EXCEDRIN 200 mg + 500 Mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Excedrin Duo, 500 mg + 200 mg, coated 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 Excedrin Duo and what is it used for
4. Important information before taking Excedrin Duo
   1. When not to take Excedrin Duo
   2. Warnings and precautions
   3. Excedrin Duo and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Excedrin Duo contains sodium
5. How to take Excedrin Duo
   1. Adults
   2. Use in children and adolescents
   3. Taking a higher dose of Excedrin Duo than recommended
   4. Missing a dose of Excedrin Duo
6. Possible side effects
   1. YOU SHOULD STOP TAKING the medicine and inform your doctor if you experience:
   2. Reporting side effects
7. How to store Excedrin Duo
8. Contents of the packaging and other information
   1. What Excedrin Duo contains
   2. What Excedrin Duo looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: February 2025

Leaflet accompanying the packaging: information for the user

Excedrin Duo, 500 mg + 200 mg, coated tablets

Paracetamol + Ibuprofen

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 this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

This medicine is called Excedrin Duo.
Excedrin Duo contains two active substances (which make the medicine work). These are: paracetamol and ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The action of NSAIDs is to relieve pain, reduce swelling, and lower elevated body temperature.
Paracetamol is a pain reliever that relieves pain and fever, working in a different way than ibuprofen.
Excedrin Duo is used for the short-term symptomatic treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscle pain, joint pain with a severity other than severe, symptoms of the common cold and flu, sore throat, and fever.
This product is particularly suitable for pain that cannot be relieved by taking only ibuprofen or only paracetamol.
Excedrin Duo is intended for adults over 18 years of age.

2. Important information before taking Excedrin Duo

When not to take Excedrin Duo

• if you are allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• if you are already taking other medicines containing paracetamol.
• if you are taking any other pain relievers, including ibuprofen, high doses of acetylsalicylic acid (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
• if you have ever had an allergic reaction, such as bronchospasm (constriction of the muscles in the lungs, which can cause shortness of breath), asthma, rhinitis, itching, and inflammation of the nasal mucosa with sneezing, urticaria (itching rash), or angioedema (swelling under the skin) when taking acetylsalicylic acid or other NSAIDs.
• if you have active or recurrent peptic ulcer or bleeding from the stomach or duodenum (small intestine) (at least two separate episodes of confirmed bleeding or ulceration).
• if you have ever had a perforation or bleeding in the stomach or duodenum caused by previous NSAID treatment.
• if you have bleeding disorders.
• if you have acute heart, liver, or kidney failure.
• during the last three months of pregnancy.

Warnings and precautions

Before starting to take Excedrin Duo, you should discuss it with your doctor or pharmacist if:

• you have an infection - see the "Infections" section below,
• you are elderly,
• you currently have asthma or have had asthma in the past,
• you have kidney, heart, liver, or bowel problems,
• you have systemic lupus erythematosus (SLE) - an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and disorders of other organs or other mixed connective tissue disease,
• you have stomach and bowel disorders or chronic non-specific enteritis (e.g., ulcerative colitis, Crohn's disease),
• you are breastfeeding or plan to become pregnant.

While taking Excedrin Duo, 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 when you are also taking flucloxacillin (an antibiotic). There have been reports of a severe condition called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Infections
Excedrin Duo may mask the symptoms of infection, such as fever and pain. Therefore, Excedrin Duo may delay the use of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, you should immediately consult a doctor.
There have been reports of severe skin reactions associated with the use of Excedrin Duo. If a skin rash, mucosal lesions, blisters, or other signs of allergy occur, you should stop taking Excedrin Duo and seek medical attention immediately, as these may be the first signs of a very severe skin reaction. See section 4.
Taking anti-inflammatory or pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose of the medicine or the duration of treatment.
Before starting to take Excedrin Duo, you should discuss it with your doctor or pharmacist if:

• you have heart problems, including heart failure, angina pectoris (chest pain), or a history of heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the lower limbs due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke", or transient ischemic attack, TIA),
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Excedrin Duo and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Excedrin Duo with:

• other medicines containing paracetamol;
• other pain relievers, including ibuprofen, acetylsalicylic acid in high doses (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors. To avoid overdose, you should control the concurrent use of other products containing ibuprofen.

