Voltadexi

Italy
Brand name Voltadexi
Form tablets, film-coated
Active substance / Dosage
DEXIBUPROFENE
Prescription type Non-prescription – not available over the counter
ATC code
M01AE14
Registration number 047939
Manufacturer HALEON ITALY S.R.L.
Voltadexi tablets, film-coated

Table of Contents

Package leaflet: Information for the user

VoltaDexi 200 mg film-coated tablets

Dexibuprofen
[For packages available without medical prescription]
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Contact your doctor if you do not notice improvement or if your symptoms worsen after 4 days (3 days in case of fever).

[For packages subject to medical prescription]
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1 What VoltaDexi is and what it is used for
Dexibuprofen, the active substance in VoltaDexi, belongs to a family of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs such as dexibuprofen are used as
painkillers and to control inflammation. They work by reducing the amount of prostaglandins
(substances that regulate inflammation and pain) produced by the body.
What VoltaDexi 200 mg is used for
VoltaDexi is used in adults for the short-term symptomatic treatment of mild to moderate acute pain of various origins, such as:

  • Musculoskeletal pain, such as backache,
  • Dental pain, pain after tooth extraction,
  • Menstrual pain,
  • Headache,
  • Pain during cold and flu (such as headache and limb pain).

Contact your doctor if you do not feel better or feel worse after 4 days for pain or after 3 days for fever.
2 What you need to know before taking VoltaDexi
Do not take VoltaDexi if:

  • You are allergic to dexibuprofen or to any of the other ingredients of this medicine (listed in section 6);
  • You are allergic to acetylsalicylic acid or other painkillers (your allergy may cause difficulty breathing, asthma, runny nose, skin rash or facial swelling);
  • You have previously experienced bleeding or perforation in the gastrointestinal system caused by NSAIDs;
  • You currently have or have previously had recurrent gastric or duodenal ulcers (vomiting blood or black stools or bloody diarrhoea may be signs of bleeding in the stomach or intestine);
  • You suffer from blood disorders of unknown origin;
  • You have cerebral haemorrhage (cerebrovascular haemorrhage) or other active bleeding;
  • You currently have an exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease);
  • You have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
  • You suffer from severe heart failure or severe liver or kidney disease;
  • You are a woman in the third trimester of pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before taking VoltaDexi if:

  • You have had a gastric or duodenal ulcer;
  • You have suffered from intestinal ulcers, ulcerative colitis or Crohn's disease;
  • You suffer from liver or kidney disease or are alcohol-dependent;
  • You have oedema (fluid accumulation in body tissues);
  • You suffer from heart disease or high blood pressure;
  • You suffer from systemic lupus erythematosus (a disease affecting joints, muscles and skin) or mixed connective tissue disease (a collagen disease affecting connective tissues);
  • You are having difficulty becoming pregnant. (In rare cases, medicines such as VoltaDexi may affect female fertility. Fertility will return to normal when you stop taking VoltaDexi);
  • You suffer from or have suffered from asthma or allergic diseases, as you may experience breathlessness;
  • You suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema (swelling mainly in the facial area, lips, eyelids or genitals) or urticaria;
  • You have recently undergone major surgery;
  • You suffer from certain inherited blood disorders (e.g. acute intermittent porphyria);
  • You have an infection – see section "Infections" below.

Cases of gastrointestinal bleeding, ulceration or perforation, which can be fatal, have
been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. When gastrointestinal bleeding or
ulceration occurs, treatment must be stopped immediately. The risk of gastrointestinal
bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcers, particularly if complicated by haemorrhage or perforation (see section 2), and in the elderly.
These patients should start treatment with the lowest available dose. Concomitant therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients as well as for patients requiring concomitant use of low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk.
If you have previously experienced gastrointestinal toxicity, especially if you are elderly, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.
Anti-inflammatory/painkillers such as dexibuprofen may be associated with a modest
increase in the risk of heart attack or stroke, particularly if used at high doses. Do not exceed the recommended dose or duration of treatment.
Consult your doctor or pharmacist before taking VoltaDexi if:

