Voltaren® rapid

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VOLTAREN® RAPID (VOLTAREN® RAPID)

Composition:

Active substance: diclofenac;

1 tablet contains 25 mg or 50 mg of diclofenac potassium;

Excipients: tablet core – colloidal anhydrous silicon dioxide, calcium phosphate, magnesium stearate, maize starch, povidone, sodium starch glycolate (type A);

tablet coating – microcrystalline cellulose, iron oxide red (E 172), titanium dioxide (E 171), povidone, polyethylene glycol 8000, sucrose, talc.

Pharmaceutical form. Sugar-coated tablets.

Main physicochemical properties:

50 mg tablets – red-brown, round, biconvex, sugar-coated tablets;

25 mg tablets – pale red, round, biconvex, sugar-coated tablets.

Pharmacotherapeutic group.

Medicinal products used in musculoskeletal disorders. Non-steroidal anti-inflammatory and antirheumatic agents. Acetic acid derivatives and related substances. Diclofenac.

ATC code M01AB05.

Pharmacological properties.

Pharmacodynamics.

Diclofenac, the active substance of Voltaren® Rapid, is a non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic effects. The primary mechanism of action is inhibition of prostaglandin biosynthesis, which play a key role in the development of inflammation, pain, and fever.

In vitro, at concentrations equivalent to those achieved in humans, diclofenac does not inhibit proteoglycan biosynthesis in cartilage tissue.

Voltaren® Rapid tablets, due to rapid absorption, are suitable for the treatment of acute conditions associated with pain and inflammation, where a fast onset of action (within 30 minutes) is desirable. In post-traumatic pain and inflammation, diclofenac rapidly relieves both spontaneous pain and pain on movement, and also reduces swelling at the site of inflammation and wound edema.

In addition, the active substance may reduce pain and decrease bleeding in primary dysmenorrhea. Diclofenac also provides analgesic effects in other conditions associated with moderate to severe pain.

In migraine attacks, Voltaren Rapid has demonstrated efficacy in alleviating headache and reducing associated symptoms of nausea.

Pharmacokinetics.

Absorption.

Diclofenac is rapidly and completely absorbed. Absorption begins immediately after administration, and the amount absorbed corresponds to that achieved after administration of an equivalent dose of sodium diclofenac in the form of gastro-resistant tablets. The mean maximum plasma concentration is 3.9 µmol/L and is reached within 20–60 minutes after administration of a 50 mg tablet. Administration with food does not affect the total amount of diclofenac absorbed, although the onset and rate of absorption may be slightly delayed.

Distribution.

Diclofenac is 99.7% bound to plasma proteins, primarily to albumin (99.4%). The volume of distribution is 0.12–0.17 L/kg.

Diclofenac penetrates into synovial fluid, where its maximum concentration is reached 2–4 hours after the peak plasma concentration. The apparent half-life in synovial fluid is 3–6 hours. Two hours after the peak plasma level, the concentration of the active substance in synovial fluid exceeds that in plasma and remains higher for up to 12 hours.

Biotransformation.

Biotransformation of diclofenac occurs partially via glucuronidation of the intact molecule, but mainly via mono- and poly-hydroxylation and methoxylation, resulting in several phenolic metabolites (3’-hydroxy-, 4’-hydroxy-, 5’-hydroxy-, 4’,5-dihydroxy-, and 3’-hydroxy-4’-methoxy-diclofenac), most of which are subsequently converted into glucuronide conjugates. Two of these phenolic metabolites are pharmacologically active, but to a much lesser extent than diclofenac. Diclofenac was detected at a low concentration (100 ng/mL) in breast milk in one nursing mother. The estimated amount of drug transferred to the infant via breast milk corresponds to a dose of 0.03 mg/kg/day.

Elimination.

The total systemic clearance of diclofenac from plasma is 263±56 mL/min (mean ± standard deviation). The terminal half-life is 1–2 hours. The half-life of four metabolites, including two active ones, is 1–3 hours. The practically inactive metabolite 3’-hydroxy-4’-methoxy-diclofenac has a much longer half-life.

Repeated administration of Voltaren® Rapid over 8 days at a daily dose of 50 mg three times daily does not lead to accumulation of diclofenac in plasma.

Approximately 60% of the dose is excreted in urine as metabolites, and less than 1% as unchanged substance. The remainder is excreted as metabolites via bile in feces.

