VOLTADVANCE 10CPR RIV 25MG

VOLTADVANCE 25 MG

active ingredients

A movie-coated tablet contains: active ingredient diclofenac sodium 25 mg. An oral powder bag contains: active ingredient diclofenac sodium 25 mg. Excipients with known effects: aromas containing lemon, linalol, eugenol. For the full list of excipients, see paragraph 6.1.

Excellent

Tablets covered with film: potassium bicarbonate; mannitolo; sodium laurilsulfate; crospovidone; magnesium stearate; glicerol dibeenate; Clear Opadry (hypromellose; macrogol). Powder for oral solution: potassium bicarbonate; mannitol; potassium acesulphame; dibeenate glycerol; mint aroma (containing lemon, linalol, eugenol); anise aroma (containing lemon and linalol).

Therapeutic indications

Pain of various kinds such as joint pain, lumbar pain, muscle pain, headaches and teeth, menstrual pain.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Ulcer, bleeding or gastrointestinal perforation in place. • History of gastrointestinal hemorrhage or perforation related to previous treatments with NSAIDs or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Last trimester of pregnancy and during lactation (see paragraph 4.6). • Severe liver failure or severe kidney failure (see paragraph 4.4). • Like other non-steroidal anti-inflammatory drugs (NSAID), diclofenac is also contraindicated in patients in whom acetylsalicylic acid or other NSAIDs were taken, asthmatic attacks, hives, angioedema or acute rites, anaphylactic or anaphylactoid reactions (see paragraph 4.4). • The product should not be used in case of alterations of the hemopoies. • In case of intensive diuretic therapy. • The product should not be taken in case of dark feces or containing blood. • Conclaimed congestive congestive heart failure (NYHA class II-IV), ischemic cardiopathy, peripheral arteriopathy and/or cerebral vasculopathy. Voltadvance should not be given to children under 14 years of age.

Population

Adults and teenagers over 14 years: 1-3 coated tablets or sachets of powder per day, at meals, even 2 in one administration. The maximum daily dose is 75 mg. Do not exceed the recommended doses; in particular, elderly patients must comply with the above minimum dosages. The coated tablets should be swallowed whole, with water or other liquid; dust bags must be dissolved in a glass of water before taking. It is recommended to take the product preferably on a full stomach. Do not exceed 3 days of treatment. Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration required to control symptoms (see paragraph 4.4). Special popularity . . Renal insufficiency: Voltadvance is contraindicated in patients with severe kidney failure (see paragraph 4.3). Caution is recommended in the administration of Voltadvance in patients with mild to moderate kidney failure (see paragraph 4.4). Epathetic insufficiency: Voltadvance is contraindicated in patients with severe liver failure (see paragraph 4.3). Caution is recommended in the administration of Voltadvance in patients with mild to moderate liver failure (see paragraph 4.4).

Conservation

This medicine does not require any special condition of conservation.

