Example SmPC - layout and explanations
Name of Product
Last updated DD/MM/YYYY view changes| Name of manufacturer contact details
Section 1. Name of the Medicinal Product
Here the brand or trade name followed by strength and pharmaceutical form of the product can be found.
Section 2. Qualitative and Quantitative Composition
Active ingredient and the quantity they are found in the product along with other ingredients and compositions are described here.
Section 3. Pharmaceutical Form
The physical form of the medication such as ointments, capsules or injections is stated. A description of the visual appearance of the product (colour, markings, etc) and dimensions for solid oral formulation, e.g. ‘Tablet white, circular 5mm, marked ‘100’ on one side’ along with information on score lines and dividing of tablets is also included see Paroxetine 10mg tablets as an example.
Section 4. Clinical Particulars
Section 4.1 Therapeutic indications
The range of therapeutic indications (including the age range the medicine is indicated for) is included in this section. There is also detail on if the treatment is for symptomatic, curative or preventive purposes. Any restrictions that may apply to certain patient populations, such as patients with renal failure are also described.
Section 4.2 Posology and method of administration
Posology or the dosage is specified clearly including any variations such as indication, age, comorbidities or method of administration.
Information about a maximum recommended single, daily or total dose, and the normal duration of use with any restrictions on duration is included. If a medicine is to be discontinued advice on discontinuation is provided and any need for tapering off or switching therapy is given such as for Agomelatine 25 mg film-coated tablets.
For the route of administration any precautions in handling (e.g. cytotoxics) and relevant information for correct administration is given. Alternative method(s) to facilitate administration (e.g. possibility of crushing, cutting, tablet, or transdermal patch, opening capsules, mixing with food, dissolution in drinks) particularly for administration via feeding tubes is mentioned where relevant.
Information on the rate or speed of injection or infusion for parenteral formulations and in some cases the maximal concentration that can be safely administered e.g ‘no more than X mg of Y/ml of solution1’ is also given.
Section 4.3 Contraindications
This section includes circumstances under which the administration of the medicinal product should be avoided. Hypersensitivity to the active substance, excipients or residues and contraindications arising from the presence of certain excipients are also included.
Section 4.4 Special warnings and precautions for use
Information on any precautions of the medicine, particularly for patients with certain co-morbidities, is given here as well as any special warnings the product may have. Specific risk minimisation measures such as ‘Liver function should be monitored before initiation of treatment and monthly thereafter1’ are also included. Need for specific clinical or laboratory monitoring explaining why, when and how the monitoring is conducted in clinical practice is provided. An example of this is Methotrexate 10 mg tablets.
Information on patient groups at increased risk of experiencing adverse reactions (serious or common), e.g. elderly, renal impaired patients or situations in which serious adverse reactions may occur is provided. There is also information on risks associated with starting the medicinal product (e.g. first dose effects) or stopping it (e.g. withdrawal effects) and actions suggested for prevention.
Excipients with any known adverse effects may also be given.
Section 4.5 Interactions with other medicinal products and other forms of interaction
Any interactions or contraindications of concomitant use with other medicines, herbal or dietary supplements, and any food or drinks is stated. The type of interaction and where known the mechanism of the interaction is described, which can be useful in understanding the effect the interaction may have. The effect of the interaction including any manifestations on laboratory parameters is described including how to monitor and manage these interactions. The need for a washout period when using medicines consecutively and patient groups where the impact of an interaction is more severe e.g. paediatric or elderly patients, is provided in this section.
Section 4.6 Pregnancy and lactation
In this section recommendations for women of childbearing potential, such as the need for contraceptive measures, may be given, an example of this is Finasteride 5 mg Film-coated Tablets. Information on relevant adverse events reported in the embryo, foetus, neonates and pregnant women, with the frequency of such events (e.g. frequency of birth defects) is included. The use of the medicinal product during the different periods of gestation, along with management of exposure during pregnancy is also included.
Clinical studies and data available on breastfeeding, with information on the presence of the medicine in breast milk and any clinical effects this may have on the infant, is given, for example Codeine phosphate 15mg Tablets. Recommendations to stop or continue breastfeeding or the treatment can also be found here.
Section 4.7 Effects on ability to drive and use machines
Impact of a patient’s ability to perform functions such as driving and operating machinery and any legislation that may relate to that medication and additional counselling points are given here.
