Flectorgo 25 mg - pain relief medicament 10 capsules

Product Description

A drug for the short-term treatment of pain.

Indications

Flectorgo is Indicated for the short-term symptomatic treatment of mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain, and muscle pain).

Composition

Active ingredients

Each soft capsule contains diclofenac in the form of 30.76 mg of diclofenac epolamine equivalent to 25 mg of diclofenac potassium.

Excipients

Capsule contents:Macrogol 600, Anhydrous glycerol, Purified water. Capsule: Gelatin, Anhydrous glycerol, Sorbitol, liquid, partially dehydrated (E420), Purified water, Hydroxypropylbetadex, Sodium hydroxide

Directions for use and Dosage

Unless otherwise prescribed, adults and adolescents over 14 years of age should start with 1 soft capsule and then continue with 1 soft capsule every 4-6 hours, as needed. In any case, no more than 3 soft capsules (equivalent to 75 mg of diclofenac potassium) should be taken in a 24-hour period.
The medicine should be taken for a short period of time. The duration of treatment should be 3 days. If symptoms persist or worsen, consult a doctor.

Paediatric population. The use of the medicine is not recommended in children and adolescents under 14 years of age.

Elderly. No special dosage adjustment is necessary. Given the potential adverse effects, elderly patients should be monitored with particular care. Renal impairment. Diclofenac is contraindicated in patients with severe renal impairment. No dose reduction is necessary in patients with mild to moderate renal impairment. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment. Hepatic impairment. Diclofenac is contraindicated in patients with severe hepatic impairment. No dose reduction is necessary in patients with mild to moderate hepatic function. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment. Method of administration. The soft capsules should be swallowed whole with a drink of water. The rate of absorption of diclofenac is reduced when the drug is taken with food. It is therefore recommended not to take the soft capsules during or immediately after meals.

Contraindications and side effects

The most commonly observed adverse events involve the gastrointestinal tract.
Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly. Adverse reactions are listed in order of frequency, the most frequent first, using the following convention: very common: (>=1/10); common (>=1/100, <1/10); uncommon (>=1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data. be defined on the basis of the available data.
List of adverse reactions. Blood and lymphatic system disorders.
Very rare: thrombocytopenia, leukopenia, pancytopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders.
Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock), angioneurotic oedema (including facial oedema).
Psychiatric disorders.
Very rare: disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
Nervous system disorders.
Common: headache, dizziness; rare: somnolence; very rare: paraesthesia, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accident.
Eye disorders.
Very rare: visual disturbances, blurred vision, diplopia.
Ear and labyrinth disorders.
Common: dizziness; Very rare: tinnitus, hearing impairment.
Cardiac disorders.
Very rare: palpitations, chest pain, cardiac failure, myocardial infarction.
Vascular disorders.
Very rare: hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders.
Rare: asthma (including dyspnoea); very rare: pneumonia.
Gastrointestinal disorders.
Common: nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia; rare: gastritis, gastrointestinal haemorrhage, haemathemesis, haemorrhagic diarrhoea, melaena, gastrointestinal ulcer (with or without bleeding or perforation); very rare: colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal stenosis, pancreatitis; not known: ischemic colitis.
Hepatobiliary disorders.
Uncommon: increased transaminases; rare: hepatitis, jaundice; very rare: hepatic failure.
Skin and subcutaneous tissue disorders:
Common: rash, pruritus; rare: urticaria; Very rare: Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, allergic purpura.
Renal and urinary disorders:
Very rare: Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions:
Rare: Oedema.
Clinical trial and epidemiological data consistently point to an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, particularly at high doses (150 mg/day) and with long-term treatment.
/>Report any suspected adverse reactions via the national reporting system.

Pregnancy and breastfeeding

Inhibition of prostaglandin synthesis may cause adverse effects on pregnancy and/or embryonic/fetal development.
Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.

The absolute risk of cardiovascular malformation increased from less than 1% to a maximum of approximately 1.5%.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, it is An increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis.
During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary.
If diclofenac is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose: the fetus to cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension) and to renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; The mother and the newborn, at the end of pregnancy, may experience a possible prolongation of bleeding time and an anti-aggregating effect that may occur even at very low doses, as well as inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, the drug is contraindicated during the third trimester of pregnancy. Like other NSAIDs, diclofenac passes into breast milk in small amounts.
Therefore, diclofenac should not be administered during breastfeeding to avoid adverse effects in the newborn.
As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive.
In women who have difficulty conceiving, diclofenac should be administered during breastfeeding. To conceive or who are undergoing diagnostic tests for infertility, discontinuation of diclofenac should be considered.

Storage

Store below 25 degrees C. Store in the original package to protect from light and moisture.

Format

10 soft capsules