Warnings

After 2-3 days of treatment without appreciable results, consult your doctor. General information: Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular risks). The use of diclofenac in conjunction with other systemic NSAIDs, including selective cyclo-oxidase-2 inhibitors, must be avoided due to the lack of any evidence showing synergistic benefits and on the basis of potential undesirable additive effects. On the basic medical level it is required caution in the elderly. Particularly in fragile elderly patients or those with low body weight, it is recommended to use the lowest effective dose. As with other NSAIDs, allergic reactions can occur in rare cases, including anaphylactic/anaphylactic reactions, without a previous exposure to diclofenac. Hypersensitivity reactions can also evolve into Kounis syndrome, a severe allergic reaction that can cause myocardial infarction. Symptoms with which such reactions occur may include chest pain that occurs in association with an allergic reaction to diclofenac. Like other NSAIDs, diclofenac may mask signs and symptoms of infections due to its pharmacodynamic properties. Prolonged use of any kind of painkiller for cephalee can make them worse. If you have had or suspected this situation, you must apply for a medical consultation and the treatment must be stopped. Diagnosis of headache from excessive use of drugs (MOH) must 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, have been reported and may appear at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration or perforation, which may be fatal. They usually have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients in diclofenac therapy, the medicine must be stopped. As with all NSAIDs, including diclofenac, strict medical supervision and special caution must be used in prescribing diclofenac to patients with indicative symptoms of gastrointestinal disorders (GI) or with an indicative history of gastric or intestinal ulcerations, bleeding or perforation, chronic intestinal inflammatory diseases (see paragraph 4.8). The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with ulcer history, especially if complicated by hemorrhage or perforation. The elderly have a greater frequency of adverse reactions, especially gastrointestinal bleeding and perforation that can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, especially if complicated by hemorrhage or perforation, and in the elderly the treatment must be started and maintained with the lowest effective dose. Concurrent use of protective agents (protonic pump inhibitors or misoprostol) must be considered for these patients and also for patients requiring the concomitant use of medicines containing low doses of acetylsalicylic acid (ASA) or other medicines that may increase the gastrointestinal risk. Patients with GI toxicity history, especially seniors, must report any unusual abdominal symptoms (especially GI hemorrhage). Caution is recommended in patients taking concomitant medicines that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-aggregating agents or selective serotonin reuptake inhibitors (see paragraph 4.5). Even in patients with ulcerative colitis or Crohn's disease, strict medical and caution must be exercised as such conditions may be exacerbated (see paragraph 4.8). NSAIDs, including diclofenac, can be associated with an increase in the risk of gastrointestinal anastomosis. It is recommended caution and close medical surveillance when using diclofenac as a result of gastrointestinal surgery. Hepatobiliary effects: In case of prescription of diclofenac to patients suffering from liver failure it is necessary close medical surveillance as their condition can be exacerbated. As with other NSAIDs, including diclofenac, can increase the values of one or more liver enzymes. During prolonged treatments with diclofenac are indicated as regular precautionary measure controls of liver function. If the parameters of liver function are persistently altered or worsened, if clinical signs or symptoms of hepatopathy develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac treatment must be stopped. Hepatitis with the use of diclofenac can occur without prodromic symptoms. Particular caution should be placed in the use of diclofenac in patients with liver porphyria, as they can trigger an attack. Renal effects: Since in combination with NSAID therapy, including diclofenac, fluid and edema retention is required in case of kidney failure, history of hypertension, in the elderly, in patients in treatment with diuretics or medicines that can significantly affect kidney function and in those patients with a substantial depletion of extracellular volume due to any cause (e.g. before or after surgery). In such cases, when diclofenac is administered, it is recommended to precaution the monitoring of kidney function. The interruption of therapy is normally followed by a return to pre-treatment conditions. Skin effects: Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltadvance must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Cardiovascular and cerebrovascular effects: Clinical trials and epidemiological data consistently indicate an increase in the risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg/dì) and long-term treatment. Patients who present significant risk factors of cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking) should be treated with diclofenac only after careful consideration. Patients with congestive heart failure (class NYHA I) must be treated with diclofenac only after careful evaluation. Since cardiovascular risks of diclofenac can increase with dose and duration of exposure, the minimum possible duration and the minimum effective daily dose must be used. Patients should be advised to consult the doctor if symptoms persist or do not improve within the recommended duration of treatment. Patients should pay attention to the signs and symptoms of severe trombotic events (e.g. chest pain, shortness of breath, weakness, difficulty of speech), which may occur without premonitory symptoms. Patients should be informed to contact a doctor immediately in case one of these events occurs. Ematologic effects: During prolonged treatment with diclofenac, as with other NSAIDs, blood crasis controls are recommended. Like other NSAIDs, diclofenac can temporarily inhibit platelet aggregation. Patients with emostase defects must be carefully monitored. Respiratory effects (pre-existing asthma): In patients with asthma, seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if connected to symptoms similar to allergic rhinitis), are more frequent than in other patients reactions to NSAIDs such as as as asthma exacerbations (called analgesic intolerance). Special precaution is therefore recommended in such patients (to prepare for emergency). This also applies to patients allergic to other substances, e.g. with skin, itching or hives. Important information about some excipients: Voltadvance 25 mg tablets coated with film contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. Voltadvance 25 mg powder per oral solution contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. Voltadvance 25 mg powder per oral solution contains anise aroma in turn containing lemon and linalol. Lemon and linalol can cause allergic reactions. Voltadvance 25 mg powder per oral solution contains aroma mint in turn containing lemon, linalol and eugenol. Lemon, linalol and eugenol can cause allergic reactions.

