Excedrin duo

Package leaflet: Information for the user

Excedrin Duo, 500 mg + 200 mg, coated tablets
Paracetamolum + Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet, or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Excedrin Duo is and what it is 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 pack and other information

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

This medicine is called Excedrin Duo.
Excedrin Duo contains two active substances (which make the medicine work): paracetamol and
ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by relieving pain, reducing swelling, and lowering fever.
Paracetamol is a painkiller which relieves pain and fever, acting in a different way than ibuprofen.
Excedrin Duo is used for the short-term symptomatic treatment of mild to moderate pain associated with migraine, headaches, backache, menstrual pain, toothache, rheumatic and muscular pain, joint pain (other than severe), symptoms of cold and flu, sore throat, and fever.
This product is particularly suitable for pain not relieved by ibuprofen or paracetamol alone.
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 the patient is allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is already taking other medicines containing paracetamol.
• if the patient is taking any other painkillers, including ibuprofen, high-dose acetylsalicylic acid (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
• if the patient has ever experienced an allergic reaction such as bronchospasm (constriction of the muscles in the lungs, which may cause difficulty breathing), asthma, rhinitis, itching, nasal mucosal inflammation with sneezing, urticaria (itchy rash), or angioedema (swelling under the skin) while taking acetylsalicylic acid or other NSAIDs.
• if the patient has active or recurrent peptic ulcer or gastrointestinal bleeding (stomach or duodenal bleeding) (at least two separate episodes of confirmed bleeding or ulceration).
• if the patient has ever had a perforation or bleeding in the stomach or duodenum caused by previous NSAID treatment.
• if the patient has blood clotting disorders.
• if the patient has acute heart, liver, or kidney failure.
• during the last three months of pregnancy.

Warnings and precautions
Before starting to take Excedrin Duo, consult your doctor or pharmacist if:

• the patient has an infection – see the section "Infections" below,
• the patient is elderly,
• the patient currently suffers from asthma or has had asthma in the past,
• the patient has kidney, heart, liver, or intestinal problems,
• the patient has systemic lupus erythematosus (SLE) – an autoimmune connective tissue disease causing joint pain, skin lesions, and organ dysfunction, or another mixed connective tissue disease,
• the patient has stomach or intestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease),
• the patient is in the first 6 months of pregnancy or is breastfeeding,
• the patient plans to become pregnant.

While taking Excedrin Duo, immediately inform your doctor if:
the patient has severe medical 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). Cases of a serious condition called metabolic acidosis (a blood and fluid imbalance) have been reported in patients who take paracetamol regularly over a long period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Infections
Excedrin Duo may mask symptoms of infection such as fever and pain. Therefore, Excedrin Duo may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and infection symptoms persist or worsen, consult a doctor immediately.

Serious skin reactions have been reported with the use of Excedrin Duo. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, stop taking Excedrin Duo immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.

The use of anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Before taking Excedrin Duo, consult your doctor or pharmacist if:

• the patient has heart problems, including heart failure, angina (chest pain), previous heart attack, peripheral artery bypass surgery, peripheral arterial disease (poor circulation in the lower limbs due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke", i.e. transient ischaemic attack [TIA]),
• the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient is a smoker.

Excedrin Duo and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take Excedrin Duo together with:

• other medicines containing paracetamol;
• other painkillers, including ibuprofen, high-dose acetylsalicylic acid (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors. To avoid overdose, monitor concomitant use of other products containing ibuprofen.

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

• corticosteroids;
• antibiotics (e.g. chloramphenicol or quinolones);
• antiemetics (e.g. metoclopramide, domperidone);
• anticoagulants (i.e. blood thinners or agents preventing blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• heart stimulants (e.g. cardiac glycosides);
• cholesterol-lowering medicines (e.g. cholestyramine);
• diuretics (medicines that help urine excretion);
• medicines to lower high blood pressure (ACE inhibitors such as captopril; beta-blockers such as atenolol; angiotensin II receptor antagonists such as losartan);
• medicines that suppress the immune system (e.g. methotrexate, cyclosporine, tacrolimus);
• medicines used to treat mania or depression (e.g. lithium or SSRIs [selective serotonin reuptake inhibitors]);
• mifepristone (for termination of pregnancy);
• medicines used in HIV infection (e.g. zidovudine);
• flucloxacillin (an antibiotic), due to the serious risk of disturbances (called metabolic acidosis) requiring urgent treatment (see section 2). Excedrin Duo may also affect the action of certain other medicines, and some other medicines may affect the action of Excedrin Duo. Therefore, always consult your doctor or pharmacist before taking Excedrin Duo together with other medicines.

Pregnancy, breastfeeding, and effects on fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not take Excedrin Duo during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. The medicine may cause kidney and heart problems in the unborn baby. It may affect bleeding tendencies in both mother and child and may delay or prolong labour.

Do not take Excedrin Duo during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or if the patient is trying to conceive, use the lowest effective dose for the shortest possible time.

If Excedrin Duo is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney function disturbances in the unborn baby, which may lead to reduced amniotic fluid (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is necessary, your doctor may recommend additional monitoring.

Breastfeeding
Only small amounts of paracetamol, ibuprofen, and its metabolites pass into breast milk. This medicine may be taken during breastfeeding if used at the recommended dose and for the shortest possible duration.

