Leaflet: information for the patient

Voltaduo 500 mg/200 mg film-coated tablets

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any aspect of your dose, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.
• You must see a doctor if your symptoms worsen or do not improve after 3 days. Do not take this medicine for more than 3 days.

1.What Voltaduo is and what it is used for

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

3.How to take Voltaduo

4.Possible side effects

5Storage of Voltaduo

6. Contents of the pack and additional information.

Voltaduo contains two active ingredients (that make the medication work). These are paracetamol and ibuprofen.

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

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

Paracetamol/ibuprofen is used in adults aged 18 years and older.

Do not take Voltaduo if:

• you areallergic to ibuprofen, paracetamolor to any of the other components of this medication (listed in section 6),
• you are takingany other medication that contains paracetamol,
• you have a history of allergic reactions (e.g., bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• 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),
• you have a history of gastrointestinal hemorrhage or perforation related to a previous treatment with NSAIDs,
• you have a cerebrovascular hemorrhage orother active hemorrhage,
• you have bleeding disorders,
• you have severeheart, liver or kidney failure,
• you areseverely dehydrated, caused by vomiting, diarrhea or inadequate fluid intake,
• you are in thelast 3 months of pregnancy,
• you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Voltaduo if:

• you are apatient of advanced age,
• you haveasthmaor have had asthma,
• you have kidney, heart, liver or intestinal problems, hepatitis or difficulty urinating,
• you are being treated concomitantly with medications that affect liver function,
• you are allergic to other substances,
• you have acid reflux, indigestion, stomach ulcers or any other stomach problem,
• you have a tendency to bleed,
• you haveGilbert's syndrome(a rare hereditary metabolic disorder with possible signs such as yellow discoloration of the skin or the white of the eyes),
• you havesystemic lupus erythematosus (SLE)(a disease of the immune system that affects connective tissue and produces joint pain, skin changes and disorders of other organsor other connective tissue disease,
• you havegastrointestinal disorders or chronic inflammatory bowel disease(e.g., ulcerative colitis, Crohn's disease),
• you have aninfection; see the section "Infections" below,
• you have ahereditary deficiencyof a certain enzyme called glucose-6-phosphate dehydrogenase,
• you have a genetic disorder or acquired disorder of certain enzymes that manifests with neurological complications or skin problems or occasionally both, i.e., porphyria,
• you havehemolytic anemia,
• 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 havelow weight or chronic malnutrition,
• you have atotal body water deficiency(dehydration),
• you have recently hadmajor surgery,
• you are in thefirst 6 months of pregnancyor arebreastfeeding,
• you areplanning to become pregnant.

During treatment with this medication, inform your doctor immediately 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 severe disease called metabolic acidosis (a blood and fluid anomaly) 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 respiratory distress with deep and rapid breathing, 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 medication or reduce the dose.

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

The concomitant use with NSAIDs, including specific COX-2 inhibitors, increases the risk of adverse reactions (see below "Other medications and Voltaduo") and should be avoided.

Warning: taking higher doses than the recommended doses does not provide greater pain relief, but increases the risk of severe liver damage. Therefore, do not exceed the maximum daily dose of paracetamol. Do not take other medications that also contain paracetamol (see also the section "Do not take Voltaduo" 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 Voltaduo than you should".

NSAIDs like ibuprofen may be associated with a small increase in the 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 medication if:

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

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

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 syndrome), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Interrupt the treatment with this medication and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

Paracetamol/ibuprofen may mask signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria 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.

Gastrointestinal symptoms

Severe 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 bleeding or perforation. Elderly patients have a higher risk of gastrointestinal adverse effects. You should analyze 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, stool with a tar-like appearance or vomiting with blood.

Prolonged use of analgesics

The prolonged use of analgesics for headaches may even worsen them. If you experience or suspect this situation, you should inform your doctor and discontinue treatment.

The regular use of analgesics, particularly in combination with several pain-relieving medications, may cause permanent kidney damage with a risk of kidney failure, a condition known as analgesic nephropathy. This risk may increase under the physical effort associated with salt loss and dehydration. Therefore, it should be avoided.

Eye problems

If you notice any problems with your vision after using Voltaduo, stop using the medication and consult a doctor.

