Diclofenac
Overview
Diclofenac
Rectal suppositories, 50 mg and 100 mg
COMPOSITION
Each suppository contains the active substance diclofenac sodium 50 mg or 100 mg.
Excipient with known effect: cetyl alcohol.
WHAT IT IS USED FOR
A non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic action. It is used for the symptomatic treatment of pain and inflammation in: rheumatic conditions (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout), musculoskeletal disorders (tendinitis, bursitis, periarthritis), low back pain, sprains, contusions, dislocations, fractures, and after minor surgical, dental or orthopaedic procedures.
HOW IT WORKS
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) that inhibits the synthesis of prostaglandins — substances involved in inflammation, pain and fever. It reduces pain, inflammation, swelling and fever. After rectal administration, absorption is rapid and the effect develops within 30–60 minutes.
HOW TO USE
Administer rectally, deep, if possible after a bowel movement. Adults: Diclofenac 50 mg — 1 suppository 2–3 times a day; Diclofenac 100 mg — 1 suppository once a day. Children over 14 years of age (Diclofenac 50 mg only) — 1 suppository 1–2 times a day. Maximum daily dose: 150 mg. Use the lowest effective dose for the shortest possible time. The duration of treatment is determined by your doctor.
WHEN IT SHOULD NOT BE USED
hypersensitivity to diclofenac sodium or to any of the excipients;
active gastric or duodenal ulcer, gastrointestinal bleeding or perforation;
history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
proctitis (inflammation of the rectal mucosa);
heart failure (NYHA II–IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease;
severe hepatic or renal impairment;
history of asthma attacks, urticaria, angioedema or acute rhinitis to ibuprofen, acetylsalicylic acid or other NSAIDs;
third trimester of pregnancy;
breast-feeding;
children under 14 years of age (Diclofenac 50 mg); children and adolescents under 18 years of age (Diclofenac 100 mg).
Important to know
Use with caution in elderly patients and those with a history of gastrointestinal ulcer, mild or moderate heart failure, hypertension, impaired renal or hepatic function, bronchial asthma, porphyria, SLE or coagulation disorders. Seek immediate medical attention if you experience severe abdominal pain, black stools, vomiting of blood, chest pain, shortness of breath, severe skin rash or signs of an allergic reaction.
Diclofenac may increase the risk of cardiovascular events (myocardial infarction, stroke), particularly at high doses and with long-term use. Do not use concomitantly with other NSAIDs. Use with caution during the first 6 months of pregnancy (consult your doctor). Dizziness, drowsiness, vertigo or visual disturbances may occur during treatment — do not drive or operate machinery in these cases. Avoid alcohol.
Read the package leaflet carefully before use.
Possible side effects
Local (rectal): irritation, burning, tenesmus, blood-streaked stools or worsening of haemorrhoids.
Common or with unknown frequency: abdominal pain, nausea, vomiting, diarrhoea, dyspepsia, flatulence, loss of appetite, headache, dizziness, vertigo, skin rashes. Rare or very rare: gastric/duodenal ulcer, gastrointestinal bleeding or perforation, hepatitis, jaundice, hepatic failure, acute renal failure, blood disorders (thrombocytopenia, leukopenia, anaemia), hypertension, myocardial infarction, stroke, severe allergic reactions (including anaphylactic shock, angioedema), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C in the original packaging. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
PACK SIZE
5 or 6 suppositories per PVC/PE blister; 1 blister of 6 suppositories or 2 blisters of 5 suppositories together with the package leaflet in a carton box.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.