Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Versatis 700mg Medicated Plaster
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lidocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Versatis contains lidocaine, a local analgesic, which works by reducing the pain in your skin. You have been given Versatis to treat a painful skin condition called post-herpetic neuralgia. This is generally characterised by localised symptoms such as burning, shooting or stabbing pain. 2.
What you need to know before you take it
e Versatis
Do not use Versatis if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6). –
if you have had an allergic reaction to other products which are similar to lidocaine, such as bupivacaine, etidocaine, mepivacaine or prilocaine.
–
on injured skin or open wounds
Warnings and precautions Talk to your doctor or pharmacist before using Versatis. If you have severe liver disease, or severe heart problems, or severe kidney problems, you should talk to your doctor before using Versatis. Versatis should only be used on the areas of skin after the shingles has healed. It should not be used on or near the eyes or mouth. Lidocaine is broken down in your liver to several compounds. One of these compounds is 2,6 xylidine which has been shown to cause tumours in rats when given lifelong in very high doses. The significance of these findings in humans is not known. Children and adolescents 1
Versatis has not been studied in patients under 18 years of age. Therefore it is not recommended for use in this patient population. Other medicines and Versatis Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Versatis should not be used in pregnancy unless clearly necessary. There are no studies of the plaster in breast-feeding women. When using Versatis, only very small amounts of the active substance lidocaine may be present in the blood stream. An effect on breast-fed infants is unlikely. Driving and using machines An effect of Versatis on the ability to drive and use machines is unlikely. Therefore you may drive or operate machinery whilst using Versatis. Versatis contains propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate The plasters contain propylene glycol (E1520) which may cause skin irritation. In addition it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions. The allergic reactions may sometimes occur after you have been using the plaster for some time. 3.
How to take it
Versatis
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual daily dose is to use between one and three plasters of the size of the painful areas of your skin. Versatis may be cut into smaller pieces to fit the affected area. You should not use more than 3 plasters at the same time. The plasters should be removed after 12 hours of use, so that you have a 12 hour period with no plaster. You can choose to apply Versatis during the day or during the night. Usually, you will feel some pain relief on the first day you use the plaster, but it may take up to 2 – 4 weeks until the full pain-relief effect of Versatis is seen. If after that time you still have a lot of pain, please talk to your doctor because the benefits of the treatment must be weighed against potential risks (see Section 2 under 'Warnings and precautions'). Your doctor will check how well Versatis is working at regular intervals. Before you stick Versatis on the affected area
- If the painful area of skin has hairs on it, you can cut the hairs off using scissors. Do not shave them off.
- The skin should be clean and dry.
- Creams and lotions may be used on the affected skin during the period when you are not wearing the plaster.
- If you have had a recent bath or shower, you should wait until your skin cools before using the plaster.
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Sticking the plaster on Step 1: open the sachet and remove one or more plasters
tear open or cut the sachet along the dotted line when using scissors, be careful not to damage the plasters take out one or more plasters depending on the size of the painful area on your skin
Step 2: close the sachet
close the sachet tightly after use the plaster contains water, and will dry out if the sachet is not closed properly.
Step 3: cut the plaster, if necessary
if required, cut the plaster to the required size to fit the painful area of skin before removing the liner.
