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Why Read Them?The Package Insert is regarded as the document that ensures the safe and effective use of the medicine under most circumstances. The information in a Package Insert (PI) is written in technical language. It is usually fairly long and may seem difficult to understand. It is important to read through them though as they contain critical information about your medicine.
If you have any questions, please ask your doctor or pharmacist to assist you with reading and understanding the Package Insert (PI). The PI follows a standard format for every medication. The following sections are listed within the PI:- Proprietary Name
- Composition
- Pharmacological Action
- Indications
- Contraindications
- Warnings
- Interactions
- Dosage and Directions For Use
- Known Symptoms Of Overdosage and Particulars Of Its Treatment
- Presentation and Storage Instructions
This is what you can expect to find in each section:
CompositionThis section gives the chemical name of the medicine and the dosage form it comes in. It also lists all inactive ingredients such as fillers, artificial colours and/or flavourings. If you have food sensitivities, this is where you can check if there are any ingredients that may cause you problems.
Pharmacological ActionFor most people who are not medically trained, a lot of the information in this section is difficult to understand and you shouldn't worry if you don't understand every word!
Basically, this section tells you how the medicine works for the approved indication(s) and the potential adverse reactions that may occur! If you have a special problem such as kidney or liver disease, this is one of the sections your doctor will consult when deciding whether to prescribe the medicine for you, and if so, how much to prescribe.
Indications This section lists the uses (indications) for which the medicine has been approved. It should define the target population and/or duration of treatment (i.e. short or long term).
ContraindicationsThis section describes situations where the use of a medicine can be life-threatening, cause death or result in serious long-term illness.
WarningsThis section discusses specific safety issues, especially those that may lead to death or serious harm (adverse effects), that may occur in people who take this medicine. You should pay attention to these warnings so you will recognize any symptoms that could suggest a serious problem. Call your doctor or pharmacist right away if you ever have a question or concern about a warning or symptoms you experience whilst taking a medicine.
InteractionsThe Precautions section tells you how to use the medication most safely and effectively. One of the most important parts of this section lists 'Drug Interactions'—the effects that this medicine may have on other prescription or over-the-counter medicines you may be taking. This section also may also warn you against taking the medicine with a particular food or other product. It's a good idea to look through this section to see if it lists any medicines or other products that you use regularly. Be sure your doctor knows about all the medications you are taking, even if you only use them occasionally. The precautions section may also tell what is known about the use of this medicine by nursing or pregnant mothers, children, and older people although this is not always the case.
Dosage and Directions For UseThis section gives the recommended dosages of the medicine and the intake of the product in relation to food intake. Separate information may also be given about dosages for women above and below a certain weight, children, older people or those with specific medical problems.
Known Symptoms Of Overdosage and Particulars Of Its TreatmentThis section describes acute symptoms and signs and potential effects of an overdosage. It also describes recommended management of such an overdose. If you suspect an overdose contact your nearest doctor, pharmacist or poison control centre immediately.
Presentation and Storage instructionsThis section lists all the available forms of this medicine, including tablets or capsules of various doses and perhaps liquids and powder. It also details storage instructions. This is where you find out whether to keep the drug in the refrigerator or not. Usually there's a recommendation against leaving the medicine out in high temperatures. If you pick up your prescription from the pharmacy on a hot day, don't leave it in the car while you run other errands!
Remember!The PI is a good source of information in addition to instructions your doctor or nurse may give you. It's a good idea to review the package insert for any new medicine you take and to look at it again if anything about your health changes!
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