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The product code(s) for this leaflet is: PL21727/0075.
Ralvo 700mg medicated plaster
Ralvo 700 mg medicated plaster
Lidocaine
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.
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.
Step 1: open the sachet and remove one or more plasters
Step 2: close the sachet
Step 3: cut the plaster, if necessary
Step 4: remove the liner
Step 5: apply the plaster and press it firmly onto the skin
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.
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.
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Ralvo 700 mg medicated plaster PL 21727/0075
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This leaflet was last revised in 09/2022