GENERIC NAME: diclofenac

BRAND NAMES: Voltaren, Cataflam, Voltaren-XR

DRUG CLASS AND MECHANISM: Diclofenac belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs) that are used for the treatment of
mild to moderate pain, fever, and inflammation. Other members of this class include ibuprofen (Motrin), indomethacin (Indocin), nabumetone (Relafen), naproxen (Aleve)
and several others. NSAIDs work by reducing the production of prostaglandins, chemicals that cause pain, fever and inflammation. NSAIDs block the enzyme that makes
prostaglandins (cyclooxygenase), resulting in lower production of prostaglandins. As a consequence, inflammation, pain and fever are reduced. Since the response to
different NSAIDs varies from patient to patient, it is not unusual for a doctor to try different NSAIDs for any given condition. The FDA approved diclofenac in July 1998.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets (delayed release): 25, 50, and 75 mg. Tablets (immediate release): 50 mg. Tablets (extended release): 100mg

STORAGE: Diclofenac should not be stored above 30°C (86°F) and should be protected from moisture.

PRESCRIBED FOR: Diclofenac is used primarily for the treatment of inflammation and pain caused by conditions such as rheumatoid arthritis, osteoarthritis, and
ankylosing spondylitis. It is also effective in treating soft tissue inflammations due to tendinitis and bursitis, and treating dysmenorrhea (menstrual cramps).

DOSING: Diclofenac should be taken with food to reduce stomach upset. The recommended dose for most conditions is 100-200 mg daily. Dosing intervals depend on
the diclofenac formulation used and the condition being treated.

DRUG INTERACTIONS: Diclofenac, like other NSAIDs is associated with several suspected or probable interactions that affect the action of other drugs. Some
examples are discussed below.

Diclofenac may increase the blood levels of lithium (Eskalith) by reducing the excretion of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.

Diclofenac may reduce the blood pressure lowering effects of blood pressure medications. This may occur because prostaglandins play a role in the regulation of blood
pressure.

When diclofenac is used in combination with aminoglycoside antibiotics [for example, gentamicin (Garamycin)] the blood levels of the aminoglycoside may increase,
presumably because the elimination of aminoglycosides from the body is reduced. This may lead to more aminoglycoside-related side effects.

Individuals taking oral blood thinners or anticoagulants [for example, warfarin (Coumadin)] should avoid diclofenac because diclofenac also thins the blood, and excessive
blood thinning may lead to bleeding.

Combining NSAIDs with methotrexate (Rheumatrex, Trexall) may reduce the elimination of methotrexate from the body and result in increased side effects from
methotrexate.

PREGNANCY: Like other NSAIDs, diclofenac is generally avoided during pregnancy because it may affect the cardiovascular system of the fetus.

ECONAC
Drug Class Description :

Non-steroidal anti-inflammatory drugs (NSAIDs).

Generic Name :

Diclofenac sodium

Drug description :

Suppositories. Solution for injection.

Presentation :

Suppositories, diclofenac sodium 100mg. Injection, diclofenac 75mg/3mL.

Indications :
Econac Suppositories: Relief of all grades of pain and inflammation in a wide range of conditions, including: arthritic conditions such as rheumatoid arthritis, osteo-
arthritis, ankylosing spondylitis, acute gout; acute musculoskeletal disorders such as peri-arthritis (eg, frozen shoulder), tendinitis, tenosynovitis, bursitis; other painful
conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Econac Injection: Acute forms of pain, including renal colic; exacerbations of osteo- and rheumatoid arthritis; acute back rheumatoid arthritis; acute back pain; acute gout;
acute trauma and fractures; postoperative pain.

Adult Dosage :

Econac Suppositories: One 100mg suppository may be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with tablets up to a
total maximum dose of 150mg diclofenac per day.

Econac Injection: one ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are
required, use the alternate buttock for the second injection. Econac injection should not be given for more than two days; if necessary, treatment can be continued with
tablets or suppositories.

Renal colic: one ampoule intramuscularly, repeated after 30 minutes if necessary.

Child Dosage :

Not suitable.

Elderly Dosage :

Use lowest effective dose.

Contra Indications :

Active or suspected peptic ulcer or gastrointestinal bleeding. Previous sensitivity to diclofenac. Patients in whom attacks of asthma, urticaria or acute rhinitis are
precipitated by aspirin or other non-steroidal anti-inflammatory drugs. Suppositories: In ulcerative or acute inflammatory conditions of the anus, rectum (proctitis) and
sigmoid colon. Injection: Hypersensitivity to the excipients mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite, sodium hydroxide.

Special Precautions :

Asthma, chronic obstructive diseases of the respiratory tract, allergic rhinitis or swelling of the nasal mucosa. Symptoms or history suggestive of gastrointestinal
ulceration. Ulcerative colitis, Crohn's disease, bleeding diathesis or haematological abnormalities. Elderly. Hepatic, renal or Hypersensitivity reactions may occur.
Pregnancy and lactation.

Interactions :

Lithium, digoxin, anticoagulants, oral hypoglycaemics, cyclosporin, methotrexate, quinolone antibiotics. Other NSAIDs, steroids, potassium-sparing diuretics.

