XIDOLFEN 500 MG/200 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Xidolfen 500mg/200mg film-coated tablets

paracetamol/ibuprofen

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.
• You must not take this medicine for more than three days.

Contents of the package leaflet

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

1. What is Xidolfen and what is it used for

Xidolfen contains the active ingredients paracetamol and ibuprofen.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or pain).

Paracetamol is an analgesic that relieves pain and reduces fever.

This medicine is used in adults for the symptomatic occasional treatment of mild to moderate pain.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before you start taking Xidolfen

Do not take Xidolfen:

• if you are allergic to paracetamol, ibuprofen, or any of the other ingredients of this medicine (listed in section 6).
• if you have had asthma, hives, or allergic reactions after taking acetylsalicylic acid or other NSAIDs.
• if you have or have had an active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding demonstrated).
• if you have or have had gastrointestinal ulceration or bleeding, including those related to NSAIDs.
• if you have coagulation defects.
• if you have had a stroke or other bleeding.
• if you have severe heart failure.
• if you have severe liver or kidney problems.
• during the last three months of pregnancy.
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Xidolfen.

Prolonged or frequent use is not recommended.

Caution:Taking a dose higher than recommended is related to a risk of severe liver damage. It is thereforenot to be takena dose higher than the maximum daily dose of paracetamol recommended. Make sure you are not taking other medicines that contain paracetamol, including over-the-counter medicines. Do not combine them to avoid exceeding the recommended daily dose (see section3 and the sectionIf you take more Xidolfen than you should). You should also ensure that you are not taking other medicines that contain ibuprofen.

Analgesics and anti-inflammatory drugs like ibuprofen may be associated with a slight increase in the risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Xidolfen immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Consult your doctor or pharmacist before starting to take this medicine if:

• You have heart problems, such as heart failure, angina pectoris (chest pain), or if you have had a heart attack, have undergone surgical revascularization, have had peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or have had a stroke (including a transient ischemic attack or TIA).
• You have high blood pressure, diabetes, or high cholesterol, have a family history of heart disease or stroke, or are a smoker.
• You weigh less than 50 kg or have malnutrition.

Consult your doctor or pharmacist if:

• You have liver problems or liver disease (including Gilbert's syndrome), liver failure, or hepatitis, or if you notice that your skin and eyes turn yellow, which may indicate jaundice or a bile duct disorder.
• You have kidney disease or have difficulty urinating.
• You are taking other medicines that are known to affect the liver.
• You are pregnant or plan to become pregnant.
• You are breastfeeding or plan to breastfeed your child.
• You have acute fever or signs of a secondary infection or persistent disease.
• You have an infection. See the section Infectionsbelow.
• You are scheduled for surgery.
• You have or have had other conditions, such as:

• Deficiency of a specific enzyme called glucose-6-phosphate dehydrogenase.
• Heartburn, indigestion, stomach ulcers, or other gastric problems.
• Vomiting blood or intestinal bleeding.
• Severe skin reactions, such as exfoliative dermatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome.
• Asthma.
• Vision problems.
• Bleeding tendency or other blood disorders.
• Intestinal problems, such as ulcerative colitis or Crohn's disease.
• Swelling of the ankles or feet.
• Diarrhea.
• A hereditary or acquired genetic disorder of certain enzymes that manifests with neurological or skin complications, or both, i.e., porphyria.
• Chickenpox.
• Autoimmune disease, such as systemic lupus erythematosus (SLE) or other connective tissue disorders.

During treatment with Xidolfen, inform your doctor immediately if:

• you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have 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.

Prolonged use of analgesics can cause headache, which should not be treated with an increase in the dose of this medicine.

Taking this medicine may interfere with the results of urine tests for the detection of 5-hydroxyindoleacetic acid (5HIAA) and may cause false-positive results. To avoid false results, do not take this medicine or other medicines that contain paracetamol for several hours before or during urine sampling.