Interactions

Before using the product, if you were taking other medications, it is advisable to inform your doctor as it may be necessary to change the dosage or stop the treatment. The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. Litio: if administered in conjunction, diclofenac may elevate plasma concentrations of lithium. It is recommended to monitor the serum levels of lithium. Digoxin: if administered in conjunction, diclofenac may elevate plasma concentrations of digoxin. It is recommended to monitor the serum levels of digoxin. Diuretics and antihypertensive agents: patients undergoing treatment with such drugs must consult the doctor before taking the product. Like other NSAIDs, concurrent use of diclofenac with diuretics or antihypertensive agents (e.g. betabloccants, inhibitors of angiotensin conversion enzyme (ACE)) can cause a decrease in their antihypertensive effect. Therefore, the association must be taken with caution and patients, especially elderly, must receive periodic monitoring of their blood pressure. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently periodically, especially for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity. Other NSAIDs and corticosteroids: concurrent use of diclofenac and other nonsteroidal systemic or corticosteroid anti-inflammatory drugs may increase the incidence of unwanted gastrointestinal effects and should be avoided (see paragraph 4.4). Antiagulants and antiplatelet agents: caution is recommended, since concurrent 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 increase in the risk of hemorrhage in patients taking concomitantly diclofenac and anticoagulants. Therefore, careful monitoring of these patients is recommended. Selective serotonin reuptake inhibitors (SSRIs): simultaneous administration of systemic NSAIDs, including diclofenac, and SSRIs can increase the risk of gastrointestinal bleeding (see paragraph 4.4). Antidiabetics: clinical studies have shown that diclofenac can be administered along with oral antidiabetics without affecting the clinical effect. However, isolated cases of both hypo- and hyperglycemizing effect have been reported, with the need to change the posology of the antidiabetic agents administered during treatment with diclofenac. For this reason, in case of concomitant therapy, it is recommended as a precautionary measure to monitor blood glucose levels. Some cases of metabolic acidosis were reported when diclofenac was co- administered with methylformin, especially in patients with pre-existing kidney failure. Methotrexate: diclofenac can inhibit renal tubular liberation of metotrexate by increasing its levels. Precaution is recommended in case of administration of NSAIDs, including diclofenac, 24 hours before or after treatment with metotrexate since the blood concentrations of metotrexate and consequently the toxicity of this substance may increase. Ciclosporin: due to its effect on kidney prostaglandins, diclofenac, like other NSAIDs, can increase the nephrotoxicity of cyclosporin. Therefore, diclofenac should be administered to doses less than those that are used in patients not in cyclosporin therapy. Drugs known to cause hyperkaliemia: concurrent treatment with diuretic drugs, potassium, cyclosporin, tacrolimus or trimetoprim may be associated with an increase in serum levels of potassium, which must therefore be monitored frequently (see paragraph 4.4). Antibacterial kinolonic: isolated cases of seizures were reported, probably due to the concomitant use of chinolone and NSAIDs. Fenitoin: when using phenytoin together with diclofenac, it is recommended to monitor plasma concentrations of phenytoin due to a predictable increase in exposure to phenytoin. Colestipolo e colestiramina: these agents may cause delay or decrease in diclofenac absorption. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after the administration of choleestipol/colestiramine. CYP2C9 inhibitors: caution is recommended when you prescribe diclofenac along with CYP2C9 inhibitors (such as sulfinpirazone and voriconazole); this can lead to a significant increase in peak plasma concentrations and exposure to diclofenac, due to the inhibition of metabolism. Diclofenac can also decrease the effectiveness of intrauterine devices and the risk of inhibition of alpha interferon has been reported.

