FORTOL FORTOL 50mg Ampharco Short -term treatment for menstrual pain (3 blisters x 10 tablets)

Sodol Fort has the main active ingredient, Diclofenac, an nonsteroidal anti -inflammatory drug (NSAID) with anti -inflammatory, painful, fever -reducing properties. Diclofenac strongly inhibits the activity of cyclooxygenase enzyme, thus reducing the formation of prostaglandin, prostacycline and thromboxan, which are intermediate substances of the inflammatory process.

Sodol Fort has a quick, suitable effect to treat inflammatory and acute pain.

Dynamic pharmacokinetics

absorption: Diclofenac is easily absorbed through the digestive tract after taken. Food does not affect the absorption of the drug. Peak concentration in plasma is achieved after 20-60 minutes after drinking.

Distribution: Diclofenac is widely connected to plasma proteins, mainly with albumin (99%). Diclofenac Potassium's apparent distribution volume is about 1.3 l/kg.

Metabolism: About 50% of oral doses are metabolized when the first liver and bioavailability in the blood circulation is approximately 50% of the bioavailability of intravenous dose.

Elimination: Semi -selling time in plasma is about 1-2 hours. About 60% of the dose is discharged through the kidneys in the form of metabolites and part of the activity and less than 1% in the form of intact drugs; The rest is discharged through bile and feces.

Be cautious when using

Unwanted effects can be maximized when the lowest dose is most effective in the shortest time needed to control symptoms.

Avoid using Diclofenac Pot

Old people:

Increasing the frequency of NSAID side effects in the elderly, especially bleeding and perforation of the stomach that can lead to death.

Must be monitored closely and especially cautious when prescribing Diclofenac for patients with symptoms of gastrointestinal disorders, with a history of suggesting ulcers, bleeding or gastric or intestinal perforation, ulcerative colitis, or Crohn's disease because these conditions may explode.

Patients with a history of stomach poisoning, especially in the elderly, should report any abdominal abdominal symptoms (especially stomach bleeding).

Bleeding, ulcers and peoples:

Bleeding or gastrointestinal ulcers may occur at any time during treatment, whether or not there is no symptoms or a history of severe gastrointestinal boundaries.

The risk of bleeding, ulcers and puncture is higher when increasing the dose of NSAID, when the patient has a history of ulcer, especially complications of bleeding or perforation and in the elderly. These patients should start therapeutic with the lowest dose possible. Coordinated therapy with protective substances (such as Misoprostol or Proton pump inhibitors) should be considered for these patients and for patients to simultaneously use low -dose aspirin or other drugs that can increase risks on the gastrointestinal tract.

It is necessary to advise patients to be cautious when sharing drugs that increase the risk of ulcers or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective inhibitors of Serotonin reabsorption or platelet anti -platelets such as aspirin.

Should stop treatment with Diclofenac potassium for patients when bleeding or gastrointestinal ulcers.

Hypersensitivity/reaction on the skin:

Like other NSAID drugs, allergic reactions, including anaphylactic/ anaphylactic reactions, may also appear without early contact with the drug. Serious reactions on the skin, one of them may be fatal, including flaking dermatitis, Steven-Johnson syndrome, and toxic skin necrosis have been reported with very rare frequency related to NSAID use, including potassium diclofenac. Patients at risk of these reactions are the highest in the early stages of therapy, large stools of the reactions that appear in the first month of therapy. Diclofenac should be stopped as soon as the skin rash appears, mucosal damage, or other signs of hypersensitivity.

Infection:

As well as other NSAID drugs, Diclofenac can hide signs of infections due to the pharmacological properties of the strain.

Systemic lupus and mixed connective tissue disease:

Patients with systemic lupus erythematosus and mixed connective tissue may be increased risk of sterile meningitis.

Cardiology, liver and kidney failure:

Using drugs can reduce the formation of prostagladin depending on the dose and promote kidney failure. Patients who are at high risk for this side effect are people with impaired renal function, heart failure, abnormalities of liver function, diuretics and elderly. Kidney function should be closely monitored in these patients.

liver:

If there are abnormal or worsening liver function tests, there are signs or clinical symptoms of progressive liver disease or other manifestations (acidic leukemia, rash), should stop using diclofenac.

Clinical monitoring should be closely monitored in patients with mild to medium liver failure. Hepatitis may occur without prior symptoms.

Using nsaids in patients with dyslyline metabolic disorders can cause disease outbreaks.

Hematology:

Diclofenac potassium can inhibit the reversible platelet aggregation. Patients with hemostasis, organs or hematurian abnormalities should be carefully monitored.

Long -term treatment:

All patients who use NSAID long -term treatment should be monitored for renal failure, liver failure (increased liver enzyme) and blood formula as a preventive measure. This is especially important in the family.

Respiratory:

Be cautious when used for patients with or have a history of bronchial asthma because NSAID has been reported to cause bronchospasm on these patients.

Cardiovascular and cerebrovascular effects - Heart thrombosis:

Suitable supervision and advice for patients with a history of hypertension and/ or mild to medium congestive heart failure due to water retention and edema that have been reported related to nsaid therapies.

Diclofenac should be used carefully in patients with congestion heart failure, with significant risk factors for cardiovascular events and a history of brain bleeding.

Non -steroid anti -inflammatory drugs (NSAIDs), non -aspirin, use systemic sugar, can increase the risk of occurrence of cardiovascular thrombosis, including myocardial 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 has no previous cardiovascular symptoms. Patients need to be warned of symptoms of serious cardiovascular events and need to visit the doctor daily when these symptoms appear.

