PARACETAMOL/IBUPROFEN WINADOL 500 MG/200 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol/Ibuprofen Winadol 500 mg/200 mg

film-coated tablets

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

Follow the instructions for administration 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 they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days. You should not take this medicine for more than 3 days.

Contents of the package leaflet

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

1. What is Paracetamol/Ibuprofeno Winadol and what is it used for

Paracetamol/Ibuprofeno Winadol contains two active substances (which make the medicine work). These are paracetamol and ibuprofen.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works differently from ibuprofen, but both active substances work together to reduce pain.

Paracetamol/Ibuprofeno is used for the symptomatic treatment of occasional mild to moderate pain. This medicine is especially indicated for pain that has not been relieved by ibuprofen or paracetamol alone.

Paracetamol/ibuprofeno is used in adults over 18 years of age.

2. What you need to know before taking Paracetamol/Ibuprofeno Winadol

Do not take Paracetamol/Ibuprofeno Winadol:

• if you are allergic to ibuprofen, paracetamolor to any of the other ingredients of this medicine (listed in section 6),
• if you are taking any other medicine that contains paracetamol,
• if you have a history of allergic reactions (e.g., bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),

• if you have an active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding confirmed).
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• if you have a cerebrovascular hemorrhage or other active bleeding,
• if you suffer from blood coagulation disorders.
• if you suffer from severe heart, liver, or kidney failure,
• if you are severely dehydrated, caused by vomiting, diarrhea, or insufficient fluid intake,
• if you are in the last 3 months of pregnancy.
• if you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol/Ibuprofeno Winadol if:

• you are an elderly patient,
• you have asthma or have suffered from asthma,
• you have kidney, heart, liver, or intestinal problems, hepatitis, or difficulty urinating,
• you are being treated concomitantly with medicines that affect liver function,
• you are allergic to other substances,
• you have stomach acid, indigestion, stomach ulcers, or any other stomach problem,
• you have a tendency to bleed,
• you have Gilbert's syndrome (a rare inherited metabolic disorder with possible signs such as yellowing of the skin or the whites of the eyes),
• you have systemic lupus erythematosus (SLE), a condition of the immune system that affects connective tissue and causes joint pain, skin changes, and disorders of other organs or other mixed connective tissue disease,
• you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease),
• you have an infection; consult the section "Infections" below,
• you have a hereditary deficiency of a certain enzyme called glucose-6-phosphate dehydrogenase,
• you have a hereditary or acquired genetic disorder of certain enzymes that manifests with neurological complications or skin problems or occasionally both, i.e., porphyria,
• you have hemolytic anemia,
• you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there may be a higher risk of allergic reactions,
• you suffer from chronic alcoholism,
• you have low weight or chronic malnutrition,
• you have a lack of body water (dehydration),
• you have recently had major surgery,
• you are in the first 6 months of pregnancy or are breastfeeding,
• you are planning to become pregnant.

Consult your doctor if any of the above warnings apply to you, or if you have suffered from them in the past. You may need to avoid this medicine or need to reduce the dose.

Side effects can be minimized by using the minimum effective dose for the shortest necessary time to control symptoms. Do not take paracetamol/ibuprofeno for more than 3 days.

Concomitant use with NSAIDs, including specific cyclooxygenase-2 inhibitors, increases the risk of adverse reactions (see below “Other medicines and Paracetamol/Ibuprofeno Winadol”) and should be avoided.

Warning: taking higher doses than the recommended doses does not provide greater pain relief, but causes the risk of severe liver damage. Therefore, do not exceed the maximum daily dose of paracetamol. Do not take other medicines that also contain paracetamol (see also the section “Do not take Paracetamol/Ibuprofeno Winadol” above). The symptoms of liver damage usually occur for the first time after a couple of days. Therefore, it is essential to consult a doctor immediately if you have taken more than recommended. See also section 3 “If you take more Paracetamol/Ibuprofeno Winadol than you should”.