Skin reactions

Severe skin reactions have been reported with this medicine. You must stop taking this medicine and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Xidolfen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4. This medicine may mask the signs of an infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

During chickenpox, it is recommended to avoid the use of this medicine.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Xidolfen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use different types of analgesics at the same time, unless your doctor tells you to (see also the section Warnings and precautions).

This medicine may affect other medicines or be affected by them. For example:

• Anticoagulant medicines (to prevent or avoid blood clot formation, such as acetylsalicylic acid, warfarin, or ticlopidine).
• Medicines that lower high blood pressure (angiotensin-converting enzyme inhibitors [ACE inhibitors], such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).
• Medicines to treat epilepsy or seizures, such as lamotrigine.
• Chloramphenicol, an antibiotic used to treat ear and eye infections.
• Probenecid (a medicine used to treat gout).
• Zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency syndrome).
• Medicines that can damage the liver, such as barbiturates, phenytoin, primidone (for the treatment of epilepsy); rifampicin (for the treatment of bacterial infections); isoniazid (for the treatment of tuberculosis).
• Diuretics.
• Lithium, a medicine used to treat some types of depression.
• Methotrexate, a medicine used to treat arthritis and some types of cancer.
• Corticosteroids, such as prednisone and cortisone.
• Propanteline, antidepressants with anticholinergic properties, and narcotic analgesics.
• Metoclopramide or domperidone, a medicine for the treatment of nausea and vomiting.
• Colestyramine, a medicine used to reduce elevated serum lipid levels (high cholesterol).
• Tacrolimus or cyclosporin, immunosuppressive drugs used after organ transplantation.
• Sulfonylureas, a medicine used to treat diabetes.
• Certain antibiotics (such as quinolones or cotrimoxazole).
• Cardiac glycosides, which are medicines to strengthen the heart.
• Mifepristone (for abortion).
• Hormonal contraceptives/estrogens.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Your doctor and pharmacist will have more information about these medicines and how they interact.

Paracetamol administration may affect the results of certain diagnostic tests, such as the measurement of uric acid in the blood using the phosphotungstic acid method and the quantification of glucose in blood using the glucose oxidase-peroxidase test.

Some other medicines may also affect or be affected by treatment with this medicine. Therefore, you should always consult your doctor or pharmacist before taking this medicine with other medicines.

Taking Xidolfen with alcohol

While taking this medicine, do not consume alcoholic beverages, as it may cause liver damage. The toxic effect of alcohol is not increased with the use of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take this medicine during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and liver problems in the fetus. It may affect your tendency and that of your child to bleed and may cause a delay or prolongation of delivery. You must not take Xidolfen during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If during this period or while trying to become pregnant, you need treatment, the lowest dose should be used for the shortest possible time. If you take Xidolfen for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductal constriction) in your child's heart. If you need treatment for more than a few days, your doctor will recommend additional monitoring.

Breastfeeding

This medicine can be used during breastfeeding, if used for a short period with the recommended dose.

Fertility

This medicine may affect fertility. If you are planning to become pregnant or are having trouble conceiving, tell your doctor.

The product belongs to a group of medicines (NSAIDs) that may negatively affect fertility in women. This effect is reversible upon discontinuation of treatment.

Driving and using machines

This medicine may cause dizziness, drowsiness, fatigue, and visual disturbances in some people. This should be taken into account in situations that require maximum alertness, such as driving.

Be careful when driving or using machines until you know how this medicine affects you.

Xidolfen contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially 'sodium-free'.

3. How to take Xidolfen

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms.

If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Higher doses than recommended may involve serious risks.

Do not take this medication for more than 3 days. If symptoms persist for more than 3 days, consult a doctor.

Adults (weighing over 50 kg):the recommended dose is one to two tablets every six hours, as needed.

Do not take more than 6tablets per day (in 24hours). A period of at least 6hours must elapse between consecutive intakes.

Adults (weighing less than 50kg): the recommended dose is 1 tablet. At least 6 hours must elapse between each dose. The maximum dose is 4 tablets per day.

