Ralvo 700mg medicated plaster - Patient Information Leaflet (PIL) (2024)

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Grunenthal Ltd contact details


Active ingredient

  • lidocaine

Legal Category

POM: Prescription only medicine


ATC code

  • N01BB02

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What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Download LeafletView the patient leaflet in PDF format

Below is a text only representation of the Patient Information Leaflet.The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD.For further information call emc accessibility on 08001985000.The product code(s) for this leaflet is: PL21727/0075.

Ralvo 700 mg medicated plaster

Lidocaine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ralvo is and what it is used for
2. What you need to know before you use Ralvo
3. How to use Ralvo
4. Possible side effects
5. How to store Ralvo
6. Contents of the pack and other information

Ralvo contains lidocaine, a local analgesic, which works by reducing the pain in your skin.

You have been given Ralvo to treat a painful skin condition called post-herpetic neuralgia. This is generally characterised by localised symptoms such as burning, shooting or stabbing pain.

  • 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

Talk to your doctor or pharmacist before using Ralvo.

If you have severe liver disease, or severe heart problems, or severe kidney problems, you should talk to your doctor before using Ralvo.

Ralvo 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.

Ralvo has not been studied in patients under 18 years of age. Therefore it is not recommended for use in this patient population.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

Ralvo should not be used in pregnancy unless clearly necessary.

There are no studies of the plaster in breast-feeding women. When using Ralvo, only very small amounts of the active substance lidocaine may be present in the blood stream. An effect on breast-fed infants is unlikely.

An effect of Ralvo on the ability to drive and use machines is unlikely. Therefore you may drive or operate machinery whilst using Ralvo.

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.

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. Ralvo 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 Ralvo 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 Ralvo 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 Ralvo is working at regular intervals.

  • 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.

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

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 Ralvo 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 Ralvo at 7am in the morning, and remove it at 7pm in the evening.

If at all possible contact with water should be avoided whilst using Ralvo. 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.

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.

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.

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 necessary or wear them for too long, this may increase the risk of getting side effects.

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.

If you have any further questions on use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

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.

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 www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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.

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.

  • The active substance is lidocaine.
  • Each 10 cm x 14 cm plaster contains 700 mg lidocaine (5% w/w)
  • 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)

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.

Grünenthal Limited
1 Stokenchurch Business Park
Ibstone Road
Stokenchurch
England
HP14 3FE
UK

Grünenthal GmbH
Zieglerstrasse 6
D-52078 Aachen
Germany

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Reference number

Ralvo 700 mg medicated plaster PL 21727/0075

This is a service provided by the Royal National Institute of the Blind.

This leaflet was last revised in 07/2021

Company contact details

Grunenthal Ltd

Ralvo 700mg medicated plaster - Patient Information Leaflet (PIL) (2)

Address

Unit 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK

Medical Information Direct Line

+44 (0)870 351 8960

WWW

Medical Information e-mail

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Ralvo 700mg medicated plaster - Patient Information Leaflet (PIL) (2024)

FAQs

What is Ralvo 700mg medicated plaster used for? ›

Ralvo is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN) in adults. The painful area should be covered with the plaster once daily for up to 12 hours within a 24 hours period.

How long does it take for Ralvo patches to work? ›

You can choose to apply Ralvo 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 Ralvo is seen.

What is medicated plaster used for? ›

Lidocaine 5% medicated plaster is a local anaesthetic producing a local, non-systemic analgesic effect. It is licensed for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia (PHN)). Trauma of ligaments, tendon, muscle, joints & soft tissue.

Is Ralvo the same as versatis? ›

It is manufactured by the same company as the Versatis® 5% medicated plaster. Ralvo® is exactly the same size, strength, and formulation as Versatis® with the same licensed indication and directions for use. Ralvo® is 15% less expensive than Versatis®.

How do you use pain relief plaster? ›

Clean and dry the affected area. Remove the backing from the patch and apply the patch to the affected area. Do not apply this medication to skin that is injured or irritated (such as skin that is cut, scraped, sunburned, infected, or has a rash). Leave the patch on the affected area for up to 8 hours.

Why are lidocaine patches removed after 12 hours? ›

Why do I need to remove my lidocaine patches after 12 hours? You can absorb too much lidocaine if you leave the patches on for more than 12 hours. This can put you at higher risk for skin irritation. Very rarely, it can also lead to serious side effects, such as seizure, heart rhythm problems, and coma.

