CATAFLAM 50 Novartis treats pain after injury, inflammation and swelling caused by sprains (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Diclofenac potassium
Ingredient Novartis Saglik Gida Ve Tarim Urunleri San. Tic.A.S

Ingredient

Composition information	Content
Diclofenac potassium	50mg

Uses

Indications

Cataflam 50mg drug is indicated for short -term treatment of the following acute conditions:

Pain after injury, inflammation and swelling like sprains.

low disease is not in joints.

Support treatment in severe inflammation infections in the ear, nose or throat, such as tonsillary pharyngitis, ear infections. According to the general treatment principle, it is necessary to treat the main disease with appropriate basic therapy. Simple sauce is not a indication. The inhibition of prostaglandin biosynthesis has been proven in the experiment, which is considered the basis for its acting mechanism. Prostaglandin plays an important role in causing inflammation, pain and fever. The drug has a significant pain to relieve pain for medium and severe pain. When inflamed, for example after trauma or surgical intervention, the drug quickly relieves both spontaneous pain and pain when moving, reducing swelling, edema wounds caused by inflammation.

Clinical studies also found that the drug is likely to relieve pain and reduce the degree of bleeding in the abolition. Cataflam 50mg also shows the effectiveness of reducing headaches and improving symptoms of nausea and vomiting.

pharmacokinetic

absorption

Diclofenac is absorbed quickly and completely from Diclofenac Potassium tablets. The average peak concentration in plasma is 3.8 micromol/l achieved within 20 - 60 minutes after taking 1 tablet of 50 mg. Use the same food that does not affect the amount of Diclofenac is absorbed, although the absorption can be slightly slow and the absorption rate is slightly reduced.

Distribution

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

Metabolism

Diclofenac's biological change is partially due to the intact molecular glucuronide, but the weakness is weakened by hydroxylation and methoxylation once or at a time, leading to forming some phenolic metabolites (3'-hydroxy, 4 -liydroxy, 5-lydroxy, 4 ', 5-dihydroxy, 5-dihydrox, and 5-dihydrox, and 5-dihydrox, and 5-dihydrox, and 5-dihydrox, and 5-dihydrox, and 5 3'-Tiydroxy-4'-Methoxy-Diclofenac) Most of this substance is transformed into glucuronid combinations.

Elimination

The average half -life in plasma is 1-2 hours.

Before taking CATAFLAM 50 Novartis treats pain after injury, inflammation and swelling caused by sprains (1 blister x 10 tablets)

How to use

Should swallow the whole tablet with drinks, preferably before the main meals, do not break or chew.

Dosage

According to general recommendations, the dose should be adjusted to each patient.

Group of common patients: Adults

The daily starting dose is 100 - 150 mg. In lighter cases, the dose of 75 - 100 mg/day is usually sufficient. In general, the total daily dose should be divided into 2-3 separate doses, if possible.

In the dysmenorrhea, daily dose should be adjusted to each patient and usually 50 - 150 mg. The starting dose of 50 mg is usually sufficient. If necessary, the starting dose of 100mg can be prescribed with a maximum dose of 200 mg/day through a few menstrual cycles. It is advisable to start treating when the first symptom appears and depending on the millions of them, continue treatment for a few days.

In migraine (migraine), the starting dose of 50 mg should be started at the first signs of the upcoming pain. In the absence of pain relief within 2 hours after the first dose, an additional 1 dose of 50 mg may be used. If necessary, the doses of 50 mg can be used 4 to 6 hours apart, not exceeding the total dose of 200 mg/day.

Special patient group

Pediatric patients (under 18 years old)

It is not recommended to use Cataflam 50mg tablets for children and teenagers under 14 years old. To treat children and teenagers under 14 years of age, diclofenac can be used in 12.5 mg and 25 mg. For teenagers aged 14 and older, dose of 75 - 100 mg/day is usually sufficient. Do not exceed the maximum dose of 150 mg/day. In general, the total daily dose should be divided into 2-3 separate doses, if possible.

Elderly patients (from 65 years of age)

Despite the dynamics of Cataflam 50mg, which is not impaired to the level of clinical related to elderly patients, so it is especially cautious when using nonsteroidal anti -inflammatory drugs. This group of patients.