Anti-inflammatory/analgesic medicines like 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 treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs and feet due to narrow or blocked arteries) or any type of stroke (including 'mini-stroke' or transient ischemic attack “TIA”),
• you have high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker

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 Paracetamol/Ibuprofeno immediately and contact your doctor or medical emergency service immediately if you notice any of these signs.

Skin reactions

Serious skin reactions have been reported associated with paracetamol/ibuprofeno treatment. Stop taking this medicine and go to the doctor immediately if you develop a skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very serious skin reaction. See section 4.

Infections

Paracetamol/Ibuprofeno may hide the signs of an infection, such as fever and pain. Therefore, this medicine may delay the proper treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonias 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 immediately.

Gastrointestinal symptoms

Serious gastrointestinal side effects (affecting the stomach and intestine) have been reported with the use of NSAIDs, including ibuprofen. These can occur with or without warning symptoms. The risk of these side effects is higher in patients with a history of stomach or intestinal ulcers, particularly if there was also bleeding or perforation. Elderly patients have a higher risk of gastrointestinal side effects. You should discuss any history of gastrointestinal problems with your doctor and remain alert to any unusual abdominal symptoms, such as nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, black tarry stools, or vomiting blood.

Prolonged use of analgesics

Prolonged use of analgesics for headaches can worsen them. If you experience or suspect this situation, you should inform your doctor and interrupt treatment.

Regular use of analgesics, particularly in combination with several pain-relieving medicines, can cause permanent kidney damage with a risk of kidney failure, a condition called analgesic nephropathy. This risk may increase under physical exertion associated with loss of salt and dehydration. Therefore, it should be avoided.

Vision problems

If you notice any problems with your vision after using paracetamol/ibuprofeno, stop using the medicine and consult a doctor.

Other considerations

In general, the habitual intake of analgesics, particularly in combination with several pain-relieving active substances, can lead to permanent kidney damage with a risk of kidney failure. Therefore, it should be avoided.

During treatment with Paracetamol/Ibuprofeno Winadol, inform your doctor immediately if:

If you have severe 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 if you 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 of discomfort (nausea) and vomiting.

Children and adolescents

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

Other medicines and Paracetamol/Ibuprofeno Winadol

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

Do not take Paracetamol/Ibuprofeno Winadol with:

• Other medicines that contain paracetamol, such as some cold and flu medicines or pain relievers.

Paracetamol/ibuprofeno may affect or be affected by other medicines. For example:

• anticoagulant medicines(used to thin the blood/prevent clotting, such as acetylsalicylic acid, warfarin, and ticlopidine).
• medicines that lower high blood pressure(ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• medicines to treat epilepsy or convulsions(e.g., phenytoin).
• chloramphenicol, an antibiotic used to treat ear and eye infections.
• probenecid and sulfinpyrazone, medicines used to treat gout.
• zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency disease).
• medicines used to treat tuberculosis, such as isoniazid.
• diuretics(to help urinate).
• lithium or ISRS, a medicine used to treat mania and some types of depression.
• methotrexate, a medicine used to treat arthritis and some types of cancer.
• corticosteroid tablets, such as prednisone, cortisone.
• antiemetic medicines(e.g., metoclopramide, domperidone),
• acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• medicines that decrease gastric emptying,
• medicines used to treat bacterial infections called aminoglycosides,
• antifungal medicinesthat inhibit the liver enzyme CYP2C9 (e.g., voriconazole, fluconazole),
• other medicines thatare known to affect the liveror that induce liver microsomal enzymessuch as alcohol and antiepileptic medicines (e.g., carbamazepine, phenobarbital, lorazepam),
• ginkgo biloba(a herbal medicine) may increase the risk of bleeding with NSAIDs,
• medicines for high cholesterol, for example: colestyramine, a medicine used to reduce increased serum lipid levels.
• tacrolimus or cyclosporin, immunosuppressive drugsused after organ transplantation.
• sulfonylureas, a medicine used to treat diabetes.
• some antibiotics(such as quinolone or cotrimoxazole antibiotics)
• cardiac glycosides (e.g., digoxin), medicines to strengthen the heart.
• mifepristone(to interrupt pregnancy)
• flucloxacillin(antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Other medicines may also affect or be affected by treatment with Paracetamol/Ibuprofeno. Therefore, you should always seek the advice of your doctor or pharmacist before using paracetamol/ibuprofeno with other medicines.