What are plasters in pharmacy? ›

[plas´ter] 1. a mixture of materials that hardens; used for immobilizing or making impressions of body parts. 2. an adhesive substance spread on fabric or other suitable backing material, for application to the skin, often containing some medication, such as an analgesic or local vasodilator.

How long does it take for lidocaine patches to work? ›

Usually you feel some pain relief on the first day you use the patch, however it can take 2-4 weeks using the patch everyday before getting the full benefit.

Are lidocaine patches good for knee pain? ›

Conclusions: In patients with moderate-to-severe OA of the knee, 2 weeks of treatment with the lidocaine patch 5% significantly reduces the intensity of pain qualities as measured by all 4 NPS composite measures.

Can you take painkillers with versatis patches? ›

However, it's fine to take over-the-counter painkillers, such as paracetamol or ibuprofen, and prescribed medicines for nerve pain like amitriptyline, gabapentin or pregabalin, while you're using Versatis plasters.

Can you buy versatis patches over the counter? ›

Versatis (5% Lignocaine) has recently been approved for the management of patients with post herpetic neuralgia. It is a prescription only medicine at present and will therefore require a hospital or doctors prescription to obtain this.

Can a GP prescribe lidocaine patches? ›

Who can prescribe lidocaine patches? Lidocaine patches will be initiated by a specialist from the Pain Team in the hospital or by your consultant. As it is expected that you will only need lidocaine patches for a short period of time, up to 10 days, your GP will not routinely continue to prescribe these for you.

What happens if I leave my lidocaine patch on too long? ›

If you wear too many lidocaine transdermal patches or topical systems or wear them for too long, too much lidocaine may be absorbed into your blood. In that case, you may experience symptoms of an overdose.

Do lidocaine patches work for nerve pain? ›

OTC lidocaine patches can help relieve minor pain conditions, including insect bites, minor burns, and back pain. But because lidocaine numbs your nerves, these patches might be able to specifically help with neuropathic (nerve) pain. This is pain caused by nerve damage.

What happens if you put lidocaine on an open wound? ›

For example, covering a large area of the body with lidocaine or leaving it on the skin for a long time can lead to absorption of the drug into the bloodstream. This can also occur when it's applied to skin that is not intact such as open wounds, blisters, or burns. Wrapping the treated area also increases absorption.

How long do you leave pain relief patches? ›

Since these plasters or patches do not emit any heat, there is no damage caused to your skin when you apply these patches even for 8 to 10 hours.

How do you get rid of pain patches without pain? ›

Soak a cotton ball or cotton swab in baby oil. If you don't have baby oil handy, olive oil, petroleum jelly, or baby shampoo will work, too. Next, gently rub it over the bandage until it falls off. You can test to see if it's working by slowly peeling up a corner of the bandage.

What patch is best for back pain? ›

Lidocaine is a numbing agent. Placing an adhesive lidocaine patch on your sore back may help to relieve your discomfort by preventing the nerves in the affected area from sending your brain pain signals.

Can I sleep with a lidocaine patch on? ›

Yes, you can sleep with a lidocaine patch on but not for more than 12 hours. For maximum effectiveness, we recommend you to use a heating pad for 15 minutes prior to bedtime; and then, apply this patch before you go to sleep.

Who should not use lidocaine patch? ›

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects.

What effect does lidocaine have on the heart? ›

LIDOCAINE (Xylocaine) has become one of the most frequently used drugs in the treatment of ventricular arrhythmias, particularly those associated with acute myocardial infarction. It has been shown to terminate ventricular tachycardia, and it has been given to suppress multiple ventricular extrasystoles.

What is the medical term for plaster? ›

[plas´ter] 1. a mixture of materials that hardens; used for immobilizing or making impressions of body parts. 2. an adhesive substance spread on fabric or other suitable backing material, for application to the skin, often containing some medication, such as an analgesic or local vasodilator.

How does plaster work on fracture? ›

Plaster casts are made up of a bandage and a hard covering, usually plaster of paris. They allow broken bones in the arm or leg to heal by holding them in place, and usually need to stay on for between 4 and 12 weeks. Taking good care of your cast will help ensure a better recovery.

How long does plaster take to dry? ›

How long does it take plaster to dry? For a freshly plastered wall to be completely dry, it can take 1-2 weeks, sometimes even more.

What kind of pain is lidocaine good for? ›

This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics.

