QUICK DETAILS:
CINAMICS 75 Content:
• Each ampoule contain 75mg of diclofenac sodium as the active ingredient.
• The other ingredients are sodium metabisulphite, propylene glycol, sodium hydroxide and water for injections.
CINAMICS 75 Character:
CINAMICS 75 is a clear, sterile solution which comes in a brown glass ampoule containing 3 ml of solution.
CINAMICS 75 Pack:
5 ampoules in a plastic tray, 2 trays in a box.
1. What CINAMICS 75 is and what it is used for
CINAMICS 75 contains the active substance Diclofenac sodium which belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).
CINAMICS 75 may be used when there is an increase in severity of rheumatoid arthritis or osteoarthritis. It may also be used for acute back pain, acute gout, pain after surgery or following injury, fracture pain, or colicky pain from the kidney area.
2. What you need to know before you take CINAMICS 75
CONTRAINDICATIONS:
You should not be given this medicine:
•if you are allergic to Diclofenac sodium or any of the other ingredients of the drug
•if you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in stools or black, tarry stools)
•if you have had any allergic reaction to ibuprofen, aspirin, or other NSAIDs (including difficulty in breathing, runny nose, swelling of the face or throat, or rash)
•if you have asthma
•if you have kidney or liver problems.
•if you are dehydrated or have recently lost a lot of blood
•if you have severe heart failure
•if you have a condition where you don’t stop bleeding normally (such as haemophilia)
•if you have had a stroke
•if you are taking other non steroidal anti-inflammatory drugs
•if you are taking anticoagulant drugs (medicines for preventing blood clots, such as
heparin and warfarin)
•if you are more than 6 months pregnant
•if you are taking medicines known as SSRIs used to treat depression.
•if you have been told by your doctor that you have an intolerance to some sugars
•if you have had stomach or bowel problems after you have taken other NSAIDs.
•if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
•if you have or have had problems with your blood circulation (peripheral arterial disease)
•if you are breast-feeding
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given CINAMICS 75:
•If you smoke
•If you have diabetes
•If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
•If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
•If you suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s disease, inflammation of the colon.
•If you have a history of any of the following: stomach or bowel ulcers, vomiting of blood or black, tarry faeces and Gastro-intestinal ulcers
•If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Diclofenac may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac.
•If you have heart, kidney or liver problems, or having medicines to increase urine volume such as diuretics, your doctor may monitor your kidney function.
•If you have kidney, liver or heart problems.
•If you are pregnant.
•If you have a history of high blood pressure and/or heart failure.
•If you suffer from or have previously suffered from asthma.
•If you suffer from systemic lupus erythematous or mixed connective tissue disorders.
•If you are an older patient.
•If you have had or are about to have major surgery.
•If you suffer from any blood or bleeding disorder.
Other medicines and CINAMICS 75
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought without a prescription.
•Digoxin (used to treat heart problems)
•Lithium (used to treat mental illness)
•Antibiotics called quinolones (such as ciprofloxacin)
•Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
•Methotrexate (used for some inflammatory diseases and cancers)
•Drugs that can increase your risk of bleeding, sometimes given if you have heart problems, such as dipyridamole or clopidogrel
•Diuretics (water tablets)
•Medicines to treat high blood pressure
•Mifepristone, used to terminate pregnancy (including if you have taken it within the last 12 days)
•Medicines to treat diabetes
•Oral steroids (an anti-inflammatory drug)
•Steroids
•Zidovudine (treatment of HIV infection)
•Phenytoin (medicines to treat epilepsy)
•Colestipol and cholestyramine (medicines to lower cholesterol level)
•CYP2C9 inhibitors: e.g. Sulfinpyrazone and voriconazole
•Other NSAIDs (for painful or inflammatory conditions) including COX2 inhibitors
•Medicines known as SSRIs used to treat depression, such as paroxetine or fluoxetine
•Medicines used to treat heart conditions or high blood pressure for example beta-blockers or ACE inhibitors.
Pregnancy
CINAMICS 75 should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.
Do not take CINAMICS 75 during the last 3 months of pregnancy as it may affect your Baby’s circulation and kidneys.
Breast-feeding
Do not take CINAMICS 75 during breast-feeding as Diclofenac passes into the breast milk in small amounts.
Fertility
Taking CINAMICS 75 may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Driving and using machinery
CINAMICS 75 may make you feel drowsy or dizzy, or cause problems with vision. If you are affected, do not drive or operate machinery.
CINAMICS 75 contains sodium metabisulphite which can cause severe allergic reactions, especially in patients with a history of asthma or other allergies.
1.How to take CINAMICS 75
CINAMICS 75 can be given by deep injection into the large muscle of the buttock.
The usual dose is one ampoule once daily. One ampoule twice daily may be required in severe cases, the second dose being injected into the buttock muscle on the other side.
