VoltadvanceGo

Package leaflet: information for the user

VoltadvanceGo 12.5 mg soft capsules, 25 mg soft capsules

Diclofenac epolamine
Generic medicine
Please read all of 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 told you to.

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

Contents of this leaflet:

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

1. What VoltadvanceGo is and what it is used for

VoltadvanceGo contains the active substance diclofenac epolamine.
VoltadvanceGo is a medicine that belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is a pain reliever that can also reduce inflammation and swelling.
VoltadvanceGo is used to provide short-term symptomatic relief in the following conditions:
mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain, and muscle pain).

2. What you need to know before taking VoltadvanceGo

Do NOT take VoltadvanceGo:

• if you are allergic to diclofenac epolamine or to any of the other ingredients of this medicine (listed in section 6), or to 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 blood cell production disorders of unknown origin
• if you have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy
• if you have had two or more episodes of gastric (in the stomach) or duodenal (in the intestine) ulcers or gastrointestinal bleeding (including blood in vomit, bleeding during defecation, fresh blood in stools, or black, tarry stools)
• if you suffer from established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (transient ischemic attack - TIA), obstruction of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such blockages
• if you think you are allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID. Signs of hypersensitivity reactions 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 circulatory 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 disorder or bleeding condition
• you have ever had asthma
• you are breastfeeding
• you suffer from angina, blood clots, high blood pressure, high cholesterol or triglyceride levels
• 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 stomach or intestinal surgery before using VoltadvanceGo, as VoltadvanceGo may sometimes impair wound healing in the intestine following surgery
• if you have ever developed severe skin rash, skin peeling, blistering rash, and/or mouth ulcers after taking Voltadvance or other pain-relieving medicines

In these cases, VoltadvanceGo may not be the right medicine for you.
Other important information
Cardiovascular disease
Medicines such as VoltadvanceGo may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. The risk is higher with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Stop treatment and contact your doctor if you experience worsening headache during treatment with VoltadvanceGo, as prolonged use of pain-relieving medicines may worsen headache in some cases.
If you experience signs or symptoms of heart or blood vessel problems such as chest pain, shortness of breath, weakness, or difficulty speaking, contact your doctor immediately.
Since it is an anti-inflammatory medicine, the active ingredient in VoltadvanceGo may mask the signs and symptoms of infection. If you feel unwell and need to see a doctor, do not forget to tell them that you are taking VoltadvanceGo.
Undesirable effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Children and adolescents
Children and adolescents under 14 years of age must not take VoltadvanceGo (see also "Do NOT take VoltadvanceGo").
Other medicines and VoltadvanceGo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ask your doctor for advice before taking VoltadvanceGo if you are using any of the following medicines:

• Digoxin (a medicine to strengthen the heart), phenytoin (a medicine to treat epilepsy), or lithium (a medicine to treat mental disorders). VoltadvanceGo may increase blood levels of these substances.
• Diuretics and medicines to lower blood pressure (diuretics and antihypertensives). VoltadvanceGo may reduce the effect of these medicines.
• Medicines that increase potassium levels in the blood (potassium-sparing diuretics, cyclosporine, tacrolimus, or trimethoprim). VoltadvanceGo may increase potassium levels in the blood, and in such cases your doctor may perform frequent blood tests.
• Medicines for treating heart failure and high blood pressure (ACE inhibitors and angiotensin II antagonists). VoltadvanceGo may reduce the effect of these medicines and may also increase the risk of kidney dysfunction.
• Anticoagulant medicines such as warfarin. Like other NSAIDs, VoltadvanceGo may enhance the effect of these medicines.
• Oral antidiabetic medicines. In some cases, dosage adjustment of antidiabetic medicines may be necessary. As a precaution, blood glucose levels should be monitored.
• Other NSAIDs (used for pain and inflammation, e.g., ibuprofen, COX-2 inhibitors, and aspirin) or medicines containing glucocorticoids. VoltadvanceGo increases the risk of gastrointestinal ulcers or bleeding.
• Platelet aggregation inhibitors such as acetylsalicylic acid (aspirin) and certain antidepressants (selective serotonin reuptake inhibitors or SSRIs). These may increase the risk of gastrointestinal bleeding.
• Cyclosporine and tacrolimus (medicines used to prevent transplant rejection, but also for treating rheumatic diseases or severe skin conditions). NSAIDs may increase the kidney-damaging effects caused by cyclosporine and tacrolimus.
• Methotrexate. Using VoltadvanceGo within 24 hours before or after methotrexate may increase methotrexate blood levels and lead to increased adverse effects of this substance.
• Sulfinpyrazone or probenecid (used for gout) and voriconazole (used for fungal infections). These may delay the excretion of VoltadvanceGo, resulting in higher VoltadvanceGo concentrations in the body and increased adverse effects.
• Colestipol and cholestyramine. These may delay or reduce the absorption of VoltadvanceGo. It is recommended to take VoltadvanceGo at least one hour before or 4–6 hours after taking the other medicine.
• Quinolones (a type of antibiotic). Isolated cases of seizures have been reported.
• Cardiac glycosides: concomitant use with NSAIDs may worsen heart failure, reduce renal filtration, and increase plasma levels of cardiac glycosides.
• Mifepristone: NSAIDs should not be used for 8–12 days after administration of mifepristone, as they may reduce its effectiveness.

