voltarenE tablets Uses, Dosage, Side Effects, Precautions & Warnings

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voltarenE tablets >> Generic drug of the Therapeutic class: Anti-inflammatory , analgesic
active ingredients: Diclofenac

what is voltarene tablet?

This medicine contains a nonsteroidal anti-inflammatory drug: diclofenac. It is indicated :

• IN ADULT AND CHILD FROM 15 YEARS:
  • in long-term treatment of:
    • some chronic inflammatory rheumatism,
    • some severe osteoarthritis,

• in short-term treatment of:
  • certain inflammations of the periphery of the joint (painful shoulders, tendonitis, bursitis),
  • certain inflammation of the joints by crystal deposits, such as gout,
  • acute pain of osteoarthritis,
  • acute lumbar pain, acute pain related to the irritation of a nerve, such as sciatica.

What is Voltaren 100 mg used for and indication?

They come from the anti-inflammatory activity of diclofenac, the importance of the manifestations of intolerance to which the drug gives rise and from its place in the range of anti-inflammatory products currently available.

· IN ADULT AND CHILD FROM 15 YEARS, they are limited to:

o Long-term symptomatic treatment:

• chronic inflammatory rheumatism, including rheumatoid arthritis, ankylosing spondylitis or related syndromes such as Fiessinger-Leroy-Reiter syndrome and psoriatic arthritis,
• some painful and disabling arthrosis.

Short-term symptomatic treatment of acute episodes of:

• Abarticular rheumatism (acute painful shoulders, tendonitis, bursitis),
•  microcrystalline arthritis,
•  arthrosis,
• lumbalgia, severe radiculalgia.

VOLTARENE  Dosage

Adverse effects can be minimized by using the lowest effective dose for the shortest duration of symptom relief .

In general, the dose must be adapted individually.

Target population

Adult

• · Attack treatment: 150 mg in 2 doses, ie 1 suppository at 100 mg, to be completed with an oral form,
• · Maintenance treatment (or required in some patients): 1 suppository at 100 mg per day, at bedtime.
• The maximum daily dose of 150 mg should not be exceeded.

Special populations

Pediatric population

• Due to its dosage, this medication should not be used in children and adolescents under 15 years of age.
• Geriatric population (patients aged 65 years or older)
• No dose adjustment of the initial dose is necessary in the elderly.

Renal failure

• VOLTARENE 100 mg, suppository is contraindicated in patients with renal impairment.
• No specific studies have been performed in patients with renal impairment. Therefore, no specific recommendation in terms of dosage adjustment can be given.
• Caution is advised when VOLTARENE 100 mg suppository is administered to patients with mild to moderate renal impairment.

Hepatic insufficiency

• VOLTARENE 100 mg, suppository is contraindicated in patients with hepatic impairment.
• No specific studies have been performed in patients with hepatic impairment. Therefore, no specific recommendation in terms of dosage adjustment can be given. Caution is advised when VOLTARENE 100 mg suppository is administered to patients with mild to moderate hepatic impairment.

Administration mode

Rectal way.

• The suppository should be inserted into the rectum. It is recommended to administer the suppository after passage of stool.
• The choice of the rectal route is determined only by the convenience of drug administration.

Duration of administration

• Use of the rectal route should be as short as possible because of the risk of local toxicity added to oral risks.

This drug is contraindicated:

– beyond 24 weeks of amenorrhea (completed 5 months of pregnancy) ( see section Pregnancy and breast-feeding ),

History of allergy or asthma triggered by taking diclofenac or substances of similar activity such as other NSAIDs, acetylsalicylic acid,

Hypersensitivity to the active substance or to any of the excipients,

History of bleeding or perforation of the digestive system during previous treatment with NSAIDs,

– progressive peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified),

Severe hepato-cellular insufficiency,

Severe renal impairment

Severe heart failure

Recent history of proctitis or rectal bleeding (contraindication related to the route of administration),

– child under 15 years old (due to the inappropriate dosage of this medicine).

ANSM alert of 08/21/2013:

• Although the benefits of diclofenac outweigh the risks, currently available data indicate an increased risk of arterial thrombotic events associated with treatment with diclofenac, comparable to that observed with treatment with anti-inflammatory drugs known as selective inhibitors of COX-2 (coxibs).
• Diclofenac is now contraindicated in patients with known congestive heart failure (NYHA stage II-IV), ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease. The treatment of patients with these contraindications should be reassessed.

