Pharmacologic Category Nonsteroidal Anti-inflammatory Drug (NSAID)

What key warnings should I know about before taking this medicine?

  • This drug may increase the risk of heart attack, stroke, This has been observed with long-term use. Use caution if you have risk factors for heart disease .
  • This medicine may increase the risk of ulcer or bleeding from the stomach or intestines. Talk with healthcare provider.
  • Please read the medication guide given to you.

Reasons not to take this medicine

  • If you have an allergy to diclofenac or any other part of this medicine.
  • Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.
  • If you have porphyria.
  • If you are more than 24 weeks pregnant.

What is this medicine used for?

  • This medicine is used to relieve pain and inflammation in various condition such as rheumatoid arthritis , osteoarthritis ,ankylosing  spondylitis  lumbago , sprains and strains .
  • This medicine is used to relieve painful menstrual cycles.
  • This medicine is used to treat gout attacks.
  • This medicine is used to treat renal colic , biliary colic , severe migraine attacks .
  • This medicine is used to treat pain after surgery..

How does it work?

  • Diclofenac blocks production and release of chemicals that cause pain and inflammation.

How is it best taken?

Your doctor will decide when and how to treat you with Safenac Ampoules. You will either

be given an intravenous infusion (a drip into a vein) or an intramuscular injection (an injection

into a muscle). The intramuscular injection is usually injection into the buttocks.

The usual dose is:

 

Adults

One or two ampoules (75 to 150 mg) each day for one or two days.

The usual dose of intravenous infusion is : 75 mg should be infused continuously over a period of 30 minutes to 2 hours , the dose should not exceed 150 mg within any period of 24 hours .

 

Elderly

Your doctor may give you a dose that is lower than the usual adult dose if you are elderly.

 

Children

Not suitable for children.

A doctor, nurse or pharmacist will prepare the injection for you.

The doctor may also prescribe another drug to protect the stomach to be taken at the same

time, particularly if you have had stomach problems before, or if you are elderly, or taking

certain other drugs as well.

What are the precautions when taking this medicine?

  • Check medicines with healthcare provider. This medicine may not mix well with other medicines.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine.
  • Tell healthcare provider if you are breast-feeding.

Are you taking other medicines?

 

Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:

• Medicines to treat diabetes

• Anticoagulants

• Diuretics

• Lithium

• Methotrexate

• Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or ibuprofen

• Cardiac glycosides (for example digoxin)

• Oral steroids

Always tell your doctor or pharmacist about all the medicines you are taking. This means

medicines you have bought yourself as well as medicines on prescription from your doctor.

 

What are some possible side effects of this medicine?

Safenac Ampoules are suitable for most people, but, like all medicines, they can sometimes cause side effects. Some side effects can be serious

Tell the doctor straight away if you notice:

• Stomach pain, indigestion, heartburn, , nausea or vomiting • Any sign of bleeding in the stomach or intestine.

• Allergic reactions which can include skin rash, itching, painful red areas, peeling,   wheezing.

• Swollen, face, lips, hands or fingers

• Yellowing of your skin or the whites of your eyes

• An unexpected change in the amount of urine produced and/or its appearance.

·         Kidney or liver disorders, presence of blood or protein in the urine.

·         Serious skin rashes

·         Hair loss.

 

Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.

Reasons to call healthcare provider immediately

  • If you suspect an overdose, call your local poison control center or emergency department immediately.
  • Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.
  • Severe nausea or vomiting.
  • Swelling of feet or hands.
  • Black, tarry, or bloody stools.
  • Blood in the urine.
  • Severe skin irritation.
  • Sudden change in vision, eye pain or irritation.
  • Any rash.
  • No improvement in condition or feeling worse.

How should I store this medicine?

  • Store below 30°C. Protect from light and heat.
  • Keep out of the reach and sight of children.
  • Do not use Safenacl Ampoules after the expiry date which is printed on the outside of the

             pack.

 

General statements

  • If you have a life-threatening allergy, wear allergy identification at all times.
  • Do not share your medicine with others and do not take anyone else's medicine.
  • Keep all medicine out of the reach of children and pets.
  • Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).
  • Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.