Voltaren 100 mg 10 rectal suppositories

Voltaren 100 mg 10 rectal suppositories

Composition:

Each suppository contains 100 mg diclofenac sodium 

Description:

Analgesic, nonopioid; nonsteroidal anti-inflammatory drug (NSAID), used in the treatment of pain, ankylosing spondylitis, dysmenorrhea, gout, migraine, osteoarthritis and rheumatoid arthritis.

Indications:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,

other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopedic, dental and other minor surgery.

100mg suppositories are not indicated for use in children.

Dosage and Method of administration:

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools.

Adults:

75-150mg daily, in divided doses (25mg, 50mg and 100mg suppositories only).

The recommended maximum daily dose of Voltaren is 150mg. This may be administered using a combination of dosage forms, e.g. tablets and suppositories.

100mg suppositories may also be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with 25mg or 50mg tablets or suppositories up to the maximum dose of 150mg per day.

Elderly

It is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight and the patient should be monitored for GI bleeding during NSAID therapy.

Paediatric population

Children (aged 1-12 years) with juvenile chronic arthritis: 1-3mg/kg per day divided into 2 or 3 doses (12.5mg and 25mg suppositories only).

Children (aged 6-12 years) with acute post-operative pain: 1-2mg/kg per day in divided doses.

Treatment of acute post-operative pain should be limited to 4 days treatment.

Contraindications

• Hypersensitivity to the active substance or any of the excipients.

• Active, gastric or intestinal ulcer, bleeding or perforation

• History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy

• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

• Last trimester of pregnancy

• Hepatic failure

• Renal failure

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

• Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

• Proctitis

Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

Diclofenac is contraindicated in patients with renal failure.

Precautions:

Cardiovascular and significant cardiovascular risk factors

Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. 

Renal impairment

Caution is advised when administering diclofenac to patients with mild to moderate renal impairment.

Hepatic impairment

Diclofenac is contraindicated in patients with hepatic failure.

Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment.

-The concomitant use of Voltarol with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

-It is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

-Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.

-Gastrointestinal effects:

Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. 

-Close medical surveillance and caution should be exercised in patients with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated.

-Hepatic effects:

Close medical surveillance is required when prescribing Voltarol to patients with impairment of hepatic function as their condition may be exacerbated.

-Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

-Renal effects:

As fluid retention and oedema have been reported in association with NSAIDs therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery.

-Skin effects:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Voltarol. 

-Cardiovascular and cerebrovascular effects:

Patients with congestive heart failure (NYHA-I) or patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.

-Haematological effects:

During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood count is recommended.

-Pre-existing asthma:

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so called intolerance to analgesics / analgesics asthma), Quincke's oedema or urticaria are more frequent than in other patients.

Pregnancy:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. 

Lactation:

Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore, Diclofenac should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Side Effects:

Very rare:

Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.

Angioneurotic oedema (including face oedema).

Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.

Visual disturbance, vision blurred, diplopia.

Tinnitus, hearing impaired.

Hypertension, hypotension, vasculitis.

Pneumonitis.

Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatitis, jaundice, liver disorder.

Rare:

Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).

Somnolence, tiredness.

Asthma (including dyspnoea).

Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).

Hepatitis, jaundice, liver disorder.

Urticaria.

Application site irritation, oedema

Common:

Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.

Transaminases increased.

Rash.

Storage Method:

Do not store above 30° C.

Package:

A carton box contains 10 rectal suppositories and an insert leaflet.