How it works VOLTARENE 100 mg?

Absorption

1. Diclofenac is rapidly and completely absorbed. The bioavailability is of the order of 40% (83% of that of gastro-resistant tablets for the same dose).
2. Maximum plasma concentrations are reached approximately 4 hours after administration and are around 0.5 mg / l for a 100 mg LP tablet.
3. Repeated doses do not lead to any accumulation of diclofenac in the plasma.

Distribution

1. Diclofenac is strongly bound to plasma proteins (> 99%).
2. In plasma, the decay of diclofenac concentrations is bi-phasic. It corresponds to a rapid phase of tissue distribution and a slower phase of elimination.
3. Diclofenac diffuses into synovial fluid where peak concentrations are measured 2-4 hours after peak plasma. The apparent half-life of synovial fluid elimination is 3 to 6 hours.
4. Diclofenac passes in small amounts into breast milk.

Metabolism

1. Diclofenac is metabolized rapidly and almost completely, mainly in the liver.
2. The main metabolic pathways are hydroxylation and glucuronidation. The metabolites obtained are devoid of pharmacological activity.

Excretion

1. Excretion is both urinary and faecal.
2. Less than 1% of the active ingredient is eliminated unchanged in the urine. About 60% of the administered amount is eliminated as metabolites in the urine, the rest is eliminated in the feces.
3. The plasma elimination half-life of unchanged diclofenac is around 1 to 2 hours. The total plasma clearance is approximately 263 ml / min.

Physio-pathological variations

1. The kinetics of diclofenac are linear in the dose range 25 to 150 mg.
2. The pharmacokinetic parameters are not modified by age.

voltaren side effects

Like all medicines, VOLTARENE 100 mg suppository can cause side effects, although not everybody gets them.

Medications such as VOLTARENE 100 mg, suppository could increase the risk of heart attack (“myocardial infarction”) or stroke.

May occur:

• allergic reactions:
  • cutaneous: rash, urticaria, eczema,
  • Respiratory: asthma attack, lung disease,
  • general, especially in patients allergic to acetylsalicylic acid,
  • others: inflammation of small blood vessels, hypotension.
• very rarely, a peeling of the skin with formation of bubbles that can rapidly spread very seriously to the whole body, a cutaneous reaction during exposure to the sun or UV, small purple spots under the skin (purpura) .
• rarely, digestive haemorrhage (discharge of blood through the mouth or in the stool, stool staining in black). This is all the more frequent as the dosage used is high.
• rarely, jaundice.

In all these cases, you should immediately stop the treatment and tell your doctor.

During treatment, it is possible that also occur:

• digestive disorders: nausea, vomiting, diarrhea, constipation, abdominal cramps, stomach upset, difficult digestion, loss of appetite, burping, inflammation of the stomach or intestine, irritation or inflammation of the anus or rectum (effects related to the route of administration), relapse of ulcerative colitis or Crohn’s disease,
• headache, dizziness, lightheadedness, drowsiness, seizures, insomnia, nervousness, fatigue, tremors, tingling, blurred vision, tinnitus,
• a hair loss,
• disorders of the functioning of the kidneys, rare oedemas,
• disorders of the functioning of the liver.

In any case, notify your doctor.

• Cases of ulceration or gastrointestinal perforation, inflammation of the pancreas, severe hepatitis (inflammation of the liver), meningitis have been reported.
• There have also been abnormalities of the blood count, liver and kidney assessments, which can be serious.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

VOLTARENE Interactions

Risk related to hyperkalemia:

• Certain drugs or therapeutic classes may promote the occurrence of hyperkalemia: potassium salts, potassium diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists, nonsteroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), immunosuppressants such as ciclosporin or tacrolimus, trimethoprim.
• The combination of these drugs increases the risk of hyperkalemia. This risk is particularly important with potassium-sparing diuretics, especially when they are combined with one another or with potassium salts, whereas the combination of an ACE inhibitor and an NSAID, for example, is safer as soon as possible. the moment that the recommended precautions are implemented.
• To know the risks and stress levels specific to hyperkalemic drugs, it is necessary to refer to the interactions specific to each substance.
• However, some substances, such as trimethoprim, are not the subject of specific interactions with regard to this risk. Nevertheless, they may act as a favorable factor when combined with other drugs such as those mentioned above.
• Simultaneous administration of diclofenac with the following products requires careful monitoring of the clinical and laboratory status of the patient.