Effects

The side effects (Table 1) are listed below by organ, apparatus/system and MedDRA frequency. The frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to Table 1

Emolinfopoietic system pathologies
Very rare	thrombocytopenia, leucopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis.
Immune system disorders
Rare	hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare	angioedema (including facial edema).
Psychiatric disorders
Very rare	disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
Diseases of the nervous system
Town	headache, dizziness.
Rare	drowsiness.
Very rare	parestesie, impairment of memory, convulsions, anxiety, tremors, aseptic meningitis, alterations of taste, cerebrovascular accidents.
Pathologies of the eye
Very rare	vision disorders, blurred vision, diplopia.
Ear and labyrinth pathologies
Town	dizziness.
Very rare	tinnitus, worsening hearing.
Heart disease
Not common*	Myocardial infarction, heart failure, palpitations, chest pain.
Notable	Kounis Syndrome
Vascular diseases
Very rare	hypertension, vasculitis.
Respiratory, chest and mediastinic pathologies
Rare	asthma (including dispnea).
Very rare	pneumonia.
Gastrointestinal diseases
Town	nausea, vomiting, diarrhea, dispepsia, abdominal pain, flatulence, anorexia.
Rare	gastritis, gastrointestinal hemorrhage, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation, which can lead to peritonitis), dry mouth and mucosa, gastrointestinal stenosis.
Very rare	colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal diaphragm disease, pancreatis, stipsi.
Notable	Ischetical Colite
Hepatobiliary diseases
Town	increased transaminasis.
Rare	hepatitis, jaundice, liver disorders.
Very rare	fulminant hepatitis, hepatic necrosis, liver failure.
Pathologies of skin and subcutaneous tissue
Town	rash.
Rare	hives.
Very rare	bollose eruptions, eczema, erythema, multiform erythema, Stevens-Johnson syndrome, epidermal toxic necrolysis ( Lyell syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purple, Henoch-Schonlein porpora, itching.
Kidney and urinary pathologies
Very rare	acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillar necrosis.
Systemic pathologies and conditions for administration
Rare	edema.

* Frequency reflects long-term treatment data with a high dose (150 mg per day). Clinical experiments and epidemiological data consistently indicate an increase in the risk of arterial thrombotic events (e.g., myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg/dì) and long-term treatment (for contraindications and special warnings and precautions of use see paragraphs 4.3 and 4.4). Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms There is no typical clinical picture resulting from diclofenac overdose. Overdose can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or seizures. In the case of significant poisoning are possible acute kidney failure and liver damage. Therapeutic measures Treatment of acute poisoning by NSAIDs, including diclofenac, consists essentially of support measures and symptomatic treatment. In case of complications such as hypotension, kidney failure, seizures, gastrointestinal disorders and respiratory depression, support and symptomatic treatment measures must be taken. Specific therapies, such as forced diuresis, dialysis or hemoperfusion, are probably not of help in eliminating NSAIDs, including diclofenac, due to their high link to plasma proteins and their remarkable metabolism. Additional treatment methods must take into account clinical indications or recommendation of the anti-veleni center, where available.

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered unless in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must be kept as low as possible and the duration of treatment must 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; - the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the time of bleeding, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Food: Like other NSAIDs, diclofenac passes into breast milk in small quantities. Therefore, diclofenac should not be administered during breastfeeding to avoid side effects. Fertility: As with other NSAIDs, the use of diclofenac can alter female fertility and is not recommended in women who want to conceive. It must be considered the suspension of diclofenac in women who have difficulty in conception or who are subject to infertility assessments.

Source: Farmadati