ANTIDOL DUAL 500 mg/200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Antidol Dual 500 mg/200 mg 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 the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as 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 should not take this medicine for more than 3 days.

Contents of the Package Leaflet

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

1. What is Antidol Dual and what is it used for

Antidol Dual contains two active substances (which make the medicine work). These are ibuprofen and paracetamol.

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.

Antidol Dual is used for the short-term symptomatic treatment of mild to moderate pain, such as headache (not migraines), back pain, menstrual cramps, toothache and muscle pain, flu and cold symptoms, and sore throat.

This medicine is especially indicated for pain that has not been relieved by ibuprofen or paracetamol alone.

Antidol Dual is used in adults over 18 years of age.

2. What you need to know before taking Antidol Dual

Do not take Antidol Dual if:

• you are allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• you are taking any other medicine that contains paracetamol,
• 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),
• you have an active peptic ulcer or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding proven),
• you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• you have a cerebrovascular hemorrhage or other active bleeding,
• you have blood coagulation disorders,
• you have severe heart, liver, or kidney failure,
• you are severely dehydrated, caused by vomiting, diarrhea, or insufficient fluid intake,
• you are in the last 3 months of pregnancy,
• you are under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Antidol Dual 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 hereditary 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 are underweight or have chronic malnutrition,
• you have a total 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.
• 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 together with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

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/ibuprofen 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 Antidol Dual") 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 Antidol Dual" above). The symptoms of liver damage usually occur for the first time after a couple of days. Therefore, it is important to consult a doctor immediately if you have taken more than recommended. See also section 3 "If you take more Antidol Dual 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 in 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 legs or feet due to narrowing or blockage of 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 Antidol Dual immediately and contact your doctor or medical emergency service immediately if you notice any of these signs.

Infections

This medicine may hide the signs of an infection, such as fever and pain. Therefore, this medicine may delay the appropriate treatment of the infection, which may 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.

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment with this medicine. Discontinue treatment with this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Gastrointestinal symptoms

Severe 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 discontinue 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 salt loss and dehydration. Therefore, it should be avoided.

Vision problems

If you notice any vision problems after using paracetamol/ibuprofen, 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.

Children and adolescents

This medicine is contraindicated in children and adolescents under 18 years of age.

Other medicines and Antidol Dual

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Do not take Antidol Dual with:

• other medicines that contain paracetamol, such as some medicines for colds and flu or pain.

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

• corticosteroid tablets,
• antibiotics (e.g., chloramphenicol or quinolones),
• antiemetic medicines (e.g., metoclopramide, domperidone),
• acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• anticoagulant medicines (e.g., to thin the blood/prevent clotting, e.g., warfarin, acetylsalicylic acid, ticlopidine),
• cardiac glycosides (e.g., digoxin), medicines to strengthen the heart,
• medicines for high cholesterol (e.g., colestyramine),
• diuretics (to help urinate),
• 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),
• medicines that suppress the immune system (e.g., methotrexate, cyclosporine, tacrolimus),
• medicines for mania or depression (e.g., lithium or SSRIs),
• mifepristone (for abortion),
• phenytoin, a medicine to prevent seizures in epilepsy,
• zidovudine, a medicine to treat HIV (the virus that causes acquired immune deficiency syndrome),
• medicines that decrease gastric emptying,
• medicines to treat bacterial infections called aminoglycosides,
• medicines to treat gout and gouty arthritis called probenecid and sulfinpyrazone,
• antifungal medicines that inhibit the liver enzyme CYP2C9 (e.g., voriconazole, fluconazole),
• other medicines that are known to affect the liver or induce hepatic microsomal enzymes such as alcohol and antiepileptic medicines (e.g., carbamazepine, phenobarbital, lorazepam),
• medicines to treat diabetes (sulfonylureas),
• ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs,
• medicines used to treat tuberculosis (e.g., isoniazid),
• flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

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

Use of Antidol Dual with food and alcohol

To reduce the likelihood of side effects, take this medicine with food.

Do not drink alcohol during treatment with this medicine. Alcohol may increase the toxicity of paracetamol in the liver.

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 if you are in the last 3 months of your pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed and delay or prolong labor more than expected. You should not take this medicine during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, this medicine may cause kidney problems in your baby if taken for more than a few days, which may cause low levels of the fluid that surrounds 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 checks.

