Diclofenac sodium Injection

Diclofenac sodium should be used with caution in: the elderly (over 65), asthma or allergic disease, reduced heart, kidney or liver function, history of gastrointestinal disease such as ulcerative colitis or Crohn’s disease, blood clotting problems, acute porphyria, uncontrolled high blood pressure, heart problems, systemic lupus erythematosus (SLE - a condition of the immune system that causes joint pain, skin changes and other organ problems), previous stroke, patients at risk of heart attacks or strokes including those with diabetes, high blood pressure, high cholesterol or smokers; women who are pregnant or breast feeding, women who are planning to become pregnant or who are having difficulty becoming pregnant, patients treated with other non-steroidal anti-inflammatory drugs (NSAIDs), eye infection (applies to eye drops), patients using other eye drops (applies to eye drops).

It should not be used in: patients who are allergic to diclofenac sodium or to any other ingredients contained in the medicine, those who have or have ever had a peptic ulcer (ulcer in the stomach or duodenum), tear (perforation) or bleeding in the stomach, patients with severe liver, kidney or heart disease, patients who experience asthma, hives, allergic rash, itchy runny nose (rhinitis) when taking ibuprofen, aspirin or other similar NSAIDs, patients with acute porphyria (a disorder of the blood cells), the last trimester (last 3 months) of pregnancy, severe heart failure.

• Feeling sick (nausea)
• Ulcers of the stomach or bleeding
• Worsening of existing bowel conditions (ulcerative colitis, Crohn‚s disease)
• Blood disorders (including anaemia and being prone to minor infections and bleeding)
• Skin problems (including hives, itching, rash, irritation)
• Small increased risk of heart attack or stroke with long-term use
• Headache
• Dizziness
• Drowsiness
• Spinning sensation
• Gastritis (inflammation of the stomach)
• Loss of weight
• Poor appetite
• Abnormal liver function tests
• Inflammation of the liver cells (hepatitis)
• Itching
• Fluid retention (swollen ankles is one of the symptoms)
• Tingling of the hands or feet
• Ringing in the ears
• Diarrhoea
• Unusual sensitivity of the skin to the sun
• Tiredness
• Mood swings and confusion
• Pancreatitis (inflammation of the pancreas, a gland located behind the stomach that plays a role in digestion)

If any of these persist or you consider them severe then inform your doctor or pharmacist

Stop taking diclofenac sodium and tell your doctor immediately if you develop any of the following symptoms:

• Indigestion or heartburn
• Unexplained pains in your stomach (abdomen) or other unusual stomach problems such as indigestion, feeling sick and or being sick
• Allergic reactions including unexplained wheezing or shortness of breath, runny nose, watery eyes, swelling of the face or tongue, dizziness, light-headedness and unconsciousness (skin problems may also develop which can be severe with peeling and blistering of the skin and sensitivity to light)
• Liver problems, that may be associated with yellowing of the skin and whites of the eyes and/or pale stools (motions) and dark urine (water)
• Kidney problems which may be associated with passing less or more water (urine) than normal, cloudy urine, blood in the urine, pain in the back and/or swelling, particularly of the legs
• Nervous system problems (severe headache, neck stiffness, disorientation, and light hurting the eyes [photophobia])
• Persistent and severe skin rash, itching or irritation at the site of application of diclofenac sodium gel
• Pass blood in your stools/motions (faeces)
• Pass black tarry stools
• Vomit any blood or black particles that look like coffee grounds.
• Severe sore throat with a high temperature
• Any type of fit or seizure
• Blurred or disturbed sight (vision), or seeing/hearing strange things

If diclofenac sodium gel comes into contact with broken skin or gets into your eyes, nose or mouth it can cause irritation. If this happens wash the affected area with plenty of water. If symptoms persist then contact your doctor or pharmacist.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Before taking diclofenac sodium, tell your doctor or pharmacist if you are allergic to it or to other non-steroidal anti-inflammatory drugs (NSAIDs); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: stomach ulcer, tear (perforation) or bleeding, severe liver, kidney or heart disease, experience asthma, allergic rash, itchy runny nose when taking ibuprofen, aspirin or similar medicines, acute porphyria (a disorder of the blood cells), are in the last 3 months of pregnancy.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: asthma or allergic disease, heart, kidney, liver or bowel problems, blood clotting problems, high blood pressure, systemic lupus erythematosus (SLE - a condition of the immune system that causes joint pain, skin changes and other organ problems), previous stroke, pregnancy, breast feeding, you are planning or having difficulty becoming pregnant, you are at significant risk of heart problems because of diabetes, high blood pressure (hypertension), high cholesterol, hyperlipidaemia or smoking. You are being treated with other NSAIDs, have an eye infection (applies to eye drops), you are using other eye drops (applies to eye drops).

Diclofenac sodium may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

• There is no information to suggest that diclofenac sodium is affected by alcohol.

The elderly: diclofenac sodium should be used with caution in the elderly as it may be associated with an increased risk of problems associated with side effects (particularly bleeding of the stomach and intestine).

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

Diclofenac sodium is not recommended to be used in the first 6 months of pregnancy unless the potential benefit to the patient outweighs the potential risk to the unborn baby.

Diclofenac sodium is not safe in the third trimester of pregnancy and should not be used in the last three months of pregnancy as it may cause damage to the unborn baby and reduce labour.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Diclofenac sodium appears in breast milk in very low amounts and should if possible be avoided when breast feeding.

Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.