VOLTADVANCEGO*20 SOFT CAPSULES 25MG

VoltadvanceGo 12.5 mg soft capsules
VoltadvanceGo 25 mg soft capsules
Diclofenac epolamine
Equivalent medicinal product

What it is and what it is used for
VoltadvanceGo contains the active ingredient diclofenac epolamine.

VoltadvanceGo is a medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is a painkiller that can also reduce inflammation and swelling.

VoltadvanceGo is used for short-term symptomatic relief in the following situations: mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain, and muscle pain).

What you need to know before taking the medicine
DO NOT take VoltadvanceGo:
• if you are allergic to
- diclofenac epolamine or any of the other ingredients of this medicine (listed in section 6)
- diclofenac, acetylsalicylic acid, or any other non-steroidal anti-inflammatory drug (NSAID)
• if you currently have a gastric (stomach) or duodenal (intestinal) ulcer, bleeding, or perforation
• if you have unknown changes in blood cell production
• if you have a history of bleeding or perforation in the digestive tract, related to previous NSAID therapy
• if you have had two or more episodes of gastric (stomach) or duodenal (intestinal) ulcer or bleeding in the digestive tract (including blood in vomit, bleeding during defecation, fresh blood in stools or black and tarry stools)
• if you suffer from established heart disease and/or cerebrovascular disease, for example, you have had a heart attack, a stroke, a mini-stroke (transient ischemic attack - TIA), or an obstruction of the blood vessels leading to the heart or brain, or surgery to eliminate or prevent such obstructions
• if you think you are allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID. Signs of a hypersensitivity reaction include swelling of the face, lips, tongue, and/or throat with difficulty swallowing (angioedema), breathing problems (difficulty breathing, asthma), chest pain, acute rhinitis (runny nose), rash, or any other allergic reaction.
• if you suffer or have suffered from blood circulation problems (peripheral arterial disease)
• if you have severe kidney, liver, or heart failure
• if you are beyond the sixth month of pregnancy (see also Pregnancy, breastfeeding, and fertility)
• if you are under 14 years of age.

If any of the above situations apply to you, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking VoltadvanceGo if:
• you suffer or have suffered from any stomach or intestinal disorder, including ulcerative colitis or Crohn's disease
• you are elderly
• you have kidney or liver problems
• you have a condition called porphyria
• you suffer from any blood or bleeding disorder
• you have ever had asthma
• you are breastfeeding
• you suffer from angina, blood clots, high blood pressure, high cholesterol, or triglycerides
• you have diabetes
• you are a smoker
• you have recently undergone surgery
• you are at risk of dehydration (e.g., due to illness or diarrhea)
• you have undergone or are about to undergo surgery on your stomach or intestinal tract before using VoltadvanceGo, as VoltadvanceGo can sometimes worsen wound healing in the intestine after surgery.
In these cases, VoltadvanceGo may not be the right medicine for you.

Other important information

Cardiovascular disease
Medicines like VoltadvanceGo may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

Stop treatment and inform your doctor if, during treatment with VoltadvanceGo, you develop worsening headaches because prolonged use of medicines to reduce headaches can, in some cases, worsen them.

If signs or symptoms of heart or blood vessel problems such as chest pain, shortness of breath, weakness, or difficulty speaking occur, contact your doctor immediately.

As it is an anti-inflammatory medicine, the active ingredient in VoltadvanceGo could mask the signs and symptoms of an infection. If you do not feel well and need to see a doctor, do not forget to tell them that you are taking VoltadvanceGo.

Side effects can be minimised by using the lowest effective dose for the shortest duration necessary.

Children and adolescents Children and adolescents under 14 years of age should not take VoltadvanceGo (see also Do not take VoltadvanceGo).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious.

Stop taking VoltadvanceGo and tell your doctor immediately if you experience:
• severe pain in the upper abdomen, feeling unwell, feeling nauseous
• vomiting blood or black particles, black stools or blood in the stools
• allergic reactions such as rash, itching, bruising, painful red areas, peeling, or blistering
• wheezing or shortness of breath (bronchospasm), difficulty swallowing, collapse
• swelling of the face, lips, hands, or fingers
• yellowing of the skin or eyes
• persistent sore throat or high temperature, unusual bleeding or bruising
• unexpected change in the amount of urine produced and/or its appearance
• mild cramps and tenderness of the abdomen, which begin shortly after starting treatment with VoltadvanceGo and are followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, frequency cannot be estimated from the available data).

Inform your doctor immediately if you notice any of the following reactions:
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines like VoltadvanceGo can be associated with an increased risk of heart attack (myocardial infarction) or stroke.

The following side effects have also been reported:
Common (may affect up to 1 in 10 people)
• Headache, dizziness, vertigo.
• Nausea, vomiting, diarrhoea, indigestion (dyspepsia), abdominal pain, flatulence, loss of appetite.
• Rash and itching.

Uncommon (may affect up to 1 in 100 people)
• Increase in liver enzyme values in the blood.

Rare (may affect up to 1 in 1,000 people)
• Hypersensitivity, anaphylactic and anaphylactoid reactions (severe allergic reactions, including blood pressure collapse and shock).
• Allergic swelling including facial oedema (angioedema).
• Drowsiness.
• Feeling of constriction of the airways (asthma) including shortness of breath (dyspnoea).
• Stomach inflammation (gastritis), gastric (stomach) or duodenal (intestinal) ulcer with or without bleeding or perforation (with possible inflammation of the peritoneum called peritonitis), gastrointestinal narrowing (stenosis).
• Hepatitis (liver inflammation), jaundice, liver disorders.
• Hives.
• Oedema (fluid retention in the body).

Very rare (may affect up to 1 in 10,000 people)
• Disorders of red and white blood cell formation.
• Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
• Sensory disturbances (paraesthesia), memory impairment, convulsive attacks or spasms, anxiety, tremor, meningitis not associated with an infection, altered taste.
• Visual disturbance, blurred or double vision.
• Ringing in the ears (tinnitus), impaired hearing.
• Palpitations, chest pain, weakness of the heart muscle (heart failure).
• High blood pressure (hypertension), inflammation of blood vessels (vasculitis).
• Lung inflammation (pneumonia).
• Colon inflammation (colitis), including bleeding and worsening of Crohn's disease or ulcerative colitis, constipation.
• Inflammation of the oral mucosa (stomatitis), inflammation of the tongue, oesophageal lesions (damage to the oesophagus), formation of membranous strictures in the intestine (intestinal diaphragm disease), inflammation of the pancreas (pancreatitis).
• Liver failure, a very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis.
• Rash (including eczema and blisters), sensitivity to light, appearance of reddish-brown spots on the skin (purpura), Henoch-Schonlein purpura, severe skin reactions such as rash with blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis /Lyell's syndrome), hair loss.
• Acute kidney dysfunction (kidney failure), blood in the urine (haematuria), protein in the urine (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein passing into the urine), damage to kidney tissue (interstitial nephritis, papillary necrosis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.