To minimize the risk of adverse events, sodol® Fort is needed at the lowest daily daily doses 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).

Fertility in women:

excipients

The drug contains sorbitol. Patients with rare genetic diseases are not tolerated with fructose should not take this medication.

The drug contains methylparaben, propylparaben and Sunset Yellow can cause allergic reactions.

The effect of the drug on driving and operating machinery

dizziness; Fatigue, drowsiness, vision problems have been reported very little in some patients. Patients are recommended not to operate machinery or driving if there are symptoms.

Use drugs for women during pregnancy and lactation

Pregnant women

Only use diclofenac during pregnancy when really necessary. It is not recommended to take the drug in the last three months of pregnancy (the risk of inhibiting the contractions of the uterus and making the arteriosus early).

breastfeeding women

diclofenac is secreted in breast milk very little. There is no data on the effect of breastfeeding. Nursing mothers can use diclofenac if needed nonsteroidal anti -inflammatory drugs.

Interactive drug

Other painkillers include selective inhibitors Cycloxygenase-2 and corticosteroids: Concentrated use of diclofenac with NSAID or Corticosteroid drugs may increase the risk of ulcer or gastrointestinal bleeding. Avoid using two or more NSAID drugs.

Diuretics and antihypertensive drugs: Like other NSAID drugs, simultaneous use of diclofenac with diuretics and antihypertensive drugs (for example, beta inhibitors, angiotensin enzyme inhibitors) can reduce the effectiveness of blood pressure of these drugs through the inhibition of Prostaglandin synthesis that has vasodilator. Therefore, be careful when using simultaneously and should monitor blood pressure periodically in patients, especially in the elderly. Patients should be adequate water supplements and consider monitoring renal function periodically after the beginning of combined therapy, especially for diuretics and ACE inhibitors due to increased risk of kidney toxicity.

cardiac glycosides: NSAID can cause heart failure, reducing glomerular filtration and increased glycosides in plasma.

Liti: If used simultaneously, Diclofenac may increase the blood concentration of Li-ti. Should monitor the concentration of Li-ti.

Methotrexate: Diclofenac can inhibit the clearance of methotrexate in the renal tubules, so it increases methotrexate levels. Be careful when NSAID drugs, including diclofenac, are used less than 24 hours before treatment with methotrexate, because the blood concentration of methotrexate can increase and increase the toxicity of the drug. Severe poisoning cases have been reported when using methotrexat with nsAID drugs including diclofenac within 24 hours. This interaction is indirectly through the cumulative methotrexate due to reduced kidney excretion when present NSAID.

ciclosporin: diclofenac, just like other NSAID drugs, can increase the kidney toxicity of ciclosporin due to the impact on the kidney prostaglandin. Therefore, the dose should be lower than the dose level for patients not using ciclosporin.

Mifepriston: Do not use NSAID within 8 - 12 days after using Mifepriston NSAID that can reduce Mifepriston's effectiveness.

Anticoagulant and anti -plateletic drugs: Be careful when used simultaneously due to increased risk of bleeding. Although clinical surveys do not allow Diclofenac to affect the effectiveness of anticoagulant drugs, there is a report on the risk of increased bleeding in patients using Diclofenac simultaneously with anticoagulant drugs. Therefore, in order not to adjust the dose of anticoagulants, it is necessary to closely monitor these patients. Like other NSAID drugs, Diclofenac at high doses can reverse the inhibition of platelet convergence.

Digoxin: If used simultaneously, diclofenac can increase the concentration of Digoxin in the blood. So need to monitor the concentration of Digoxin in the blood.

Anti -plateletic anti -platelets and reconciliation inhibitors Serotonin (SSRIs): Increased risk of stomach -intestinal bleeding.

tacrolimus: can be toxicity on the kidneys when shared with NSAID with Tacrolimus. This interaction can be intermediate through the anti -prostagladin effect of both NSAID and Calcineurin inhibitors.

Quinolon antibiotics: Convulsions may occur due to the interaction between quinolon and NSAID drugs. This interaction can occur in patients with or without a history of epilepsy or previous seizures. Therefore, it is necessary to be careful when considering the use of a quinolon in patients using NSAID.

Phenytoin: When using Phenytoin with diclofenac simultaneously, it is advisable to monitor the level of phenytoin in the blood because it is expected to increase the contact of phenytoin.

Colestipol and Cholestyramin: These drugs can slow or reduce Diclofenac absorption. Therefore, diclofenac should be used at a few hours ago or 4-6 hours after using Colestipol/ Cholestyramin.

Zidovudin: The risk of increased hematology when sharing NSAID with zidovudin. There is evidence of an increase in the risk of hematoma in joints and other organs in Hemophilia HIV patients positive to be treated simultaneously with zidovudin and ibuprofen.

Diabetes medication: Clinical studies show that Diclofenac Potassium can be used with diabetes medications without affecting their clinical impact. However, there have been reports on the impact of increased or hypoglycemia, resulting in the adjustment of hypoglycemic dose. For this reason, the monitoring of blood glucose levels is recommended as a precaution in the combined treatment.

The drugs are known to cause hyperkalemia: Concomitant treatment with potassium -saving diuretic, ciclosporin, tacrolimus or trimethoprim may increase blood potassium levels, so regular monitoring of blood potassium.

CYP2C9 fragile inhibitors: Be careful when prescribing Diclofenac with strong CYP2C9 inhibitors (such as voriconazole) may significantly increase the peak concentration and contact of diclofenac due to metabolic inhibition of diclofenac.