VOLTADVANCE * OS POLV 20BUST25MG

  • GLAXOSMITHKLINE C.HEALTH.Srl
  • 035500040

Diclofenac-based drug with analgesic and anti-inflammatory action.

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VOLTADVANCE * OS POLV 20BUST25MG

Therapeutic indications

Pain of various kinds such as, for example, pain in the joints, lumbago, muscle pain, headache and toothache, menstrual pain.

Dosage and method of use

Adults and adolescents over 14 years: 1-3 coated tablets or sachets of powder for oral solution per day, with meals, even 2 in a single administration. The maximum daily dose is 75 mg. Do not exceed the recommended dose; in particular elderly patients must follow the minimum dosages indicated above. The coated tablets should be swallowed whole, with water or other liquid; the sachets of powder should be dissolved in a glass of water before taking. We recommend taking the product preferably on a full stomach. Do not exceed 3 days of treatment. Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Special populations . Kidney failure: Voltadvance is contraindicated in patients with severe renal insufficiency (see section 4.3). Caution is recommended when administering Voltadvance to patients with mild to moderate renal impairment (see section 4.4). Hepatic insufficiency: Voltadvance is contraindicated in patients with severe hepatic impairment (see section 4.3). Caution is recommended when administering Voltadvance to patients with mild to moderate hepatic impairment (see section 4.4).

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Active gastrointestinal ulcer, bleeding or perforation. • History of gastrointestinal bleeding or perforation related to previous NSAID treatment or history of recurrent peptic bleeding / ulcer (two or more distinct episodes of proven ulceration or bleeding). • Last trimester of pregnancy and during lactation (see section 4.6). • Severe hepatic insufficiency or severe renal insufficiency (see section 4.4). • Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients who have experienced asthma attacks, urticaria, angioedema or acute rhinitis, anaphylactic or anaphylactoid reactions after taking acetylsalicylic acid or other NSAIDs (see section 4.4 ). • The product should not be used in case of hematopoiesis 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 vasculopathy. Voltadvance should not be given to children under the age of 14.

Side effects

Undesirable effects (Table 1) are listed below by organ, organ / system, and MedDRA frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 in Table 1

Disorders of the blood and lymphatic system
Very rare thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis.
Disorders of the immune system
Rare hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare angioedema (including face edema).
Psychiatric disorders
Very rare disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
Nervous system disorders
Common headache, dizziness.
Rare drowsiness.
Very rare paraesthesia, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accidents.
Eye disorders
Very rare vision disturbances, blurred vision, diplopia.
Ear and labyrinth disorders
Common dizziness.
Very rare tinnitus, hearing impairment.
Cardiac pathologies
Uncommon* Myocardial infarction, heart failure, palpitations, chest pain.
Not known Kounis syndrome
Vascular pathologies
Very rare hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders
Rare asthma (including dyspnoea).
Very rare pneumonia.
Gastrointestinal disorders
Common nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhea, melaena, gastrointestinal ulcer (with or without bleeding or perforation, which can lead to peritonitis), dry mouth and mucous membranes, gastrointestinal stricture.
Very rare colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal diaphragm disease, pancreatitis, constipation.
Not known Ischemic colitis
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 rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, Henoch-Schonlein 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 edema.

* The frequency reflects the data of long-term treatment with a high dose (150 mg per day). Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment ( for contraindications and special warnings and precautions for use see sections 4.3 and 4.4). Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