Section 4.8 Undesirable effects
This section includes side-effects in a table or structured listing including the impact they may have to the patient with their respective occurrence and severity. See Quetiapine 200mg Film-Coated Tablets as an example. Information may include the duration, any management of side effects and measures to be taken to avoid specific adverse reactions. Any side effects that may be associated with a certain population such as paediatric patients is also mentioned.
As healthcare professionals responsibility on reporting side effects, can be done via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Section 4.9 Overdose
This section includes effects of an overdose, (including symptoms and risk factors), and the management of an overdose in relation to monitoring or use of specific agonists/antagonists, antidotes or methods to increase elimination of the medicinal product.
Section 5. Pharmacological Properties
Section 5.1 Pharmacodynamic properties
Pharmacodynamic properties, which is the effect the medication has on the body, is described in this section along with the mechanism of action (if known), pharmacodynamic effects and clinical efficacy and safety. See Gabapentin 100mg capsules as an example.
Section 5.2 Pharmacokinetic properties
Here, basic pharmacokinetic principles such as bioavailability, clearance and half- life and details of medicine absorption, distribution, metabolism and excretion, can be found. Variations with respect to factors such as age, weight, gender, smoking status and comorbidities such as renal failure, hepatic disease are also included.
Section 5.3 Preclinical safety data
Any testing or clinical studies carried out on the medicine with the data produced is given, including any adverse reactions that may have been observed in clinical studies. Where appropriate additional information on genotoxicity, carcinogenic potential and toxicity is also given.
Section 6. Pharmaceutical Properties
Section 6.1 List of excipients
Additional ingredients are listed individually and can be useful for patients with certain intolerances or lifestyle choices. E numbers are listed with the common name of the excipient. For transdermal patches, all ingredients (the adhesive, release liner and backing film) are listed, such as for BuTrans 15 microgram/hour transdermal patch.
Section 6.2 Incompatibilities
This includes information on physical and chemical incompatibilities with other medicinal products that this medicinal product is likely to be mixed or co-administered with, particularly for medicinal products that are to be reconstituted or diluted before parenteral administration.
Section 6.3 Shelf life
Information on the shelf life of the medicine as packaged, after dilution, reconstitution or after first opening is given, such as for Cefaclor 125mg/5ml suspension. Temporary storage requirements such as ‘shelf-life 24 months at 2-8°C of which 3 months could be below 25°C’ and if shelf life varies with different containers, can be found here.
Section 6.4 Special precautions for storage
Storage requirements including whether the product is sensitive to light, moisture or any particular temperatures is included, such as ‘store in the original container in order to protect from moisture.’
Section 6.5 Nature and contents of container
This section has information on the packaging and material of the container (‘glass vials’, ‘PVC/Aluminium blisters1’), along with additional components such as desiccants. Information on containers with child resistant caps is also given where relevant.
Section 6.6 Special precautions for disposal and other handling
The disposal including if any product needs to be disposed of in accordance with local requirements can be found in this section.
Special precautions for the handling and disposal of certain medicines (e.g cytotoxics and teratogenics) are stated.
Section 7. Marketing Authorisation Holder
The details of the pharmaceutical company who holds the licence to sell the medicine is found here. The Marketing Authorisation Holder may have a different pharmaceutical company to sell the medicine.
Section 8. Marketing Authorisation Number(s)
This is the number a regulatory authority gives when they approve a medicine. The information found in sections 7 and 8 are useful when contacting manufacturers or distributors.
Section 9. Date of First Authorisation/Renewal of the Authorisation
In this section the date regulatory authorities first approved the medicine is noted. A renewal authorisation date is if the Marketing Authorisation was suspended and then granted another approval.
Section 10. Date of Revision of the Text
Any changes made to the SmPCs have to be approved by the regulatory authority for approval, an example is when there is a new medicine on the market, any post marketing surveillance may reveal some new information about that medicine which is then added to the product information. This section is blank if it is the first Marketing Authorisation.
Section 11. Dosimetry
This section applies to radiopharmaceutical products. Information on how much radiation the patient might be exposed to is stated.
Section 12. Instructions for Preparation of Radiopharmaceuticals
This section applies to radiopharmaceutical products. Instructions for extemporaneous preparation and quality control of such preparation, and disposal of containers and unused contents is included.
Legal Category
This section has the legal classification of the medication i.e. General Sale List (GSL), Pharmacy Only (P), Prescription Only Medicine (POM).
Reference: European Commission. A guideline on summary of product characteristics (SmPC)
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