Other considerations

In general, the regular consumption of analgesics, particularly in combination with several active analgesic principles, may lead to permanent kidney damage with a risk of kidney failure. Therefore, it should be avoided.

Children and adolescents

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

Other medications and Voltaduo

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Do not take Voltaduo with:

• othermedications that contain paracetamol, such as e.g., some cold and flu medications or pain relievers.

Voltaduomay affect or be affected by other medications. Inform your doctor or pharmacist if you are taking:

• tabletsof corticosteroids,
• antibiotics(e.g., chloramphenicol or quinolones),
• antiemeticmedications(e.g., metoclopramide, domperidone),
• acetylsalicylic acid, salicylates or other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• anticoagulantmedications(i.e., blood thinners/ prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• cardiac glycosides (e.g., digoxin), medications to strengthen the heart),
• medications forhigh cholesterol(e.g., cholestyramine),
• diuretics(to help urinate),
• medications that reducehigh blood pressure(e.g., ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• medications tosuppress the immune system(e.g., methotrexate, cyclosporine, tacrolimus),
• medications formanic or depressive disorders(e.g., lithium or SSRIs),
• mifepristone(for abortion),
• phenytoin, a medication to prevent seizures in epilepsy,
• zidovudine, a medication to treat HIV (the virus that causes acquired immunodeficiency syndrome),
• medications that decreasegastric emptying,
• medications to treat bacterial infections calledaminoglycosides,
• medications to treat gout and gouty arthritis calledprobencid and sulfinpyrazone,
• antifungal medicationsthat inhibit the CYP2C9 liver enzyme (e.g., voriconazole, fluconazole),
• other medications thatare known toaffect the liverorinduce liver microsomal enzymessuch as alcohol and antiepileptic medications (e.g., carbamazepine, phenobarbital, lorazepam),
• medications to treat diabetes (sulfonamides),
• ginkgo biloba (a herbal medication) may increase the risk of bleeding with NSAIDs
• medications used to treat tuberculosis (e.g.,isoniazid),
• flucloxacillin(antibiotic), due to a severe risk of blood fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2)

Other medications may also affect or be affected by Voltaduo treatment. Therefore, always consult your doctor or pharmacist before using paracetamol/ibuprofen with other medications.

Voltaduo with food and alcohol

To reduce the risk of side effects, take Voltaduo with food.

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take ibuprofen 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 unborn baby. It may affect your tendency and that of your baby to bleed and make labor longer or later than expected. Do not take ibuprofen during the first 6 months of pregnancy unless 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 time possible. If taken for more than a few days after 20 weeks of pregnancy, ibuprofen may cause kidney problems in the fetus that may lead to low amniotic fluid levels 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.

Breastfeeding

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

Fertility

Ibuprofen belongs to a group of medications that may affect female fertility. Paracetamol/ibuprofen may make it difficult to become pregnant. This is reversible by stopping the medication.

Driving and operating machines

Paracetamol/ibuprofen may cause dizziness, concentration problems and drowsiness.

If affected, do not drive or operate tools or machines.

Voltaduo contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

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

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

Leave at least6 hours between doses.

If a tablet does not control symptoms, you can take up to a maximum of 2 tablets up to three times a day. Leave at least 6 hours between doses.

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

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

Use in elderly patients

No special dose adjustments are required. There is a higher risk of severe adverse reactions. The lowest possible dose should be used for the shortest possible time.

Use in children and adolescents

Not suitable for use in children and adolescents under 18 years old.

You may need 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 well 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 lowest effective dose should be used for the shortest possible time 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 Voltaduodel 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), gastrointestinal bleeding, headache, ringing in the ears, confusion, and nystagmus (trembling eye movement) or, less frequently, diarrhea. In addition, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hypokalemia (low potassium levels in the blood), increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold in the body, and respiratory problems.

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 and potentially fatal liver damage. 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 Voltaduo

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 6 hours later.

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

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

Regarding the following side effects, it should be noted that they depend to a great extent on the dose and vary from one patient to another.

The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, black stools, vomiting with blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Less frequently, gastritis has been observed. 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 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 with blood or liquid that looks like coffee grounds, blood in the stool, black stools).