The injection should not be given for more than 2 days. For colicky pain from the kidney area the dose is one ampoule injected into the buttock muscle and this dose may be repeated after 30 minutes if necessary.
The total dose in one day should not exceed 150mg (two ampoules). Your doctor may decide on smaller doses if you are:
This medicine is not recommended for children and adolescents. It must not be given to children under 14 years of age.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
2.Possible side effects
Like all medicines, CINAMICS 75 can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
•Chest pain or tightness with shortness of breath (may affect between 1 and 10 in every 1000 patients)
•Breathlessness, difficulty of breathing when lying down, swelling of the feet or legs (may affect between 1 and 10 in every 1000 patients)
•Vomiting of blood, bleeding from the bowel (may affect from less than 1 to 10 in every 10,000 patients)
•Sudden slurred speech, facial drooping, weakness, disorientation, or speech problems (may affect from less than 1 to 10 in every 10,000 patients)
•allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering, wheezing or shortness of breath (“bronchospasm”), swollen face, lips hands or fingers, hypotension (low blood pressure) and fainting (may affect from less than 1 to 10 in every 10,000 patients)
Refer to detailed leaflet for more details.
•an older person
•frail
•or you have a low body weight
If you are given too much CINAMICS 75
If you think you have been given too much CINAMICS 75, tell your doctor or nurse straight away. The following effects may happen: vomiting, bleeding in your stomach, diarrhoea, feeling dizzy, hearing problems or fits. In severe overdose kidney or liver problems can happen.
Some side effects could be serious. Stop having CINAMICS 75 and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Contents of the pack and other information
What CINAMICS 75 contains
•Each ampoule contain 75mg of diclofenac sodium as the active ingredient.
•The other ingredients are sodium metabisulphite, propylene glycol, sodium hydroxide and water for injections.
What CINAMICS 75 looks like and contents of the pack
CINAMICS 75 is a clear, sterile solution which comes in a brown glass ampoule containing 3 ml of solution.
5 ampoules in a plastic tray, 2 trays in a box.
How to store CINAMICS 75
CINAMICS 75 must not be used after the expiry date ‘EXP’ shown on the container. Keep out of the reach and sight of children.
Store below 30℃, protect from light.
QUICK DETAILS:
CINAMICS 75 Content:
• Each ampoule contain 75mg of diclofenac sodium as the active ingredient.
• The other ingredients are sodium metabisulphite, propylene glycol, sodium hydroxide and water for injections.
CINAMICS 75 Character:
CINAMICS 75 is a clear, sterile solution which comes in a brown glass ampoule containing 3 ml of solution.
CINAMICS 75 Pack:
5 ampoules in a plastic tray, 2 trays in a box.
1. What CINAMICS 75 is and what it is used for
CINAMICS 75 contains the active substance Diclofenac sodium which belongs to a group of medicines called non-steroid anti-inflammatory drugs (NSAIDs).
CINAMICS 75 may be used when there is an increase in severity of rheumatoid arthritis or osteoarthritis. It may also be used for acute back pain, acute gout, pain after surgery or following injury, fracture pain, or colicky pain from the kidney area.
2. What you need to know before you take CINAMICS 75
CONTRAINDICATIONS:
You should not be given this medicine:
•if you are allergic to Diclofenac sodium or any of the other ingredients of the drug
•if you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in stools or black, tarry stools)
•if you have had any allergic reaction to ibuprofen, aspirin, or other NSAIDs (including difficulty in breathing, runny nose, swelling of the face or throat, or rash)
•if you have asthma
•if you have kidney or liver problems.
•if you are dehydrated or have recently lost a lot of blood
•if you have severe heart failure
•if you have a condition where you don’t stop bleeding normally (such as haemophilia)
•if you have had a stroke
•if you are taking other non steroidal anti-inflammatory drugs
•if you are taking anticoagulant drugs (medicines for preventing blood clots, such as
heparin and warfarin)
•if you are more than 6 months pregnant
•if you are taking medicines known as SSRIs used to treat depression.
•if you have been told by your doctor that you have an intolerance to some sugars
•if you have had stomach or bowel problems after you have taken other NSAIDs.
•if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
•if you have or have had problems with your blood circulation (peripheral arterial disease)
•if you are breast-feeding
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given CINAMICS 75:
•If you smoke
•If you have diabetes
•If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
•If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
•If you suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s disease, inflammation of the colon.
•If you have a history of any of the following: stomach or bowel ulcers, vomiting of blood or black, tarry faeces and Gastro-intestinal ulcers
•If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
Because it is an anti-inflammatory medicine, Diclofenac may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Diclofenac.
•If you have heart, kidney or liver problems, or having medicines to increase urine volume such as diuretics, your doctor may monitor your kidney function.