Associations advised against

Other NSAIDs

• Increased risk ulcerogenic and haemorrhagic digestive.

Acetylsalicylic acid at anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g daily) or at analgesic or antipyretic doses (≥ 500 mg taken and / or <3 g daily)

• Increased risk ulcerogenic and haemorrhagic digestive.

Oral anticoagulants

• Increased bleeding risk of oral anticoagulant (aggression of gastric and duodenal mucosa by NSAIDs). NSAIDs may increase the effects of anticoagulants, such as warfarin ( see Warnings and Precautions section ).
• If the association can not be avoided, close clinical and biological monitoring.

 Unfractionated heparins, low molecular weight and related heparins (in curative doses and / or in the elderly)

• Increased risk of haemorrhage (inhibition of platelet function and aggression of gastric and duodenal mucosa by NSAIDs).
• If the association can not be avoided, close clinical supervision.

 Lithium

• Increased lithemia that can reach toxic values ​​(decreased renal lithium excretion).
• If the combination can not be avoided, closely monitor for lithium and adjust the dosage of lithium during the combination and after stopping the NSAID.

Methotrexate used at doses greater than 20 mg / week

• Increased haematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs).

Pemetrexed (in patients with mild to moderate renal function, creatinine clearance between 45 ml / min and 80 ml / min)

• Risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).

Associations subject to precautions for use

Ciclosporin, tacrolimus

• Risk of addition of nephrotoxic effects, especially in the elderly.
• Monitor renal function at the beginning of treatment with the NSAID.

 Diuretics, ACE inhibitors, angiotensin II receptor antagonists

• Acute renal failure in the patient at risk (elderly and / or dehydrated) by reduction of glomerular filtration (inhibition of vasodilator prostaglandins due to NSAIDs).
• Moreover, reduction of the antihypertensive effect.
• Hydrate the patient and monitor kidney function at the beginning of treatment.

 Methotrexate, used at doses less than or equal to 20 mg / week

• Increased haematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs).
• Weekly control of the blood count during the first weeks of the association.
• Increased monitoring for impaired (even mild) renal function, as well as in the elderly.

 Pemetrexed (in patients with normal renal function)

• Risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
• Biological monitoring of the renal function.

Associations to consider

 Acetylsalicylic acid at anti-aggregating doses (from 50 mg to 375 mg daily in 1 or more doses)

• Increased risk ulcerogenic and haemorrhagic digestive.

 Glucocorticosteroids (except hydrocortisone as replacement therapy)

• Increased risk of ulceration and gastrointestinal bleeding ( see Warnings and Precautions section )

 Platelet aggregation inhibitors and selective serotonin reuptake inhibitors (SSRIs)

• Increased risk of gastrointestinal bleeding ( see Warnings and Precautions section ).

 Unfractionated heparins (at preventive doses)

• Increased haemorrhagic risk

 Beta-blockers (except esmolol)

• Reduction of antihypertensive effect (inhibition of vasodilator prostaglandins by NSAIDs and retention of water with NSAIDs pyrazole).

 Deferasirox

• Increased risk ulcerogenic and haemorrhagic digestive.

Warnings and Precautions

Warnings

• Concomitant use of VOLTARENE LP 100 mg, sustained release coated tablet with other NSAIDs, including selective cyclooxygenase 2 (cox-2) inhibitors, should be avoided.
• The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration of treatment required to alleviate symptoms  and paragraphs “Gastrointestinal Effects”. “and” Cardiovascular and cerebrovascular effects “below).

Asthmatic subjects

• Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis have a higher risk of allergic reaction when taking acetylsalicylic acid and / or nonsteroidal anti-inflammatory drugs. than the rest of the population. The administration of this specialty may lead to an asthma attack, particularly in certain subjects allergic to acetylsalicylic acid or to an NSAID.

Elderly

• Elderly patients have an increased risk of adverse effects to NSAIDs, particularly gastrointestinal bleeding and potentially fatal perforations .

