CARTREX 100 mg Uses, Dosage, Side Effects, Precautions & Warnings

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Generic drug of the Therapeutic class: Anti-inflammatory
active ingredients: Aceclofenac

what is CARTREX?

This medication is a nonsteroidal anti-inflammatory drug. It is indicated in adults and children from 15 years of age in the treatment of arthritis attacks and the treatment of certain inflammatory rheumatism.

what is CARTREX medication used for and indication?

Pharmacotherapeutic group: anti-inflammatory / anti-rheumatic drugs, non-steroidal – ATC code:

• M01AB16.
• CARTREX is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs have anti-inflammatory and analgesic properties. The active substance in CARTREX 100 mg film-coated tablets is eclofenac.
• CARTREX is used to relieve pain and inflammation if you have different types of joint inflammation (joint diseases such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis).

CARTREX Dosage

Oral route.

• The tablets are to be swallowed whole with at least half a glass of water or other liquid. CARTREX can be taken with food.

Adults

• The maximum recommended dose is 200 mg per day in two divided doses, i.e. one 100 mg tablet in the morning and evening.

Older subjects

• In general, it is not necessary to reduce the dosage; however, precautions should be taken (see section Warnings and precautions for use ).

Children

• The safety and efficacy of the product have not been demonstrated in children and adolescents.

Hepatic impairment

• In case of mild to moderate hepatic impairment, the dosage will be reduced. The recommended starting dose is 100 mg per day.

Kidney failure

• In the event of mild renal insufficiency, it is not necessary to reduce the dosage; however, precautions must be taken.
• The occurrence of side effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary for the relief of symptom.

Contraindications

• History of asthma attack, bronchospasm, acute rhinitis or hives triggered by NSAIDs or aspirin
• Progressive peptic ulcer
• History of peptic ulcer or recurrent gastrointestinal bleeding
• Hemorrhage
• History of hemorrhage or digestive perforation by NSAIDs
• NYHA Class II-IV Heart Failure
• Ischemic heart disease

• Peripheral arterial disease
• Cerebrovascular disease
• Severe hepatic impairment
• Severe renal failure
• 3rd trimester pregnancy
• Child under 6
• Varicella
• Pregnancy 1st trimester
• 2nd trimester pregnancy
• Feeding with milk
• Woman who wishes to conceive
• Reduced female fertility
• Woman’s fertility check-up

Aceclofenac is contraindicated in the following situations:

Hypersensitivity to aceclofenac or to one of the excipients mentioned in the Composition section or hypersensitivity to molecules of similar activity such as other NSAIDs, aspirin,

– Patients in whom taking aspirin or other NSAIDs may trigger an asthma attack, bronchospasm, acute rhinitis or hives,

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

Gastrointestinal bleeding or any other type of bleeding,

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

Known congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease,

Severe hepatic or renal insufficiency,

– During the last three months of pregnancy (see section Fertility, pregnancy and breast-feeding).

HOW TO TAKE CARTREX?

• Be sure to always take this medicine exactly as your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
• Your doctor will prescribe the lowest effective dose for the shortest time possible to reduce side effects.
• Do not exceed the recommended daily dose.
• Adults: The recommended dose is 200 mg (2 tablets). One 100 mg tablet should be taken in the morning and another 100 mg tablet in the evening.
• In patients with hepatic impairment, the recommended starting dose is 100 mg.
• The tablets should be swallowed as is with a glass of water and can be taken with food.

If you take more CARTREX 100 mg film-coated tablet than you should

• If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital for the emergency department. Please take this leaflet and the CARTREX box with you so that the doctor will know what you have taken.
• Symptoms of overdose may include nausea, vomiting, stomach pain, dizziness, drowsiness, and headache.
• If you forget to take CARTREX 100 mg film-coated tablet
• If you miss a dose, don’t worry, just take the next dose at the usual time. Do not take a double dose to make up for the dose you forgot to take.
• If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

If you stop taking CARTREX 100 mg film-coated tablets

• Not applicable.

If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.

How it works ?