VoltadvanceGo and alcohol
While taking VoltadvanceGo, you must not drink alcohol. Alcohol may increase the possible adverse effects of VoltadvanceGo, particularly fatigue and dizziness, and may worsen gastrointestinal effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take VoltadvanceGo during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor. You should not take VoltadvanceGo during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required 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, VoltadvanceGo may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing 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
VoltadvanceGo must not be taken if you are breastfeeding, as it may be harmful to the newborn. Inform your doctor if you are breastfeeding.
Fertility
VoltadvanceGo belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is discontinued.
Therefore, use of VoltadvanceGo is not recommended for women who are trying to conceive, have difficulty conceiving, or are undergoing infertility investigations.
Driving and using machines
When using VoltadvanceGo, adverse effects such as visual disturbances, dizziness, drowsiness, feeling sleepy, or other central nervous system disorders may occur. These effects are increased when combined with alcohol.
If you experience these effects, you must not drive or operate machinery.
This medicine contains, respectively, a maximum of 8.02 mg and 10.07 mg of sorbitol per 12.5 mg and 25 mg capsule.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e., essentially 'sodium-free'.

3. How to take VoltadvanceGo

Swallow the capsules whole with a glass of water.
To ensure the medicine works as effectively as possible, take the capsule on an empty stomach.
Adults and adolescents aged 14 years and older:
It is important that you use the lowest effective dose that controls your pain and that you do not take VoltadvanceGo for longer than necessary.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If in doubt, consult your doctor or pharmacist.
For VoltadvanceGo 12.5 mg
Initially take 1 or 2 soft capsules and, if necessary, subsequently take 1 or 2 soft capsules every 4–6 hours. In any case, do not take more than 6 soft capsules (75 mg) within 24 hours.
For VoltadvanceGo 25 mg
Initially take 1 soft capsule and, if necessary, subsequently take 1 soft capsule every 4–6 hours. In any case, do not take more than 3 soft capsules (75 mg) within 24 hours.
VoltadvanceGo must not be taken for more than 3 days. If symptoms persist or worsen, consult your doctor.
If you take more VoltadvanceGo than you should
If you accidentally take too much medicine, inform your doctor immediately or go straight to the nearest emergency department, taking the medicine pack with you. You may require medical treatment.
If you forget to take VoltadvanceGo
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and take the next capsule at your usual time. Do not take a double dose to make up for the forgotten dose.

4. 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 contact your doctor immediately if you experience:

• severe pain in the upper abdomen, feeling unwell, general malaise
• vomiting blood or black particles, black stools or blood in the stools
• allergic reactions such as skin rash, itching, bruising, red painful areas, skin 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 changes in the amount and/or appearance of urine produced
• mild cramps and abdominal tenderness starting shortly after beginning treatment with VoltadvanceGo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours after the onset of abdominal pain (frequency not known, frequency cannot be estimated from the available data)
• a severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters and itching (Drug-induced fixed bullous eruption).

