Voltaren SR 75mg Novartis treat inflammation and degeneration of rheumatism (10 blisters x 10 tablets)

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

Ingredient

Composition information	Content
Sodium Diclofenac	75mg

Uses

indications

Voltaren 75mg drug is indicated in the following cases:

Inflammation and degenerative forms of rheumatoid arthritis: rheumatoid arthritis, vertebral arthritis, osteoarthritis and vertebral arthritis, spinal pain syndrome, osteoarthritis. extra.

In post -surgery and postoperative conditions, Voltaren relieves both spontaneous pain and pain when moving, reducing inflammation and edema due to wounds.

Slowed Launching tablets Voltaren 75mg and 100mg are very suitable for patients who are assigned daily dose of 75mg and 100mg. The daily daily dose makes long -term treatment simplicity and avoid confusion about dosage. Voltaren 75 mg slow release tablet also allows the maximum dose of 150 mg to be divided into two times a day.

Pharmacokinetics

absorption

The release of the main active ingredient is slower than the prolonged release of the Voltaren tablet, so the peak concentration in plasma is lower than the observation peak concentration when using the tablet form insoluble in the stomach with the same dose.

Pharmacokinetic properties do not change when using the dose repeated. There is no phenomenon of drug accumulation between two recommended doses.

Food does not significantly affect the absorption and systemic effects of the Voltaren tablet for prolonged release.

Distribution

99.7% Diclofenac is attached to serum protein, mainly associated with 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 to 4 hours after reaching the maximum concentration at plasma.

Metabolism

The biological change of Diclofenac 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 ' - and 3' - 4 ' Diclofenac), most of these substances converted into contact glucuronide. In these substances, there are two phenolic metabolites with biological activity, but weaker than the biological activity of Diclofenac.

Elimination

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 the form of unprocessed. The rest is eliminated in the form of metabolism through bile dung.

Before taking Voltaren SR 75mg Novartis treat inflammation and degeneration of rheumatism (10 blisters x 10 tablets)

How to use

Voltaren SR 75mg is used by oral. Should swallow all pills with drinks, preferably during meals and not to break or chew.

Dosage

General patient group

Daily starting dose is recommended from 100 mg to 150 mg, with 1 tablet of 100 mg voltaren oral tablets 100 mg for extended release or 2 prolonged release tablets of Voltaren 75mg.

In lighter cases and prolonged treatment, usually only use 75 - 100 mg/day is sufficient.

If the most severe symptoms at night or in the morning, you should use a long -lasting release tablet for Voltaren 75mg and 100mg in the evening.

Special patient group

Children

Due to the content of the drug, the Exchange of Voltaren 75mg and 100mg is not suitable for children and adolescents.

Elderly patients (over 65 years old)

No start dose adjustment for elderly patients.

Cardiovascular disease or important cardiovascular risk factors

generally do not recommend treatment for Voltaren in patients with cardiovascular disease or uncontrolled hypertension. If necessary, patients with cardiovascular disease, non -control hypertension or important cardiovascular risk factors are only treated with Voltaren after careful consideration and at the dose ≤ 100 mg/day if treatment is over 4 weeks.

kidney failure

Voltaren is contraindicated in patients with severe renal impairment. There is no separate study conducted in patients with mild to moderate renal function, so it is not recommended to adjust the dose adjustments on this patient. Be careful when using Voltaren for patients with mild to medium impaired renal function.

Hepatic failure

Voltaren is contraindicated in patients with severe liver failure. There is no separate research conducted in patients with mild to moderate liver function impairment, so it is not recommended to adjust the dose adjustments on this patient object. Be careful when using Voltaren for patients with mild to moderate liver function.

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 using overdose?

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 SR 75mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous system disorders: headache, dizziness.

Disorders of ear and vestibular: dizziness.

Stomach disorders: Nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, anorexia.

Liver disorders: increased transaminase.

Skin and subcutaneous disorders: rash.

Uncommon, 1/1000

Heart disorders: myocardial infarction, heart failure, chest drum, chest pain.