Effect on fertility
Excedrin Duo may make it more difficult to become pregnant. Ibuprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible upon discontinuation of the medicine. Inform your doctor if you have difficulty becoming pregnant.

Driving and using machines
After taking NSAIDs, adverse effects such as dizziness, drowsiness, fatigue, and visual 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, i.e. it is considered "sodium-free".

3. How to take Excedrin Duo

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use only and for short-term use only.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects. If the patient has an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
If the patient has liver or kidney disease or is elderly, the doctor will determine the appropriate dose, which will be as low as possible. Do not use this medicine if the patient has severe renal or hepatic impairment.
Do not take Excedrin Duo for longer than 3 days. If symptoms worsen or persist, consult a doctor.

Adults
Take one tablet, up to three times a day.
The interval between doses must be at least 6 hours.
If one tablet does not provide adequate symptom control, up to 2 tablets may be taken up to three times a day. A single dose of two tablets is intended for patients weighing 60 kg or more. Maintain an interval of at least 6 hours between doses.
Do not take more than six tablets within 24 hours (equivalent to 3000 mg paracetamol, 1200 mg ibuprofen).
Excedrin Duo should be taken with a glass of water.
To reduce the likelihood of adverse 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 further questions about the use of this medicine, consult a doctor or pharmacist.

Overdose of Excedrin Duo
If more than the recommended dose of Excedrin Duo is taken, or if the medicine is accidentally ingested by a child, contact a doctor or the nearest hospital immediately for advice on potential risks and necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (blood may appear in vomit), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, disorientation, and nystagmus. Stimulation, drowsiness, disorientation, or coma may also occur. Occasionally, seizures may occur in individuals taking the medicine.
After ingestion of high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling of whole-body coldness, and breathing difficulties may be reported. Additionally, prolonged prothrombin time/INR may occur, likely due to disturbances in circulating coagulation factors. Acute renal failure and liver damage may also occur. In individuals with asthma, disease exacerbation is possible. Additionally, hypotension and respiratory depression may occur. In case of overdose of this medicine, contact a doctor immediately, even if the patient feels well. This is because an excessive dose of paracetamol may cause delayed, severe liver damage.

Missed dose of Excedrin Duo
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as possible, and then take the next dose no sooner than after another 6 hours have passed.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
THE USE OF THE MEDICINE SHOULD BE DISCONTINUED and a doctor should be informed if the patient experiences:

• heartburn, indigestion (common adverse effects, may occur in up to 1 in 10 people); symptoms of intestinal bleeding (severe abdominal pain, vomiting blood or a substance resembling coffee grounds, blood in stool, black tarry stools) (uncommon adverse effects; may occur in up to 1 in 100 people);
• symptoms of inflammation of the membranes surrounding the brain (meningitis), such as neck stiffness, headache, nausea or vomiting, fever, or confusion (very rare adverse effects, may occur in up to 1 in 10,000 people);
• symptoms of severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing, worsening of asthma symptoms) (very rare adverse effects, may occur in up to 1 in 10,000 people);
• severe skin reactions, such as blistering – see also information below.

A serious skin reaction called DRESS syndrome (frequency unknown). Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
A widespread red, peeling rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, initially accompanied by fever (acute generalized exanthematous pustulosis) (frequency unknown). If such symptoms occur, Excedrin Duo should be discontinued immediately and medical help should be sought without delay. See also section 2.

Other possible adverse effects
Common (may occur in up to 1 in 10 people):

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

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

• headache and dizziness;
• flatulence (intestinal gas) and constipation;
• mouth ulcers, exacerbation of ulcerative colitis and Crohn's disease, gastritis or pancreatitis;
• skin rashes, facial swelling, itching;
• increased activity of liver enzymes (AST, ALP) and creatine kinase, decreased haemoglobin levels (protein in red blood cells) or increased platelet count (cells involved in blood clotting) (as per blood test results).

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

• decreased blood cell counts (causing sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising and nosebleeds);
• visual disturbances, tinnitus, sensation of dizziness;
• confusion, depression, hallucinations;
• fatigue, general malaise;
• red or purple spots on the skin that do not fade under pressure, caused by subcutaneous bleeding (purpura);
• high blood pressure, fluid retention;
• liver problems (causing yellowing of the skin and whites of the eyes);
• kidney problems (causing reduced urine output or decreased urination, swelling of the legs);
• heart failure (causing shortness of breath, oedema);
• tingling, numbness or itching;
• optic neuritis;
• somnolence.

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

• skin photosensitivity;
• serious condition that may cause blood to become more acidic (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

The use of medicines such as Excedrin Duo may be associated with a small increased risk of myocardial infarction ("heart attack") or stroke (see section 2).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Excedrin Duo

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Excedrin Duo contains

• The active substances in this medicine are paracetamol and ibuprofen. Each film-coated tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
• Other ingredients are sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, colloidal anhydrous silica, stearic acid, magnesium stearate. Coating: polyvinyl alcohol-polyethylene glycol grafted copolymer, talc, pearl pigment based on mica, glycerol monooctanoate, 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, grey tablet.
Excedrin Duo is available in blister packs containing 10 or 20 film-coated tablets or in a bottle containing 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for marketing 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