Elderly patients:no dose adjustment is necessary, but given the increased risk of adverse effects, the lowest effective dose should be used for the shortest possible time.

Hepatic impairment

If you have severe hepatic impairment or regularly drink a large amount of alcohol, do not take this medication.

If you have a liver function disorder (especially due to Gilbert's syndrome), inform your doctor or pharmacist before starting to take this medication. You should not take more than 1 tablet, and at least 6 hours must elapse between each dose (a maximum of 4 tablets per day).

Renal impairment

If you have severe renal impairment, do not take Xidolfen.

If you have mild to moderate renal impairment, inform your doctor or pharmacist before taking this medication.

The dose of paracetamol should be reduced according to the severity of renal impairment.

How to take Xidolfen

Swallow the tablet with a full glass of water. It is recommended to take it with food to reduce the risk of adverse effects.

If you take more Xidolfenthan you should

If you have used or taken too much of the medication, contact your doctor or pharmacist immediately.

Taking too many tablets can cause severe delayed liver and kidney damage, which could be fatal, and you may need urgent medical attention.

In case of overdose or accidental ingestion (by children and adolescents), consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested, to find out about the risk and ask for advice on the measures to be taken. Do this even if you do not experience signs of discomfort or intoxication.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood clots), headache, ringing in the ears, confusion, and involuntary eye movement. With high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported. These symptoms usually appear within 24 hours after taking the medication. The symptoms of liver damage may appear after a few hours or a few days after taking the medication.

To avoid the risk of possible liver damage, it is essential that your doctor administers an antidote as soon as possible. Massive absorption of paracetamol requires urgent hospitalization.

If you forget to take Xidolfen

If it is almost time to take the next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember and continue taking the tablets as usual.

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

If you are unsure whether to skip the dose, consult your doctor or pharmacist.

A period of at least 6 hours must elapse between two consecutive doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If any of these serious side effects occur, stop taking this medication and inform your doctor immediately.

Frequent

• vomiting blood or coffee-ground-like material;
• rectal bleeding, black and tarry stools, or bloody diarrhea;
• swelling of the face, lips, or tongue, which can cause difficulty swallowing or breathing.

Rare

angioedema, which includes symptoms such as swelling of the face or throat.

• Very rareasthma, wheezing, shortness of breath;
• very rare cases of severe skin reactions have been reported, including sudden or severe itching, skin rash, and hives;
• red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];

• worsening of pre-existing severe skin infections (you may experience a rash, blistering, and changes in skin color, fever, drowsiness, diarrhea, and discomfort) or worsening of other infections, including chickenpox, shingles, or a severe infection accompanied by tissue destruction (necrosis) and muscle damage, blistering, and skin peeling;
• fever, general malaise, nausea (feeling of dizziness), stomach pain, headache, and neck stiffness.

Frequency not known

• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• anaphylactic shock(a severe allergic reaction that can cause skin rash, itching, nausea, and vomiting). The symptoms can worsen with the development of respiratory problems and swelling of the lips, tongue, throat, or face. If left untreated, it can cause respiratory or circulatory arrest (when the blood stops circulating through the body).
• a serious condition that can cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Other side effects:

Frequent(may affect up to 1 in 10 people):

• nausea or vomiting;
• loss of appetite;
• stomach upset or pain in the upper stomach;
• cramps, gas, diarrhea, or mild gastrointestinal bleeding;
• skin rash, itching;
• feeling nervous;
• unusual weight gain, swelling, and fluid retention, swelling of the ankles or legs (edema).
• increased sweating.

