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RALVO 700 MG MEDICATED PLASTER

Active substance(s): LIDOCAINE

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Package leaflet: Information for the user

Ralvo® 700 mg medicated plaster
Lidocaine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
– 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.
What is in this leaflet
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
1. What Ralvo is and what it is used for
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.
2. What you need to know before you use Ralvo
Do not use Ralvo
– 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 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.
Children and adolescents
Ralvo 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 Ralvo
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.
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.
Driving and using machines
An effect of Ralvo on the ability to drive and use machines is unlikely.
Therefore you may drive or operate machinery whilst using Ralvo.
Ralvo 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.

Material No.

93022751

CMO Mat. No.



Customer Mat. No.



Class. No.

50/017/23

Product Name

GI RALVO PFLASTER EN GBR

Font Size

10 pt

Dimension

210 X 297 MM

Previous Mat. No.

3. How to use Ralvo
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.
Before you stick Ralvo 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.
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

R_RL_090916-04

Laetus Code
Colors &
Collating Marks

Grain Direction

297 MM

Date/Version

42
BLACK.................. 33

16.01.2017 V5 | DMA/CPR

Step 4: remove the liner
• r emove the transparent liner from the plaster
• t ry 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
• p ress 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.
Bathing, showering and swimming
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.
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 Ralvo
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 Ralvo
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.
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 www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this medicine.

Material No.

93022751

CMO Mat. No.



Customer Mat. No.



Class. No.

50/017/23

Product Name

GI RALVO PFLASTER EN GBR

Font Size

10 pt

Dimension

210 X 297 MM

Previous Mat. No.

5. How to store Ralvo
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.
How to throw away Ralvo
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.
6. Contents of the pack and other information
What Ralvo contains
– 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)
What Ralvo 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 Limited
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex
UB11 1BD
United Kingdom
Manufacturer:
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 02/2017

R_RL_090916-04

93022751

Laetus Code
Colors &
Collating Marks

Grain Direction

297 MM

Date/Version

42
BLACK.................. 33

16.01.2017 V5 | DMA/CPR

50/017/23

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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