  • You have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including "mini-stroke" or transient ischaemic 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 this medicine, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with dexibuprofen.
Stop taking VoltaDexi immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
If you take high doses of painkillers for a long time (off-label use), you may develop headaches. In this case, consult your doctor; do not take more VoltaDexi to treat the headache.
In general, habitual use of analgesics, especially combinations of multiple painkillers, may cause permanent kidney damage, including risk of kidney failure (analgesic nephropathy).
Skin reactions
Serious skin reactions have been reported with treatment, including exfoliative dermatitis,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using VoltaDexi and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Infections
VoltaDexi may mask symptoms of infections such as fever and pain. Therefore, VoltaDexi may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella. If you take this medicine while you have an infection and infection symptoms persist or worsen, contact your doctor immediately.
In case of varicella zoster infection (chickenpox), you should avoid taking NSAIDs.
Other medicines and VoltaDexi
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
VoltaDexi may affect or be affected by other medicines. For example:

  • Anticoagulant medicines (i.e. thin the blood/prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine) may prolong bleeding time.
  • Medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with VoltaDexi.
Therefore, you should always consult your doctor or pharmacist before using VoltaDexi with other
medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines, in addition to those listed above:
Do not take the following medicines with VoltaDexi unless under strict medical supervision:

  • Non-steroidal anti-inflammatory drugs (medicines for pain, fever and inflammation). The risk of ulcers and gastrointestinal bleeding increases if you take VoltaDexi with other NSAIDs or acetylsalicylic acid as a painkiller.

You may take the following medicines together with VoltaDexi, but for safety reasons you should inform your doctor:

  • Lithium used to treat certain mood disorders. VoltaDexi may increase the effect of lithium.
  • Methotrexate (a medicine for cancer or rheumatism). VoltaDexi may increase the side effects of methotrexate.
  • Diuretics (medicines to increase urination) because dexibuprofen may reduce the effects of these medicines.
  • Corticosteroids: may increase the risk of gastrointestinal ulcers and bleeding.
  • Certain antidepressants (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.
  • Digoxin (a medicine for the heart). VoltaDexi may increase the side effects of digoxin.
  • Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus), sulfonylureas (some oral antidiabetic medicines) and aminoglycoside antibiotics (medicines to treat infections); - kidney damage may occur.
  • Quinolone antibiotics, as the risk of seizures may be increased.
  • Potassium-sparing diuretics, as this may lead to increased potassium levels in the blood.
  • Phenytoin used to treat epilepsy. VoltaDexi may increase the side effects of phenytoin.
  • Pemetrexed (a medicine for treating certain types of cancer).
  • Zidovudine (a medicine to treat HIV/AIDS); dexibuprofen may increase the risk of bleeding into joints or bleeding causing swelling.
  • Baclofen (a muscle relaxant): side effects of baclofen may occur with the initiation of dexibuprofen use.
  • Sulfinpyrazone, probenecid (medicines for gout) as excretion of ibuprofen may be delayed.

