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About SPC information

When a product is granted an authorisation by the regulatory authorities (e.g. Irish Medicines Board (IMB)) allowing it to be sold or supplied in Ireland, that authorisation contains a document known as the summary of product characteristics (known as SPC or SmPC), the wording of which has been agreed with the regulatory authority as part of the regulatory approval process. The SPC is designed to assist doctors and pharmacists in prescribing and supplying the product and describes wha's in the product, what it's used for, the dose, side effects, when not to use it etc.

The information in the SPC is set out under a number of headings as follows:

1. Name of the Medicinal Product

The brand name of the product, usually registered as a trademark by the manufacturer. There may be more than one brand available of the same drug. Different brands of the same drug may be introduced after the original company's patent protection expires

2. Qualitative and Quantitative Composition

The generic or chemical names of the active ingredients and the amount of each active ingredient e.g. amount per tablet, amount per ml of solution, etc.

3. Pharmaceutical form

The physical form in which the medicine is presented, e.g. tablets, suppositories, ointment etc.

4. Clinical particulars

How the medicine should be used or taken

4.1 Therapeutic indications

The diseases or conditions that the medicine is licensed to treat.

4.2 Posology and method of administration

Information on the dose and how and when the medicine should be used or taken. Where appropriate, details are included on changing dose with age or other diseases and the maximum dose that can be given.

4.3 Contraindications

Any situations where a medicine should either definitely or generally not be used.

4.4 Special warnings and precautions for use

Any situations where a medicine should be used carefully, for example, in patients with kidney or liver disease or in elderly people.

4.5 Interactions with other medicinal products and other forms of interaction

Details of any medicines that are known to or may react when taken together, as well as potential interactions with food or alcohol if relevant.

4.6 Pregnancy and lactation

Information on the risks of using the medicine during pregnancy or breast-feeding.

4.7 Effects on ability to drive and use machines

Whether or not the medicine is likely to alter the user's performance, particularly if it will affect the ability to drive or operate machines.

4.8 Undesirable effects

The side effects you might have with the medicine. It describes how likely the side effect is to occur, how severe it may be, and how long it might last for.

4.9 Overdose

What may happen if you take or use too much of the medicine and what your doctor should do in this situation.

5. Pharmacological properties

HHow the medicine affects the body.

5.1 Pharmacodynamic properties

How the medicine achieves, or is believed to achieve its therapeutic effect in the body.

5.2 Pharmacokinetic properties

Information on how the medicine is absorbed and distributed in the body and then removed.

5.3 Preclinical safety data

Any effects of the medicine that have been found from laboratory or animal studies, before it was used in humans, which could be relevant.

6. Pharmaceutical properties

Information on the medicine's ingredients, storage and packaging.

6.1 List of excipients

The non-biologically active ingredients of the medicine, such as binding agents, preservatives, flavourings, etc.

6.2 Incompatibilities

In addition to the information in Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interactions, this section gives information on any other medicines that shouldn't be mixed.

6.3 Shelf life

The maximum length of time for which the medicine may be stored under the specified conditions. It should not be used after this date.

6.4 Special precautions for storage

How the medicine should be stored.

6.5 Nature and contents of container

Information on the medicine's packaging, including anything else you may find in the pack, such as desiccants.

6.6 Special precautions for disposal and other handling

Information on the correct disposal or other handling of the product.

7. Marketing authorisation holder

The name of the company originally authorised to market the medicine. By commercial arrangement, the medicine may subsequently be marketed and distributed by another company.

8. Marketing authorisation number(s)

The number of the marketing authorisation for the medicine granted by the licensing authority, e.g. Irish Medicines Board. Marketing authorisations may also be granted by the European Union.

9. Date of first authorisation/renewal of the authorisation

The date when the marketing authorisation was first granted or last renewed (marketing authorisations must be renewed every five years).

10. Date of revision of the text

The last date on which a change to the wording of the SPC was made, e.g. a new side effect or a new pack size added. These changes must be approved by the regulatory authority that granted the marketing authorisation. There may not have been any changes to the text since the marketing authorisation was granted or renewed, in which case this section will be blank.

11. Dosimetry

For radiopharmaceuticals, full details of internal radiation dosimetry.

This section is only applicable for radiopharmaceutical products and may not appear in the SPC if radiopharmaceuticals are not involved.

12. Instructions for preparation of radiopharmaceuticals

For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality control of such preparation and, where appropriate, maximum storage time during which any intermediate preparation such as an eluate or the ready-to-use pharmaceutical will conform with its specifications.

This section is only applicable for radiopharmaceutical products and may not appear in the SPC if radiopharmaceuticals are not involved.