Pharmacokinetics in specific patient populations.

No significant differences in absorption, metabolism, and elimination of the drug have been observed depending on patient age.

In patients with impaired renal function, the kinetics of a single dose do not indicate any accumulation of unchanged active substance under normal dosing regimens. In patients with creatinine clearance below 10 mL/min, theoretical steady-state concentrations of metabolites in plasma are approximately four times higher than in patients with normal renal function. However, ultimately, these metabolites are excreted via bile.

In patients with impaired liver function (patients with chronic hepatitis or compensated cirrhosis), pharmacokinetic parameters and diclofenac metabolism are similar to those in patients without liver disease.

Clinical characteristics.

Indications.

Voltaren® Rapid 25 mg and 50 mg

Short-term treatment (maximum 1 week) of the following acute conditions:

• Post-traumatic pain, inflammation, and swelling, e.g., due to sprains;
• Postoperative pain, inflammation, and swelling, e.g., following dental or orthopedic surgery;
• Pain and/or inflammation associated with inflammatory gynecological disorders, e.g., primary dysmenorrhea or adnexitis;
• Spinal pain syndromes;
• Rheumatic disorders of periarticular tissues;
• As an adjunctive agent in infections of the ear, nose, and throat (ENT), e.g., pharyngotonsillitis, otitis, accompanied by pronounced pain and inflammation.

Voltaren® Rapid 50 mg in adult patients

• Migraine attacks with or without aura.

According to generally accepted approaches to the treatment of infectious-inflammatory diseases, etiotropic agents should also be used. Isolated fever is not an indication for the use of Voltaren® Rapid.

Contraindications.

• Hypersensitivity to the active substance or to any of the other components of the medicinal product;
• History of allergic reactions such as asthma attacks, bronchospasm, angioedema, urticaria, acute rhinitis, nasal polyps, or allergy-like symptoms following the use of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy;
• Active peptic ulceration of the stomach or duodenum / bleeding, or recurrent peptic ulcer / bleeding in history (two or more separate episodes of confirmed ulcer or bleeding);
• Inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
• Hepatic insufficiency (Child-Pugh class C);
• Renal insufficiency (creatinine clearance < 15 mL/min/1.73 m²);
• Uncontrolled arterial hypertension;
• Congestive heart failure (NYHA II–IV);
• Treatment of perioperative pain in coronary artery bypass grafting (CABG) (or use of cardiopulmonary bypass);
• Ischemic heart disease in patients with angina or history of myocardial infarction;
• Cerebrovascular diseases in patients with history of stroke or transient ischemic attacks;
• Peripheral arterial disease;
• Third trimester of pregnancy;
• Children under 14 years of age.

Interaction with other medicinal products and other types of interactions.

The following interactions have been observed with the use of Voltaren® Rapid and/or other doses and formulations of diclofenac.

Litium. Diclofenac may increase plasma lithium concentrations when used concomitantly. Monitoring of serum lithium levels is recommended.

Digoxin. Diclofenac may increase plasma digoxin concentrations when used concomitantly. Monitoring of serum digoxin levels is recommended.

Diuretics and antihypertensive agents. As with other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g., beta-blockers, angiotensin-converting enzyme (ACE) inhibitors) may reduce the antihypertensive effect. Therefore, such combinations should be used with caution; blood pressure should be monitored periodically, especially in elderly patients. Adequate hydration should be maintained, and renal function should be monitored after initiation of combined therapy and regularly thereafter, particularly when diuretics and ACE inhibitors are used due to an increased risk of nephrotoxicity.

Agents causing hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus, or trimethoprim may lead to increased serum potassium levels; therefore, more frequent monitoring of patients is recommended.

Other NSAIDs, including selective cyclooxygenase-2 inhibitors and corticosteroids. Concomitant use of diclofenac with other systemically acting NSAIDs or corticosteroids may increase the frequency of gastrointestinal adverse reactions. Concomitant use of two or more NSAIDs should be avoided.

Anticoagulants and antithrombotic agents. Should be used with caution, as concomitant use with diclofenac may increase the risk of bleeding.

Although clinical studies have not shown that diclofenac affects the action of anticoagulants, there have been isolated reports of increased bleeding risk in patients receiving diclofenac and anticoagulants simultaneously. Continuous monitoring of such patients is recommended. Like other nonsteroidal anti-inflammatory drugs, diclofenac at high doses may transiently inhibit platelet aggregation.