After 2-3 days of treatment without noticeable results, consult your doctor. General informations: Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks). The use of diclofenac concomitantly with other systemic NSAIDs, including selective cyclo-oxygenase-2 inhibitors, should be avoided due to the lack of any evidence showing synergistic benefits and based on potential additive side effects. On a basic medical level, caution is required in the elderly. Particularly in frail elderly patients or those with a 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. Hypersensitivity reactions can also develop into Kounis syndrome, a severe allergic reaction that can lead to myocardial infarction. Symptoms with which such reactions occur may include chest pain occurring in association with an allergic reaction 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 drug overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite regular use of headache medications. Gastrointestinal effects: During treatment with all NSAIDs, including diclofenac, they have been reported and may appear at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration or perforation, which can be fatal. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued. As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history indicative of gastric or intestinal ulceration, bleeding or perforation. chronic inflammatory bowel diseases (see section 4.8). The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation. The elderly have a higher frequency of adverse reactions, especially gastrointestinal bleeding and perforation which can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose. Concomitant use of protective agents (proton pump inhibitors or misoprostol) should be considered for these patients and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA) or other medicinal products that may increase the risk gastrointestinal. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (see section 4.5). Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease as these conditions may be exacerbated (see section 4.8). NSAIDs, including diclofenac, may be associated with an increased risk of leakage from gastrointestinal anastomosis. Caution and close medical surveillance is recommended when using diclofenac following gastrointestinal surgery. Hepatobiliary effects: Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency as their condition may be exacerbated. As with other NSAIDs, including diclofenac, the values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure. If liver function parameters are persistently altered or worsened, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations (e.g. eosinophilia, rash) occur, diclofenac treatment should be discontinued. A hepatitis with the use of diclofenac can occur without prodromal symptoms. Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as they can trigger an attack. Kidney effects: Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, special caution is required in case of renal insufficiency, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may affect significantly on renal function and in those patients with substantial extracellular volume depletion due to any cause (e.g. before or after major surgery) (see section 4.3). In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac. Discontinuation of therapy is usually followed by a return to pre-treatment conditions. Skin effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltadvance should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Cardiovascular and cerebrovascular effects: Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment . Patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. Patients with congestive heart failure (NYHA class I) should only be treated with diclofenac after careful consideration. Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest possible duration and lowest effective daily dose should be used. Patients should be advised to consult their physician if symptoms persist or do not improve within the recommended treatment duration. Patients should be alert for signs and symptoms of severe thrombotic events (e.g. chest pain, shortness of breath, weakness, slurred speech), which can occur without warning symptoms. Patients should be advised to contact a physician immediately if any of these events occur. Hematological effects: During prolonged treatment with diclofenac, as with other NSAIDs, blood count checks are recommended. Like other NSAIDs, diclofenac can temporarily inhibit platelet aggregation. Patients with haemostatic defects should be carefully monitored. Respiratory effects (pre-existing asthma): In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (eg nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to allergic rhinitis), are more common than in other patients reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance / analgesic asthma), Quincke's edema or urticaria. Special precaution is therefore recommended in such patients (prepare for emergency). This also applies to patients allergic to other substances, eg. with skin reactions, itching or hives. Important information about some of the ingredients: Voltadvance 25 mg film-coated tablets contain less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Voltadvance 25 mg powder for oral solution contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Voltadvance 25 mg powder for oral solution contains aniseed flavor which in turn contains limonene and linalool. Limonene and linalool can cause allergic reactions. Voltadvance 25 mg powder for oral solution contains the mint flavor which in turn contains limonene, linalool and eugenol. Limonene, linalool and eugenol can cause allergic reactions.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased by less than 1%, up to about 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-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. 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 as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; - the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Feeding time: Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be administered during breastfeeding to avoid undesirable effects in the infant. Fertility: As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women wishing to conceive. Discontinuation of diclofenac should be considered in women who have difficulty conceiving or who are undergoing investigation of infertility.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Before using the product, if you are taking other drugs, it is advisable to inform your doctor as it may be necessary to change the dosage or stop treatment. The following interactions include those observed with diclofenac gastro-resistant tablets and / or other pharmaceutical forms of diclofenac. Lithium: when administered concomitantly, diclofenac can elevate plasma lithium concentrations. Monitoring of serum lithium levels is recommended. Digoxin: when administered concomitantly, diclofenac may elevate plasma concentrations of digoxin. Monitoring of serum digoxin levels is recommended. Diuretics and antihypertensive agents: Patients undergoing treatment with these drugs should consult their doctor before taking the product. Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be taken with caution and patients, especially the elderly, should receive periodic monitoring of their blood pressure. Patients should be adequately hydrated and renal function monitoring should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. Other NSAIDs and corticosteroids: Concomitant use of diclofenac and other systemic non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of gastrointestinal side effects and should be avoided (see section 4.4). Anticoagulants and antiplatelet agents: Caution is recommended as concomitant administration may increase the risk of bleeding. Although clinical investigations do not seem to indicate an influence of diclofenac on the action of anticoagulants, there are reports of an increased risk of haemorrhage in patients taking concomitant diclofenac and anticoagulants. Therefore, close monitoring of such patients is recommended. Selective Serotonin Reuptake Inhibitors (SSRIs): Co-administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4) Antidiabetic: Clinical studies have shown that diclofenac can be administered together with oral antidiabetic agents without affecting their clinical effect. However, there have been isolated reports of both hypo- and hyperglycaemic effects, with the need to modify the dosage of the antidiabetic agents administered during treatment with diclofenac. For this reason, monitoring of blood glucose levels is recommended as a precautionary measure in case of concomitant therapy. Some cases of metabolic acidosis have also been reported when diclofenac was co-administered with metformin, especially in patients with pre-existing renal insufficiency. Methotrexate: diclofenac may inhibit renal tubular release of methotrexate by increasing its levels. Caution is advised when administering NSAIDs, including diclofenac, 24 hours before or after methotrexate treatment as blood concentrations of methotrexate and consequently the toxicity of this substance may increase. Cyclosporine: due to its effect on renal prostaglandins, diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine. Therefore, diclofenac should be administered at lower doses than those used in patients not on cyclosporine therapy. Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretic drugs, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in serum potassium, which should therefore be monitored frequently (see section 4.4). Quinolone antibacterials: Isolated cases of seizures have been reported, possibly due to concomitant use of quinolones and NSAIDs. Phenytoin: When using phenytoin together with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in phenytoin exposure. Colestipol and cholestyramine: These agents may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after colestipol / cholestyramine administration. CYP2C9 inhibitors: Caution is advised when prescribing diclofenac together with CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this may lead to a significant increase in peak plasma concentrations and diclofenac exposure due to inhibition of its metabolism. Diclofenac may also decrease the efficacy of intrauterine devices and the risk of inhibition of interferon alpha has been reported.

Overdose

Symptoms There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In the case of significant poisoning, acute renal failure and liver damage are possible. Therapeutic measures Treatment of acute NSAID poisoning, including diclofenac, essentially consists 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 adopted. Specific therapies, such as forced diuresis, dialysis or haemoperfusion, are unlikely to aid in eliminating NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism. Additional treatment modalities should consider clinical indications or the recommendation of the poison control center, where available.

Active principles

One film-coated tablet contains: active ingredient diclofenac sodium 25 mg. One sachet of powder for oral solution contains: active ingredient diclofenac sodium 25 mg. Excipients with known effects: flavors containing limonene, linalool, eugenol. For the full list of excipients, see section 6.1.

Excipients

Film-coated tablets: potassium bicarbonate; mannitol; sodium lauryl sulfate; crospovidone; magnesium stearate; glycerol dibeenate; Clear Opadry (hypromellose; macrogol). Powder for oral solution: potassium bicarbonate; mannitol; acesulfame potassium; glycerol dibeenate; mint flavoring (containing limonene, linalool, eugenol); anise flavor (containing limonene and linalool).

035500040
12 Items