Voltaren 50mg Novartis treat inflammation and degeneration of rheumatism (1 blister x 5 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Diclofenac sodium

Ingredient

Composition information	Content
Diclofenac sodium	50mg

Uses

indication

Voltaren 50 is indicated in the following cases:

Inflammation and degenerative forms of rheumatism: rheumatoid arthritis , rheumatoid arthritis in teenagers, stiff spine, osteoarthritis, spinal pain, spinal pain syndrome, low disease not in joints. Figure. Function.

In post -traumatic and postoperative inflammation, Voltaren quickly relieves both spontaneous pain and swelling when moving, reducing swelling in inflammation and wound edema.

In clinical trials, Voltaren has also been recorded as a clear pain relief in average pain and severe pain from low disease. Clinical studies have also found that in the first dysmenorrhea, Voltaren has the ability to relieve pain and reduce blood release level.

Pharmacokinetics

absorption

Diclofenac is completely absorbed from the insoluble tablets in the stomach after passing through the stomach. Although the rapid absorption, onset may be slowly due to the tablet of the tablet insoluble in the stomach. The average peak concentration in plasma is 1.5 µg/l (5 µmol/l) achieved an average of 2 hours after taking 1 tablet of 50 mg. The path of the tablet passing through the stomach is slower when used during meals or after meals compared to when used before meals, but the amount of Diclofenac is absorbed the same.

Distribution

99.7% Diclofenac is associated with serum protein, mainly attached to albumin (99.4%). The apparent distribution volume is 0.12 - 0.17 l/kg.

diclofenac goes into the epidemic and reaches a maximum concentration of 2-4 hours after reaching the maximum concentration at plasma. The semi -cancellation time in the epidemic is 3-6 hours. 2 hours after reaching the peak concentration in plasma, the main active ingredient concentration in the epidemic will be higher than the plasma concentration and remain at a higher level of up to 12 hours.

Metabolism

Diclofenac's biological transformation occurs partly due to the intact molecular glucuronide but mainly due to hydrolysis and methoxylation once or more times, creating some phenolic metabolic substances (3'-hydroxy-, 4''-hydroxy-, 5'-hydroxy-, 4 ', 5-dihydroxy-, and 3'-iproxy-4'-methoxy-4' Diclofenac), most of these substances convert to complex glucuronide. In these substances, there are two phenolic metabolites with biological activity, but weaker than the biological activity of Diclofenac.

Elimination

Diclofenac is eliminated from plasma with a total clearance coefficient of 263 ± 56 ml/min (average value ± standard deviation). The final half -life is from 1 to 2 hours. Four metabolites, of which 2 active metabolites also have short half -life from 1 to 3 hours. Metabolic agent 3'-Hydroxy-4'-methoxy diclofenac has a longer half-life. However, this metabolic is almost no activity.

About 60% of the active ingredient is excreted in the urine in the form of a molecular glucuronide in the form of intact molecules and in the form of metabolites, and all of these substances also turn into combined glucuronide. Under 1% of the active ingredient is excreted in a constant form. The rest is eliminated in the form of metabolism through bile dung.

Before taking Voltaren 50mg Novartis treat inflammation and degeneration of rheumatism (1 blister x 5 tablets)

How to use

The tablets are swallowed all with liquid, preferably before meals, and not divided or chewed.

Dosage

According to general recommendations, the dose should be adjusted to each patient. Unwanted effects can be minimized by using the lowest doses to be effective in the shortest time needed to control symptoms.

The maximum dose is 150 mg/day.

General patient group

Adults

The daily starting dose is 100 - 150 mg.

In lighter cases as well as in long -term treatment, the dose of 75 - 100 mg/day is usually sufficient.

generally the total daily dose should be divided into 2-3 times. To prevent night pain and stiffness in the morning, it is possible to supplement the treatment of the tablets during the day by using an additional tablet at bedtime (maximum total dosage/day is 150 mg).

In first dysmenorrhea, daily dose should be adjusted to each patient and usually 50 - 150 mg. A dose of 50 - 100 mg should be taken at the beginning and if necessary, increasing in a few menstrual cycles to a maximum of 200 mg/day. Should start treatment when there is first symptom and depending on the symptoms, continue treatment for a few days.