Selective serotonin reuptake inhibitors (SSRIs). Concomitant use of systemically acting NSAIDs, including diclofenac, with SSRIs may increase the risk of gastrointestinal bleeding.

Antidiabetic agents. Clinical studies have shown that diclofenac can be used concomitantly with oral antidiabetic agents without affecting their clinical efficacy. However, isolated reports of hyperglycemia and hypoglycemia have been reported, requiring dose adjustment of antidiabetic agents. Monitoring of blood glucose levels during combination therapy is recommended. Changes in interaction processes caused by metformin/metabolic acidosis. Isolated cases of metabolic acidosis have also been reported with concomitant use of diclofenac, particularly in patients with pre-existing renal impairment.

Methotrexate. NSAIDs should be used with caution at least 24 hours before or 24 hours after methotrexate treatment, as methotrexate blood concentrations may increase, enhancing toxicity. Serious toxicity cases have been reported when methotrexate and NSAIDs, including diclofenac, were administered with intervals less than 24 hours. This interaction is mediated by methotrexate accumulation due to impaired renal excretion in the presence of NSAIDs.

Cyclosporine and tacrolimus. Diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine and tacrolimus due to effects on renal prostaglandins. Therefore, diclofenac should be used at lower doses in patients receiving cyclosporine or tacrolimus compared to those not receiving these agents.

Tacrolimus. Concomitant use of NSAIDs with tacrolimus increases the risk of nephrotoxicity, possibly mediated by renal anti-prostaglandin effects of NSAIDs and calcineurin inhibitors.

Quinolone antibiotics. Isolated reports of seizures possibly associated with concomitant use of quinolones and NSAIDs have been reported. This may occur in patients both with and without a history of epilepsy or seizures. Therefore, caution should be exercised when prescribing quinolones to patients already receiving NSAIDs.

Cholestyramine and colestipol. These agents may delay or reduce diclofenac absorption. Therefore, it is recommended to administer diclofenac at least 1 hour before or 4–6 hours after cholestyramine/colestipol.

Cardiac glycosides. Concomitant use of cardiac glycosides and NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase glycoside levels in plasma.

Mifepristone. NSAIDs should not be used within 8–12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.

CYP2C9 inhibitors. Diclofenac should be used with caution when administered concomitantly with CYP2C9 inhibitors (e.g., sulfaphenazole, voriconazole), as this may lead to a significant increase in plasma peak concentration and exposure to diclofenac.

Phenytoin. When phenytoin is used concomitantly with diclofenac, plasma phenytoin concentrations should be monitored due to the potential for increased phenytoin effects.

CYP2C9 inducers. Caution is required when co-prescribing diclofenac with CYP2C9 inducers (e.g., rifampicin), as this may lead to a significant increase in plasma concentration and exposure to diclofenac.

Special precautions for use.

• General warnings regarding the use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs)

Cases of gastrointestinal bleeding (including vomiting of blood, melena), ulceration, or perforation have been reported with the use of all NSAIDs, including diclofenac, and may be fatal. These events can occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. To minimize this risk, the lowest effective dose should be used for the shortest duration possible.

Placebo-controlled studies have shown an increased risk of thrombotic cardiovascular and cerebrovascular complications with certain selective COX-2 inhibitors. It is currently unknown whether this risk is directly associated with selective COX-1/COX-2 inhibitors or other NSAIDs. Since comparative clinical data on long-term treatment with maximum doses of diclofenac are not currently available, a similar increase in risk cannot be excluded. Until such data become available, a careful benefit-risk assessment should be performed before prescribing diclofenac to patients with clinically confirmed ischemic heart disease, cerebrovascular disorders, peripheral arterial occlusive disease, or significant risk factors (such as hypertension, hyperlipidemia, diabetes mellitus, smoking). Due to this risk, the lowest effective dose should also be used for the shortest possible treatment duration.

Renal effects of NSAIDs include fluid retention with edema and/or arterial hypertension. For this reason, diclofenac should be used with caution in patients with impaired cardiac function and in patients with other conditions leading to fluid retention. Caution is also recommended in patients taking diuretics or concomitant angiotensin-converting enzyme (ACE) inhibitors, or those at increased risk of hypovolemia.

