Leaflet: information for the user

DalsydolDuo 500mg/200mg coated tablets

paracetamol/ibuprofen

Read this leaflet carefully before you start to take this medicine because it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.
• You should consult a doctor if you get worse or do not improve after 3days.

Content of the leaflet

1. What Dalsydol Duo is and for what it is used
2. What you need to know before starting to take Dalsydol Duo
3. How to take Dalsydol Duo
4. Possible side effects
5. Storage of Dalsydol Duo
6. Contents of the pack and additional information

DalsydolDuo contains two active ingredients, which are paracetamol and ibuprofen.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain and inflammation.

Paracetamol is an analgesic that works differently from ibuprofen to relieve pain.

This medicine is used in adults 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 requires stronger analgesia than paracetamol or ibuprofen alone.

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

Do not take Dalsydol Duoif you

• are already takingany other medication that contains paracetamol;
• are takingany other analgesic,including ibuprofen, high doses of acetylsalicylic acid(more than 75mg per day), orother nonsteroidal anti-inflammatory drugs (NSAIDs), including specific cyclooxygenase-2 (COX-2) inhibitors;
• areallergic to ibuprofen, paracetamolor to any of the other components of this medication (listed in section6);
• have had aprevious allergic reaction, such as difficulty breathing, asthma attacks, nasal mucosa inflammation, skin rash and swelling (angioedema) of the face, lips, tongue, or throat, or skin reactions after takingacetylsalicylic acid or other NSAID analgesics;
• have or have hadulcers or recurrent bleeding in the stomach or duodenum(at least two distinct episodes of confirmed bleeding or a single ulcer);
• have hadprevious gastrointestinal bleeding, ulcers, or perforation caused by NSAID treatment;
• haveblood clotting disorders;
• havesevere heart, liver, or kidney failure;
• are in thelast trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to takethis medication if you:

• are an elderly patient;
• have aninfection(see the section "Infections" below);
• haveasthmaor have had asthma;
• havekidney, heart, liver, or intestinal problems;
• havesystemic lupus erythematosus (SLE), a condition that affects the connective tissue and causes joint pain, skin changes, and other organ problems,or other mixed connective tissue disease;
• havegastrointestinal disorders or chronic inflammatory bowel disease(e.g., ulcerative colitis, Crohn's disease);
• are in thefirst 6months of pregnancyorbreastfeeding;
• areplanning to become pregnant.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially at high doses. Do not exceed the recommended dose or treatment duration.

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

• have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (such as "mini-stroke" or transient ischemic attack "TIA");
• have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
• Consult your doctor before using this medication if you suffer from any of the conditions mentioned above.

Infections

This medicationmay mask signs of infection such as fever and pain. Therefore, it is possible that the use ofthis medicationmay delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor immediately

Skin reactions

• Severe skin reactions have been reported in association with treatment with this medication. Stop taking this medication and seek medical attention immediately if you develop any skin rash, mucous membrane lesions, blisters, or other signs of allergy orif you develop a generalized febrile rash associated with pustules,as these may be the first signs of a very severe skin reaction. See section4.
• Older adults
• Patients over 65 years of age have a higher risk of side effects when taking NSAIDs, especially those related to the stomach and intestines.
• Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of treatment.
• Children and adolescents

This medication should not be administered to children or adolescents under 18years of age.

Other medications and Dalsydol DuoDuo

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

Do not takeDalsydolDuo with

• other medications thatcontain paracetamol;
• other medications thatcontain NSAIDssuch as acetylsalicylic acid (at doses above 75mg per day), ibuprofen, or other NSAIDs including selective cyclooxygenase-2 (COX-2) inhibitors.

Care is required, as some medications may interact with this medication, for example:

• tablets withcorticosteroids, used to relieve inflamed areas of the body (e.g., cortisone, prednisone);
• antibiotics(e.g., chloramphenicol or quinolones);
• antibiotic(flucloxacillin) due to the risk of severe blood and fluid imbalance (metabolic acidosis with high anion gap)that must be treated urgently and which may occur especially in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood and cause damage to organs), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used;
• medicationsfor nausea(e.g., metoclopramide, domperidone);
• heart stimulants(e.g., glycosides);
• medications forhigh cholesterol(e.g., cholestyramine);
• diuretics, medications that facilitate the elimination of excess water;
• medications tosuppress the immune system(e.g., methotrexate, cyclosporine, tacrolimus);
• medications to treatmanic episodes and bipolar disorders or depression(e.g., lithium or SSRIs);
• mifepristone(to interrupt pregnancy);
• medications for HIV(e.g., zidovudine).

This medication may affect or be affected by other medications.

For example:

• medications that areanticoagulants(i.e., prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• medications thatreduce blood pressure(ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Some other medications may also affect or be affected by treatment with this medication. Therefore, you should consult with your doctor or pharmacist before using this medication with other medications.

Use of DalsydolDuo with food, drinks, and alcohol

Do not drink alcohol during treatment, due to the possibility of increased risk of liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication if you are in the last trimester of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may cause you and your baby to bleed easily and delay or prolong delivery.

Be especially careful if you are in the first 6months of pregnancy. Do not take this medication during the first 6months of pregnancy, unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, use the lowest doses and for the shortest time possible. If you take it for a few days from week20 of pregnancy onwards, this medication may cause kidney problems in the fetus, 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 you need treatment for more than a few days, your doctor may recommend additional follow-up.