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

• symptoms of aseptic meningitis, inflammation of the brain lining 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 heart rate, low blood pressure (anaphylaxis, angioedema or severe shock),
• respiratory reactivity including asthma, worsening of asthma, wheezing, difficulty breathing,
• flat, red, non-elevated patches on the trunk, often with

blistering in the center, skin peeling, mouth ulcers, throat, nose, genital and eye ulcers. These severe skin eruptions may be preceded by fever and similar symptoms

such as those of the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• worsening of existing severe skin infections (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 skin, tissue and muscle, blisters and skin peeling.

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

• a severe skin reaction known as DRESS (frequency not known). DRESS symptoms include: skin rash, fever, lymph node inflammation and an increase in eosinophils (a type of white blood cell),
• a red, scaly, generalized rash, with bumps under the skin and blisters located mainly in skin folds, the trunk and upper limbs, accompanied by fever at the start of treatment (generalized acute pustular exanthema). Stop taking this medicine if you develop these symptoms and seek medical attention immediately. See also section 2.
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Other possible side effects

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

• gastrointestinal discomfort such as stomach pain, heartburn, indigestion, nausea, vomiting, gas and constipation, diarrhea, mild gastrointestinal bleeding that may 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,
• increased levels of creatinine and urea in the blood.

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

• central nervous system alterations such as headache, dizziness, insomnia, agitation, irritability or fatigue,
• urticaria, itching,
• inability to completely empty the bladder (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 the blood, increased creatine phosphokinase in the blood, increased platelet count (blood clotting cells).

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

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

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, symptoms similar to the flu, severe fatigue, unexplained bleeding, hematomas and nasal bleeding,
• optic neuritis and somnolence, aseptic meningitis in patients with existing conditions (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, dizziness, confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, light sensitivity, exfoliative dermatitis,
• red rash 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 white of the eyes, also known as jaundice; in paracetamol overdose, it may cause acute liver failure, liver failure, liver necrosis and liver damage,
• renal toxicity in various forms, including interstitial nephritis, nephrotic syndrome and acute and chronic renal failure,
• rapid or irregular heartbeats, also known as palpitations, tachycardia, arrhythmia and other cardiac arrhythmias, heart failure (which causes difficulty breathing, swelling), myocardial infarction.

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

• the skin becomes sensitive to light.
• a generalized, red, scaly rash, with bumps under the skin and blisters located mainly in skin folds, the trunk and upper limbs, accompanied by fever at the start of treatment (generalized acute pustular exanthema). Stop taking this medicine if you develop these symptoms and seek medical attention immediately. See also section 2.
• A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Medicines like paracetamol/ibuprofen may be associated with a small increase in the 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 possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keepthis medicationout of the 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 box and the blister pack. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of your pharmacy.Ask your pharmacist if you are unsure about how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Voltaduo

• The active principles are paracetamol and ibuprofen. Each tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
• The other components are:

Tablet core: sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, anhydrous colloidal silica, stearic acid, magnesium stearate.

Coating:polymer of grafting of macrogol and poly(vinyl alcohol), talc, pearlescent pigment based on mica (Mica/titanium dioxide (E-171)), glycerol monocaprinate, poly(vinyl alcohol), titanium dioxide (E-171), iron oxide black (E-172).

Appearance of the product and content of the packaging

Voltaduo are coated tablets with a grey film, oval in shape, with a shine. Size of the coated tablet: length: 18.9-19.4 mm, width: 8.9-9.3 mm.

Voltaduo is packaged:

• in blisters of Aluminio/PVC/PVDC. The packaging contains 10 or 20 coated tablets.

Holder of the marketing authorization and responsible for the manufacturinging

Holder of the marketing authorization

Haleon Spain, S.A.

C/ Severo Ochoa 2,

28760- Tres Cantos, Madrid.

Spain

Responsible for the manufacturing

Zaklady Farmaceutyczne Polpharma SA

(Pharmaceutical Works Polpharma SA)

ul. Pelplinska 19

83-200 Starogard Gdanski

Poland

Date of the last review of this leaflet:April 2025

Other sources of information:

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