Voltadvance 20 Coated Tablets 25mg

Voltadvance Tablets is an over-the-counter drug based on Diclofenac , a principle with analgesic, antipyretic and anti-inflammatory action. Voltadvance Tablets is used in the treatment of pain of various kinds such as, for example, joint pain , lumbago, muscle pain, headache, toothache and menstrual pain .

Dosage and method of use Voltadvance 20 Coated Tablets 25mg

Voltadvance tablets should be taken in these doses and modalities:

Adults and adolescents over 14 years : Take 1-3 Voltadvance coated tablets a day, preferably with meals, even 2 in a single dose. The coated tablets should be swallowed whole with water or other liquid.

The maximum daily dose is 75 mg. Do not exceed the recommended dose; in particular elderly patients must comply with the minimum dosages indicated above. Do not exceed 3 days of treatment.

Active Ingredients Voltadvance 20 Coated Tablets 25mg

Active ingredient: Diclofenac sodium 25 mg

Excipients: Potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibehenate; Clear Opadry (hypromellose; macrogol).

Contraindications Voltadvance 20 Coated Tablets 25mg

Voltadvance Tablets are contraindicated in case of:

• Hypersensitivity to the active substance or to any of the excipients
• Active gastrointestinal ulcer, bleeding or perforation
• History of gastrointestinal bleeding or perforation related to previous NSAID treatment or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Last trimester of pregnancy and while breastfeeding
• Severe hepatic insufficiency or severe renal insufficiency

Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients who have experienced asthmatic attacks, urticaria or acute rhinitis, anaphylactic or anaphylactoid reactions after taking acetylsalicylic acid or other NSAIDs.
The product should not be used in case of haematopoiesis alterations.
In case of intensive diuretic therapy.

The product should not be taken in case of dark or bloody stools.
Overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, and/or cerebral vascular disease
Voltadvance should not be given to children under 14 years of age.

Side Effects Voltadvance 20 Coated Tablets 25mg

Undesirable effects are listed below by organ system/system and by frequency. The following side effects include those reported with short-term or long-term use. If any of these effects occur during treatment with Voltadvance, it is advisable to discontinue the drug and consult your doctor:

• Blood and lymphatic system disorders: Very rare thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anaemia), agranulocytosis.
• Immune system disorders: Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Very rare: angioneurotic edema (including facial oedema).
• Psychiatric disorders: Very rare: disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
• Nervous system disorders: Common: headache, dizziness. Rare: somnolence Very rare: paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste perversion, cerebrovascular accident.
• Eye disorders: Very rare: visual disturbances, blurred vision, diplopia.
• Ear and labyrinth disorders: Common: vertigo. Very rare: tinnitus, hearing impaired.
• Cardiac disorders: Uncommon*: Myocardial infarction, heart failure, palpitations, chest pain.
• Vascular disorders: Very rare: hypertension, vasculitis.
• Respiratory, thoracic and mediastinal disorders: Rare: asthma (including dyspnoea). Very rare: pneumonia.
• Gastrointestinal disorders: Common: nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Rare: gastritis, gastrointestinal haemorrhage, haematemesis, bloody diarrhoea, melaena, gastrointestinal ulcer (with or without bleeding or perforation), dry mouth and mucous membranes. Very rare: Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal stricture, pancreatitis, constipation.
• Hepatobiliary disorders: Common: increased transaminases. Rare: hepatitis, jaundice, liver disorders. Very rare: fulminant hepatitis, hepatic necrosis, hepatic failure.
• Skin and subcutaneous tissue disorders: Common: rash. Rare: urticaria Very rare: bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, pruritus.
• Renal and urinary disorders: Very rare: acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
• General disorders and administration site conditions: Rare: oedema

Overdose

There is no typical clinical picture resulting from an overdose of diclofenac. Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus or convulsions. In case of significant poisoning, acute renal failure and liver damage are possible.

Treatment of acute poisoning with NSAIDs, including diclofenac, consists essentially of supportive measures and symptomatic treatment. In case of complications such as hypotension, renal insufficiency, convulsions, gastrointestinal disturbances and respiratory depression, supportive measures and symptomatic treatment should be implemented.

Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric emptying (eg vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose. Specific therapies, such as forced diuresis, dialysis or haemoperfusion, are probably not helpful in eliminating NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism.

Warnings Voltadvance 20 Coated Tablets 25mg

After 2-3 days of treatment with Voltadvance 20 Tablets without appreciable results, consult your doctor.

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Concomitant use of diclofenac with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to a lack of any evidence demonstrating synergistic benefits and based on potential additive side effects. On a basic medical basis, caution is required in the elderly. In particular in frail elderly patients or those with low body weight, the use of the lowest effective dose is recommended. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may also occur in rare cases without prior exposure to diclofenac.

Like other NSAIDs, diclofenac can mask the signs and symptoms of infections due to its pharmacodynamic properties. Prolonged use of any type of pain reliever for headaches can make them worse. If this situation has occurred or is suspected, medical advice should be sought and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite regular use of headache medications.

Voltadvance 20 Coated Tablets 25 mg in Pregnancy and lactation

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%.

The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

Voltadvance 20 Coated Tablets should not be administered during the first and second trimester of pregnancy unless strictly necessary .

If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be kept as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose - the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; - the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be administered during lactation to avoid undesirable effects in the infant.

Expiration and storage Voltadvance 20 Coated Tablets 25mg

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

This medicine does not require any special storage conditions.

Warning: do not use the medicine after the expiry date indicated on the package.