Voltarol 140 Mg Medicated Plaster

Document: spc-doc_PL 44673-0158 change

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Voltarol 140 mg Medicated Plaster

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each medicated plaster contains 140 mg diclofenac sodium.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Medicated Plaster

Voltarol 140 mg Medicated Plaster is a white 10x14 cm sized self-adhesive plaster made of non-woven fabric on one and paper on other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Short term treatment (max. 7 days)

Local symptomatic and short term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries in adolescents from 16 years of age and adults.

4.2 Posology and method of administration Posology

Adults and adolescents from 16 years of age

One medicated plaster should be applied to the painful area twice daily, in the morning and in the evening. The maximum daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Therefore, only one painful area can be treated at a time.

Duration of use

Voltarol 140 mg Medicated Plaster is for short-term treatment.

The duration of use should not exceed 7 days. The therapeutic benefit of longer use has not been established.

If there is no improvement, during the recommended duration of treatment or a worsening of symptoms, a doctor should be consulted.

Voltarol 140 mg Medicated Plaster is to be used for the shortest duration necessary to control symptoms depending on the indication.

Elderly patients and patients with renal or hepatic impairment

This medication should be used with caution in elderly patients who are more

prone to adverse events (see also section 4.4).

In treatment of elderly and patients with renal or hepatic impairment see section 4.4.

Paediatric _ population

Voltarol 140 mg Medicated Plaster is not recommended for use in children and adolescents under 16 years of age because of insufficient data on safety and efficacy (see also section 4.3).

In adolescents aged 16 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen, the patient/parents of the adolescent is/are advised to consult a doctor.

Method of administration

Cutaneous use only.

The product should be applied only to intact non-diseased skin and should not be worn when bathing or showering.

The medicated plaster should not be divided.

If necessary, the medicated plaster can be held in place using a net bandage. The medicated plaster must not be used together with an occlusive dressing.

4.3 Contraindications

- Hypersensitivity to the active substance or to any of the excipients

listed in section 6.1;

- In patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs [NSAIDs];

- In patients who have previously experienced an asthma attack, urticaria or acute rhinitis when taking acetylsalicylic acid or any other nonsteroidal anti- inflammatory drugs (NSAIDs);

- In patients with active peptic ulcer;

- On damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound;

- During the last trimester of pregnancy.

Children and adolescents:

The use in children and adolescents aged less than 16 years is contraindicated.

4.4 Special warnings and precautions for use

A physician should be consulted if symptoms persist for longer than 7 days or worsen.

The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes. It should be applied only to intact non-diseased skin, and not to skin wounds or open injuries.

Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Undesirable effects can be reduced by using the lowest effective dose for the shortest possible period of time (see section 4.2).

Treatment must be stopped immediately if a skin rash develops after applying the medicated plaster.

Patients should be warned against exposure to sunlight or solarium radiation after removal of the medicated plaster in order to reduce the risk of photosensitisation.

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).

Although the systemic effects are expected to be minimal, the medicated plaster should be used with caution in patients with impaired renal, cardiac or hepatic function, or a history of peptic ulcer, inflammatory bowel disease or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients as they are more likely to experience undesirable effects.

No other medicinal products containing diclofenac or any other non-steroidal anti-inflammatory drugs (NSAIDs) should be used concomitantly, neither topically nor systemically.

The label contains the following statement: “Do not use with any other Voltarol products or any other NSAID’s.”

Paediatric population

Voltarol 140 mg Medicated Plaster is not recommended for use in children and adolescents under 16 years of age.

4.5 Interaction with other medicinal products and other forms of interaction

Since systemic absorption of diclofenac during labelled use of the medicated plasters is very low, the risk of developing clinically relevant drug-drug interactions is negligible.

4.6 Fertility, pregnancy and lactation Pregnancy

The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with pharmaceutical forms with systemic uptake, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre-and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

- inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Breastfeeding

Like other NSAIDs, diclofenac is excreted into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plaster no effects on the suckling child are anticipated.

Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, Voltarol 140 mg Medicated Plaster should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

4.7 Effects on ability to drive and use machines

Voltarol 140 mg Medicated Plaster has no influence on the ability to drive and use machines.