Voltaren® Rapid, sugar-coated tablets do not have a gastroresistant coating. Release of the active substance in the stomach may cause local irritation of the gastric mucosa.

Consequences are generally more serious in elderly patients. If gastrointestinal bleeding or ulceration occurs in patients receiving Voltaren® Rapid, treatment should be discontinued.

Hypersensitivity reactions may progress to Kounis syndrome, a serious allergic reaction that may lead to myocardial infarction. Symptoms of such reactions may include chest pain occurring in combination with an allergic reaction to diclofenac.

• Skin effects.

Very rarely, serious skin reactions (including some fatal cases), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs, including Voltaren® Rapid. The highest risk of such reactions occurs early in treatment, with onset typically within the first month of therapy. Voltaren® Rapid should be discontinued at the first signs of rash, mucosal lesions, or any other signs of hypersensitivity.

• Masking signs of infection.

Like other NSAIDs, diclofenac, due to its pharmacodynamic properties, may mask signs and symptoms of infection.

• Precautions

Concomitant use of Voltaren® Rapid and other systemic NSAIDs, including selective COX-2 inhibitors, should be avoided, as there is no evidence of synergistic benefit and an increased risk of adverse effects.

As with all analgesics, prolonged use of the drug for headache treatment may lead to improvement or worsening of symptoms (medication-overuse headache). If medication-overuse headache develops, the dose of analgesics should not be increased; in such cases, treatment should be discontinued. Medication-overuse headache should be suspected in patients with frequent or daily headaches occurring despite (or because of) regular analgesic use.

To minimize adverse effects, the lowest effective dose should be used for the shortest possible duration. In rare cases, as with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even without prior exposure to diclofenac.

Voltaren® Rapid should be used with caution in patients over 65 years of age. In particular, the lowest effective doses are recommended for physically frail elderly patients or those with body weight below normal.

Voltaren® Rapid tablets contain sucrose and therefore are not recommended for patients with rare hereditary forms of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

• History of asthma.

In patients with asthma, seasonal allergic rhinitis, nasal mucosal swelling (e.g., nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections (especially with symptoms resembling allergic rhinitis), adverse effects such as asthma exacerbation (so-called analgesic intolerance or analgesic-induced asthma), Quincke's edema, or urticaria occur more frequently than in other patients when taking NSAIDs. Therefore, special precautionary measures (readiness for emergency intervention) are required for such patients. The above also applies to patients with allergic reactions to other drugs, such as rash, pruritus, or urticaria.

• Effects on the gastrointestinal tract (GI tract).

These events generally have more serious consequences in elderly patients. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be discontinued.

As with other NSAIDs, careful medical monitoring and special caution are required when prescribing Voltaren® Rapid to patients with symptoms indicating gastrointestinal disorders (see section "Contraindications").

The risk of gastrointestinal bleeding increases with higher NSAID doses and in patients with a history of peptic ulcer, especially if complicated (bleeding or perforation), and in elderly patients. To reduce the risk of GI toxicity in such patients, treatment should be initiated and maintained at the lowest effective doses. For such patients, as well as those requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of GI harm, consideration should be given to prescribing combination therapy with protective agents (e.g., proton pump inhibitors or misoprostol).

Patients with a history of GI toxicity, especially elderly patients, should inform their physician about any unusual abdominal symptoms (particularly gastrointestinal bleeding). Exercise caution when prescribing the drug to patients who are concurrently using medications that may increase the risk of ulceration or bleeding (systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors).

Use of NSAIDs, including diclofenac, may be associated with an increased risk of gastrointestinal anastomotic dehiscence. Close monitoring and caution are recommended when using diclofenac after gastrointestinal surgery.

• Effects on the liver.

Patients with hepatic impairment should be under continuous medical supervision, as their condition may worsen.

As with other NSAIDs, levels of one or more liver enzymes may increase.

This has been observed very commonly during clinical trials with diclofenac (in approximately 15% of patients), but rarely accompanied by clinical symptoms. In most cases, increases were to borderline levels. Moderate increases (≥ 3 to < 8 times the upper limit of normal) occurred frequently (in 2.5% of cases), while marked increases (≥ 8 times the upper limit of normal) occurred in about 1% of cases. In the aforementioned clinical trials, elevated liver enzyme levels were associated with clinical signs of liver injury in 0.5% of cases. Increases in enzyme levels were generally reversible upon discontinuation of the drug.