Absorption

• After oral administration, aceclofenac is rapidly absorbed and its bioavailability reaches almost 100%. Maximum plasma concentrations are reached approximately 1.25 to 3 hours after ingestion. The simultaneous intake of food delays the Tmax while the absorption is not influenced.

Distribution

• Aceclofenac is highly protein bound (> 99.7%).
• It enters the synovial fluid where its concentration reaches about 60% of the plasma concentration.
• The volume of distribution is approximately 30 liters.

Elimination

• The mean plasma elimination half-life is 4-4.3 hours. The clearance is estimated at 5 liters per hour. About two thirds of the administered dose is excreted in the urine, mainly in the form of hydroxymetabolites. After a single oral dose, only 1% is excreted unchanged.
• Aceclofenac is probably metabolized via CYP2C9 to its major metabolite
  4′-OH-aceclofenac, the clinical activity of which is probably negligible. Among all the metabolites, diclofenac and 4′-OH-diclofenac have been detected.

Characteristics in some patients:

• No change in the pharmacokinetics of aceclofenac has been demonstrated in the elderly.
• Slowing of the elimination of the product has been observed in the event of impaired hepatic function, after administration of a single dose of aceclofenac.
• A repeated dose study of 100 mg per day shows that the pharmacokinetic parameters are not changed between healthy subjects and subjects with mild to moderate hepatic impairment.
• Likewise in patients with mild to moderate renal impairment, there is no clinically significant difference in pharmacokinetic parameters after administration of a single dose of aceclofenac.

HOW TO STORE CARTREX?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the blister pack after “EXP”. The expiration date refers to the last day of that month.
• Store at a temperature not exceeding 30 ° C.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

CARTREX Side Effects

Like all medicines, CARTREX 100 mg film-coated tablets can cause side effects, although not everybody gets them.

• Allergic skin reactions may occur: rash on the skin, itching, inflammation of the skin, or general: facial edema, allergic shock.
• Exceptional serious skin infections in chickenpox.
• In rare cases, it is possible that digestive bleeding occurs. This is all the more frequent the higher the dosage used.
• Medicines such as CARTREX may increase the risk of a heart attack (“myocardial infarction”) or stroke.

In all cases, the treatment should be stopped immediately and your doctor should be notified.

During treatment, it is possible that:

• digestive disorders: difficult digestion, abdominal pain, nausea, vomiting, diarrhea, constipation, bloating,
• dizziness, headache, fatigue, tremors, ringing in the ears,
• disorders of mood, sensitivity, vision and taste, sleep,
• weight gain, edema, hypertension,
• palpitations, cramps, flushing of the face, eczema, discomfort or difficulty in breathing,
• inflammation of the mouth.

In all cases, you should notify your doctor.

• Cases of inflammation of the stomach, pancreas, liver or blood vessels, as well as digestive ulcerations, kidney damage may occur.
• A few rare cases of biological changes may eventually necessitate a check-up of blood, liver and kidney tests.

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

Keep out of the reach and sight of children.

CARTREX Interactions

No pharmacokinetic interaction studies (except with warfarin) have been performed.

Aceclofenac is metabolized via cytochrome P450 2C9 and in vitro data indicate that aceclofenac may be an inhibitor of this enzyme. There is therefore a risk of pharmacokinetic interaction with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.

As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs with active renal elimination, such as methotrexate and lithium.

Aceclofenac is almost completely bound to plasma proteins (Albumin). The possibility of interaction with drugs strongly bound to plasma proteins should be taken into account.

Due to the lack of pharmacokinetic interaction study the following recommendations are based on information with other NSAIDs:

Not recommended associations

Methotrexate (high doses)

• NSAIDs inhibit its tubular secretion. A slight metabolic interaction by reduced clearance of methotrexate can be observed.
• Therefore, the prescription of NSAIDs should always be avoided during treatment with high dose methotrexate.

Lithium and digoxin

• Several NSAIDs inhibit renal clearance of lithium and digoxin, thereby increasing their serum concentrations.
• If the combination cannot be avoided, increased monitoring of lithium or digoxin levels should be performed.