Gastrointestinal effects

• Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs including diclofenac at any time during treatment, without necessarily warning signs or history of diclofenac. serious gastrointestinal adverse effects.
• The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with the dose used in patients with a history of ulcer, particularly in the case of complications such as haemorrhage or perforation .
•  as well as in the elderly, fragile, low body weight. In these patients, treatment should be started at the lowest dose possible. Protective mucosal therapy (eg, misoprostol or proton pump inhibitor) should be considered for these patients, as for patients requiring low-dose acetylsalicylic acid therapy or other drugs that may beInteractions with other drugs and other forms of interaction ).
• Patients with a gastrointestinal history, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
• Special attention should be paid to patients receiving associated therapies that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral anticoagulants such as warfarin, selective reuptake inhibitors, and Serotonin (SSRI) and antiplatelet agents such as acetylsalicylic acid.
• If bleeding or ulceration develops in a patient receiving VOLTARENE LP 100 mg, sustained release coated tablet, treatment should be discontinued.
• Diclofenac should be administered with caution and under close supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) due to a risk of aggravating the disease.

Cardiovascular and cerebrovascular effects

• Adequate monitoring and recommendations are required in patients with a history of hypertension and / or mild to moderate heart failure, with cases of fluid retention and edema associated with NSAID therapy.
• Clinical studies and epidemiological data suggest that the use of diclofenac, especially when used at a high dose (150 mg daily) and for a long duration of treatment, may be associated with a slightly increased risk of thrombotic events arterial (for example, myocardial infarction or stroke).
• Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and / or history of stroke (including transient ischemic attack) should be treated with diclofenac only after careful consideration.
• Similar attention should be paid to initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes or smoking).

Skin effects

• Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndromes, and Lyell syndromes have been reported very rarely in NSAID therapy ( see section 4.8 ).
• The incidence of these adverse effects appears to be greater at the beginning of treatment, the delay of onset being, in the majority of cases, during the first month of treatment. VOLTARENE LP 100 mg, sustained release coated tablet should be discontinued at the onset of rash, mucosal lesions or other signs of hypersensitivity.

Functional renal insufficiency

NSAIDs including diclofenac, by inhibiting the vasodilator action of renal prostaglandins, are likely to cause functional renal failure by decreasing glomerular filtration. This side effect is dose dependent.

At the beginning of treatment or after an increase in dosage, monitoring of diuresis and renal function is recommended in patients with the following risk factors:

• · Elderly subjects,
• · Associated drugs such as: ACE inhibitors, sartans, diuretics ( see section Interactions with other medicinal products and other forms of interaction ),
• · Hypovolemia, whatever the cause,
• · heart failure,
• · Chronic renal failure,
• · nephrotic syndrome,
• · Lupus nephropathy,
• · Decompensated hepatic cirrhosis.

Hydro-Sodium Retention

• Fluid-sodium retention with possibility of edema, hypertension or hypertension, aggravation of heart failure. Clinical monitoring is necessary from the beginning of treatment in case of hypertension or heart failure. A decrease in the effect of antihypertensives is possible ( see section Interactions with other medicinal products and other forms of interaction ).

hyperkalemia

• Hyperkalemia favored by diabetes or concomitant treatment with hyperkalemic drugs (see section Interactions with other medicinal products and other forms of interaction ).
• Regular monitoring of serum potassium should be performed under these circumstances.
• This medication should be avoided if treated with another nonsteroidal anti-inflammatory drug, with an oral anticoagulant, with lithium, with aspirin at analgesic, antipyretic or anti-inflammatory doses, with methotrexate for doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and / or in the elderly), with pemetrexed, in patients with mild to moderate renal function ( see section Interactions with other medicinal products and other forms of interaction ).

Hepatic effect

• As with most NSAIDs, there may be an increase in the level of one or more liver enzymes. Discontinue treatment for persistent abnormalities or worsening of liver function, clinical signs of liver disease or other manifestations (eosinophilia, rash …).

Special precautions for use

• Diclofenac, like any drug that inhibits the synthesis of cyclooxygenases and prostaglandins, can impair fertility. Its use is not recommended for women who want to conceive a child.
• During prolonged treatment, it is recommended to check the blood count, liver function and kidney function.
• Diclofenac exists as other dosages that may be more suitable.
• This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency.

ANSM alert of 14/06/13:

• In view of the reassessment of the PRAC, the ANSM recommends systematically informing all patients at risk of cardiovascular risk of the use of NSAIDs systemically, and diclofenac in particular.
• Before any prescription of NSAIDs, all risk factors, including cardiovascular and gastrointestinal factors, must be taken into account.
• It is recommended to use, whenever possible, patients with cardiovascular risk therapeutic alternatives, especially for long-term treatments.