SECRETING HEART

SECRETING HEALTH DRIVN (according to the attitude of the heart failure according to the New York - NYHA heart failure) or important cardiovascular risk factors for patients with congestive heart failure (the tbor of the function of the heart failure according to the New York Heart Association - NYHA), uncontrolled hypertension or there are important cardiovascular risk factors should only be treated with CataFlam 50mg after a thorough consideration and only on the dose of

kidney failure

Cataflam 50mg contraindicated in patients with severe renal impairment (GFR

Hepatic failure

Cataflam 50mg contraindicated in patients with severe liver failure (see the contraindications). There is no separate research conducted in patients with mild to medium impaired impairment, so there is no recommendation to adjust the dose on this patient. Be careful when using Cataflam 50mg 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? In the case of severe poisoning, acute renal failure and liver damage.

Diclofenac acute poisoning management, mainly includes supportive measures and treatment. Symptomatic support and treatment should be taken for complications such as hypotension, kidney failure, convulsions, digestive disorders and respiratory failure.

It is possible to consider using activated carbon after overdose that is likely to cause poisoning, and stomach disinfection (such as causing vomiting, gastric lavage) after overdose is potentially life -threatening.

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 Cataflam 50mg you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurological disorders: headache, dizziness.

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

Rare, 1/10000

Gastrointestinal disorders: gastritis, gastric hemorrhage, bowel, vomiting blood, hemorrhagic diarrhea, black stool, stomach ulcer (with or without hemorrhage, stenosis of the digestive tract, or perforation, can cause peritonitis). (including hypotension and shock).

Very rare ADR

Blood disorders and lymphatic systems: thrombocytopenia, leukopenia, anemia, granulocytosis. bacteria, taste disorders, stroke. Blood, colitis due to ischemia and increased severity of colic ulcer or Crohn disease), constipation, stomatitis, tongue inflammation, esophagus disorders, intestinal stenosis, pancreatitis.

Skin and subcutaneous tissue disorders: Water dermatitis, eczema, rash, polymorphic erythema, Stevens-Johnson syndrome, poisoned epidermal necrosis (lyell syndrome), scaled dermatitis, hair hair loss, light sensitivity, hemorrhage, hemorrhage Henoch-schonlein, itching. Blood, proteinuria, nephrotic syndrome, nephritis - interstitial renal tubular, kidney necrosis.

Heart disorders: Kounis syndrome.

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

Cataflam 50mg contraindications in the following cases:

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

severe renal failure (GFR

Patients whose use of acetylsalicylic acid or other NSAIDs can cause asthma attacks, angiography, urticaria or inflammation. The nose (cross reactions caused by NSAID).

History of gastrointestinal bleeding or gastrointestinal perforation related to NSAID treatment.

Precautions when using

Warning and caution general

It is not recommended for patients with rare problems in non-intolerance of genetic, absorbent Glucose-Galactose or Sucrose-Isomaltase.

Effects on the gastrointestinal tract

Bleeding, ulcers or gastric perforation can be recognized to all NSAIDs, including diclofenac and may occur at any time during treatment, some or without millions of warnings or history of serious stomach - intestinal incidents. In general, these cases have more serious consequences in the elderly. Cataflam 50mg should be stopped if hemorrhage or stomach - intestines occur in patients being treated with this drug.

Like all other NSAIDs, including Diclofenac, is required to closely monitor medical and need to be careful when prescribing Cataflam 50mg for patients with symptoms of digestive disorders or a history of suggestive ulcer, bleeding or gastric or intestinal 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 complication of hemorrhage or perforation and in the elderly.

To reduce the risk of toxicity to the stomach - intestines patients with a history of ulcer, especially if there is complication of hemorrhage or perforation, and in the elderly, it is advisable to start and maintain treatment with the lowest doses that are effective and effective.

Consider the combination of protective drugs (such as proton or misplostol pump inhibitors) for these patients, and for patients who are in need of simultaneous use of acetylsalicylic acid (Asa) low doses or other drugs that can increase the risk of the stomach - bowel.

