The package leaflet

Every medicine, whether self-medication or requiring a doctor’s prescription, must by law contain the package leaflet.

Homeopathic medicines and herbal medicines classified as supplements are excluded from this rule.

The package insert contains the most significant information for the patient: before using a medicine it is therefore always good to read the leaflet and if you have doubts ask your doctor for an opinion.

To make the best use of homeopathic and herbal medicines, it is advisable to seek advice from your doctor or pharmacist.

Here is the information that we find inside the leaflet.

Name and composition

Next to the trade name of the medicine are also the names and quantity of the “ingredients”. That is, the active principle and excipients.

The active ingredient is the substance it treats, the one with pharmacological activity. The excipients are instead all those substances that allow to give the drug the appropriate form depending on the route through which it will be taken and to store it for a certain period of time without altering it.

Knowing the ingredients is important because two drugs even with different names can in fact be the same thing if they have the same doses of active ingredient and the same excipients.

Furthermore, since the effect of a drug depends on the dose of the active ingredient, to take it correctly you need to know how much active ingredient is contained in a tablet, sachet or scoop of syrup.

Knowing what is inside a medicine also helps in case of any allergies or intolerances, which can occur to one or more excipients or to certain active ingredients.

Pharmacological group and therapeutic indications

The pharmacological category indicates the group to which the drug belongs from the point of view of its action. For example, it can be an antibiotic or an analgesic.

The indications specify which pathology or symptoms it treats. For example, on which bacterial infections it works, if it is used for cystitis or pneumonia, or if it is better for headaches or back pain.

Pharmaceutical form, doses and timing of administration

In the package inserts is also indicated the formulation of the drug. And that is if it comes in tablets, ampoules, syrup, sachets of granules, ointment, suppositories or patch and so on.

A unit, i.e. a measuring cup, sachet, tablet or ampoule or suppository is generally considered as a single dose.

Often the same drug is available in several pharmaceutical formulations, for example tablets or suppositories and sometimes in the same leaflet there are indications on how to use each of the available formulas.

In this part of the package leaflet it is also written how much active substance is contained in each individual dose.

Next to the pharmaceutical form is indicated how much should be taken each day, the minimum and maximum dose, the interval between two administrations and the duration of treatment to achieve the desired effect.

Contraindications and interactions

This package insert entry indicates all cases in which the drug cannot be taken or should be used with special caution and medical advice.

Intolerances or allergies that can make taking the drug dangerous and diseases that must arouse attention are also mentioned.

Some pathologies also make it risky to take certain drugs at the same time. They are usually those that interfere with the intake, absorption and elimination of the drug and therefore are diseases affecting the stomach, blood, liver and kidneys.

Under interaction can be listed the other drugs that, if taken at the same time, may alter the absorption or effect of the drug in question.

Precautions for use and special warnings

In these two categories are indicated the methods for a correct intake of the drug, the special attention that certain categories of people must have or the precautions that must be paid in some situations.

In this item it is indicated for example whether to take a drug near or between meals, if it can be taken with water or other liquids. If it interferes with sleep and possibly driving, whether or not it can be given during pregnancy or breastfeeding. If it interferes with alcohol. How the elderly or children and infants should behave. What happens if you forget to take it. How to behave in the presence of unexpected effects.

Effects

In the chapter side effects are mentioned all those effects that the drug can have on the body that have nothing to do with the therapeutic action.

Generally side effects are not the consequence of excessive doses or poor intake, but are unwanted or unpleasant effects related to the normal intake of a medicine. For example, drowsiness, stomach pain, nausea, tremor.

There are some very common and some very rare, but all of them must be mentioned because each has manifested itself at least once in the history of that drug.

Some side effects are mild and allow you to continue therapy. Others manifest themselves only at the beginning of therapy and then disappear. Others are serious and require discontinuation of treatment.

Other side effects occur only when the drug is taken for long or very long periods and are an adverse consequence of taking a medicine for chronic therapy.

Expiration and storage

This package leaflet entry specifies where the expiry date is located in the outer packaging and in the inner cartons containing the doses.

It also indicates whether the drug should be used by a certain date after opening the package and whether the package should be stored with special precautions, for example in the refrigerator, the minimum and maximum temperature, if it alters with exposure to light or humidity.

Marketing Authorisation Holder A.I.C.

This entry in the leaflet indicates which is the company that has registered the drug in Italy and that is authorized to distribute and sell it.