Special patient group

Pediatric patients (under 18 years old):

Children 1 year and older and teenagers should use 0.5 - 2 mg/kg body weight/day divided into 2-3 times, depending on the severity of the disease. To treat rheumatoid arthritis in teenagers, daily dose may increase to a maximum of 3 mg/kg/day, divided into several times.

Do not exceed the maximum dose/day of 150 mg.

Due to high content, do not recommend the tablet of Voltaren 50 mg for children and teenagers under 14 years old; The tablet can be taken in the 25 mg voltaren intestine in these patients.

Elderly patients (from 65 years of age):

Although Voltaren's pharmacokinetic properties are not clinically significant in the elderly, nonsteroidal anti -inflammatory drugs should be used in special cautious ways for these elderly patients - who are prone to adverse events. Especially recommended to use the lowest dose effectively for old or mild old patients and these patients should be monitored gastrointestinal bleeding during non -steroid anti -inflammatory treatment.

SECRETING HEART (NYHA Classification) or important cardiovascular risk factors:

Patients with congestive heart failure (classification of NYHA) and patients with important cardiovascular risk factors only treated with voltaren after careful consideration and at the dose ≤ 100 mg/day if treatment for more than 4 weeks.

kidney failure:

Voltaren is contraindicated in patients with renal failure (GFR impaired renal function , so no recommendations to adjust the dose on this patient object.

Be careful when using Voltaren for patients with renal function.

Hepatic failure:

Voltaren is contraindicated in patients with liver failure. There is no separate study conducted in patients with impaired liver function, so no recommendations to adjust the dose on this patient subject. Be careful when using Voltaren for patients with mild to moderate liver function.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Symptoms

There is no typical clinical disease due to overdose diclofenac . Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions.

In case of severe poisoning, acute renal failure and liver damage.

Treatment measures

Handling acute poisoning with NSAID, including Diclofenac, mainly includes measures to support and treat symptoms of complications such as lowering blood pressure, kidney failure, convulsions, gastric disorders and respiratory failure. Specific measures such as diuretic, juris or blood transfusion are probably not to help eliminate NSAIDs, including diclofenac, because NSAID has a strong combination rate with protein - plasma and strong transformation. Activated carbon can be used after an overdose that is likely to be toxic, and to detoxify the stomach (such as causing vomiting, gastric lavage) after overdose that is likely to be life -threatening.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Voltaren 50 , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system: headache , dizziness.

digestive: Nausea, vomiting, diarrhea , indigestion, abdominal pain, flatulence, anorexia. liver: Increase transaminase.

Skin and subcutaneous tissue: rash.

Uncommon, 1/1000

Cardiovascular: myocardial infarction, heart failure , chest drum, chest pain.

Rare, ADR

Blood and lymphatic system: thrombocytopenia, leukopenia, anemia (including hemolytic anemia and hydrophobic anemia), granulocytosis.

The immune system: hypersensitivity, anaphylactic reactions and anaphylaxis (including hypotension and shock). Neurological edema - pulse (including face edema).

Mental system: loss of orientation, depression, insomnia, nightmares, irritability, mental disorders.

Nervous system: Sleep. Perception, memory loss, convulsions, anxiety, tremor, sterile meningitis, taste disorders, stroke.

eyes: visual disorders, blurred vision, gravity.

ears and mesmerizing: tinnitus , hearing loss. vascular: hypertension, vasculitis.

Respiratory, chest and mediastinum: asthma, pneumonia.

digestive: gastritis, gastrointestinal bleeding, vomiting blood, hemorrhagic diarrhea, black stool, stomach ulcers (with or without hemorrhage, gastrointestinal stenosis, or perforation, can cause peritonitis). Colitis (including bleeding colitis, colitis due to ischemia and increased severity of colitis or Crohn's disease), constipation , gastritis, tongitis, esophagitis, bowel stenosis, pancreatitis. liver: hepatitis, jaundice, liver disorders. Hepatitis, liver necrosis, liver failure.