Excedrin Duo may affect the action of some other medicines, and some other medicines may affect the action of Excedrin Duo. You should inform your doctor or pharmacist if you are taking:

• corticosteroids;
• antibiotics (e.g., chloramphenicol or quinolones);
• antiemetic medicines (e.g., metoclopramide, domperidone);
• anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• heart stimulants (e.g., glycosides);
• cholesterol-lowering medicines (e.g., cholestyramine);
• diuretics (which facilitate urination);
• medicines that lower high blood pressure (e.g., ACE inhibitors, such as captopril; beta-blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan);
• immunosuppressive medicines (e.g., methotrexate, cyclosporine, tacrolimus);
• medicines used to treat mania or depression (e.g., lithium or selective serotonin reuptake inhibitors, SSRIs);
• mifepristone (for abortion);
• medicines used in HIV infection (e.g., zidovudine);
• flucloxacillin (an antibiotic), due to the serious risk of disorders (called metabolic acidosis), which requires emergency treatment (see section 2). Excedrin Duo may also affect the action of some other medicines, and some other medicines may affect the action of Excedrin Duo. Therefore, before taking Excedrin Duo with other medicines, you should always consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Excedrin Duo during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. The medicine may cause kidney and heart problems in the fetus. It may affect the tendency to bleed in the mother and child and cause delayed or prolonged labor.
Do not take Excedrin Duo during the first six months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or if you are trying to become pregnant, you should use the smallest dose for the shortest possible time.
If Excedrin Duo is taken for more than a few days after the 20th week of pregnancy, it may cause kidney problems in the fetus, which can lead to a decrease in the amount of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the fetus's heart. If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of paracetamol, ibuprofen, and its metabolites pass into breast milk.
This medicine can be taken during breastfeeding if used in the recommended dose and for the shortest possible time.
Fertility
Excedrin Duo may make it harder to become pregnant. Ibuprofen belongs to a group of medicines that may have a negative effect on female fertility. This effect is reversible after stopping the medicine. You should inform your doctor if you have problems becoming pregnant.

Driving and using machines

After taking non-steroidal anti-inflammatory drugs (NSAIDs), side effects such as dizziness, drowsiness, fatigue, and vision disturbances may occur. If these occur, patients should not drive or operate machinery.

Excedrin Duo contains sodium

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

3. How to take Excedrin Duo

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
For oral administration and only for short-term use.
Taking the medicinal product in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects. If you have an infection, you should immediately consult a doctor if the symptoms (such as fever and pain) persist or worsen (see section 2).
If you have liver or kidney disease or are elderly, your doctor will determine the appropriate dose, which will be as low as possible. Do not take this medicine if you have severe kidney or liver failure.
Do not take Excedrin Duo for more than 3 days. If symptoms worsen or persist, you should consult a doctor.

Adults

Take one tablet, up to a maximum of 3 times a day.
The interval between doses of the medicine must be at least 6 hours.
If one tablet of the medicine does not provide control of symptoms, you can take up to 2 tablets up to three times a day. A single dose of two tablets is intended for patients with a body weight of 60 kg and above. You should maintain an interval of at least 6 hours between doses.
Do not take more than six tablets in 24 hours (which corresponds to 3000 mg of paracetamol, 1200 mg of ibuprofen).
Take Excedrin Duo with a glass of water.
To minimize the likelihood of side effects, Excedrin Duo should be taken with food.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

Taking a higher dose of Excedrin Duo than recommended

In case of taking a higher dose of Excedrin Duo than recommended or accidental ingestion of the medicine by children, you should always contact a doctor or the nearest hospital for advice on the risk and what actions to take.
Overdose symptoms may include nausea, abdominal pain, vomiting (with blood possibly appearing in the vomit), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. You may also experience agitation, drowsiness, disorientation, or coma. Seizures have been reported in some cases. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, the presence of blood in the urine, low potassium levels in the blood, feeling cold all over, and breathing problems have been reported. Additionally, there may be a prolonged prothrombin time/INR, probably due to disturbances in the action of circulating clotting factors. Acute kidney failure and liver damage may occur. In people with asthma, the disease may worsen. Additionally, low blood pressure and reduced breathing may occur. If you have taken too much of this medicine, you should immediately contact a doctor, even if you feel well. This is because too much paracetamol can cause delayed, severe liver damage.