Adverse Reactions :

Gastrointestinal effects including nausea, vomiting, diarrhoea and minor GI blood loss. Occasionally, dyspepsia, flatulence, intestinal cramps, anorexia, peptic or intestinal
ulcer. Isolated cases of aphthous stomatitis, glossitis, oesophageal lesions, lower abdominal pain, constipation. CNS effects including headache, excititation, irritability,
insomnia, tiredness, confusion and giddiness.

Occasionally, hypersensitivity reactions (rarely, Stevens-Johnson syndrome). Acute renal insufficiency (haematuria, proteinuria) or renal damage (interstitial nephritis,
nephrotic syndrome or necrosis of renal papillae). Elevation of liver enzymes. Pancreatitis. Haematological effects including thrombocytopenia, agranulocytosis,
haemolytic and aplastic anaemia. Peripheral oedema. Suppositories: local reactions including itching, burning and increased bowel movements. Injection: rarely, injection
site disorders, eg, local pain and induration; in isolated cases, abscesses and local necrosis.

What Buscopan is used for

Buscopan is known as an anticholinergic medicine. It relieves the pain of stomach and bowel cramps by helping your digestive system to relax. It is also used to help relax
gallbladder (biliary) spasms and kidney (renal) spasms, and as a diagnostic aid in radiology.

Buscopan reduces the peristalsis (wave-like contractions) of smooth muscle resulting in relief from spasms in certain organs in the digestive system.

Your doctor may have prescribed Buscopan for another reason.

Ask your doctor if you have any questions about why Buscopan has been prescribed for you.
Return to top 2. Before being treated with Buscopan

2a When Buscopan should not be used

You will only receive treatment with Buscopan ampoules if it has been prescribed for you by a doctor.

You should not be treated with Buscopan if you are allergic to it or to any of the ingredients. These ingredients are listed in full at the end of this leaflet (See 7b
ingredients).

If you are uncertain as to whether you have such an allergy you should raise this concern with your doctor.

Buscopan should not be used if you have myasthenia gravis, glaucoma, porphyria or a condition of the bowel known as megacolon.

Seek advice from your doctor if you have, or have had, a prostate or heart condition.

This is because Buscopan should not be used in some types of prostate disease and a certain type of heart complaint.

Buscopan should not be used when there is a blockage in the stomach or bowel, or in certain conditions when there is reduced bowel activity.

These conditions are best explained by your doctor.

Buscopan ampoules should not be used after the EXPIRY DATE on the carton or ampoule.

2b Before you receive Buscopan

It is essential that your doctor knows your medical history before prescribing Buscopan.

Before you receive Buscopan you must tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription.

In particular you must tell your doctor if you are taking:

• metoclopramide, quinidine or amantadine

• any medicine which contains antihistamines (commonly used to treat allergies)
• any medicine for the treatment of emotional disorders, heart disease or respiratory disease
• any other medicine for the treatment of this or another stomach or bowel condition

It is important to discuss this with your doctor because Buscopan may not work as well in the presence of some other medicines or side effects may be increased.

2c Pregnancy

Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication.

Special care is recommended during pregnancy, particularly in the first three months.

2d Breastfeeding

Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication.

Special care is recommended if you are breastfeeding as no studies have been conducted in nursing women.

2e Children

Buscopan should only be given to children under the advice of your doctor.

Return to top 3. Treatment with Buscopan

3a Recommended Dose

The recommended dose is one or two ampoules (20 - 40 milligrams). It can be given as an injection or as a slow injection into the vein.
The maximum dose per day is 100 milligrams (equivalent to five ampoules).

Your doctor might prescribe a different dose or duration of treatment to that described here. If you want more information, ask your doctor.

Buscopan should only be used under the supervision of a doctor and in a setting where appropriate equipment is readily available for diagnosis and patient monitoring.

3b Overdose

Overdose is unlikely because Buscopan ampoules are used under medical supervision.

If you do receive too much Buscopan, signs may include drowsiness, dry mouth, difficulty passing urine, reddening of the skin, decreased gastrointestinal tract movement,
fast heart rate and sight disturbances.
Tell your doctor or medical staff immediately if you experience any signs of overdose.

Return to top 4. Side effects

You should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has
weighed the risks of using Buscopan against the benefits they expect it will have for you.

Ask for the advice of your doctor or other medical staff if you have any concerns about the effects of taking this medicine.

Buscopan ampoules may cause:

• temporary blurred vision (due to reduced eye focussing).

• dry mouth and fast heart rate
• reduced sweating and difficulty with passing urine.

If these occur, they usually disappear when you are no longer being given Buscopan.

erious, but very rare, side effects include:

• a drop in blood pressure

• flushing
• shortness of breath
• allergic reactions (such as skin rashes, or swelling of the face and difficulty in breathing), and other sudden life-threatening allergic reactions (anaphylaxis with
episodes of shortness of breath and shock).

There have also been isolated reports of coma, hallucinations (seeing, feeling or hearing things that are not there), dystonia (unusual muscle tone causing distortion of the
body), confusion, agitation and dizziness. These side effects were relieved when the patients stopped Buscopan ampoules and received appropriate treatment from the
medical staff.

Tell your doctor as soon as possible if you experience any side effects during or after treatment with Buscopan, so that these may be properly treated.

In addition, unexpected effects, not listed above, can occur with any medicine.

You should tell your doctor or other medical staff if you notice anything unusual, during or after treatment with Buscopan.