Skin and subcutaneous tissue: rash urticaria . Water polished dermatitis, Eczema, erythema, polymorphic erythematosus, Stevens-Johnson syndrome, poisoned epidermal necrosis (Lyell syndrome), flaking dermatitis, hair loss, photosynthetic reaction, bleeding, Schonlein bleeding, itching.

Kidney and urinary: Acute renal failure, urinary blood, proteinuria, kidney syndrome, renal tubular inflammation- interstitial tissue, kidney necrosis. all body: edema.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Voltaren 50 mg contraindicated in the following cases:

Knowing hypersensitivity to active ingredients or any excipients of the drug.

In ulcer, hemorrhage, or gastric or intestinal perforation.

The last 3 months of pregnancy.

Severe liver failure.

Severe renal failure (GFR

As well as other nonsteroidal anti -inflammatory drugs (NSAID), Voltaren also contraindicated in patients where asthma attacks, urticaria or acute rhinitis are likely to occur due to acetyl salicylic acid or other NSAIDs.

History of gastrointestinal bleeding or gastric perforation related to nsaids treatment.

Set of congestive heart failure (classification of NYHA IL - IV), ischemic heart disease, peripheral artery disease and/or brain vascular disease.

Children weighing less than 35 kg (not suitable for the form of drugs).

Caution when using

influence on the gastrointestinal tract:

ulcer, bleeding or gastric perforation, which can lead to death, have been reported to all NSald, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or previous history of serious stomach disease. In general, these reactions have more serious consequences in the elderly. If there is bleeding or gastric ulcer in patients using Voltaren, it is necessary to stop taking the drug.

Like all other NSAIDs, including Diclofenac, is required to closely monitor medical and need to be careful when prescribing Voltaren for patients with symptoms of disorders in the gastrointestinal tract or a history of suggestive ulcers, bleeding or gastric or perforation. The risk of stomach - intestinal bleeding is higher when increasing the dose of NSAID and in patients with a history of ulcer, especially if there is a complication of hemorrhage or perforation and in the elderly.

To reduce the risk of toxicity to the stomach - intestines in patients with a history of ulcer, especially if there is a complication of hemorrhage or perforation, and in the elderly, it is advisable to start and treat the lowest and effective dose. Treatment should be considered for combinations of protective drugs (such as proton or Misoprostol pump inhibitors) for these patients, and for patients who are in need of simultaneous use of acetylsalicylic acid (Asa)/aspirin or other drugs that can increase the risk of stomach - intestinal.

Patients with a history of ulcerative ulcer, gastric bleeding, especially in the elderly, should report any abnormal symptoms in the digestive tract. Be careful in patients who are taking simultaneously drugs that may increase the risk of ulcers or bleeding such as corticosteroids using systemic sugar, anticoagulic drugs, anti -plateletic drugs or selective Serotonin recovery inhibitors.

Need to monitor medical closely and be cautious in patients with ulcerative colitis or Crohn's disease, as their condition may get worse.

Cardiovascular effects:

Treatment with NSAID drugs including Diclofenac, especially in high and long -term doses, can be associated with a small risk of increased cardiovascular thrombosis (including myocardial and stroke infarction).

In general, it is not recommended to use Voltaren for patients with cardiovascular disease (congestive heart failure of NYHA level I, heart anemia, peripheral artery disease) or uncontrolled hypertension. If necessary, patients with cardiovascular disease, uncontrolled hypertension or important cardiovascular risk factors (such as hypertension, hyperlipidemia, diabetes and smoking) should only be treated with Voltaren after careful consideration and at the dose of ≤ 100 mg a day at continuous treatment for more than 4 weeks.

Because Diclofenac's cardiovascular risks may increase at doses and contact time, the lowest daily dose is effective, so it is used in the shortest possible time. It is advisable to re -evaluate the need for patients in response and symptomatic treatment, especially when treated continuously for more than 4 weeks. Patients should be alert with signs and symptoms of arterial thrombosis (such as chest pain, short breath (shortness of breath), weakness, difficulty speaking) may appear beyond warning. In such cases, patients should be directed to see a doctor immediately.

Hematology effects:

When using long -term voltaren, as well as other NSAIDs, blood recipe must be monitored.

As with other NSAIDs, Voltaren can temporarily inhibit platelets. Need to carefully monitor patients with hemostatic disorders.