•If you have kidney, liver or heart problems.
•If you are pregnant.
•If you have a history of high blood pressure and/or heart failure.
•If you suffer from or have previously suffered from asthma.
•If you suffer from systemic lupus erythematous or mixed connective tissue disorders.
•If you are an older patient.
•If you have had or are about to have major surgery.
•If you suffer from any blood or bleeding disorder.
Other medicines and CINAMICS 75
Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes any herbal products or medicines bought without a prescription.
•Digoxin (used to treat heart problems)
•Lithium (used to treat mental illness)
•Antibiotics called quinolones (such as ciprofloxacin)
•Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after transplants)
•Methotrexate (used for some inflammatory diseases and cancers)
•Drugs that can increase your risk of bleeding, sometimes given if you have heart problems, such as dipyridamole or clopidogrel
•Diuretics (water tablets)
•Medicines to treat high blood pressure
•Mifepristone, used to terminate pregnancy (including if you have taken it within the last 12 days)
•Medicines to treat diabetes
•Oral steroids (an anti-inflammatory drug)
•Steroids
•Zidovudine (treatment of HIV infection)
•Phenytoin (medicines to treat epilepsy)
•Colestipol and cholestyramine (medicines to lower cholesterol level)
•CYP2C9 inhibitors: e.g. Sulfinpyrazone and voriconazole
•Other NSAIDs (for painful or inflammatory conditions) including COX2 inhibitors
•Medicines known as SSRIs used to treat depression, such as paroxetine or fluoxetine
•Medicines used to treat heart conditions or high blood pressure for example beta-blockers or ACE inhibitors.
Pregnancy
CINAMICS 75 should only be used during pregnancy when your doctor decides the benefits to you are greater than any possible risk to the unborn baby.
Do not take CINAMICS 75 during the last 3 months of pregnancy as it may affect your Baby’s circulation and kidneys.
Breast-feeding
Do not take CINAMICS 75 during breast-feeding as Diclofenac passes into the breast milk in small amounts.
Fertility
Taking CINAMICS 75 may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Driving and using machinery
CINAMICS 75 may make you feel drowsy or dizzy, or cause problems with vision. If you are affected, do not drive or operate machinery.
CINAMICS 75 contains sodium metabisulphite which can cause severe allergic reactions, especially in patients with a history of asthma or other allergies.
1.How to take CINAMICS 75
CINAMICS 75 can be given by deep injection into the large muscle of the buttock.
The usual dose is one ampoule once daily. One ampoule twice daily may be required in severe cases, the second dose being injected into the buttock muscle on the other side.
The injection should not be given for more than 2 days. For colicky pain from the kidney area the dose is one ampoule injected into the buttock muscle and this dose may be repeated after 30 minutes if necessary.
The total dose in one day should not exceed 150mg (two ampoules). Your doctor may decide on smaller doses if you are:
This medicine is not recommended for children and adolescents. It must not be given to children under 14 years of age.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
2.Possible side effects
Like all medicines, CINAMICS 75 can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
•Chest pain or tightness with shortness of breath (may affect between 1 and 10 in every 1000 patients)
•Breathlessness, difficulty of breathing when lying down, swelling of the feet or legs (may affect between 1 and 10 in every 1000 patients)
•Vomiting of blood, bleeding from the bowel (may affect from less than 1 to 10 in every 10,000 patients)
•Sudden slurred speech, facial drooping, weakness, disorientation, or speech problems (may affect from less than 1 to 10 in every 10,000 patients)
•allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering, wheezing or shortness of breath (“bronchospasm”), swollen face, lips hands or fingers, hypotension (low blood pressure) and fainting (may affect from less than 1 to 10 in every 10,000 patients)
Refer to detailed leaflet for more details.
•an older person
•frail
•or you have a low body weight
If you are given too much CINAMICS 75
If you think you have been given too much CINAMICS 75, tell your doctor or nurse straight away. The following effects may happen: vomiting, bleeding in your stomach, diarrhoea, feeling dizzy, hearing problems or fits. In severe overdose kidney or liver problems can happen.
Some side effects could be serious. Stop having CINAMICS 75 and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Contents of the pack and other information
What CINAMICS 75 contains
•Each ampoule contain 75mg of diclofenac sodium as the active ingredient.
•The other ingredients are sodium metabisulphite, propylene glycol, sodium hydroxide and water for injections.
What CINAMICS 75 looks like and contents of the pack
CINAMICS 75 is a clear, sterile solution which comes in a brown glass ampoule containing 3 ml of solution.
5 ampoules in a plastic tray, 2 trays in a box.
How to store CINAMICS 75
CINAMICS 75 must not be used after the expiry date ‘EXP’ shown on the container. Keep out of the reach and sight of children.
Store below 30℃, protect from light.