Can lidocaine cause nerve damage? ›

Ester local anesthetics and carbonated lidocaine produce widespread and severe damage of the nerve fibers and the blood-nerve barriers when injected within the fascicles.

Does lidocaine make you sleepy? ›

Does lidocaine make you sleepy? One of the rare side effects of topical lidocaine is drowsiness or a feeling of overt sleepiness. Call your doctor for medical advice if these side effects are extreme or concerning. Take precautions to not overdose to prevent any severe side effects.

What ointment is good for joint pain? ›

In the United States, the Food and Drug Administration has approved several topical products (Voltaren, Solaraze, others) that contain the prescription NSAID diclofenac for the treatment of osteoarthritis in joints close to the skin's surface, such as the hands and knees.

Where do you place lidocaine patch for knee pain? ›

You should apply the patch to cover your skin where you have the most pain. However, the skin has to be intact and shouldn't have blisters. If the most painful area has blisters or sores, you should instead select the closest area of skin that is intact.

Do lidocaine patches help with arthritis? ›

It works by blocking pain signals at the nerve endings in the skin but doesn't decrease inflammation. Studies about lidocaine for arthritis are limited. A small 2017 study found that lidocaine patches (5% concentration) effectively reduced pain in patients with total knee arthroscopy.

Can lidocaine patches make you sleepy? ›

Some people have also reported the following side effects while using lidocaine patches: Dizziness or lightheadedness. Headache. Sleepiness.

Who should not use lidocaine patch? ›

This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects.

Can lidocaine patches be used for back pain? ›

Lidocaine is a numbing agent. Placing an adhesive lidocaine patch on your sore back may help to relieve your discomfort by preventing the nerves in the affected area from sending your brain pain signals.

How much does a box of lidocaine patches cost? ›

The cost for Lidoderm topical film 5% is around $771 for a supply of 30 film, depending on the pharmacy you visit.

What are the dangers of lidocaine? ›

Side Effects
  • Bluish-colored lips, fingernails, or palms blurred or double vision.
  • chest pain or discomfort.
  • cold, clammy, pale skin.
  • continuing ringing or buzzing or other unexplained noise in the ears.
  • difficulty breathing.
  • difficulty swallowing.
  • dizziness or lightheadedness.
1 Sept 2022

Does lidocaine affect the heart? ›

The administration of lidocaine resulted in a significant overall increase in mean heart rate: for the healthy control group an increase of 5.5 +/- 2.2% (mean +/- SE), for the IMI group an increase of 9.4 +/- 3.5%, and for the AMI group an increase of 8.1 +/- 2.9% (p < 0.01 for all).

What happens if I leave my lidocaine patch on too long? ›

If you wear too many lidocaine transdermal patches or topical systems or wear them for too long, too much lidocaine may be absorbed into your blood. In that case, you may experience symptoms of an overdose.

Can lidocaine cause nerve damage? ›

Ester local anesthetics and carbonated lidocaine produce widespread and severe damage of the nerve fibers and the blood-nerve barriers when injected within the fascicles.

Does lidocaine help nerve pain? ›

Lidocaine skin patch is used to relieve nerve pain caused by herpes zoster or shingles (postherpetic neuralgia). Lidocaine belongs to the family of medicines called local anesthetics. This medicine prevents pain by blocking the signals at the nerve endings in the skin.

How long does lidocaine patch stay in your system? ›

Less than 10% of lidocaine is excreted unchanged. The half-life of lidocaine elimination from the plasma following IV administration is 81 to 149 minutes (mean 107 ± 22 SD, n = 15). The systemic clearance is 0.33 to 0.90 L/min (mean 0.64 ± 0.18 SD, n = 15).

How long do lidocaine patches take to kick in? ›

How long will it take to work? You may feel some pain relief on the first application, but it can take up to 2-4 weeks of using the patch(es) every day before you notice any pain relief. If they are not helping the pain after 4 weeks, you should stop using them.

Is lidocaine a muscle relaxant? ›

Background: Many studies have demonstrated that lidocaine directly relaxes airway smooth muscle. The underlying mechanisms, especially in relation to Ca2+ mobilization, remain to be elucidated.

How can I relieve sciatica pain permanently? ›

The two main surgical options for sciatica are diskectomy and laminectomy. Diskectomy. During this procedure, your surgeon removes whatever is pressing on your sciatic nerve, whether it's a herniated disk, a bone spur, or something else.

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