Antidol Dual 500 mg/200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Antidol Dual 500 mg/200 mg film-coated tablets

Paracetamol/Ibuprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those provided 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days. You must not take this medicine for more than 3 days.

Contents of the leaflet

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

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

Antidol Dual contains two active substances (the components responsible for the medicine's action): 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 act together to reduce pain.

Antidol Dual is used for the short-term symptomatic treatment of mild to moderate pain, such as headache (not migraines), backache, menstrual pain, dental and muscular 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 intended for use 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 containing 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 active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding confirmed),
• you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• you have cerebral haemorrhage or any other active bleeding,
• you suffer from blood coagulation disorders,
• you suffer from severe heart, liver, or kidney failure,
• you are severely dehydrated due to vomiting, diarrhoea, or insufficient fluid intake,
• you are in the last 3 months of pregnancy,
• you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Antidol Dual if:

• you are elderly,
• you have asthma or have previously had 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 acid reflux, indigestion, stomach ulcers, or any other stomach problems,
• you have a tendency to bleed,
• you have Gilbert's syndrome (a rare inherited metabolic disorder with possible signs such as yellowish discoloration of the skin or whites of the eyes),
• you have systemic lupus erythematosus (SLE), an immune system disorder affecting connective tissue and causing joint pain, skin changes, and disorders of other organs, or another mixed connective tissue disease,
• you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease),
• you have an infection; see the section "Infections" below,
• you have an inherited deficiency of an enzyme called glucose-6-phosphate dehydrogenase,
• you have an inherited or acquired genetic disorder of certain enzymes that manifests with neurological complications or skin problems, or occasionally both, i.e., porphyria,
• you have haemolytic anaemia,
• you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there may be an increased risk of allergic reactions,
• you suffer from chronic alcoholism,
• you have low body weight or chronic malnutrition,
• you have a total lack of body water (dehydration),
• you have recently undergone major surgery,
• you are in the first 6 months of pregnancy or are breastfeeding,
• you are planning to become pregnant,
• you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body 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. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breaths, drowsiness, feeling unwell (nausea), and vomiting.

Consult your doctor if any of the above warnings apply to you, or if you have experienced them in the past. You may need to avoid this medicine or require a reduced dose.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not take paracetamol/ibuprofen for more than 3 days.

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

Warning: Taking higher doses than recommended does not provide greater pain relief but increases the risk of severe liver damage. Therefore, the maximum daily dose of paracetamol must not be exceeded. Do not take other medicines that also contain paracetamol (see also section “Do not take Antidol Dual” above). Symptoms of liver damage typically appear a few days after overdose. It is therefore 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 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.

Talk to your doctor or pharmacist about your treatment before taking this medicine if:

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

Signs of allergic reaction to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Antidol Dual immediately and contact your doctor or emergency medical services immediately if you experience any of these symptoms.

Infections

This medicine may mask signs of infection, such as fever and pain. Therefore, it may delay appropriate treatment of the infection, increasing 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 infection symptoms persist or worsen, consult a doctor immediately.

Skin reactions

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

Gastrointestinal symptoms

Serious gastrointestinal adverse effects (affecting the stomach and intestine) have been reported with the use of NSAIDs, including ibuprofen. These may 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 adverse effects. You should discuss any history of gastrointestinal problems with your doctor and remain alert for any unusual abdominal symptoms such as nausea, vomiting, diarrhoea, constipation, indigestion, abdominal pain, tar-like stools, or vomiting blood.

Prolonged use of analgesics

Prolonged use of analgesics for headaches may worsen them. If you experience or suspect this condition, inform your doctor and discontinue treatment. Regular use of analgesics, particularly in combination with multiple pain-relieving medicines, may cause permanent kidney damage with risk of kidney failure, a condition known as analgesic nephropathy. This risk may increase with 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, regular intake of analgesics, particularly in combination with multiple analgesic active ingredients, may lead to permanent kidney damage with 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

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

Do not take Antidol Dual with:

• other medicines containing paracetamol, such as some cold and flu or pain medicines.

Paracetamol/ibuprofen may interact with 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., cholestyramine),
• diuretics (to help urinate),
• medicines to lower high blood pressure (e.g., ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• medicines to suppress the immune system (e.g., methotrexate, cyclosporine, tacrolimus),
• medicines for mania or depression (e.g., lithium or SSRIs),
• mifepristone (for termination of pregnancy),
• phenytoin, a medicine to prevent seizures in epilepsy,
• zidovudine, a medicine to treat HIV (the virus that causes acquired immunodeficiency syndrome),
• medicines that reduce 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 hepatic enzyme CYP2C9 (e.g., voriconazole, fluconazole),
• other medicines known to affect the liver or induce hepatic microsomal enzymes such as alcohol and antiepileptic medicines (e.g., carbamazepine, phenobarbital, lorazepam),
• medicines for diabetes (sulfonylureas),
• ginkgo biloba (a herbal medicine) which may increase the risk of bleeding with NSAIDs,
• medicines used to treat tuberculosis (e.g., isoniazid),
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbance (called metabolic acidosis with high anion gap) which must be treated urgently (see section 2).

Other medicines may also affect or be affected by paracetamol/ibuprofen treatment. Therefore, you should always seek advice from your doctor or pharmacist before using paracetamol/ibuprofen 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 liver toxicity of paracetamol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, this medicine may cause kidney problems in your fetus if taken for more than a few days, which may 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of 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.