ANSM alert of 21/08/2013:

• Treatment with diclofenac should be initiated only after careful evaluation in patients with risk factors for cardiovascular events (eg, hypertension, hyperlipidemia, diabetes mellitus, and smoking).
• The lowest effective dose of diclofenac for the shortest time needed to control patient symptoms should be used.

Drive and use machines

• Voltaren LP, sustained release coated tablet has no or negligible influence on the ability to drive and use machines.
• However, patients should be advised that if vision problems, drowsiness, dizziness or other central nervous system disorders occur, it is recommended that you refrain from driving or operating machinery.

VOLTARENE 100 mg and PREGNANCY / BREAST FEEDING / FERTILITY

women of childbearing age:

• There is no specific recommendation regarding women of childbearing age.

Pregnancy

• Inhibition of prostaglandin synthesis may affect the course of pregnancy and / or the development of the embryo or fetus. Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis after treatment with an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%.
• The risk appears to increase depending on the dose and duration of treatment.
• In animals, administration of an inhibitor of prostaglandin synthesis has been shown to cause increased pre- and post-implant loss and increased embryo-fetal lethality.
• In addition, a higher incidence of some malformations, including cardiovascular, has been reported in animals that received an inhibitor of prostaglandin synthesis during the organogenesis phase of pregnancy.
• Unless absolutely necessary, Voltarene LP, coated tablet prolonged release should not be prescribed during the first 24 weeks of amenorrhea (5 months of pregnancy). If Voltarene LP, a sustained-release coated tablet is administered to a woman who wishes to become pregnant or pregnant for less than 5 months, the dose should be as low as possible and the duration of treatment as short as possible.

After 24 weeks of amenorrhea (5 months), all inhibitors of prostaglandin synthesis may exhibit:

• the fetus:
  • cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension);
  • renal dysfunction that may progress to renal failure associated with oligohydroamnios;
• the mother and the newborn at the end of pregnancy:
  • an increase in bleeding time due to antiplatelet action that may occur even after administration of very low doses of drug;
  • inhibition of uterine contractions resulting in delayed or prolonged delivery.

As a result, Voltarene LP, sustained-release coated tablet is contraindicated beyond 24 weeks of amenorrhea (5 months).

An inadvertent intake beyond 24 weeks of amenorrhea (5 months) justifies cardiac and renal, fetal and / or neonatal monitoring according to the term of exposure.

The duration of this monitoring will be adapted to the elimination half-life of the molecule.

Breastfeeding

• NSAIDs pass into breast milk as a precautionary measure and should not be administered to women who are breastfeeding.

Fertility

• As with other NSAIDs, the use of Voltarene LP, a sustained-release coated tablet, can affect female fertility and is not recommended for women who want to have a baby. In women who have difficulty conceiving or who are undergoing fertility tests, the discontinuation of Voltarene LP, a sustained-release coated tablet should be considered.
• Do not take a double dose to make up for the dose you forgot to take.

What happens if I overdose from VOLTARENE 100 mg ?

Symptoms:

There is no characteristic clinical picture resulting from overdose with diclofenac. Overdose can lead to symptoms such as:

• headache,
• tinnitus,
• dizziness,
• motor agitation,
• muscle twitching,
• increased irritability,
• ataxia,
• dizziness;

convulsions, especially in young children;

• epigastric pain, nausea, vomiting, haematemesis, diarrhea, peptic ulcer, gastrointestinal bleeding;
• liver function disorders;
• oliguria.
• In cases of severe intoxication, acute renal failure and liver injury are possible.
  

To behave :

immediate transfer to a specialized hospital;

• rapid evacuation of the product ingested by gastric lavage.
• The management of acute intoxication with NSAIDs, including diclofenac, is based primarily on measures and symptomatic treatment for complications such as hypotension, renal failure, seizures, gastrointestinal disease or respiratory depression.
• In convulsions, diazepam or phenobarbital may be used.
• Special measures such as forced diuresis, dialysis, or transfusion of packed red cells are probably of no use in eliminating NSAIDs, including diclofenac, because of their strong protein binding and important metabolism.

Administration of activated charcoal may be considered after ingestion of a potentially toxic dose and gastric emptying (eg, vomiting, gastric lavage) after ingestion of a potentially lethal dose.

What is  Forms and Composition ?

• 100 mg sustained-release coated tablet (round, biconvex, bevelled edge, one engraved side “CGC” and the other “CG”, pink):  Box of 15, under blister. 75 mg sustained-release coated tablet (light pink):   Box of 30, under blister packs.

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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