EXCEDITE 250 MG/250 MG/65 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Excedite 250 mg / 250 mg / 65 mg film-coated tablets

Acetylsalicylic acid / Paracetamol / Caffeine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Excedite and what is it used for
2. What you need to know before you take Excedite
3. How to take Excedite
4. Possible side effects
5. Storage of Excedite
6. Contents of the pack and other information

1. What is Excedite and what is it used for

Each tablet contains three active substances: acetylsalicylic acid, paracetamol, and caffeine.

• Acetylsalicylic acid and paracetamol relieve pain and reduce fever. Acetylsalicylic acid also reduces inflammation.
• Caffeine is a moderate stimulant and increases the effect of acetylsalicylic acid and paracetamol.

Excedite is used to treat acute headache and migraine attacks with or without aura (symptoms such as headache, nausea, and sensitivity to light and sound).

2. Before taking Excedite

Do not take Excedite if:

• you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, or any of the other ingredients of Excedite (listed in section 6).
• you have ever had an allergic reaction to other pain-relieving medicines, such as acetylsalicylic acid and salicylates, or any other non-steroidal anti-inflammatory drug (NSAID), such as diclofenac or ibuprofen. Reactions can include asthma, wheezing, or difficulty breathing, skin rash or hives, swelling of the face or tongue, runny nose. Consult your doctor or pharmacist if you are not sure.
• you have a stomach or intestinal ulcer or have had a stomach ulcer in the past.
• you have detected blood in your stools or black stools (symptoms of intestinal bleeding or perforation).
• you are haemophiliac or suffer from another blood disorder.
• you have serious heart, liver, or kidney problems.
• you take more than 15 milligrams of methotrexate per week (see the section: other medicines and Excedite)
• you are in the last 3 months of pregnancy (see pregnancy, breastfeeding, and fertility).

Warnings and precautions

Excedite contains paracetamol. Do not take more than the recommended dose, as this can cause serious liver damage.

Acetylsalicylic acid can cause bleeding. You should inform your doctor if you experience any unusual bleeding.

The following are reasons why Excedite may not be suitable for you. Before taking this medicine, you should consult your doctor if:

• You have not been diagnosed with migraine before, as it is necessary to rule out the existence of potentially serious conditions related to the brain and nerves before treatment

• you have migraine that is so severe that it requires bed rest, or a headache different from your usual migraines, or if you have vomiting associated with the headache of your migraine.
• you start having a headache after a head injury, exercise, coughing, or turning.
• you have chronic headaches (15 days a month or more for more than 3 months), or if you experience your first headache after the age of 50.
• You suffer from liver or kidney problems, are underweight, malnourished, or drink alcohol regularly. It may be necessary to avoid using the medicine altogether or limit the amount of paracetamol you take.
• You have a severe infection, are severely malnourished, have a severely low weight, are a chronic consumer of large amounts of alcohol, as this can increase the risk of metabolic acidosis. The symptoms of metabolic acidosis include: deep, rapid, and difficult breathing, nausea, vomiting, loss of appetite. Contact a doctor if you suffer from a combination of these symptoms.
• you suffer from a hereditary disease called glucose-6-phosphate dehydrogenase deficiency that affects red blood cells and can cause anaemia, jaundice, or spleen enlargement when exposed to certain foods, medicines (e.g., anti-inflammatory drugs such as acetylsalicylic acid), or other diseases.
• you have ever had gastrointestinal problems such as stomach ulcers, bleeding, or black stools. If you have had stomach upset or acid reflux after taking painkillers or anti-inflammatory medicines in the past.
• you suffer from haemorrhagic disorders or abnormal vaginal bleeding, different from your menstrual period (e.g., heavier and longer menstrual periods than usual).
• you have recently undergone surgery (including minor surgery such as dental surgery) or are going to undergo surgery in the next 7 days.
• you have asthma, pollen allergy, nasal polyps, a chronic respiratory disease, or develop allergy symptoms (skin irritation, itching, and hives).
• you have gout, diabetes, hyperthyroidism, arrhythmia, uncontrolled hypertension, reduced kidney or liver function.
• you have alcohol problems (see Taking Excedite with food and drink).
• you are taking other medicines that contain acetylsalicylic acid or paracetamol, as well as any other medicine, as some may interfere with Excedite and cause side effects (see Other medicines and Excedite)
• you are at risk of possible dehydration (e.g., vomiting, diarrhoea, or before or after major surgery).
• you are under 18 years of age. There is a possible association between acetylsalicylic acid and Reye's syndrome when administered to children and adolescents. Reye's syndrome is a rare disease that affects the brain and liver and can be fatal. For this reason, Excedite should not be administered to children or adolescents under 18 years of age unless your doctor indicates otherwise.