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 SR 75mg contraindications in the following cases:

Sensitive to the main active ingredient or any excipients.

ulcer, bleeding or gastric - intestinal puncture.

The last three months of pregnancy.

Severe liver failure.

Severe kidney failure.

Severe heart failure.

Like other nonsteroidal anti -inflammatory drugs (NSAID), Voltaren is also contraindicated for patients with acute asthma, urticaria or acetylsalicylic acid or other NSAIDs.

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 these reactions have more serious consequences in the elderly. If bleeding or stomach ulcers in patients use Voltaren, it is necessary to stop taking the drug. Should start treatment and maintenance treatment with the lowest and effective doses.

Consider the combination 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)/low -dose acetylic acids or other drugs capable of increasing risk to stomach - intestinal.

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

Heart effect

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, heart anemia, peripheral artery disease) or uncontrolled hypertension. If necessary, only Voltaren should be treated after careful consideration and at the dose

Hematological 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 respiratory (asthma before)

Reactions with NSAIDs such as asthma attacks (called intolerance with painkillers/asthma due to painkillers), rhymes or urticaria, more common in other patients. 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 bile liver system

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

Use diclofenac, the value of one or more liver enzymes can increase, regularly monitor liver function is indicated as a preventive measure. 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.

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, elderly people, patients treated simultaneously with diuretics or drugs that affect kidney function, and patients with non -cell loss patients due to any cause.

Elderly patients

It is necessary to be cautious for the elderly who are having basic medical diseases. Especially recommend the lowest doses effectively in old patients or lightweight people.

Covering the signs of infection

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 adequate data on the use of diclofenac in pregnant women. Therefore, Voltaren should not be used in the first 3 months and the middle 3 months of pregnancy unless the expected benefits for mothers are higher than the risk that may have for the fetus. Like other NSAIDs, contraindicated use of diclofenac for the last 3 months of pregnancy due to the possibility of uterine stubbornness and/or early closing the ductus artery

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

CYP2C9 strong inhibitor: Be cautious when using Diclofenac with strong CYP2C9 inhibitors (such as sulfinPyrazone and Voriconazole), this can significantly increase the peak concentration in plasma and Diclofenac exposure due to the inhibition of the transformation of DiClofenac.

Lithium: If used simultaneously, diclofenac may increase the concentration of lithium plasma. Control of lithium concentration in serum is recommended.

Digoxin: If used simultaneously, diclofenac can increase the concentration of plasma of digoxin. Control of Digoxin concentration in serum is recommended.

Diuretics and anti -hypertension drugs: Like other NSAIDs, simultaneously use Diclofenac with diuretics or anti -hypertension drugs (for example, beta blockers, angiotensin (ACE) inhibitors can reduce the anti -hypertension effect of these drugs).

ciclosporin: diclofenac, like other NSAIDs, can increase the toxicity of the kidneys of ciclosporin due to the effect on prostaglandin in the kidney. Therefore, in this case, the diclofenac dose must be used lower than the dose commonly used in patients not using ciclosporin.

Hemorrhage -causing drugs: Concomitance with diuretics holding potassium, ciclosporin, tacrolimus or trimethoprim may increase the concentration of potassium in serum, therefore should be regularly monitored in serum potassium levels.

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

Other NSAIDs and corticosteroids: simultaneously use diclofenac and other systemic nsaids or corticosteroids may increase the frequency of side effects on the stomach.

Anticoagulants and platelet resistance: Caution should be careful because simultaneous use may increase the risk of bleeding.

Selective Serotonin Restrain Inhibitors (SSRI): Timultant to the bodyburges, including Dicloífenac, and SSRI may increase the risk of stomach -intestinal bleeding.

anti -diabetes drugs: Clinical studies show that Diclofenac can be used with oral anti -diabetic drugs without affecting their clinical effect. However, there are sporadic reports on increased and hypoglycemic effects that require changing 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.

Phenytoin: When using simultaneously phenytoin with diclofenac, the control of phenytoin concentration in plasma is recommended due to an increase in predictions of exposure to phenytoin.

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

Storage

Leave a cool place, avoid light, temperature below 30⁰C

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