Package Inserts

Patient Information

These five tips will help you to put the information in the package insert into perspective

Package inserts can be a scary read. So scary that some people would rather live with their disease than risk any of those horrid side effects. These golden rules may help you to put the information into perspective.

The drug is here to fight a disease or to prevent an impending health issue.

Your doctor prescribed you the drug to treat a disease or prevent a condition from getting worse. These positive effects were observed in hundreds or thousands of patients.

After checking all the data, the health authorities decided that the drug’s benefits outweigh its risks in this patient population.

Side effects cannot be ruled out entirely. But it is far more likely that the drug will help you get better than expose you to the risk of serious side effects.

Use the drug exactly as it is described in the package insert, or as your doctor or pharmacist told you to.

The dosage regimen – i.e. how much of the drug you should use, how often, and before, during or after a meal – has been determined in the course of clinical studies with hundreds or thousands of patients. The optimal dose balances the positive effects with potential side effects.

Changing the dosage on your own accord can not only diminish the benefits, but also increase the risk of unwanted side effects.

Read the sections on “Instructions for Use, Contraindications, Warnings and Precautions and Drug Interactions” carefully.

In these sections, the insert tells you in which cases you should not use this particular drug, e.g. if you are allergic to any of the ingredients, suffer from kidney or liver problems, use certain other medications, or if you are pregnant.

If any of the criteria listed in the package insert apply to you, you have an increased risk of experiencing negative drug effects.

In this case, you should consult your doctor or pharmacist first.

Take the expiry date and storage information on the package seriously.

If milk gets sour, you will smell it and won’t drink it anymore. When a drug gets too old or has not been stored properly, it will very likely look unchanged. But it may have lost its efficacy or not be well tolerated anymore.

When you get a new drug, check the storage information on the package insert. And before you use a drug, make sure that it has not expired yet.

You should not use drugs after they have expired or if you are unsure if they have been stored properly. When in doubt, show the drug to your pharmacist for advice.

Be aware of the side effects listed in the package insert.

The package insert lists the side effects and also states how often each effect occurred. “Frequent” means 1 in 10 to 1 in 100 patients; “very rare” side effects affect fewer than 1 in 10,000 patients.

While under medication, be alert to the side effects listed in the package insert as well as to any other unusual reactions.

If you notice that your health and wellbeing seem to be affected while using a medicine, contact your doctor or pharmacist immediately for advice.