Your doctor and pharmacist will have more information about these medicines and how to act.

Taking Paracetamol/Ibuprofeno Winadol with food and alcohol

To reduce the likelihood of side effects, take paracetamol/ibuprofeno with food. Do not drink alcohol during treatment with this medicine. Alcohol may increase the toxicity of paracetamol in the liver. The intoxicating effect of alcohol does not increase when taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Pregnancy

Do not take this medicine if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your baby. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. The use of this product should be avoided in women who are pregnant or planning to become pregnant. You should not take paracetamol/ibuprofeno during the first 6 months of pregnancy unless it is absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days from 20 weeks of pregnancy, paracetamol/ibuprofeno may cause kidney problems in your baby at birth, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) 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.

Paracetamol/ibuprofeno may make it difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems conceiving.

• Breastfeeding

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

• Fertility

Ibuprofen belongs to a group of medicines that may affect female fertility. Paracetamol/ibuprofeno may make it difficult to become pregnant. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

Paracetamol/ibuprofeno may cause dizziness, concentration problems, and drowsiness. If you are affected, do not drive or use tools or machines.

Paracetamol/Ibuprofeno Winadol contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Paracetamol/Ibuprofen Winadol

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

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Doses higher than recommended can produce serious risks.

Adults:The recommended dose is 1 to 2 tablets every 6 hours as needed.

Do not take more than 6 tablets in a 24-hour period. Leave at least 6 hours between doses.

Do not take this medication for more than 3 days.

How to take the medication

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

If you take more Paracetamol/Ibuprofen Winadol than you should

If you have taken more Paracetamol/Ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, 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 there are no signs of discomfort or intoxication.

Taking too many tablets can cause serious liver and kidney damage, which can be fatal. You may need urgent medical attention.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported. Additionally, there may be low blood pressure and decreased breathing.

If you forget to take Paracetamol/Ibuprofeno Winadol

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 not sure whether to skip or not, talk to your doctor or pharmacist.

Always leave at least 6 hours between doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people suffer from them.

Regarding the following side effects, it should be noted that they depend largely on the dose and vary from patient to patient.

The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatally, especially in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease have been reported. Gastritis has been observed less frequently. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of use.

Cases of edema, high blood pressure, and heart failure have been reported in association with treatment with NSAIDs. Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

STOP TAKING the medication and inform your doctor if you experience:

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

• signs of intestinal bleeding, (severe stomach pain, vomiting blood or liquid that looks like coffee grounds, blood in the stool, black tarry stools).

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

• symptoms of aseptic meningitis, inflammation of the brain lining such as: stiffness in the neck, headache, nausea or vomiting, fever or loss of consciousness,
• severe allergic reactions. Symptoms may include: swelling of the face, tongue, or larynx, difficulty breathing, rapid heartbeat, low blood pressure (anaphylaxis, angioedema, or severe shock),
• respiratory reactivity including asthma, worsening of asthma, wheezing, difficulty breathing,
• severe forms of skin reactions, such as blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis,
• worsening of severe existing skin infections (may notice rash, blisters, and skin discoloration, fever, drowsiness, diarrhea, and nausea), or worsening of other infections, such as chickenpox or herpes zoster or severe infection with destruction (necrosis) of the skin, subcutaneous tissue, and muscle, blisters, and skin peeling.