Voltaren® Rapid is recommended only for short-term treatment (no more than 1 week). The drug should be discontinued if liver function impairment or deterioration occurs, if clinical signs or symptoms suggest liver disease, or if other symptoms such as eosinophilia or rash develop.

Hepatitis may occur without prodromal symptoms.

In addition to elevated liver enzymes, serious hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and liver failure, some of which were fatal, have been reported rarely.

Diclofenac should be used with caution in patients with hepatic porphyria due to the potential to provoke an attack.

• Effects on the kidneys.

Particular caution is required in patients with cardiac or renal impairment, history of arterial hypertension, elderly patients, patients concurrently taking diuretics or drugs that may significantly affect renal function, and patients with substantial reduction in extracellular fluid volume (e.g., pre-/post-surgery). When prescribing Voltaren® Rapid in such cases, monitoring of renal function is recommended. After discontinuation of therapy, the patient's condition usually normalizes.

• Cardiovascular and cerebrovascular effects.

A slight increase in the risk of arterial thrombotic events (e.g., myocardial infarction or stroke) may be associated with diclofenac use, particularly at high doses and with prolonged treatment. Therapy with Voltaren® Rapid is contraindicated in patients with established cardiovascular disease (patients with NYHA class II-IV heart failure, stable ischemic heart disease, peripheral arterial disease) or uncontrolled arterial hypertension.

Diclofenac should be prescribed to patients with significant cardiovascular risk factors (such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking) only after careful clinical evaluation and only at a dose ≤100 mg daily if treatment lasts no more than four weeks. Since cardiovascular risks of diclofenac may increase with higher doses and longer treatment duration, it should be used for the shortest possible time and at the lowest effective dose. The need for continued diclofenac use for symptom relief and response to therapy should be reviewed periodically. Patients should be vigilant for serious signs and symptoms of atherothrombosis (e.g., chest pain, dyspnea, weakness, speech disturbances), which may occur without warning. Patients should be advised to seek immediate medical attention if such symptoms occur.

• Effects on hematological parameters.

Voltaren® Rapid is recommended only for short-term treatment. If longer-term use is required, regular monitoring of the hemogram is recommended, as with other NSAIDs.

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation; therefore, careful monitoring is required in patients with coagulation disorders, hemorrhagic diathesis, or hematological disorders.

• Systemic lupus erythematosus and mixed connective tissue diseases.

Patients with systemic lupus erythematosus and mixed connective tissue diseases may have an increased risk of developing aseptic meningitis. Appropriate monitoring and advice are necessary for patients with a history of arterial hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported with NSAID use, including diclofenac. Clinical and epidemiological data indicate that diclofenac use, particularly at high doses (150 mg/day) and with prolonged treatment, may be associated with a slight increase in the risk of arterial thrombotic events (e.g., myocardial infarction or stroke).

Voltaren® Rapid contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological data suggest an increased risk of miscarriage and/or congenital heart defects and gastroschisis after use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%.

In animal studies, prostaglandin synthesis inhibitors have been shown to increase pre- and post-implantation loss and embryonic/fetal mortality. Additionally, in animals treated with prostaglandin synthesis inhibitors during organogenesis, an increased incidence of various developmental abnormalities, including cardiovascular defects, has been observed.

First/second trimester

During the first and second trimesters of pregnancy, Voltaren® should be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. If Voltaren® is used by a woman planning pregnancy or by a pregnant woman in the first or second trimester, the dose should be as low as possible and the duration of treatment as short as possible.

Oligohydramnios / renal dysfunction in newborns / constriction of the arterial duct

NSAID use from the 20th week of pregnancy may lead to fetal renal dysfunction, causing oligohydramnios and, in some cases, renal impairment in the newborn. These adverse effects are typically observed after several days or weeks of treatment, although oligohydramnios has developed as early as 48 hours after starting NSAID therapy in rare cases. Oligohydramnios often, but not always, resolves after discontinuation of NSAID treatment. Complications of prolonged oligohydramnios may include limb contractures and pulmonary hypoplasia. In some post-marketing clinical observations, renal dysfunction in newborns required invasive procedures such as exchange transfusion or dialysis.

