VOLTADVANCEGO 25 MG SOFT CAPSULES 20 CAPSULES IN PVC/PE/PVDC/AL BLISTER

Name
VoltadvanceGo 12.5 mg soft capsules
VoltadvanceGo 25 mg soft capsules
Diclofenac epolamine
Equivalent medicine


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

VoltadvanceGo is a medicine that belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). This medicine is a pain reliever that can also reduce inflammation and swelling.
v VoltadvanceGo is used to provide 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 nonsteroidal anti-inflammatory drug (NSAID);
• if you currently have a gastric (stomach) or duodenal (intestine) ulcer , bleeding or perforation;
• if you have alterations of unknown origin in the production of blood cells ;
• 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 (intestine) ulcers or bleeding in the digestive tract (including blood in vomiting, bleeding during bowel movements, fresh blood in stools or black, tarry stools);
• if you suffer from a known heart disease and/or cerebrovascular disease , for example if you have had a heart attack, a stroke, a mini-stroke (transient ischemic attack - TIA) or a blockage of the blood vessels to the heart or brain or if you have had surgery to remove or avoid such blockages;
• if you think you may be 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), skin rash, or any other allergic-type 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, talk to your doctor or pharmacist.


Warnings and precautions
Talk to your doctor or pharmacist before taking VoltadvanceGo if:

• suffer or have suffered from any stomach or intestinal disorder, including ulcerative colitis or Crohn's disease;
• is elderly;
• have kidney or liver problems;
• has a condition called porphyria;
• suffer from any blood or bleeding disorder;
• has ever had asthma;
• is breastfeeding;
• have angina, blood clots, high blood pressure, high cholesterol or triglyceride levels;
• has diabetes;
• is a smoker;
• has recently undergone surgery;
• is at risk of dehydration (e.g. from illness or diarrhea);
• have had or are about to have surgery on your stomach or intestinal tract before using VoltadvanceGo, as VoltadvanceGo can sometimes worsen wound healing in your intestine following 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 small 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 duration of treatment.

Stop treatment and tell your doctor if you develop worsening headaches while taking VoltadvanceGo, as prolonged use of medicines to reduce headaches can sometimes make them worse.

If you experience signs or symptoms of heart or blood vessel problems such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor immediately.

Because it is an anti-inflammatory medicine, the active ingredient in VoltadvanceGo may mask the signs and symptoms of an infection. If you feel unwell and need to see a doctor, don't forget to tell your doctor you are taking VoltadvanceGo.

Undesirable 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:
• sharp pain in the upper abdomen, feeling sick, feeling unwell;
• vomiting blood or black particles, black stools or blood in the stool • 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 in the abdomen, which begin shortly after starting treatment with VoltadvanceGo and are followed by bleeding from the rectum or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, frequency cannot be estimated from the available data).

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

Medicines such as VoltadvanceGo may 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, digestive disorders (dyspepsia), abdominal pain, flatulence, loss of appetite;
• skin rash and itching.

Uncommon (may affect up to 1 in 100 people)
• increased 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 drop in blood pressure and shock);
• allergic swelling including facial swelling (angioedema);
• drowsiness;
• feeling of constriction of the airways (asthma) including shortness of breath (dyspnea);
• inflammation of the stomach (gastritis), gastric (stomach) or duodenal (intestine) ulcer with or without bleeding or perforation (with possible inflammation of the peritoneum called peritonitis), gastrointestinal narrowing (stenosis);
• hepatitis (inflammation of the liver), jaundice, liver disorders;
• hives;
• edema (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;
• disturbances in sensation (paraesthesia), memory impairment, convulsive seizures or spasms, anxiety, tremor, meningitis not associated with an infection, altered taste;
• visual disturbance, blurred or double vision;
• noises in the ear (tinnitus), impaired hearing;
• palpitations, chest pain, weakness of the heart muscle (heart failure);
• high blood pressure (hypertension), inflammation of the blood vessels (vasculitis);
• inflammation of the lungs (pneumonia);
• inflammation of the colon (colitis), including bleeding and worsening of Crohn's disease or ulcerative colitis, constipation;
• inflammation of the oral mucosa (stomatitis), inflammation of the tongue, esophageal lesions (damage to the esophagus), formation of membranous narrowings in the intestine (intestinal diaphragm disease), inflammation of the pancreas (pancreatitis);
• liver failure, very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis;
• skin rash (including eczema and blisters), sensitivity to light, appearance of red-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 (renal failure), blood in the urine (hematuria), protein in the urine (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein passed into the urine), damage to kidney tissue (interstitial nephritis, papillary necrosis).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.