During treatment with Excedite, inform your doctor immediately if:

If you have serious diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other precautions

As with any type of pain reliever, taking Excedite too often (which means taking more than 10 days a month of this medicine) coinciding with chronic headaches (15 days a month or more), for more than 3 months, could worsen your headache or migraine. If you think this may be your case, contact your doctor for advice. You may need to stop taking Excedite to resolve this problem.

Excedite may reduce the symptoms of an infection (e.g., headache, high temperature) and therefore may make it more difficult to detect. If you feel unwell and need to see a doctor, remember to tell them that you are taking this medicine.

Excedite may interfere with laboratory test results. If you are going to have a blood test, urine test, or other laboratory test, remember to inform that you are taking Excedite.

Excedite contains 0.03 mg of benzoic acid (E 210) per tablet. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Other medicines and Excedite

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are taking any of the following medicines:

• any other medicine that contains paracetamol, acetylsalicylic acid, or any other pain-relieving or fever-reducing substance.
• medicines used to prevent blood clots ("blood thinners") such as oral anticoagulants (e.g., warfarin), heparin, thrombolytics (e.g., streptokinase), or other antiplatelet agents (ticlopidine, clopidogrel, cilostazol).
• corticosteroids (used to provide relief from inflammation).
• barbiturates and benzodiazepines (for treating anxiety and insomnia).
• lithium, selective serotonin reuptake inhibitors, or fluvoxamine (for treating depression).
• sulfonylureas and insulin (for treating diabetes).
• methotrexate (for treating certain types of cancer, arthritis, or psoriasis)
• certain medicines used to treat infections (e.g., rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid).
• levothyroxine (for treating hypothyroidism).
• metoclopramide (for treating nausea and vomiting).
• medicines for epilepsy.
• medicines for high blood pressure and heart failure.
• diuretics (to increase urine production and reduce excess fluid)
• medicines for treating gout.
• oral contraceptives.
• zidovudine (for treating HIV).
• medicines for treating slow stomach emptying such as propantheline.
• clozapine (for treating schizophrenia).
• sympathomimetics (to raise low blood pressure or treat nasal congestion).
• antihistamines (to prevent or relieve allergies).
• theophylline (for treating asthma).
• terbinafine (for treating fungal infections).
• cimetidine (for treating heartburn and stomach ulcers).
• disulfiram (for treating alcohol dependence).
• nicotine (used in smoking cessation)
• cholestyramine (for treating high cholesterol levels).
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Excedite with food and drink

• Alcohol:

If you consume 3 or more alcoholic beverages per day, consult your doctor before taking this medicine or any other pain reliever or fever-reducing medicine. Paracetamol and acetylsalicylic acid can cause liver damage and stomach bleeding.

• Caffeine:

The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Limit your intake of medicines, foods, or beverages that contain caffeine during treatment with this medicine, as too much caffeine can cause nervousness, irritability, insomnia, and occasionally, rapid heartbeat.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended during pregnancy. If you are pregnant or think you may be pregnant, consult your doctor and do not take Excedite.

Pregnancy - last trimester

Do not take this medicine in the last 3 months of pregnancy, as it can cause harm to the baby before birth and problems during delivery due to its content of acetylsalicylic acid. It can cause problems in the fetus's kidneys and heart. It can affect your coagulation and that of your baby, leading to delayed or prolonged delivery.

Pregnancy - first and second trimester

Due to its content of acetylsalicylic acid, you should not take this medicine during the first 6 months of pregnancy unless it is absolutely necessary and has been recommended by your doctor. If you need to use this treatment during this period of pregnancy or while trying to become pregnant, you should use the lowest possible dose for the shortest possible time. If taken for more than a few days from week 20 of pregnancy onwards, acetylsalicylic acid can cause kidney problems in your baby before birth, leading to a lower than normal amount of amniotic fluid around the fetus (oligohydramniosis) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Women who are breastfeeding should not take this medicine, as it can be harmful to their baby.

Consult your doctor or pharmacist before using any medicine.

