Voltaduo 500 mg/200 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Voltaduo 500 mg/200 mg film-coated tablets

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

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

Contents of the leaflet

What Voltaduo is and what it is used for
What you need to know before taking Voltaduo
How to take Voltaduo
Possible side effects
Storage of Voltaduo
Contents of the pack and other information

1. What Voltaduo is and what it is used for

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

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

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

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

2. What you need to know before taking Voltaduo

Do not take Voltaduo if:

you are allergic to ibuprofen, paracetamol, or any of the other components 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 hemorrhage or perforation related to previous treatment with NSAIDs,
you have cerebrovascular hemorrhage or another active bleeding condition,
you suffer from blood coagulation disorders,
you suffer from 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 Voltaduo if:

you are an elderly patient,
you have asthma or have previously experienced 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 acidity, indigestion, stomach ulcers, or any other stomach condition,
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 a hereditary deficiency of an enzyme called glucose-6-phosphate dehydrogenase,
you have a hereditary or acquired genetic disorder affecting certain enzymes, manifesting 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 an increased risk of allergic reactions,
you suffer from chronic alcoholism,
you have low body weight or chronic malnutrition,
you have total body fluid deficiency (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.

During treatment with this medicine, inform your doctor immediately if:

you have serious conditions such as severe kidney 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 over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (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 dose reduction.

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 Voltaduo”) 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 containing paracetamol (see also section “Do not take Voltaduo” above). Symptoms of liver damage typically appear after a few days. It is therefore important to consult a doctor immediately if you have taken more than recommended. See also section 3 “If you take more Voltaduo 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 treatment duration.

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 have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in 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 smoke.

Signs of allergic reaction to ibuprofen, such as breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

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 with ibuprofen treatment. 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.

Infections

Paracetamol/ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonias and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Gastrointestinal symptoms

Serious gastrointestinal adverse effects (affecting the stomach and intestine) have been reported with 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 discuss any history of gastrointestinal problems with your doctor and remain alert for any unusual abdominal symptoms such as nausea, vomiting, diarrhea, 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 agents, 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 Voltaduo, stop using the medicine and consult a doctor.

Other considerations

In general, habitual 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 Voltaduo

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

Do not take Voltaduo with:

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

Voltaduo may affect or be affected by other medicines. Inform your doctor or pharmacist if you are taking:

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 (i.e., blood thinners/prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine),
cardiac glycosides (e.g., digoxin), medicines to strengthen the heart,
medicines for high cholesterol (e.g., cholestyramine),
diuretics (to help urinate),
medicines to reduce 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 causing acquired immunodeficiency syndrome),
medicines that reduce gastric emptying,
medicines to treat bacterial infections known as aminoglycosides,
medicines to treat gout and gouty arthritis known as probenecid and sulfinpyrazone,
antifungal medicines that inhibit the hepatic enzyme CYP2C9 (e.g., voriconazole, fluconazole),
other medicines known to affect the liver or that 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 abnormality (called metabolic acidosis) requiring urgent treatment (see section 2).

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

Voltaduo with food and alcohol

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

Do not drink alcohol during treatment with this medicine. Alcohol may increase paracetamol-induced liver toxicity.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take ibuprofen 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 unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor. You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and prescribed by your doctor. If treatment is needed during this period or while trying to conceive, the lowest dose for the shortest possible time should be used. If taken for more than a few days beyond 20 weeks of pregnancy, ibuprofen may cause kidney problems in the fetus leading 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 is needed 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 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.

Voltaduo contains sodium

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

3. How to take Voltaduo

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

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

Leave 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. Leave at least 6 hours between doses.

Do not take more than six tablets within a 24-hour period (equivalent to 1,200 mg of ibuprofen and 3,000 mg of paracetamol 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 possible dose for the shortest possible duration should be used.

Use in children and adolescents

Not suitable for use 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 longer 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 Voltaduo 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 immediately, go to the nearest hospital, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested, to assess the risk and receive advice on the measures to take.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding, headache, tinnitus, confusion, and tremulous eye movements (nystagmus), or, more rarely, diarrhoea. In addition, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hypokalaemia (low blood potassium levels), prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, 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, and breathing difficulties may occur.

Contact a doctor immediately if you have taken too much medicine, even if you feel well.

The reason is that excessive amounts of paracetamol can cause delayed, severe liver damage, which may be fatal. Even in the absence of discomfort or poisoning symptoms, you may still require urgent medical attention. Liver damage may become irreversible if treatment is delayed. To prevent liver damage, it is essential to obtain medical treatment as soon as possible.

If you forget to take Voltaduo

Do not take a double dose to make up for forgotten 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.

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

The most frequently observed adverse effects are of a gastrointestinal nature. Peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, especially 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 treatment with NSAIDs.

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-shaped, or circular skin rashes on the trunk, 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 serious infection with destruction (necrosis) of subcutaneous skin, tissue, and muscle, blisters, and skin peeling.

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

a serious skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell),
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). Stop taking this medicine if you develop these symptoms and seek immediate medical attention. See also section 2.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other possible adverse effects

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

gastrointestinal discomfort such as stomach pain, heartburn, indigestion, nausea, vomiting, gas, 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 levels of creatinine and urea in blood.

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 (Crohn's disease), ulcerative stomatitis, gastritis,
decreased hemoglobin and hematocrit, increased aspartate aminotransferase, increased alkaline phosphatase in blood, increased creatine phosphokinase in blood, increased number of platelets (blood clotting cells).

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

abnormal dreams,
kidney tissue damage (particularly with long-term use),
high level of uric acid in 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). 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 must 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, hepatic necrosis, and liver damage,
nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure,
rapid or irregular heartbeat, also known as palpitations, tachycardia, arrhythmia, and other cardiac arrhythmias, heart failure (causing difficulty breathing, swelling), myocardial infarction.

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

skin becomes sensitive to light.
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). Stop taking if you experience these symptoms and seek immediate medical attention. See also section 2.
A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

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

5. Storage of Voltaduo

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 which is stated on the carton and blister pack. 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 containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltaduo

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

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

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

Nature of the product and pack contents

Voltaduo are film-coated, grey, oval-shaped tablets with a shiny appearance. Size of the film-coated tablet: length: 18.9–19.4 mm, width: 8.9–9.3 mm.

Voltaduo is packaged:

in aluminum/PVC/PVDC blisters. The packs contain 10 or 20 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor - 28046 – Madrid – Spain

Manufacturer

Zaklady Farmaceutyczne Polpharma SA

(Pharmaceutical Works Polpharma SA)

ul. Pelplinska 19

83-200 Starogard Gdanski

Poland

Date of the most recent revision of this leaflet: April 2025

Other sources of information:

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/)