Patients with a history of stomach toxicity, especially in the elderly, should report any abdominal abdominal symptoms (especially stomach bleeding). Caution should be careful in patients who are using simultaneously drugs that may increase the risk of ulcer or bleeding such as corticosteroids using systemic sugar, anticoagulic drugs, platelet anti -coagules or selective reconciliation inhibitors.

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

Heart thrombosis

Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, using systemic sugar can increase the risk of cardiovascular thrombosis, including myocardial infarction and stroke, which can lead to death. This risk can appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses.

Doctors need to periodically evaluate the appearance of cardiovascular events, even if the patient does not have previous cardiovascular symptoms. Patients need to be warned of symptoms of serious cardiovascular events and need to see a doctor as soon as they appear.

To minimize the risk of adverse events, the lowest effective daily daily daily dose is needed in the shortest possible time.

Careful consideration when using diclofenac for patients with risk factors for cardiovascular events (such as hypertension, increased serum lipid, diabetes, tobacco addiction). Patients with congestive heart failure (according to the function of the heart failure according to the New York - NYHA heart failure), uncontrolled hypertension or important cardiovascular risk factors such as hypertension, hyperlipidemia, diabetes, smoking) should only be treated with diclofenac after careful consideration and only at the dose should periodically reassess the need for patient symptoms and response to treatment, especially when treated continuously for more than 4 weeks. The effect of hematology using Cataflam 50mg is only recommended for short -term treatment. However, if Cataflam 50mg is used for a long time, it is advisable to monitor the amount of blood asleep as with other NSAIDs. Like other NSAIDs, Diclofenac can temporarily inhibit platelet settlement. Patients with hemostatic defects should be carefully monitored.

The effect on 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, the reactions with nsaids such as asthma attacks (called non -tolerant with pain relievers/asthma due to pain relievers) are more common in other patients. Be cautious with such patients (prepared for emergency media).

Effects on bile liver system

Strict medical monitoring requirements when prescribing cataflam 50mg 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 Cataflam 50mg, regular monitoring of liver function is indicated as a preventive measure. If the liver function test is abnormally or worse, if there are clinical signs or symptoms associated with liver disease developing or if other manifestations appear (such as eosin leukemia, rash) should stop using cataflam 50mg. Hepatitis can occur when using the heterotrophic with no warning symptoms.

Be cautious when using Cataflam 50mg for diseases. The dyslylin metabolism 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 Cataflam 50mg. Patients with the highest risk of these reactions early in the treatment process, in most cases the reaction trigger occurs within the first month of treatment. Must stop the cataflam 50mg 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

There have been reports related to the treatment of nsaids including diclofenac that causes fluid and edema, especially paying special attention when used for 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 exclusive cells due to larger or after surgery. Monitoring of kidney function is an early preventive measure when using Cataflam 50mg in such cases. Stop treatment often recovers the state before treatment.

Elderly patients

It is necessary to be cautious for the elderly based on the basic medical condition of the patient, especially the old patients or the mild weight.

Interaction with other NSAIDs

Should avoid simultaneous use of Cataflam 50mg with NSAIDs using systemic sugar including the selective inhibitors of Cycloxygenase-2 because there is no evidence that proves the benefits of force and due to the possibility of adding adverse reactions (see increased risk of kidney toxicity.

Covering signs of infection

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

Reproduction

Like other NSAIDs, the use of Cataflam 50mg 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 using Cataflam 50mg.

The ability to drive and operate machinery

Patients with visual disorders, dizziness, dizziness, chicken sleep or other nervous system disorders when using Cataflam 50mg should not drive or operate machinery.

Pregnancy

Data from epidemiological studies shows that there is a risk of increasing miscarriage and/or heart defects and umbilical hernia after using prostaglandin synthetic inhibitors in the early stages of pregnancy. The absolute risk of heart defects increases from less than 1% to about 1.5%.

The risk is thought to increase by dose and treatment time. In animals, the use of synthetic inhibitors prostaglandin leads to an increase in failure before and after the nesting process of the embryo and death in the embryo.

In addition, the incidence of many different defects increased, including on the heart, which was reported on animals that were used for prostaglandin synthetic inhibitors during the formation of organs. If using Cataflam 50mg for women who are trying to conceive or in the first 3 months of pregnancy, should be used at the lowest doses and the shortest therapy time as 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).