4.8 Undesirable effects

The following frequency categories are used for reporting undesirable effects:

Very common	>1/10
Common	>1/100 to <1/10
Uncommon	>1/1,000 to <1/100
Rare	>1/10,000 to <1/1,000
Very rare	<1/10,000
Not known	cannot be estimated from the available data

Infections and infestations
Very rare	Rash pustular
Immune system disorder
Very rare	Hypersensitivity (including urticaria), angioneurotic oedema, anaphylactic type reaction
Respiratory, thoracic and mediastinal disorders
Very rare	Asthma
Skin and subcutaneous tissue disorders
Common	Rash, eczema, erythema, dermatitis (including allergic and contact dermatitis), pruritus
Rare	Dermatitis bullous (e.g.

	erythema bullosum), dry skin
Very rare	Photosensitivity reaction
General disorders and administration site conditions
Common	Application site reactions

Systemic plasma diclofenac levels measured during labelled use of the cutaneous patches are very low compared to those obtained after oral intake of diclofenac. The risk of developing systemically induced side effects (like gastric, hepatic and renal disorders) during use of the plaster therefore appears to be low. However, in particular when the medicated plaster is used on a large area of skin and over a prolonged period of time, systemic side effects may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

There is no experience with overdose of diclofenac medicated plaster.

Should significant systemic undesirable effects occur following incorrect use or accidental overdose (e.g. in children), the precautions appropriate for poisoning with non-steroidal anti-inflammatory drugs should be taken.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Topical products for joint and muskular pain; Antiinflammatory preparations, non-steroids for topical use ATC code: M02AA15

Diclofenac is a non-steroidal anti-inflammatory/analgesic drug which, via inhibition of prostaglandin synthesis, has been shown to be effective in standard animal models of inflammation. In humans, diclofenac reduces inflammation-related pain, swelling and fever. In addition, diclofenac reversibly inhibits ADP- and collagen-induced platelet aggregation.

5.2 Pharmacokinetic properties

Diclofenac is absorbed slowly and incompletely from cutaneous formulations. The plasma concentrations of diclofenac at steady state are characterised by continuous absorption of diclofenac from the plaster, regardless of whether the plaster is applied in the morning or in the evening. Following cutaneous application, diclofenac may be absorbed into a dermal depot, from where it is released slowly into the central compartment. The systemic absorption of topical products is about 2-10% of that obtained with same dose administered orally.

The observed therapeutic efficacy is mainly explained by therapeutically relevant drug tissue concentrations beneath the site of application. Penetration to the site of action may vary with the extent and nature of the condition and depending on the site of application and action.

Mean plateau concentrations are approximately 3 ng/ml. Plasma protein binding of diclofenac is high at 99%. Metabolism and elimination are similar after cutaneous and oral administration. Following rapid hepatic metabolism (hydroxylation and binding to glucuronic acid), % of the drug is eliminated renally and ^XV by the biliary route.

5.3 Preclinical safety data

Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazards for humans beyond those already outlined in other sections of the Summary of Product Characteristics. In animal studies, chronic toxicity of diclofenac following systemic administration mainly manifested as gastrointestinal lesions and ulcers. In a 2-year toxicity study, rats treated with diclofenac showed a dose-related increase in thrombotic occlusion of the cardiac vessels.

In animal studies on reproductive toxicity, systemically administered diclofenac caused inhibition of ovulation in rabbits and impairment of implantation and early embryonic development in rats. The gestational period and duration of parturition were prolonged by diclofenac. The embryotoxic potential of diclofenac was studied in three animal species (rat, mouse, rabbit). Foetal death and growth retardation occurred at maternotoxic dose levels. Based on the available non-clinical data, diclofenac is regarded as nonteratogenic. Doses below the maternotoxic threshold had no impact on the postnatal development of the offspring.

Conventional studies on local tolerability reveal no special hazards for humans.

6.1 List of excipients

Supporting layer:

Polyester non-woven fabric

Adhesive layer:

Basic butylated methacrylate coplymer Copolymer acrylate vinyl acetate PEG 12stearate Sorbitan oleate

Liner:

Mono silicone coated paper

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 30°C.

Store in the original package in order to protect from desiccation and light. Keep the sachet tightly closed in order to protect from desiccation and light.

6.5 Nature and contents of container

Voltarol 140 mg medicated plasters are individually enclosed in sealed sachets of 145 x 228 mm made of paper/Alu/PEX laminate, provided with easy open and packed in a cardboard box.

Each pack contains 2, 5 or 10 medicated plasters.

Not all pack sizes may be marketed.

Special precautions for disposal

6.6

Used plasters should be folded in half, with the adhesive side inwards.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0158

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/04/2013

10 DATE OF REVISION OF THE TEXT

29/03/2016