The effect on the respiratory (asthma before):

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal lining (such as nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections (especially if it is related to symptoms such as allergic rhinitis), NSAIDs reacts such as asthma attacks (called intolerance with pain relievers/asthma due to pain reliever), more often than other patients with rigerators. Therefore, it is necessary to be particularly cautious with such patients (prepared for emergency media). Special attention must be paid to patients who have been allergic to other substances, such as skin reactions, itching or urticaria.

Effects on the liver system:

Strict medical monitoring requirements when prescribing Voltaren for patients with impaired liver function because their condition may worsen.

Like other NSAIDs, including diclofenac, the value of one or more liver enzymes can increase. During prolonged treatment with Voltaren (as with the form of tablets or drugs), regular monitoring of liver function is indicated as a preventive measure. If the abnormal or worse liver function tests are taken, if there are clinical signs or symptoms associated with liver disease, or if other manifestations appear (such as eosin leukemia, rash) should stop using Voltaren. Hepatitis may occur when using diclofenac without prior symptoms. Be cautious when using Voltaren for patients with dyslyline metabolic disorders of the liver because it can cause acute porphyrin attacks.

Skin reaction:

Serious skin reactions, some deaths, including scaled dermatitis, Stevens-Johnson syndrome and poisoned epidermal necrosis were recorded in very rare cases with NSAID use, including Voltaren. Patients with the highest risk of these reactions early in the treatment process, onset the reaction occurs in most cases in the first month of treatment. Voltaren must be stopped when the first manifestation of skin rash, mucosal damage or any other hypersensitivity signs.

Like other NSAIDs, allergic reactions, including anaphylactic/anaphylactic reactions, can occur in rare cases with diclofenac without previous exposure to the drug.

Effects on the kidneys:

NSAIDS drugs including Diclofenac often cause fluid and edema, so special attention should be paid to patients with heart or kidney damage, with a history of hypertension, the elderly, patients treated simultaneously with diuretic or drugs that affect kidney function, and patients with non -cellular fluid due to any cause, for example, for example, for example, for example, for example or after surgery. Monitoring of kidney function is an early preventive measure when using Voltaren in such cases. Stop treatment often restores the state before treatment.

Elderly patients:

It is necessary to be cautious for the elderly who are having basic medical diseases. Especially recommended the lowest dose effective in old patients-or mild people.

Interaction with NSAIDs:

Do not use the voltaren simultaneously with NSAIDs using systemic sugar including cyclooxygenase-2 inhibitors to avoid unwanted effects.

Covering the signs of infection:

Like other NSAIDs, voltaren can cover the signs and symptoms of infections due to its pharmacological properties.

Reproduction:

Like other NSAIDs, the use of Voltaren can reduce fertility in women and do not recommend in women who are trying to get pregnant, in women who have difficulty conceiving or those who are being checked in infertility, should consider stopping Voltaren.

The ability to drive and operate machinery

Patients with visual disorders, dizziness, dizziness, chicken sleep or other central nervous system disorders when using Voltaren should not drive and operate machinery.

Pregnancy

There is no recommended clinical data for pregnant women.

Prostaglandin synthesis inhibitors may adversely affect pregnancy and/or embryo/fetal development. Data from epidemiological studies shows that there is a risk of increased miscarriage and/or cardiac malformation and umbilical hernia after using prostaglandin synthetic inhibitors in the early stages of pregnancy. The absolute risk of cardiac deformities increases from less than 1% to about 1.5%. The risk is thought to increase at dosage and treatment time. In animals, the use of prostaglandin synthesis inhibitors leads to an increase in failure before and after the nesting of the workpiece and death in the embryo - fetus. In addition, the increase in the incidence of many different defects, including on the heart, has been reported on animals for use of prostaglandin synthetic inhibitors during the formation of organs. If using Voltaren for women who are trying to get pregnant or in the first 3 months of pregnancy, should be used at the lowest doses and the shortest therapy time possible.

In the last 3 months of pregnancy, all Prostaglandin synthesis inhibitors are at risk of embryo exposure to:

Cardiac toxicity (causing early arteriosclerosis and pulmonary hypertension).