This medication can be used during breastfeeding if used for short-term treatment at the recommended dose.

This medication may make it difficult to become pregnant.

Ibuprofen belongs to a group of medications that may affect fertility in women. This effect is reversible when treatment with the medication is stopped. Inform your doctor if you are planning to become pregnant or if you have difficulty doing so.

Driving and operating machinery

This medication may cause dizziness, concentration problems, visual disturbances, and drowsiness in some people.

Be aware of this when you need to be highly alert, for example, when driving. Be careful when driving or operating machinery until you know how this medication affects you.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Only for oral use and short-term.

The effective dose should be used for the shortest time necessary to relieve symptoms.This medication should not be taken for more than 3days.If your symptoms worsen or persist, especially if you have an infection with symptoms such as fever and pain, consult your doctor without delay.

Adults: The recommended dose is one tablet withwater and food, a maximum of 3times a day.

Leave at least6hours between one dose and another..

If a single tablet does not control symptoms, a maximum of two tablets may be taken not more than three times a day. Due to the presence of paracetamol, the individual dose of two tablets is intended for patients with a body weight of 60kg or more.

Do not take more than six tablets in a 24hour period(equivalent to 3000mg of paracetamol and 1200mg of ibuprofen per day).

If you have mild to moderate liver or kidney insufficiency or are an elderly patient, your doctor will tell you the correct dose to take, which will be the lowest possible dose. Do not take this medication if you have liver or kidney insufficiency.

Use in children and adolescents

This medication should not be administered to children or adolescents under 18years of age.

Administration form

The tablets should be taken with a glass of water.

To reduce the probability of side effects, take this medication with food.

If you take more DalsydolDuo than you should

If you have taken more DalsydolDuo than you should, or if a child has accidentally ingested this medication, consult immediately with a doctor or pharmacist, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

Consult your doctor immediately if you take too much of this medication, even if you feel well. This is because excessive paracetamol can cause severe delayed liver damage.

If you forgot to take DalsydolDuo

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• signs of intestinal bleeding(severe stomach pain, vomiting with blood or coffee ground-like liquid, blood in the stool, black, tarry stools) (infrequent);
• signs of brain lining inflammationsuch as: stiff neck, headache, nausea or vomiting, fever, or feeling disoriented (very rare);
• signs of a severe allergic reaction. Symptoms include swelling of the face, tongue, and throat, difficulty breathing, rapid heart rate, and hypotension (very rare);
• asthma, wheezing, shortness of breath (very rare);
• severe skin reactionswith blister formationsuch as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (very rare);
• severe skin reaction known as DRESS syndrome. DRESS syndrome symptoms include: skin rash, fever, lymph node inflammation, and an increase in eosinophils (a type of white blood cell) (unknown frequency);
• severe skin reaction known as PEGA (acute generalized pustular psoriasis). This is a generalized red and scaly 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 (very rare).

Other possible side effects

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

• stomach pain or discomfort, indigestion, nausea, or vomiting,diarrhea,
• high levels of liver enzymes (evidenced in blood tests),
• excessive sweating,
• fluid retention with swelling of the ankles or legs (edema).

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

• headache and dizziness,
• gas and constipation,
• reduction in the number of red blood cells or increase in the number of platelets (cells that clot blood), causing bleeding, bruises, and unexplained nosebleeds,
• abnormal results in laboratory tests (blood test and liver and kidney enzyme results),
• worsening of colitis and Crohn's disease,
• gastritis (stomach inflammation),
• pancreatitis (inflammation of the pancreas accompanied by severe abdominal pain that radiates to the back and vomiting),
• skin rash, itching (pruritus),
• mouth ulcers.

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

• tingling in hands and feet.

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

• reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, and nosebleeds),
• visual disturbances, ringing in the ears, feeling like the world is spinning,
• confusion, depression, hallucinations,
• fatigue, general feeling of malaise,
• skin sensitivity to light,
• high blood pressure,
• liver problems (causing yellowing of the skin and eyes),
• kidney problems (causing increased or decreased urination, swelling of the legs),
• heart failure (causing shortness of breath, swelling),
• optic nerve inflammation and drowsiness.

Medicines like paracetamol/ibuprofen may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke (see section2).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Dalsydol Duo

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

The other components are:

Core tablet: maize starch, crospovidone (type A) (E1202), anhydrous colloidal silica (E551), povidone K-30 (E1201), pregelatinized maize starch, talc (E553b), stearic acid (50).

Coating material: poly(vinyl alcohol) (E1203), talc (E553b), macrogol 3350 (E1521), titanium dioxide (E171).

Appearance of Dalsydol Duo and packaging contents

The tablets are white to off-white, oval-shaped, film-coated, and have dimensions of 19.7mm ×9.2mm.

They are available in carton boxes with blisters of 10, 12, 16 or 20film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larissa Industrial Area,

Larissa, 41500

Greece

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Republic of Czechia:Brufen Combi 500 mg/200 mgpotahované tablety

Denmark:Paracetamol/IbuprofenViatris 200 mg/500 mgfilmovertrukne tabletter

Italy:Brufeduo

Norway:Ibuprofen/ParacetamolViatris 200 mg/500 mgfilmdrasjerte tabletter

Slovakia:Brufen Combi 500mg/200mg filmom obalené tablety

Spain:Dalsydol Duo 500mg/200mg comprimidos recubiertos con película

Last review date of this leaflet:December 2024.

Further detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/