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/ibuprofen may make it more difficult to become pregnant. This is reversible upon discontinuation of the medicine.

Driving and using machines

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

Antidol Dual contains sodium

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

3. How to Take Antidol Dual

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.

Adults: the recommended dose is 1 tabletwith water, up to 3 times a day.

Allow at least 6 hours to pass between doses.

If one tablet does not control the symptoms, you can take up to a maximum of 2 tablets up to three times a day.

Do not take more than six tablets in a 24-hour period(equivalent to 3,000 mg of Paracetamol, 1,200 mg of Ibuprofen per day).

To reduce the likelihood of adverse effects, it is recommended to take paracetamol/ibuprofen with food.

Use in Elderly Patients

No special dose modifications are required. There is a greater risk of serious adverse reactions. The lowest possible dose should be used for the shortest possible time.

Use in Children and Adolescents

This medication is contraindicated in children and adolescents under 18 years of age.

It may be necessary to reduce your dose to a maximum of 4 tablets per day if:

• you have kidney problems,
• you have liver problems,
• you weigh less than 50 kg,
• you suffer from chronic malnutrition,
• you regularly drink alcohol (chronic alcoholism),
• you are not sufficiently hydrated.

If any of the above applies to you, talk to your doctor before taking paracetamol/ibuprofen (see also section 2 "Warnings and Precautions").

Only for oral use and for short-term use.

Do not take this medication for more than 3 days.

If your symptoms worsen or persist, consult your doctor.

The effective lowest dose should be used for the shortest time necessary for symptom relief.

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

If you take more Antidol Dual 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 or pharmacist immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4), headache, ringing in the ears, confusion, and eye tremors (nystagmus) or, more rarely, diarrhea. Additionally, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (high potassium levels in the blood), increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, somnolence, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling of cold in the body, and respiratory problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Talk to a doctor immediately if you have taken too much medication, even if you feel well. The reason is that an excessive amount of paracetamol can cause severe late liver damage, which can be fatal. Even if there are no signs of discomfort or poisoning, you may need urgent medical attention. Liver damage can become irreversible in case of late intervention. To avoid liver damage, it is essential to receive medical treatment as soon as possible.

If you forgot to take Antidol Dual

Do not take a double dose to make up for missed doses. If you forget to take a dose, take it as soon as you remember and then take the next dose at least 6 hours later.

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

4. Possible Adverse Effects

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

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

The most frequently observed adverse 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 AINE treatment.

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,
• red, non-raised, target-like or circular spots on the torso, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• worsening of existing severe skin infections (you 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):

• generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• a generalized, red, and scaly rash, with bumps under the skin and blisters mainly on the skin folds, torso, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).
• a serious condition that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Other Possible Adverse Effects

Frequent(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,
• elevated alanine aminotransferase, elevated gamma-glutamyltransferase, and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of the ankles or legs (edema); fluid retention usually responds quickly to discontinuation of the combination,
• increased creatinine and urea levels in the blood.

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,
• decreased hemoglobin and hematocrit, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased creatine phosphokinase in blood, increased 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 formation disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia). The first signs are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds,
• optic neuritis and somnolence, 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, feeling of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, sensitivity to light, exfoliative dermatitis,
• red spots on the skin (purpura),
• hair loss,
• high blood pressure, vasculitis,
• esophageal inflammation, pancreatitis, 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.
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse 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 adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Antidol Dual

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 that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or 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 Antidol Dual

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

• The other components are sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate.

Coating: macrogol and poly(vinyl alcohol) graft copolymer, talc, pearlescent pigment based on mica (mica/titanium dioxide (E-171)), glycerol monocaprylate, poly(vinyl alcohol), titanium dioxide (E-171), black iron oxide (E-172).

Appearance of the Product and Package Contents

Antidol Dual is presented in the form of gray, oval, shiny film-coated tablets with the code "200 M 500" on one face. Tablet length 18.9 - 19.4 mm and tablet width 8.9 - 9.3 mm.

The tablets are packaged:

• in opaque white aluminum/PVC/PVDC blisters. The packages contain 10 or 20 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Zaklady Farmaceutyczne POLPHARMA S.A.

(Pharmaceutical Works POLPHARMA S.A.) ul. Pelplinska 19,

83-200 Starogard Gdanski - Poland

Date of the Last Revision of this Prospectus: February 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/