Renal failure can progress to renal failure and cause amniotic fluid.

At the end of pregnancy, mothers and babies may have:

Prolonged bleeding time, platelet assembly condition can occur even at very low doses.

Inhibiting uterine contractions that make labor delayed or prolonged.

Therefore, contraindicated voltaren in the last 3 months of pregnancy.

The period of breastfeeding

as well as other NSAIDs, Diclofenac goes into breast milk in small amounts. Therefore, Voltaren should not be used while breastfeeding to avoid unwanted effects for children.

Drug interaction

The following drug interactions include the cases that have been observed when using the Voltaren tablet insoluble in the stomach and/or other forms of diclofenac.

Interactions should be considered

CYP2C9 inhibitors:

Precautions are recommended when using Diclofenac simultaneously with CYP2C9 inhibitor (such as Voriconazole ), this can significantly increase the peak concentration in plasma and DiClofenac exposure due to inhibition of DiClofenac metabolism.

lithium:

If used simultaneously, diclofenac may increase lithium plasma concentrations. Need to monitor serum lithium level.

digoxin:

If used simultaneously, Diclofenac may increase the plasma concentration of digoxin. Need to monitor the serum digoxin concentration.

Diuretics and anti -hypertension drugs:

Like other NSAIDs, simultaneously use Diclofenac with diuretics or anti -hypertension drugs (such as beta blockers, angiotensin -moving enzymes - ACE) can reduce the anti -hypertension effect of these drugs. Therefore, the combination needs to be cautious and in these patients, especially the elderly, should periodically check blood pressure. Patients should be fully rehydrated and need to be tested for kidney function after starting to use and periodically checked, especially for diuretics and ACE inhibitors because they can increase the risk of kidney toxicity.

ciclosporin and tacrolimus:

diclofenac, like other NSAIDs, can increase the toxicity of the kidneys of ciclosporin and tacrolimus due to the effect on prostaglandin in the kidney. Therefore, diclofenac should be used lower than the dose commonly used in non -ciclosporin or tacrolimus patients.

Hemorrhage -causing medicine:

Concentrated with potassium diuretics (such as spironolacton), ciclosporin , tacrolimus or trimethoprim may increase the level of potassium in serum, thus need to be monitored regularly.

Quinolone antibacterial drugs:

There have been individual reports on convulsions due to simultaneous use of Quinolone and NSAID.

Expected interactions are considered

Other NSAIDs and corticosteroids:

Simultaneous use of diclofenac and other systemic nsaids or corticosteroids may increase the frequency of side effects on the stomach.

anticoagulants and platelets:

Be careful because simultaneous use may increase the risk of bleeding. Although clinical studies do not show that Diclofenac affects the activity of anticoagulants, there are sporadic reports on increased risk of bleeding in patients with simultaneous use of Diclofenac and anticoagulant drugs. Therefore, closely monitoring these patients is recommended.

Selective Serotonin reabsorption inhibitors (SSRI):

Concentrated use of systemic lines, including diclofenac, and SSRI may increase the risk of stomach -intestinal bleeding.

anti -diabetic drugs:

Clinical studies show that Diclofenac can be used with oral anti -diabetic drugs without affecting their clinical effectiveness. However, there are sporadic reports on both increased effects and hypoglycemia requires a change in the dose of anti -diabetes drugs when treated with Diclofenac. For this reason, the control of blood sugar levels is recommended as a preventive measure when treated simultaneously. There are also individual reports on metabolic acidosis when used simultaneously diclofenac with metformin, especially in patients with kidney failure from before.

phenytoin:

When using simultaneously phenytoin with diclofenac, the control of phenytoin concentration in plasma is recommended by an increase in predictions of phenytoin content.

methotrexate:

Be careful when NSAID, including Diclofenac prescribed less than 24 hours before or after treatment with methotrexate, due to increased blood methotrexate levels and toxicity of this substance may increase.

CYP2C9 touch substances:

Caution recommends when prescribing Diclofenac simultaneously with CYP2C9 (such as rifampicin), this may reduce the meaning of plasma concentrations and Diclofenac exposure.

Storage

Temperature does not exceed 30 ° C.

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