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

• a severe skin reaction known as DRESS syndrome (frequency not known). The symptoms of DRESS include: skin rash, fever, lymph node inflammation, and an increase in eosinophils (a type of white blood cell),
• red, scaly, generalized rash, with bumps under the skin and localized blisters mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you develop these symptoms and seek immediate medical attention. See also section 2.
• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Other possible side effects:

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

• gastrointestinal disorders such as stomach pain, heartburn, indigestion, nausea, vomiting, gas, and constipation, diarrhea, mild gastrointestinal bleeding that can cause anemia in exceptional cases,
• alanine aminotransferase elevated, gamma-glutamyltransferase elevated, and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of ankles or legs (edema); fluid retention usually responds quickly to discontinuation of the combination,

increase in blood creatinine and urea levels

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

• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability, or fatigue,
• urticaria, itching,
• inability to empty the bladder completely (urinary retention),
• thick mucus in the respiratory tract,
• various types of rash,
• gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of colon inflammation (colitis) and digestive tract (Crohn's disease), ulcerative stomatitis, gastritis,
• decrease in hemoglobin and hematocrit, increase in aspartate aminotransferase, increase in alkaline phosphatase in blood, increase in creatine phosphokinase in blood, increase in platelet count (blood clotting cells).

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

• abnormal dreams
• kidney tissue damage (particularly with long-term use)
• high uric acid levels in the blood (hyperuricemia),
• abnormal skin sensation (tingling)

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

• blood disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia). The first signs are: fever, sore throat, superficial ulcers in the mouth, symptoms similar to those of the flu, severe fatigue, unexplained bleeding, bruising, and nosebleeds,
• optic neuritis and drowsiness, aseptic meningitis in patients with existing disorders (such as systemic lupus erythematosus and mixed connective tissue disease), symptoms include stiffness in the neck, headache, nausea, vomiting, fever, or loss of consciousness,
• visual disturbances; in this case, you should stop using this medication and consult a doctor,
• hearing loss, ringing in the ears, sensation of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, sensitivity to light, exfoliative dermatosis,
• rash with red spots on the skin (purpura),
• hair loss,
• high blood pressure, vasculitis,
• esophageal inflammation, pancreatic inflammation, formation of intestinal structures similar to a diaphragm,
• liver problems, dysfunction, liver damage (particularly with long-term use), liver failure, acute hepatitis, yellowing of the skin and/or the whites of the eyes, also called jaundice; in paracetamol overdose, it can cause acute liver failure, liver failure, liver necrosis, and liver damage,
• nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure,
• rapid or irregular heartbeats, also called palpitations, tachycardia, arrhythmia, and other cardiac arrhythmias, heart failure (which causes difficulty breathing, swelling), myocardial infarction.

Not known(cannot be estimated from the available data):

• the skin becomes sensitive to light.

Medications like paracetamol/ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (see section 2).

Reporting of side effects

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

5. Conservation of Paracetamol/Ibuprofen Winadol

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack, after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°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. Package contents and additional information

Composition of Paracetamol/Ibuprofen Winadol

• The active ingredients are paracetamol and ibuprofen. Each tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.

• The other components are:

Core of the tablet: Pregelatinized cornstarch (gluten-free), povidone, stearic acid, crospovidone, croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Coating: Poly (vinyl alcohol), titanium dioxide (E-171), macrogol 4000, talc, and polysorbate 80.

Appearance of the product and package contents

White, oblong, biconvex, and scored film-coated tablets, with a length of 18.5 mm; width of 8.4 mm and thickness of 0.2 mm approximately.

Each package contains 10 or 20 tablets packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder

Nutra Essential OTC, S.L

C/ La Granja, 1, 3rd floor

28108, Alcobendas (Madrid)

Spain

Manufacturer

Farmalider, S.A

C/ Aragoneses, 2

28108, Alcobendas (Madrid)

Spain

or

Toll Manufacturing Services, S.L

C/ Aragoneses, 2

28108, Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus:June 2025

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/