VoltaDexi with food, drinks and alcohol
You may take VoltaDexi on an empty stomach, but it is better to take it with food, as this may help prevent stomach problems, especially with prolonged use.
You should limit or avoid alcohol while taking VoltaDexi, as this may increase gastrointestinal problems.
Pregnancy, fertility and breastfeeding
If you are pregnant, suspect you are pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
You must not take VoltaDexi during the last 3 months of pregnancy, as this could seriously harm the fetus, even at very low doses. This medicine may cause kidney and heart problems in the fetus. In addition, it may affect your tendency to bleed and that of your baby, and delay or prolong labour more than expected.
You must not take VoltaDexi during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, if taken for more than a few days, VoltaDexi may cause kidney problems in the fetus that may lead to reduced 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.
Fertility
In addition, you should not take VoltaDexi if you are planning a pregnancy, as the medicine may make it more difficult to become pregnant.
Breastfeeding
Only small amounts of VoltaDexi pass into breast milk. However, if you are breastfeeding, you should not take VoltaDexi for long periods or at high doses.
Driving and using machines
If you experience side effects such as dizziness, fatigue or blurred vision after taking VoltaDexi, avoid driving or using dangerous machinery (see section 4).
3 How to take VoltaDexi 200 mg film-coated tablets
[For packages available without medical prescription]
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
[For packages subject to medical prescription]
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take VoltaDexi with a glass of water or other liquid. VoltaDexi acts more quickly if taken on an empty stomach. Taking it with food is recommended, as this may help prevent stomach problems, especially with prolonged use.
The initial dose is 1 tablet of VoltaDexi 200 mg (200 mg of dexibuprofen), then 1 tablet every 6-8 hours as needed. Leave at least six hours between doses and do not exceed 3 VoltaDexi tablets (600 mg of dexibuprofen) per day without consulting your doctor.
If a lower dose is recommended: the score line on the tablets (see section "Description of the appearance of VoltaDexi 200 mg film-coated tablets") allows them to be divided into equal parts. To split the tablet, place it on a hard surface and press with two index fingers or thumbs.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Patients with liver or kidney disease
Greater caution is required in patients with renal or hepatic impairment. Consult your doctor.
Use in children and adolescents
Since there is insufficient experience in children and adolescents, VoltaDexi must not be used in individuals under 18 years of age.
Elderly patients
In elderly patients, the dosage is the same as for adults, but greater caution is required (see section Warnings and precautions).
Duration of treatment
Consult your doctor if in adults it is necessary to take the product for more than 4 days (3 days if feverish) or if symptoms worsen.
If you think the effects of VoltaDexi tablets are too strong or too weak, consult your doctor or pharmacist.
If you take more VoltaDexi than you should
If you have taken more VoltaDexi than you should or if children have accidentally taken this medicine, always contact a doctor or go to the nearest hospital for advice on risk and actions to take. Symptoms may include nausea, stomach ache, vomiting (possibly with blood streaks), headache, ringing in the ears, confusion and tremulous eye movements. At high doses, cases of drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in urine, feeling cold and breathing problems have been reported.
If you forget to take VoltaDexi
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimised by taking the lowest dose for the shortest time needed to relieve symptoms. Elderly patients using this medicine are at higher risk of developing problems associated with side effects.
The following list includes all known possible side effects, including those from long-term treatment with high doses, e.g. for rheumatic conditions. They may occur less frequently when a low dose is used and only for a short time as recommended for VoltaDexi 200 mg.
Stop taking VoltaDexi and contact your doctor immediately:

  • If you experience severe stomach pain, especially when you start taking VoltaDexi;
  • If you have black stools, bloody diarrhoea or if you vomit blood;
  • If you experience chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
  • If you develop flat, non-elevated reddish spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or 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]; if you develop widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome);
  • If you develop widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
  • If you experience symptoms such as fever, sore throat and mouth pain, flu-like symptoms, feeling of fatigue, nosebleeds and skin bleeding. These may be caused by a reduction in white blood cells in the body (agranulocytosis);
  • If you suffer from severe or persistent headache;
  • If you have yellowing of the skin and whites of the eyes (jaundice);
  • If you have swelling of the face, tongue or pharynx, difficulty swallowing or breathing (angioedema), leading to worsening of asthma.

Common: may affect from 1 to 10 users in 100

  • Gastrointestinal disorders, such as abdominal pain, feeling unwell and indigestion, diarrhoea, gas in the intestine (flatulence), constipation, heartburn, vomiting and slight blood loss in the stomach and/or intestine which may exceptionally cause anaemia.

Uncommon: may affect from 1 to 10 users in 1,000

  • Gastric or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the mouth mucosa with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;
  • Disorders of the central nervous system such as headache, dizziness, insomnia, agitation, irritability or fatigue;
  • Visual disturbances;
  • Urticaria;
  • Hypersensitivity reactions, including urticaria (skin rash with red, raised, itchy swellings) and pruritus.