Excedite belongs to a group of medicines (NSAIDs) that can reduce fertility in women. Although this effect is reversible when you stop taking the medicine.

Driving and using machines

Excedite does not affect the ability to drive or use machines. If you notice side effects such as dizziness or drowsiness, do not drive vehicles or operate machinery and consult your doctor as soon as possible.

3. How to take Excedite

Follow the instructions for taking this medicine exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults (18 years of age or older):

• For headache treatment:

Take 1 tablet with a full glass of water when the pain appears. If necessary, you can take another tablet 4 to 6 hours later.

If the pain is more intense, take 2 tablets with a full glass of water when the pain appears. If necessary, you can take 2 more tablets 4 to 6 hours later.

Do not use this medicine for more than 4 days for headache without consulting your doctor.

• For migraine treatment:

Take 2 tablets with a full glass of water when migraine symptoms appear. If necessary, you can take 2 more tablets 4 to 6 hours later.

If you do not notice relief within 2 hours after the first dose of 2 Excedite tablets, consult your doctor.

Do not use this medicine for more than 3 days for migraine without consulting your doctor.

For both headache and migraine treatment, do not take more than 6 tablets in 24 hours. This corresponds to a dose of 1500 mg of acetylsalicylic acid, 1500 mg of paracetamol, and 390 mg of caffeine.

Prolonged use without medical supervision can be harmful.

Do not take more than the indicated dose. Use the lowest dose that you need to treat your symptoms and use this medicine for the shortest time necessary.

Children and adolescents:

This medicine should not be administered to children and adolescents under 18 years of age (see Take special care with Excedite)

Elderly patients (over 65 years of age):

There are no special recommendations. If you have a low body weight, you should consult your doctor or pharmacist.

Patient with liver or kidney problems:

Consult your doctor if you have liver or kidney problems. It may be necessary to adjust the dose, intervals, or duration of treatment. Do not take this medicine if you have serious kidney or liver problems.

If you take more Excedite than you should

These tablets contain acetylsalicylic acid, paracetamol, and caffeine. Do not take more than the recommended dose and do not use any other product that contains these ingredients or other non-steroidal anti-inflammatory drugs while taking Excedite.

Contact your doctor, pharmacist, or go to the nearest hospital as soon as possible if you think you have taken an overdose. Immediate medical attention is critical due to the potential risk of irreversible liver damage due to paracetamol. Do not wait for symptoms to appear, as an overdose may not initially produce noticeable symptoms.

In case of overdose or accidental ingestion, go to a medical centre immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of overdose are:

• Due to acetylsalicylic acid: dizziness, ringing in the ears, deafness, sweating, hyperventilation, fever, nausea, vomiting, headache, confusion, restlessness, circulatory collapse, or respiratory failure.
• Due to paracetamol: the first symptoms that may appear are nausea, vomiting, loss of appetite, paleness, restlessness, sweating, and later abdominal pain.
• Due to caffeine: anxiety, nervousness, restlessness, insomnia, excitement, muscle tremors, confusion, convulsions, hyperglycaemia, rapid heartbeat, or cardiac arrhythmia.

Even if these symptoms do not appear or have disappeared, it is very important to seek medical help immediately.

In case of overdose or accidental ingestion, go to a medical centre immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Excedite

Take the dose as soon as you can, do not take a double dose to make up for forgotten doses.

Do not take more than 6 tablets a day.

Consult your doctor or pharmacist in case of doubts about the use of this medicine.

In case of overdose or accidental ingestion, go to a medical centre immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount taken.

4. Possible Adverse Effects

Like all medications, Excedite can produce adverse effects, although not all people suffer from them.

Suspend treatment with Excedite and inform your doctor if you suffer from any of the following adverse effects:

• Allergic reactions such as swelling of the face, lips, tongue, or throat. This can cause difficulty swallowing, wheezing, difficulty exhaling, and a feeling of chest pressure (signs of asthma). Often these symptoms are associated with skin rashes or itching, as well as fainting.
• Redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, or ulcers in the mouth.
• Bleeding in the stomach or intestine, stomach ulcer that may be accompanied by acute stomach pain, black or bloody stools, bloody vomiting. As with other pain relievers and fever-reducing medications, this can occur at any time during treatment, without any previous history, and can be fatal. These adverse effects are particularly serious in elderly patients.
• Yellow eyes or skin (signs of liver failure)
• Dizziness or lightheadedness (signs of low blood pressure).
• Irregular heartbeats.
• If you had previously suffered from respiratory problems with acetylsalicylic acid or non-steroidal anti-inflammatory drugs, and you experience a similar reaction with this product.
• Unexplained bruising or bleeding.
• Increased frequency of nosebleeds or bruising.
• Swelling or water retention.
• Ringing in the ears or temporary hearing loss.
• Changes in behavior, nausea, and vomiting (could be symptoms of Reye's syndrome)