Missing a dose of Excedrin Duo

Do not take a double dose of the medicine to make up for a missed dose. If you miss a dose, you should take it as soon as possible, and the next dose of the medicine should be taken no earlier than after a further 6 hours.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

YOU SHOULD STOP TAKING the medicine and inform your doctor if you experience:

• heartburn, indigestion (frequent side effects, may occur in up to 1 in 10 people); symptoms of gastrointestinal bleeding (severe abdominal pain, vomiting blood or coffee-ground-like material, presence of blood in stool, black, tarry stools) (uncommon side effects; may occur in up to 1 in 100 people);
• symptoms of meningitis (such as stiff neck, headache, nausea or vomiting, fever, or disorientation) (very rare side effects, may occur in up to 1 in 10,000 people);
• symptoms of a severe allergic reaction (swelling of the face, tongue, or throat, difficulty breathing, worsening of asthma symptoms) (very rare side effects, may occur in up to 1 in 10,000 people);
• severe skin reactions, such as blistering - see also the information below.

A severe skin reaction called DRESS syndrome (frequency not known). The symptoms of DRESS syndrome include skin rash, fever, swelling of lymph nodes, and an increase in the number of eosinophils (a type of white blood cell).
A red, scaly, widespread rash with bumps under the skin and blisters, mainly on the skin folds, torso, and upper limbs, which is accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis) (frequency not known). If you experience such symptoms, you should stop taking Excedrin Duo and seek medical attention immediately. See also section 2.
Other possible side effects
Common (may occur in up to 1 in 10 people):

• abdominal pain or discomfort, nausea or vomiting, diarrhea;
• increased activity of some liver enzymes ALT, GGT, creatinine, and urea (found in blood tests);
• increased sweating.

Uncommon (may occur in up to 1 in 100 people):

• headache and dizziness,
• bloating (gas) and constipation,
• mouth ulcers, worsening of ulcerative colitis and Crohn's disease, gastritis or pancreatitis,
• skin rashes, facial swelling, itching,
• increased activity of liver enzymes (AST, ALP) and creatine phosphokinase, decreased hemoglobin (a protein in red blood cells) or increased platelet count (cells involved in blood clotting) (according to blood test results).

Very rare (may occur in up to 1 in 10,000 people):

• decrease in blood cell count (causing sore throat, mouth ulcers, flu-like symptoms, increased fatigue, unexplained bleeding, bruising, and nosebleeds);
• vision disturbances, ringing in the ears, feeling of dizziness;
• disorientation, depression, hallucinations;
• fatigue, general malaise;
• red or purple spots on the skin that do not fade under pressure and are caused by bleeding under the skin (purpura);
• high blood pressure, fluid retention;
• liver problems (causing yellowing of the skin and whites of the eyes);
• kidney problems (causing adaptation or decreased urination, swelling of the legs);
• heart failure (causing shortness of breath, swelling);
• tingling, numbness, or itching;
• optic neuritis;
• drowsiness.

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

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

Taking medicines like Excedrin Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Excedrin Duo

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Excedrin Duo contains

• The active substances of this medicine are paracetamol and ibuprofen. Each coated tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
• The other ingredients are sodium croscarmellose, hydroxypropyl cellulose, microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate. Coating: copolymer of methacrylic acid and ethyl acrylate, talc, pearlescent pigment based on mica, glycerol monicaprylocaprate, polyvinyl alcohol, titanium dioxide (E 171), black iron oxide (E 172).

What Excedrin Duo looks like and contents of the pack

Excedrin Duo is an oval gray tablet.
Excedrin Duo is available in blisters containing 10 or 20 coated tablets or in a bottle containing 30 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
(Pharmaceutical Works POLPHARMA S.A.)
ul. Pelplińska 19
83-200 Starogard Gdański

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Latvia: Metafenex, 500mg/200mg, apvalkotā tabletes
Bulgaria: Метафен Макс, 500 mg/200 mg, филмирани таблетки
Lithuania: Metafenex, 500mg/200mg, plėvele dengta tabletės
Cyprus: Panadol Duo 500 mg/200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Czech Republic: Panadol Duo
Greece: Panadol Plus 500 mg/200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Panadol Duo 500 mg/200 mg filmtabletta
Ireland: Paracetamol/Ibuprofen Haleon 500 mg/200 mg film-coated tablets
Malta: Panadol Duo 500 mg/200 mg film-coated tablets
Poland: Excedrin Duo
Romania: Panadol Duo 500 mg/200 mg comprimate filmate
Slovakia: Panadol Duo

Date of last revision of the leaflet: February 2025