Additionally, constriction of the arterial duct has been reported after second-trimester treatment, which usually resolves after discontinuation of therapy.

If treatment with Voltaren® lasts more than 48 hours, ultrasound monitoring of amniotic fluid and fetal heart should be considered. If oligohydramnios or arterial duct constriction occurs, Voltaren® should be discontinued and appropriate treatment initiated according to clinical practice.

Third trimester

During the third trimester of pregnancy, use of Voltaren® is contraindicated.

All prostaglandin synthesis inhibitors may:

• expose the fetus to the following risks:
  • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
  • renal dysfunction, which may progress to renal failure with oligohydramnios;
• expose the mother and child to the following risks:
  • possible prolongation of bleeding time—antiplatelet aggregation effect, which may occur even with very low doses; inhibition of uterine contractions, leading to delayed or prolonged labor.

Breastfeeding.

Like other NSAIDs, diclofenac passes into breast milk in small amounts; therefore, Voltaren® Rapid should not be prescribed during breastfeeding to avoid adverse effects in the infant. If treatment is essential, breastfeeding should be discontinued.

Fertility.

Like other NSAIDs, Voltaren® Rapid may affect female fertility and is therefore not recommended for women planning pregnancy. The drug should be discontinued in women who are unable to conceive and in women undergoing infertility investigations.

Ability to affect reaction speed when driving or operating machinery.

Patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system (CNS) disorders while taking Voltaren® Rapid should not drive or operate machinery.

Method of Administration and Dosage.

The drug should be used at the lowest effective dose for the shortest duration necessary, taking into account the individual treatment needs of each patient.

Tablets should be swallowed whole, without chewing, with water, preferably before meals.

Adults

The recommended dose is 100–150 mg per day. In cases of mild to moderate symptoms, a daily dose of 75–100 mg is generally sufficient. The daily dose should be divided into 2–3 administrations.

Special Patient Groups

Children aged 14 years and older

The daily dose is 50–100 mg, divided into 2–3 doses. There are currently no data on the use of Voltaren® Rapid for the treatment of migraine attacks in children under 18 years of age.

Elderly patients (aged 65 years and older)

Dose adjustment is generally not required in elderly patients. However, the lowest effective dose is recommended for frail elderly patients and those with low body weight.

Primary Dysmenorrhea

The daily dose of Voltaren® Rapid should be individually adjusted. The usual daily dose ranges from 50–100 mg. An initial dose of 50 mg is typically recommended. If necessary, the dose may be increased to 100 mg and further titrated over the next few menstrual cycles up to a maximum of 150 mg per day. Treatment with Voltaren® Rapid tablets should begin at the onset of symptoms and continue for several days, depending on symptom response.

Migraine

The drug should be administered at the first signs of an attack. The recommended single dose is 50 mg. A further 50 mg may be taken 2 hours after the first dose if adequate pain relief has not been achieved. If needed, the drug may be continued after 4–6 hours; however, the total daily dose must not exceed 150 mg.

Established Cardiovascular Diseases or Significant Cardiovascular Risk Factors

Treatment with Voltaren® Rapid is generally not recommended in patients with established cardiovascular diseases or uncontrolled arterial hypertension. If treatment is necessary in patients with established cardiovascular disease, uncontrolled hypertension, or significant cardiovascular risk factors, Voltaren® Rapid should only be used after careful consideration and at doses not exceeding 100 mg daily, particularly if treatment lasts longer than 4 weeks.

Renal Impairment

Voltaren is contraindicated in patients with renal impairment (creatinine clearance < 15 mL/min/1.73 m²).

No specific studies have been conducted in patients with renal impairment; therefore, no specific dosage recommendations can be made. Caution is recommended when administering Voltaren® Rapid to patients with renal impairment.

Hepatic Impairment

Voltaren® Rapid is contraindicated in patients with hepatic impairment.

No specific studies have been conducted in patients with hepatic impairment; therefore, no specific dosage recommendations can be made. Caution is recommended when administering Voltaren® Rapid to patients with mild to moderate hepatic dysfunction.

Children

The drug is contraindicated in children under 14 years of age due to the high content of active ingredient.

Overdose.

Symptoms. There is no typical clinical picture associated with diclofenac overdose.
Symptoms that may occur include vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, seizures, headache, nausea, epigastric pain, disorientation, agitation, coma, and drowsiness. Acute renal failure and liver injury are possible in cases of severe intoxication.