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

Extend the bleeding time, the anti -platelet aggregation may occur even in very low doses.

Therefore, contraindicated Cataflam 50mg in the last 3 months of pregnancy.

Breastfeeding period

diclofenac excreted in breast milk in small amounts. Therefore, do not use Cataflam 50mg during breastfeeding to avoid unwanted effects in children.

Drug interaction

The following interactions include the cases that have been observed with the Cataflam 50mg and/or other forms of Diclofenac.

Observed interaction

CYP2C9 inhibitors: Be careful when using Diclofenac simultaneously with CYP2C9 inhibitors (such as Voriconazole), this can be worth the peak concentration in plasma and Diclofenac exposure.

Lithium: If used simultaneously, diclofenac may increase lithium concentration in plasma, need to monitor serum lithium level.

Digoxin: If used simultaneously, diclofenac may increase the concentration of digoxin in plasma, need to monitor the concentration of Digoxin in the serum.

Diuretics and hypertension drugs: Like other NSAIDs, simultaneously use Diclofenac with diuretics or hypertension drugs (such as beta blockers, Angiotensin - ACE -ACE inhibitors) can reduce their treatment for hypertension. Therefore, it is necessary to be cautious when used in combination and patients, especially the elderly, should be monitored with blood pressure periodically. Patients should be fully water supply and should be considered and monitored the kidney function after starting treatment and then periodically monitoring, especially for diuretics and ACE inhibitors due to increased risk of kidney toxicity.

Ciclosporin and Tacrolimus: Like other NSAIDs, Diclofenac may increase the toxicity of the kidneys of ciclosporin and tacrolimus due to the effect on prostaglandin in the kidney. Therefore, lower doses must be used lower than common doses in patients not using ciclosporin or tacrolimus.

The drugs can cause hyperkalemia: Concomitance with diuretics holding potassium, ciclosporin, tacrolimus or trimethoprim may be related to the increase in the level of potassium in serum, so regular monitoring of serum potassium.

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

Interactions can occur

Non -steroid anti -inflammatory drugs (other NSAID and corticosteroids): simultaneous use of diclofenac and other NSAIDs systemic or corticosteroids may increase the frequency of unwanted effects in the stomach - intestines.

Anticoagulants and anti -platelets: should be cautious because simultaneous use may increase the risk of bleeding. Although sieve research does not show that Diclofenac affects the effects of anticoagulants, there are reports on increased risk of bleeding in patients who are using Diclofenac simultaneously and anticoagulants. So monitor these patients.

Selective Serotonin recording inhibitors (SSRI): simultaneously use the system of systemic tract, including diclofenac, and SSRI may increase the risk of stomach -intestinal bleeding.

Diabetes treatment: Clinical studies have shown that DiClofenac can be used with oral diabetes drugs without affecting their clinical effectiveness. However, there have been separate reports on both hypoglycemic effects and hyperglycemia, it is imperative to change the dose of diabetes during Diclofenac treatment. For this reason, it is necessary to monitor blood sugar levels as a preventive measure while simultaneously. There are individual reports on acidic infections when using simultaneously diclofenac with metformin, on patients with kidney failure before.

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

Methotrexate: Be careful when using NSAID, including diclofenac, less than 24 hours before or after methotrexate, methotrexate concentration in the machine may increase and toxicity of this substance.

cardiac glycosides: simultaneous use of cardiac glycosides and in patients can worsen heart failure, reduce GFR and increase plasma heart glycosides.

tacrolimus: Using NSAID along with Tacrolimus increases the risk of kidney toxicity. This occurs through the effects of renal prostaglandin resistance of both NSAID and purin inhibitors.

Colestipol and Cholestyramine: The factors can slow or reduce the absorption of Diclofenac, encourage the use of Diclofenac at one or 4 - 6 hours after taking Colestipol and Cholestyramine.

CYP2C9 touch substance: Caution recommends prescribing Diclofenac is similar to CYP2C9 (such as Rifampicin), which can reduce the meaning of plasma concentrations and Diclofenac exposure.

Storage

Do not store drugs above 30 ° C.

avoid moisture.

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