Fertility

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

Driving and use of machines

Paracetamol/ibuprofen may cause dizziness, difficulty concentrating, and drowsiness. If affected, do not drive or operate tools or machinery.

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 exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Allow at least 6 hours between doses.

If one tablet does not control symptoms, up to a maximum of 2 tablets may be taken up to three times a day.

Do not take more than six tablets within 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 adjustments are required. However, there is an increased risk of serious adverse reactions. The lowest effective dose for the shortest possible duration should be used.

Use in children and adolescents

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

Your dose may need to be reduced 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 drink alcohol regularly (chronic alcoholism),
• you are not adequately hydrated.

If any of the above apply to you, speak with your doctor before taking paracetamol/ibuprofen (see also section 2 “Warnings and precautions”).

For oral use only and for short-term use only.

Do not take this medicine for more than 3 days.

If your symptoms worsen or persist, consult your doctor.

The lowest effective dose for the shortest necessary duration should be used 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).

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 medicine, contact your doctor or pharmacist immediately or go to the nearest hospital for advice on the risks and measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood streaks), gastrointestinal bleeding (see section 4), headache, tinnitus, confusion, and tremulous eye movements (nystagmus), or, more rarely, diarrhea. In addition, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated potassium levels in blood), prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low potassium levels in blood, feeling cold, and breathing difficulties may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and amount ingested.

Speak to a doctor immediately if you have taken too much medicine, even if you feel well. This is because an excessive amount of paracetamol can cause delayed, severe liver damage, which may be fatal. Even if there are no signs of discomfort or poisoning, you may still require urgent medical attention. Liver damage may become irreversible if treatment is delayed. To prevent liver damage, it is essential to receive medical treatment as soon as possible.

If you forget 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 after the previous one.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects should be considered in the context that they are largely dose-dependent and may vary from patient to patient.

The most frequently observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation, or bleeding, sometimes fatal, may occur, particularly in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting of blood, ulcerative stomatitis, and exacerbation of colitis or 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 NSAID treatment.

STOP TAKING the medicine 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 material that looks like coffee grounds, blood in stools, black tarry stools).

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

• symptoms of aseptic meningitis, inflammation of the lining of the brain such as: neck stiffness, 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 reactions including asthma, worsening of asthma, wheezing, difficulty breathing,
• non-elevated red, target-like or circular skin rashes, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may 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 shingles, or severe infection with destruction (necrosis) of subcutaneous tissue, muscle, blisters, and skin peeling.

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

• widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• a widespread, red, scaly rash with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with serious illness using paracetamol (see section 2).

Other possible adverse effects

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

• gastrointestinal discomfort such as stomach pain, heartburn, indigestion, nausea, vomiting, gas, and constipation, diarrhea, minor gastrointestinal blood loss which may exceptionally lead to anemia,
• elevated alanine aminotransferase, elevated gamma-glutamyltransferase, and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of ankles or legs (edema); fluid retention usually responds rapidly to discontinuation of the combination,
• increased blood creatinine and urea levels.

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

• central nervous system disturbances such as headache, dizziness, insomnia, restlessness, irritability, or fatigue,
• urticaria, itching,
• inability to completely empty the bladder (urinary retention),
• thick mucus in the airways,
• various types of rash,
• gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of colon inflammation (colitis) and gastrointestinal tract inflammation (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 blood levels of uric acid (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, leucopenia, neutropenia, pancytopenia, and thrombocytopenia). Early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising, and nosebleeds,
• optic neuritis and drowsiness, aseptic meningitis in patients with pre-existing disorders (such as systemic lupus erythematosus and mixed connective tissue disease), symptoms include neck stiffness, headache, nausea, vomiting, fever, or loss of consciousness,
• visual disturbances; in this case, you should stop using this medicine and consult a doctor,
• hearing loss, ringing in the ears, sensation of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, light sensitivity, exfoliative dermatoses,
• skin rash with red spots (purpura),
• hair loss,
• high blood pressure, vasculitis,
• inflammation of the esophagus, inflammation of the pancreas, formation of diaphragm-like intestinal structures,
• liver problems, dysfunction, liver damage (particularly with long-term use), liver failure, acute hepatitis, yellowing of the skin and/or whites of the eyes, also known as jaundice; in paracetamol overdose, it may 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 heartbeat, also called palpitations, tachycardia, arrhythmia, and other cardiac arrhythmias, heart failure (causing difficulty breathing, swelling), myocardial infarction.

Not known (cannot be estimated from available data):

• skin becomes sensitive to light.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines such as 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 adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Antidol Dual

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Antidol Dual

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

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

Coating: polyethylene glycol-grafted copolymer and poly(vinyl alcohol), talc, pearly pigment based on mica (mica/titanium dioxide (E-171)), glycerol monocaprylocaprate, poly(vinyl alcohol), titanium dioxide (E-171), black iron oxide (E-172).

Appearance of the product and contents of the pack

Antidol Dual is available as grey, oval, glossy film-coated tablets, marked with the code "200 M 500" on one side. Tablet length: 18.9 – 19.4 mm; tablet width: 8.9 – 9.3 mm.

The tablets are packed in:

• Opaque white aluminum/PVC/PVDC blisters. Packs 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 most recent revision of this leaflet: February 2025

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