Step 4: remove the liner
remove the transparent liner from the plaster try not to touch the sticky part of the plaster
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Step 5: apply the plaster and press it firmly onto the skin
apply up to three plasters to the painful area of skin press the plaster onto your skin press for at least 10 seconds to make sure the plaster sticks firmly make sure that all of it sticks to your skin, including the edges
Leave the plaster on for 12 hours only
It is important that Versatis is in contact with your skin for only 12 hours. For example, if you have more pain at night you might want to apply the plaster at 7pm in the evening and remove it at 7am in the morning. If you have more pain during the day than at night you might want to apply Versatis at 7am in the morning, and remove it at 7pm in the evening. Bathing, showering and swimming If at all possible contact with water should be avoided whilst using Versatis. Bathing, showering or swimming can be done in the time period when you are not wearing the plaster. If you have had a recent bath or shower, you should wait until your skin cools before using the plaster. If the plaster comes off Very rarely the plaster might fall off, or come unstuck. If it does, try sticking it back on the same area. If it does not stay on, remove it and put a new plaster on the same area. How to remove Versatis When changing the plaster, remove the old plaster slowly. If it does not come off easily, you can soak it in warm water for a few minutes before removing the plaster. If you forget to remove the plaster after 12 hours As soon as you remember, remove the old plaster. A new plaster can be used again after 12 hours. If you use more plasters than you should If you use more plasters than necessary or wear them for too long, this may increase the risk of getting side effects. If you forget to use Versatis After the 12 hour period with no plaster, if you have forgotten to use a new plaster, you should stick on a new plaster as soon as you remember. 4
If you have any further questions on use of this product, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects or symptoms to look out for and what to do if you are affected: If irritation or burning sensation occurs whilst you are using the plaster, the plaster should be removed. The area of irritation should remain plaster free until the irritation stops. Other side effects that may occur: Very common (may affect more than 1 in 10 people): Skin conditions at or around the site of plaster application, which may include redness, rash, itching, burning, dermatitis, and small blisters. Uncommon (may affect up to 1 in 100 people): Skin injury and skin wounds. Very rare (may affect up to 1 in 10,000 people): Open wound, severe allergic reaction and allergy. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Ireland HPRA Pharmacovigilance, Website: www.hpra.ie. UK The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Versatis
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze. After first opening: Keep the sachet tightly closed to protect from light. Shelf-Life after first opening of the sachet: 14 days. Do not use this medicine if you notice that the sachet has been damaged. If this has occurred, the plasters may dry out and become less sticky. How to throw away Versatis Used plasters still contain active ingredient, which may be harmful to others. Fold the used plasters in half, with the sticky sides together and throw them away so that they are out of the reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What Versatis contains
- The active substance is lidocaine.
- Each 10 cm x 14 cm plaster contains 700 mg (equivalent to 5% w/w) lidocaine
- The other ingredients in the plaster (excipients) are glycerol, liquid sorbitol, carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminium glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water. Backing fabric and release liner: polyethylene terephthalate (PET) What Versatis looks like and contents of the pack The medicated plaster is 14 cm long and 10 cm wide. It is white and made of fleece fabric marked with "lidocaine 5%". The plasters are packed in re-sealable sachets, each containing 5 plasters. Each carton contains 5, 10, 20, 25 or 30 plasters packed in 1, 2, 4, 5 or 6 sachets, respectively. Not all pack sizes may be marketed. Marketing Authorisation Holder: Grünenthal Pharma Ltd 4045 Kingswood Road Citywest Business Park Citywest Co. Dublin Ireland Manufacturer: Grünenthal GmbH Zieglerstrasse 6 52078 Aachen Germany Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call: 0044 173 3375 370 (Ireland only) 0800 198 5000 (UK Only) Please be ready to give the following information: Product name
Reference number
Versatis 700 mg medicated plaster
PA 2242/7/1
Versatis 700 mg medicated plaster
PL 50414/0012
This is a service provided by the Royal National Institute of the Blind.
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This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Romania, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Versatis Portugal: Vessatis This leaflet was last revised in September 2021.
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Frequently asked questions about Versatis 700mg Medicated Plaster
What is the active substance in Versatis 700mg Medicated Plaster?
The active substance in Versatis 700mg Medicated Plaster is lidocaine.
Are there equivalent medicines to Versatis 700mg Medicated Plaster?
Medicines with the same active substance, strength and form include: Lidocaine Grunenthal 700 mg medicated plaster. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Versatis 700mg Medicated Plaster, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Versatis 700mg Medicated Plaster without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: lidocaine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Versatis is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN) in adults.
4.2. Posology and method of administration
Adults and elderly patients
The painful area should be covered with the plaster once daily for up to 12 hours within a 24 hours period. Only the number of plasters that are needed for an effective treatment should be used. When needed, the plasters may be cut into smaller sizes with scissors prior to removal of the release liner. In total, not more than three plasters should be used at the same time.
The plaster must be applied to intact, dry, non-irritated skin (after healing of the shingles).
Each plaster must be worn no longer than 12 hours. The subsequent plaster-free interval must be at least 12 hours. The plaster can be applied during the day or during the night.
The plaster must be applied to the skin immediately after removal from the sachet and following removal of the release liner from the gel surface. Hairs in the affected area must be cut off with a pair of scissors (not shaved).
Treatment outcome should be re-evaluated after 2-4 weeks. If there has been no response to Versatis after this period (during the wearing time and/or during the plaster-free interval), treatment must be discontinued as potential risks may outweigh benefits in this context (see sections 4.4 and 5.1). Long-term use of Versatis in clinical studies showed that the number of plasters used decreased over time. Therefore treatment should be reassessed at regular intervals to decide whether the amount of plasters needed to cover the painful area can be reduced, or if the plaster-free period can be extended.
Renal impairment
In patients with mild or moderate renal impairment a dosage adjustment is not required.