Corticosteroids

• Increased risk of gastrointestinal ulceration and bleeding.

Anticoagulants

• NSAIDs may enhance the effects of anticoagulants, such as warfarin . For patients combining treatment with anticoagulants and aceclofenac, close monitoring should be undertaken.

 Antiplatelet drugs and selective serotonin reuptake inhibitors (SSRIs)

• Increased risk of gastrointestinal bleeding.

Interactions requiring dose adjustments or precautions for use

Methotrexate (low doses)

• A possible interaction between an NSAID and methotrexate even when used at low doses should be considered, especially in patients with reduced renal function.
• If the combination cannot be avoided within the same 24 hour period, renal function should be monitored due to the increase in methotrexate levels which can reach toxic values.

Ciclosporin and tacrolimus

The combination of an NSAID with ciclosporin or tacrolimus increases the risk of nephrotoxicity, due to the decrease in the synthesis of renal prostacyclins.

In case of combination, it is important to control renal function.

+ Other NSAIDs including aspirin (> 3 g per day) and corticosteroids: the combination with other NSAIDs including aspirin and corticosteroids may increase the frequency of side effects; caution is therefore required.

+ Diuretics, ACE inhibitors, angiotensin II antagonists: NSAIDs may reduce the effects of diuretics and other antihypertensive drugs.

• In some patients with impaired renal function (for example dehydrated patients or some elderly patients), the combination of an angiotensin converting enzyme inhibitor or angiotensin II receptor blocker with treatments that inhibit cyclooxygenase may cause further deterioration of kidney function, including acute kidney failure, which is usually reversible. Therefore, any such combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered when initiating concomitant therapy and then at regular intervals.
• Concomitant administration with potassium diuretics may be accompanied by an increase in serum potassium concentration. The latter must then be monitored.
• When co-administered with bendrofluazide, aceclofenac would not affect blood pressure; however an interaction with antihypertensive drugs cannot be excluded.

Other possible interactions

• Anti-diabetic treatments : In clinical studies it has been shown that diclofenac can be administered in combination with oral anti-diabetics without influencing their clinical efficacy. However, isolated cases of hypoglycemia and hyperglycemia have been reported with aceclofenac. The doses of drugs that may cause hypoglycemia should therefore be adjusted in combination with aceclofenac.
• Zidovudine : increased risk of haematological toxicity in the event of treatment combining NSAIDs and zidovudine. An increased risk of hemato-arthrosis and hematomas has been shown in HIV (+) hemophiliacs receiving simultaneous treatment with zidovudine and ibuprofen.

Drive and use machines

If you experience dizziness, vertigo, or other central nervous system adverse effects while taking NSAIDs, you should not drive or use machinery.

Warnings and Precautions

Special warnings

THIS MEDICINE SHOULD ONLY BE TAKEN UNDER MEDICAL SUPERVISION

• NSAIDs such as CARTREX may increase the risk of a heart attack (“myocardial infarction”) or stroke. The risk is all the greater as the doses used are high and the duration of treatment prolonged.
• Do not exceed the recommended doses or the duration of treatment.
• If you have heart problems, if you have had a stroke or if you think you have risk factors for this type of pathology (for example in case of high blood pressure, diabetes, high cholesterol level) or if you smoke, talk to your doctor or pharmacist.
• In chickenpox, the use of this medication is not recommended due to exceptional serious skin infections.

BEFORE USING A NON-STEROID ANTI-INFLAMMATORY ANTI-INFLAMMATORY, ADVISE YOUR DOCTOR in the event of:

• coagulation disorders, concomitant anticoagulant therapy. This medicine can cause serious gastrointestinal symptoms,
• digestive history,
• heart, liver or kidney disease,
• treatment with diuretics, recent surgery,
• treatment with oral corticosteroids, anticoagulants, antidepressants such as serotonin reuptake inhibitors or antiplatelet agents,
• porphyria (hereditary disease),
• systemic lupus erythematosus.