Contact 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, indigestion (dyspepsia), abdominal pain, flatulence, loss of appetite.
• Skin rash and itching.

Uncommon (may affect up to 1 in 100 people)

• Increased levels of liver enzymes in the blood.

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

• Hypersensitivity, anaphylactic and anaphylactoid reactions (severe allergic reactions, including low blood pressure and shock).
• Allergic swelling including facial oedema (angioedema).
• Drowsiness.
• Feeling of tightness in the airways (asthma), including shortness of breath (dyspnoea).
• Inflammation of the stomach (gastritis), gastric (stomach) or duodenal (intestine) ulcer, with or without bleeding or perforation (possibly leading to inflammation of the peritoneum called peritonitis), gastrointestinal narrowing (stenosis).
• Hepatitis (liver inflammation), jaundice, liver disorders.
• Urticaria.
• Oedema (fluid retention in the body).

Very rare (may affect up to 1 in 10,000 people)

• Disorders in the formation of red and white blood cells.
• Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
• Sensory disturbances (paraesthesia), memory impairment, seizures or spasms, anxiety, tremor, non-infectious meningitis, altered taste.
• Visual disturbances, blurred or double vision.
• Ringing in the ears (tinnitus), impaired hearing.
• Palpitations, chest pain, heart muscle weakness (heart failure).
• High blood pressure (hypertension), inflammation of blood vessels (vasculitis).
• Inflammation of the lungs (pneumonitis).
• Inflammation of the colon (colitis), including bleeding and worsening of Crohn’s disease or ulcerative colitis, constipation.
• Inflammation of the mouth lining (stomatitis), inflammation of the tongue, oesophageal lesions (damage to the oesophagus), formation of membrane-like constrictions in the intestine (intestinal diaphragm disease), inflammation of the pancreas (pancreatitis).
• Liver failure, very severe and sudden onset hepatitis (fulminant hepatitis), liver necrosis.
• Skin rash (including eczema and blisters), light sensitivity, appearance of red-brown spots on the skin (purpura), Henoch-Schönlein purpura, severe skin reactions such as blistering rash (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyell’s syndrome), hair loss.
• Acute kidney dysfunction (renal failure), blood in the urine (haematuria), protein in the urine (proteinuria), nephrotic syndrome (fluid retention in the body and high levels of protein in the urine), damage to kidney tissue (interstitial nephritis, papillary necrosis).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, blistering rash and itching (drug-induced fixed eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A drug-induced fixed eruption usually recurs at the same site (or sites) if the medicine is taken again.

Reporting of side effects
If you experience any side effects, including those 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/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store VoltadvanceGo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
• Store below 25°C.
• Store in the original packaging to protect from light and moisture.

6. Package contents and other information

What VoltadvanceGo contains
The active substance is diclofenac epolamine.
For VoltadvanceGo 12.5 mg
Each soft capsule contains diclofenac in the form of 15.38 mg of diclofenac epolamine, equivalent
to 12.5 mg of diclofenac potassium.
For VoltadvanceGo 25 mg
Each soft capsule contains diclofenac in the form of 30.76 mg of diclofenac epolamine, equivalent
to 25 mg of diclofenac potassium.
The other components are:
Capsule contents:
Macrogol 600, anhydrous glycerol, purified water
Capsule shell:
Gelatin, anhydrous glycerol, partially dehydrated liquid sorbitol (E420), hydroxypropylbetadex, sodium
hydroxide, purified water.

Description of the appearance of VoltadvanceGo and package contents
For VoltadvanceGo 12.5 mg
Oval, transparent, yellowish soft gelatin capsule, approximately 0.8 cm in size, containing a slightly viscous solution.
For VoltadvanceGo 25 mg
Oval, transparent, yellowish soft gelatin capsule, approximately 1 cm in size, containing a slightly viscous solution.
The soft capsules are packaged in blisters.
For VoltadvanceGo 12.5 mg
Pack sizes: 10, 20, 30 or 40 soft capsules.
For VoltadvanceGo 25 mg
Pack sizes: 10 or 20 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
Manufacturer
IBSA Farmaceutici Italia S.r.l., via Martiri di Cefalonia 2, 26900 Lodi