.
Paracetamol passes into breast milk in amounts that are not clinically significant. Available data do not indicate any contraindications to breastfeeding during treatment with this medicine. Like other medicines, this medicine should only be used during breastfeeding if necessary.

Driving and using machines

Excedrin Sprint has no influence or negligible influence on the ability to drive and use machines.

3. How to take Excedrin Sprint

Take this medicine always exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
For oral use only.

Use in adults and children over 12 years old (with a body weight over 50 kg):

Orally 1-2 tablets. If necessary, the dose can be repeated at intervals of not less than 4 hours, up to 4 times a day. Maximum daily dose of paracetamol: 4000 mg (8 tablets).

Children aged 6-11 years

Orally ½ - 1 tablet (250 mg -500 mg). If necessary, the dose can be repeated at intervals of not less than 4 hours, up to 4 times a day. Maximum daily dose of paracetamol: 60 mg/kg body weight/24 hours, divided into 4 doses of 15 mg/kg body weight.

Do not give the medicine to children under 6 years old.

• Do not use the medicine regularly for more than 3 days without consulting a doctor.
• Do not take a dose higher than recommended.
• Do not take the medicine more frequently than every 4 hours.
• Always use the lowest effective dose for the shortest possible time.
• Do not take other medicines containing paracetamol at the same time.

Taking a higher dose of Excedrin Sprint than recommended

In case of taking a dose higher than recommended, immediately seek medical advice, even if the patient's condition is good and no symptoms of poisoning have been observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. In case of taking a single dose of paracetamol of 5 g or more and if no more than an hour has passed since ingestion, vomiting can be induced. Administer 60-100 g of activated charcoal orally, preferably mixed with water.
Overdose of paracetamol may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Excedrin Sprint

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.
Stop taking the medicine and consult a doctor if you experience:

• 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, mouth, eyes, and genitals, fever, and joint pain or bursting giant subcutaneous blisters, extensive skin erosion, and fever,
• breathing problems, if similar problems have occurred in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as ibuprofen,
• bruises or bleeding of unknown cause,
• nausea, loss of appetite, weight loss in a short period, yellowing of the eyes and skin. The above reactions occur very rarely (i.e., less than 1 in 10,000 patients).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Excedrin Sprint

Do not store above 30°C.

Keep the medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, bottle, and outer packaging after EXP. The expiry date refers to the last day of the month.
Dispose of the packaging in an appropriate manner. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Excedrin Sprint contains

• The active substance of the medicineis paracetamol. Each coated tablet contains 500 mg of paracetamol.
• Other ingredientsare: maize starch, calcium carbonate, alginic acid, crospovidone Type A, povidone K-25, magnesium stearate, silica colloidal anhydrous, purified water. Coating: Opadry White YS-1-7003 (containing titanium dioxide (E171), hypromellose 2910, 3cp, hypromellose 2910, 6cp, macrogol 400, polysorbate 80), carnauba wax, purified water.

What Excedrin Sprint looks like and what the pack contains

The medicine is in the form of white or almost white coated capsules-shaped tablets, with the letter "P" embossed on one side and a score line on the other. The tablet can be divided into equal doses.
The tablets are packaged in blisters in cardboard boxes or "wallet" packs of 6, 8, 12, 24, 48, or 96 pieces or in high-density polyethylene bottles containing 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Haleon Italy Manufacturing S.r.l.
Via Nettunense, 90
04011 Aprilia (LT)
Italy
Haleon Ireland Dungarvan Limited
Knockbrack, Lisfennel,
Dungarvan,
Co. Waterford,
X35 RY76,
Ireland

Date of last revision of the leaflet: February 2025