Rare: may affect from 1 to 10 users in 10,000

  • Tinnitus (ringing in the ears), hearing problems with prolonged treatment;
  • Kidney damage (papillary necrosis), elevated blood urea levels and elevated blood uric acid levels;
  • Liver function disorders (usually reversible).

Very rare: may affect less than 1 user in 10,000

  • Difficulty breathing (mainly in patients with bronchial asthma), worsening of asthma;

  • Inflammation of the oesophagus or pancreas, formation of a membrane-like narrowing in the small and large intestine (intestinal strictures similar to a diaphragm);

  • High blood pressure, inflammation of blood vessels, palpitations, heart failure;

  • Reduced urine output compared to normal and swelling (especially in patients with hypertension or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which may cause acute kidney failure. If any of the above symptoms occur or if you experience a general feeling of malaise, stop taking VoltaDexi and consult your doctor immediately, as these may be the first signs of kidney damage or kidney failure;

  • Psychotic reactions and depression;

  • Liver damage, especially during long-term treatment, impaired liver function, acute inflammation of the liver (hepatitis) and jaundice;

  • Problems in blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) - early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, you must stop treatment immediately and consult a doctor. Do not treat these symptoms with painkillers or fever-reducing medicines (antipyretics);

  • Worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been described associated with the use of some painkillers (NSAIDs). If signs of infection appear or worsen during ibuprofen use, contact your doctor immediately to assess the need for anti-infective/antibiotic therapy;

  • In exceptional cases, severe skin infections and soft tissue complications during varicella infection;

  • Symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, malaise, fever or confusion have been observed when using ibuprofen.
    Patients with autoimmune diseases (systemic lupus erythematosus [SLE], mixed connective tissue disease) may be more likely to be affected. If you experience these disorders, contact a doctor immediately;

  • Severe forms of skin reactions such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia);

  • Severe general hypersensitivity reactions (facial, tongue and laryngeal oedema, dyspnoea, tachycardia, hypotension, severe shock, worsening of asthma).

Not known (frequency cannot be estimated from the available data)

  • A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).
  • A widespread, red, scaly rash, with pustules forming 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 using the medicine if you develop these symptoms and contact your doctor immediately. See also section 2.

Medicines such as VoltaDexi may be associated with a modest increase in the risk of heart attack ("myocardial infarction") or stroke.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5 How to store VoltaDexi 200 mg film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated after "Exp." on the pack and blister.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6 Contents of the pack and other information
What VoltaDexi contains

  • The active substance is dexibuprofen. One film-coated tablet contains 200 mg of dexibuprofen.
  • The other ingredients are Tablet core: hypromellose, microcrystalline cellulose, calcium carmellose, colloidal anhydrous silica, talc. Coating: hypromellose, titanium dioxide (E171), triacetin, talc, macrogol 6000.

Description of the appearance of VoltaDexi 200 mg film-coated tablets and contents of the pack
The 200 mg tablets are white, round tablets with a score line on one side.
Diameter: approx. 10.2 mm
Height: approx. 4.9 mm

Stylized drawing of a thick, circular white tablet with a vertical score line in the center

VoltaDexi film-coated tablets are supplied in boxes of <10, 20, 30, 50, 60, 100 and 100 x1> tablets in transparent PVC/PVDC/aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
HALEON ITALY S.R.L.
Via Monte Rosa, 91
20149 Milan (MI)
Italy
Manufacturer
Gebro Pharma GmbH
Bahnhofbichl 13
A-6391 FIEBERBRUNN
Austria
This product is authorised in the European Economic Area (EEA) member states under the following names:
Austria: Movone 200 mg Filmtabletten
Czech Republic: Ibolex 200 mg potahovaná tableta
Slovakia: Ibolex 200 mg filmom obalená tablet
Hungary: Dexibuprofen Gebro 200 mg filmtabletta
Italy: VoltaDexi 200 mg compresse rivestite con film
Portugal: Seractil 200, 200 mg comprimidos revestidos por película