DURING TREATMENT WITH A NON-STEROID ANTI-INFLAMMATORY ANTI-INFLAMMATORY, STOP THE TREATMENT AND IMMEDIATELY CONTACT A DOCTOR OR AN EMERGENCY MEDICAL SERVICE in the event of:

• signs suggestive of allergy to this medication, in particular asthma attack, hives, sudden swelling of the face, peeling of the skin and / or mucous membranes,
• gastrointestinal bleeding (discharge of blood from the mouth, blood in the stools, or stool staining black).

THIS MEDICINAL PRODUCT CONTAINS A NON-STEROID ANTI-INFLAMMATORY: ACECLOFENAC.

You should not take other medicines containing nonsteroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors) and / or aspirin at the same time as this medicine.

Carefully read the package leaflets for other medicines you are taking to make sure you are free from NSAIDs and / or aspirin.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• There are no data from the use of aceclofenac in pregnant women. But in general, prostaglandin synthesis inhibitors can affect pregnancy and / or embryofoetal development. Data from epidemiological studies show an increased risk of spontaneous abortion, heart malformation and gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of a heart defect increases from less than 1% to about 1.5%. This risk seems to increase with the dose and the duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has been shown to be associated with pre- and post-implantation loss and embryo-fetal lethality.
• In addition, an increased incidence of various malformations (eg cardiovascular) has been reported in animals receiving prostaglandin synthesis inhibitors during organogenesis. During the 1st and 2nd trimesters of pregnancy, NSAIDs should only be administered in cases of clearly identified need. In the event that NSAIDs are administered to a woman wishing to become pregnant or during the 1st and 2nd trimesters of pregnancy, the doses and duration of treatment should be as low as possible.

During the 3rd trimester of pregnancy, administration of prostaglandin synthesis inhibitors exposes the fetus to:

• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• Renal dysfunction which may progress to renal failure with oligo-hydroamnios.

Administration of prostaglandin synthesis inhibitors at the end of pregnancy exposes the mother and the unborn child to:

• A possible prolongation of the bleeding, an antiplatelet effect which can occur even at low doses;
• An inhibition of uterine contractions resulting in delay and prolongation of labor.
• Therefore, NSAIDs are contraindicated during the 3rd trimester of pregnancy (see section Contraindications).

Feeding with milk

• There are no data regarding the excretion of aceclofenac in human milk.
• However, no significant transfer of radiolabeled (14C) aceclofenac was observed in the milk of lactating female rats.
• Therefore, continued breast-feeding or treatment with CARTREX should be considered taking into account the expected benefit of breast-feeding for the child and the expected benefit of the treatment for the mother.

Fertility

• The use of CARTREX, like any medicine which inhibits the synthesis of cyclo-oxygenases / prostaglandins, may decrease fertility and is not recommended in women trying to have a child. Consideration should be given to stopping CARTREX in women who have difficulty becoming pregnant or attending infertility.

What happens if I overdose from CARTREX ?

• There are insufficient data available on the consequences of overdose in humans. Symptoms could be: nausea, vomiting, stomach pain, dizziness, drowsiness and headache.
• Treatment of NSAID overdose consists of, if necessary, the use of antacids and other symptomatic treatments for complications such as hypotension, renal failure, seizures, gastrointestinal irritation, and respiratory depression.
• Treatment of an overdose with aceclofenac consists of stopping absorption by gastric lavage and repeated administrations of activated charcoal.
• Forced diuresis, dialysis or hemoperfusion may fail to eliminate NSAIDs, due to their strong binding to plasma proteins and extensive metabolism.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

What is  Forms and Composition ?

SHAPES and PRESENTATIONS

• 100 mg film-coated tablet (round; 8 mm in diameter; white):   Box of 30, in blisters.

COMPOSITION

	p cp
Aceclofenac	100 mg

• Excipients:microcrystalline cellulose, croscarmellose sodium, povidone, glycerol palmitostearate. Film- coating : hypromellose, macrogol 40 stearate, titanium dioxide (E 171), microcrystalline cellulose (Sepifilm 752 white).

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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