Treatment. Management of acute poisoning with nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac, generally involves supportive measures and symptomatic treatment of complications such as arterial hypotension, renal failure, seizures, gastrointestinal disturbances, and respiratory depression.

Specific interventions such as forced diuresis, dialysis, or hemoperfusion do not enhance the elimination of NSAIDs from the body due to their high degree of protein binding and extensive metabolism.

In cases of potentially toxic overdose, activated charcoal should be administered. In life-threatening overdose, evacuation of gastric contents (induced emesis or gastric lavage) should be performed.

Adverse Reactions

The adverse effects listed below include reactions reported during short-term or long-term treatment with Voltaren® Rapid and/or other dosage forms of diclofenac.

Adverse effects are classified by frequency of occurrence: very common (> 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated cases.

Blood and lymphatic system disorders:

Very rare: thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

Immune system disorders:

Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock);

Very rare: angioneurotic edema (including facial swelling).

Psychiatric disorders:

Very rare: confusion, depression, insomnia, nightmares, irritability, psychotic disorders.

Central nervous system disorders:

Common: headache, dizziness;

Rare: somnolence, fatigue;

Very rare: paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke;

Not known: confusion, hallucinations, sensory disturbances, malaise.

Eye disorders:

Very rare: visual disturbances, blurred vision, diplopia;

Not known: optic neuritis.

Ear and labyrinth disorders:

Common: vertigo;

Very rare: tinnitus, hearing impairment.

Cardiac disorders:

Uncommon: palpitations, chest pain, heart failure, myocardial infarction;

Not known: Kounis syndrome.

Vascular disorders:

Common: arterial hypertension.

Very rare: hypotension, vasculitis. Clinical trial data and epidemiological evidence indicate an increased risk of thrombotic events (e.g., myocardial infarction or stroke) associated with diclofenac use, particularly at high therapeutic doses (150 mg daily) and with prolonged treatment.

Respiratory, thoracic and mediastinal disorders:

Rare: asthma (including dyspnea);

Very rare: pneumonitis.

Gastrointestinal disorders:

Common: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, loss of appetite;

Rare: gastritis, gastrointestinal hemorrhage, vomiting of blood, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation), gastrointestinal stenosis or perforation (sometimes fatal, especially in elderly patients), which may lead to peritonitis;

Very rare: colitis (including hemorrhagic colitis, ischemic colitis, and exacerbation of ulcerative colitis or Crohn’s disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, diaphragm-like intestinal strictures, pancreatitis.

Changes in the course of gastrointestinal stenosis, peritonitis, and ischemic colitis represent more specific/severe forms of the aforementioned gastrointestinal adverse effects.

Hepatobiliary disorders:

Common: increased transaminase levels;

Rare: hepatitis, jaundice, liver function abnormalities;

Very rare: fulminant hepatitis, hepatic necrosis, liver 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, alopecia, photosensitivity, purpura, allergic purpura, pruritus.

Renal and urinary disorders:

Common: fluid retention, edema;

Very rare: acute kidney injury (acute renal failure), hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions:

Rare: edema.

Reproductive system and breast disorders:

Very rare: impotence.

Visual disorders:

Visual disturbances such as blurred vision, visual impairment, and diplopia are class effects of NSAIDs and are generally reversible upon discontinuation of the drug. The most likely mechanism of ocular effects is inhibition of prostaglandin synthesis and related compounds, which may disrupt retinal blood flow regulation and lead to visual disturbances. If such symptoms occur during diclofenac treatment, an ophthalmological examination should be performed to rule out other possible causes.

Shelf life.

For 50 mg tablets – 3 years.

For 25 mg tablets – 2.5 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at temperatures not exceeding 30°C. Protect from moisture. Keep out of reach of children.

Packaging.

10 tablets per blister, 1 or 2 blisters per cardboard box for 50 mg, 3 blisters per cardboard packaging box for 25 mg.

Prescription status.

Prescription only.

Manufacturer.

Novartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S. / Novartis Health, Food and Agricultural Products Manufacturing and Trading Co. Inc.

Manufacturer's address.

Yenisehir Mahallesi, Ihlara Vadisi Sokak No. 2, Pendik, Istanbul, TR 34912, Turkey.