The following adverse effects were recorded in the 16 clinical trials conducted with Excedite on 4800 treated subjects. Consult your doctor if you notice any of the following adverse effects:

Frequent (Affects 1 to 10 out of every 100 patients):

• Nervousness, dizziness
• Nausea, abdominal discomfort

Infrequent (Affects 1 to 10 out of every 1000 patients):

• Insomnia, tremors, numbness, headache
• Dry mouth, diarrhea, vomiting
• Fatigue, agitation
• Increased heart rate

Rare (Affects 1 to 10 out of every 10,000 patients):

• Throat pain, difficulty swallowing, numbness or tingling around the mouth, excessive salivation
• Reduced appetite and altered taste
• Anxiety, euphoria, tension
• Loss of attention, memory loss, and altered coordination
• Pain in the cheeks and forehead
• Pain in the eye and vision disorders
• Hot flashes, peripheral vascular problems (e.g., in arms and legs)
• Nosebleeds, slow and shallow breathing, nasal discharge.
• Belching, flatulence
• Excessive sweating, itching, rash, increased skin sensitivity
• Stiffness in muscles, bones, or joints; neck, back, and muscle spasms.
• Weakness and chest discomfort

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

• A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

The following adverse effects have been reported during the marketing of the medication. In general, the frequency in post-marketing surveillance cannot be determined precisely, so it is indicated as "unknown".

• Restlessness, general abnormal or uncomfortable feeling
• Somnolence, migraine
• Redness, rash
• Palpitations, dyspnea, sudden difficulty breathing, and feeling of tightness in the chest with wheezing or cough (asthma)
• Abdominal pain, stomach discomfort after meals
• Increased liver enzymes
• Swelling and irritation inside the nose
• Kidney problems

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Excedite

Keep out of sight and reach of children.

Do not use after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Excedite

• The active ingredients are: acetylsalicylic acid, paracetamol, and caffeine.

Each film-coated tablet contains 250 mg of acetylsalicylic acid, 250 mg of paracetamol, and 65 mg of caffeine.

• The other components (excipients) are:

Core of the tablet:low-substituted hydroxypropylcellulose, microcrystalline cellulose (E460), stearic acid.

Coating:hypromellose (E464), titanium dioxide (E171), propylene glycol, benzoic acid (E210), carnauba wax (E903).

Appearance of Excedite and Packaging Content

White, oblong-shaped, film-coated tablet with an "E" marked on one of its faces.

The tablets are presented in blisters that are packaged in boxes containing 10, 16, 20, 30, and 32 film-coated tablets. Not all packaging sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 – Madrid – Spain

Manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG

Barthstrasse, 4 - 80339

Munich (Germany)

Or

GlaxoSmithKline Consumer Healthcare Sp. z o.o.,

Gnatowice Stare 30, 05-085 Kampinos, Poland

Or

GLAXOSMITHKLINE CONSUMER HEALTHCARE

Address:ul. Rzymowskiego 53 - Warszawa - 02-697 – Poland

Or

Famar Italia S.P.A

Via Zambeletti, 25, 20021 Baranzate (MI), Italy

Or

Haleon Germany GmbH

Barthstrasse, 4 - 80339

Munich (Germany)

This medication is authorized in EEA member states under the following names:

Belgium: Excedryn, film-coated tablets

Cyprus: Panmigran

Bulgaria: Excedrin 250mg / 250mg / 65mg ????????? ????????

Germany: Paracetamol/ASS/Coffein Kopfschmerz & Migräne 250mg/250mg/65mg Filmtabletten

Greece: Excedrin

Ireland: Excedrin film-coated tablets

Luxembourg: Excedryn, film-coated tablets

Malta: Panmigran

Netherlands: Excedrin, film-coated tablets

Poland: Excedrin MigraStop

Portugal: Excedrin

Slovakia: Excedrin

Slovakia: Excedrin

Date of the last revision of this prospectus: June 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/