Versatis should be used with caution in patients with severe renal impairment (see section 4.4).
Hepatic impairment
In patients with mild or moderate hepatic impairment a dosage adjustment is not required.
Versatis should be used with caution in patients with severe hepatic impairment (see section 4.4).
Paediatric population
The safety and efficacy of Versatis in children below 18 years has not been established. No data are available.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The plaster is also contraindicated in patients with known hypersensitivity to other local anaesthetics of the amide type e.g. bupivacaine, etidocaine, mepivacaine and prilocaine.
The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.
4.4. Special warnings and precautions for use
The plaster should not be applied to mucous membranes. Eye contact with the plaster should be avoided.
The plaster contains propylene glycol (E1520) which may cause skin irritation. It also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
The plaster should be used with caution in patients with severe cardiac impairment, severe renal impairment or severe hepatic impairment.
One of the lidocaine metabolites, 2,6 xylidine, has been shown to be genotoxic and carcinogenic in rats (see section 5.3). Secondary metabolites have been shown to be mutagenic. The clinical significance of this finding is unknown. Consequently long term treatment with Versatis is only justified if there is a therapeutic benefit for the patient (see section 4.2).
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No clinically relevant interactions have been observed in clinical studies with the plaster.
Since the maximum lidocaine plasma concentrations observed in clinical trials with the plaster were low (see section 5.2), a clinically relevant pharmacokinetic interaction is unlikely.
Although normally the absorption of lidocaine from the skin is low, the plaster must be used with caution in patients receiving Class I antiarrhythmic medicinal products (e.g. tocainide, mexiletine) and other local anaesthetics since the risk of additive systemic effects cannot be excluded.
4.6. Fertility, pregnancy and lactation
Pregnancy
Lidocaine crosses the placenta. However, there are no adequate data from the use of lidocaine in pregnant women.
Animal studies do not indicate a teratogenic potential for lidocaine (see section 5.3).
The potential risk for humans is unknown. Therefore, Versatis should not be used during pregnancy unless clearly necessary.
Breast-feeding
Lidocaine is excreted in breast milk. However, there are no studies of the plaster in breast-feeding women. Since the metabolism of lidocaine occurs relatively fast and almost completely in the liver, only very low levels of lidocaine are expected to be excreted into human milk.
Fertility
No clinical data regarding fertility are available. Animal studies have not shown effects on female fertility.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. An effect on the ability to drive and use machines is unlikely because systemic absorption is minimal (see section 5.2)
4.8. Undesirable effects
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Approximately 16% of patients can be expected to experience adverse reactions. These are localised reactions due to the nature of the medicinal product.
The most commonly reported adverse reactions were administration site reactions (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles).
The table below lists adverse reactions that have been reported in studies of post herpetic neuralgia patients receiving the plaster. They are listed by system organ class and frequency. Frequencies are defined as 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).
Body system
Adverse drug reaction
Skin and subcutaneous tissues disorders
uncommon
Skin lesion
Injury, poisoning and procedural complications
uncommon
Skin injury
General disorders and administration site conditions
Very common
Administration site reactions
The following reactions have been observed in patients receiving the plaster under post-marketing conditions:
Body system
Adverse drug reaction
Injury, poisoning and procedural complications
Very rare
Open wound
Immune system disorders
Very rare
Anaphylactic reaction, hypersensitivity
All adverse reactions were predominantly of mild and moderate intensity. Of those less than 5% lead to treatment discontinuation.
Systemic adverse reactions following the appropriate use of the plaster are unlikely since the systemic concentration of lidocaine is very low (see section 5.2). Systemic adverse reactions to lidocaine are similar in nature to those observed with other amide local anaesthetic agents (see section 4.9).
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose with the plaster is unlikely but it cannot be excluded that inappropriate use, such as use of a higher number of plasters at the same time, with prolonged application period, or using the plaster on broken skin might result in higher than normal plasma concentrations. Possible signs of systemic toxicity will be similar in nature to those observed after administration of lidocaine as a local anaesthetic agent, and may include the following signs and symptoms:
dizziness, vomiting, drowsiness, seizures, mydriasis, bradycardia, arrhythmia, and shock.
In addition, known drug interactions related to systemic lidocaine concentrations with beta-blockers, CYP3A4 inhibitors (e.g. imidazole derivatives, macrolides) and antiarrhythmic agents might become relevant with overdose.
In case of suspected overdose the plaster should be removed and supportive measures taken as clinically needed. There is no antidote to lidocaine.
💬 Ask about this leaflet
Ask anything about Versatis 700mg Medicated Plaster. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.