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

• decreased red blood cell count, bleeding episodes, such as nosebleeds, abnormal or prolonged bleeding during menstruation;
• allergic reactions: skin rash, joint pain (e.g., serum sickness, lupus erythematosus, angioedema);
• breast enlargement in men; low blood sugar levels;
• insomnia;
• headache;
• dizziness;
• mood changes, such as depression, confusion, and nervousness;
• eye problems, such as blurred vision (reversible), pain, and redness of the eyes, itching:
• increased mucus thickness;
• severe stomach pain or tenderness; peptic ulcer/gastrointestinal ulcer; constipation;
• inflammation of the intestine and worsening of inflammation of the colon (colitis) and the digestive tract (Crohn's disease), as well as complications of diverticulitis (perforation or fistula);
• inability to empty the bladder completely (urinary retention);
• abnormal test results (blood test results and liver and kidney enzyme tests).

Rare(may affect up to 1 in 1,000 people):

• tingling in the hands and feet;
• liver function disorders, liver failure, liver cell death (necrosis), jaundice (with symptoms such as yellowing of the skin or eyes);
• itching, rash, hives;
• general malaise;
• overdose and poisoning.

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

• low potassium levels: weakness, fatigue (tiredness), muscle cramps (hypokalemia);
• signs of anemia, such as fatigue, headache, shortness of breath, and paleness;
• bleeding or bruising more easily than normal, red or purple spots under the skin;
• blood disorders (decreased red blood cell, white blood cell, or neutrophil count);
• severe or persistent headache;
• visual disturbances, feeling of spinning (vertigo), ringing in the ears;
• rapid or irregular heartbeat (also known as palpitations);
• increased blood pressure and possible heart problems;
• esophageal inflammation;
• liver damage (hepatotoxicity, especially with prolonged use);
• signs of frequent or severe infections, such as fever, chills, sore throat, or mouth ulcers;
• confusion, depression, hallucinations,
• allergic reactions that require discontinuation of treatment;
• cloudy urine.

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

• anemia (reduction in the number of red blood cells);
• hepatitis (liver inflammation);
• severe kidney failure after prolonged use of high doses.

Generalized, red, and scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). If you experience these symptoms, stop taking this medication and seek medical attention immediately. See also section 2.

There may be cases of a reaction known as DRESS syndrome. The symptoms of DRESS syndrome include generalized skin rash, elevated body temperature, swollen lymph nodes, and increased eosinophil count (a type of white blood cell). If you experience these symptoms, stop taking this medication and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

The above list includes serious side effects that may require medical attention. Serious side effects are rare with low doses of this medication and when used for a short period.

Reporting side effects

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

5. Storage of Xidolfen

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Xidolfen composition

• The active ingredients are paracetamol and ibuprofen. Each film-coated tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
• The other ingredients are:

Tablet core: povidone (E-1201), microcrystalline cellulose, sodium carboxymethyl starch (from potato), magnesium stearate.

Tablet coating: polyvinyl alcohol, macrogol, talc (E-553b), and titanium dioxide (E-171).

Xidolfen appearanceand package contents

Film-coated tablet, oblong, white to off-white, and 20 mm in length.

The tablets are presented in opaque white PVC/PVDC-Al blisters containing 3, 6, 8, 9, 10, 12, 16, 18, or 30 film-coated tablets or in opaque white plastic bottles containing 30 film-coated tablets.

The tablets are presented in single-dose perforated blisters with 90 × 1, 120 × 1, 180 × 1, 200 × 1, or 240 × 1 film-coated tablets or in opaque white plastic bottles containing 120 film-coated tablets for hospital use.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratoires S.M.B. S.A.

Rue de la Pastorale 26-28

1080 Brussels

Belgium

S.M.B. Technology S.A.

Rue du Parc Industriel 39

6900 Marche-en-Famenne

Belgium

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium Nuralgan 500 mg/200 mg

Denmark Xidolfen 500 mg/200 mg

Spain Xidolfen 500 mg/200 mg

Luxembourg Nuralgan 500 mg/200 mg

Netherlands Nuralgan 500 mg/200 mg

Portugal Xidolfen 500 mg/200 mg

Sweden Algifen 500 mg/200 mg

Date of the last revision of this prospectus: January/2025.

Other sources of information

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