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CARLOSAFINE 35 MICROGRAMS/H TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the user

Carlosafine 35 micrograms/h transdermal patch
Carlosafine 52.5 micrograms/h transdermal patch
Carlosafine 70 micrograms/h transdermal patch
buprenorphine
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.
Package leaflet:
Information for the user

Carlosafine 35 micrograms/h
transdermal patch
Carlosafine 52.5 micrograms/h
transdermal patch
Carlosafine 70 micrograms/h
transdermal patch
buprenorphine

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

1. What Carlosafine is and what it is used for
The active substance of Carlosafine is buprenorphine.
Carlosafine is an analgesic (a pain-relieving medicine) intended to relieve
moderate to severe cancer pain and severe pain that has not responded to
other types of painkillers. Carlosafine acts through the skin. Buprenorphine
is an opioid (strong pain reliever), which reduces pain by acting on the
central nervous system (specific nerve cells in the spinal cord and in
the brain). The effect of the transdermal patch lasts for up to four days.
Carlosafine is not suitable for the treatment of acute (short-lasting) pain.

2. What you need to know before you use Carlosafine
Do not use Carlosafine
- if you are allergic to buprenorphine or any of the other ingredients of this
medicine (listed in section 6);
- if you are dependent on strong pain relievers (opioids);
- if you suffer from a disease in which you have or may have great
difficulty breathing
- if you are taking monoamine oxidase (MAO) inhibitors (certain
medicines used to treat depression) or you have taken this type of
medicine in the last two weeks (see “ Other medicines and Carlosafine”);
- if you suffer from myasthenia gravis (a certain type of severe muscle
weakness);
- if you suffer from delirium tremens (confusion and trembling caused
by abstinence from alcohol following habitual excessive drinking or
occurring during an episode of heavy alcohol consumption);
- if you are pregnant.
Carlosafine must not be used to treat withdrawal symptoms in drugdependent persons.
Warnings and precautions
Talk to your doctor or pharmacist before using Carlosafine
- if you have recently drunk a lot of alcohol;
- if you suffer from seizures or convulsions (fits)
- if your consciousness is disturbed (feeling light-headed or faint) for an
unknown reason;
- if you are in a state of shock (cold sweat might be a sign of it);
- if the pressure in your skull is increased (for instance after head injury or
in brain disease), and artificial respiration is not possible;
- if you have difficulty breathing or are taking other medicines that may
make you breathe more slowly or weakly (see “Other medicines and
Carlosafine”);
- if your liver does not work properly;
- if you are inclined to abuse medicines or drugs.

Also, please be aware of the following precautions:
- Some people may become dependent on strong pain relievers such as
Carlosafine when they use them over a long period of time. They may
have withdrawal effects when they stop using them (see “If you stop
using Carlosafine”).
- Fever and external heat may lead to larger quantities of buprenorphine in
the blood than normal. Also, external heat may prevent the transdermal
patch from sticking properly. Therefore, do not expose yourself to
external heat (e.g. sauna, infra-red lamps, electric blankets, hot water
bottles) and consult your doctor if you have fever.
Athletes should be aware that this medicine may cause a positive reaction to
sports doping control tests.
Children and adolescents
Carlosafine should not be used in persons below the age of 18 years, because
no experience has so far been gained in this age group.
Other medicines and Carlosafine
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
- Carlosafine must not be used together with monoamine oxidase (MAO)
inhibitors (certain medicines used to treat depression), or if you have
taken this type of medicine for the last 2 weeks.
- Carlosafine may make some people feel drowsy, sick, or faint or
make them breathe more slowly or weakly. These side effects may be
intensified if other medicines that may produce the same effects are
taken at the same time. These other medicines include other strong pain
relievers (opioids), certain sleeping pills, anaesthetics, and medicines
used to treat certain psychological diseases such as tranquillizers, antidepressants, and neuroleptics.
- If Carlosafine is used together with some medicines, the effects of
the transdermal patch may be increased. These medicines include e.g.
certain anti-infectives/anti-fungals (e.g. containing erythromycin or
ketoconazole) or HIV medicines (e.g. containing ritonavir)
- If Carlosafine is used together with other medicines, the effects of the
transdermal patch may be reduced. These medicines include certain
products, e.g. dexamethasone; medicines to treat epilepsy (e.g. containing
carbamazepine, or phenytoin) or medicines for tuberculosis (e.g.
rifampicin).
Carlosafine with food, drink and alcohol
You should not drink alcohol while using Carlosafine. Alcohol may intensify
certain side effects of the transdermal patch and you may feel unwell.
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
using this medicine.
There is insufficient experience regarding the use of Carlosafine in pregnant
women. Therefore, you must not use Carlosafine during pregnancy.
Buprenorphine, the active substance contained in the transdermal patch,
inhibits milk formation and passes into breast milk. Therefore, you should
not use Carlosafine if you are breast-feeding.
Driving and using machines
Carlosafine may make you feel dizzy or drowsy or experience blurred or
double vision and affect your reactions to such an extent that you may not
react adequately or quickly enough in the event of unexpected or sudden
occurrences. This applies particularly
- at the beginning of treatment,
- when your dose is changed,
- when you switch to Carlosafine from another pain reliever,
- if you also use other medicines that act on the brain,
- if you drink alcohol.
If you are affected, you should not drive or operate machinery whilst using
Carlosafine. This applies also at the end of treatment with Carlosafine. Do
not drive or operate machinery for at least 24 hours after the patch has been
removed.
Discuss with your doctor or pharmacist if you are unsure about anything.

Applying the transdermal patch

3. How to use Carlosafine
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Carlosafine is available in three strengths: Carlosafine 35 micrograms/h
transdermal patch, Carlosafine 52.5 micrograms/h transdermal patch and
Carlosafine 70 micrograms/h transdermal patch.

- S
 tep 1: Each transdermal patch
is sealed in a sachet. Just before
use, cut the sachet along the sealed
edge with scissors. Take out the
transdermal patch.

The choice of which strength of Carlosafine will suit you best will be made
by your doctor. During treatment your doctor may change which transdermal
patch you use to a smaller or larger one if necessary.
The recommended dose is:
Adults
Unless your doctor has told you differently, attach one Carlosafine
transdermal patch (as described in detail below) and change it after 4 days
at the latest. For convenience of use, you can change the transdermal patch
twice a week at the same days, e.g. always on Monday mornings and
Thursday evenings. To help you remember when to change your transdermal
patch, you should make a note on the calendar on the outer packaging. If
your doctor has advised you to take other pain relievers in addition to the
transdermal patch, strictly follow the doctor’s instructions, otherwise you
will not fully benefit from treatment with Carlosafine.

- 
Step 2: The sticky side of the
transdermal patch is covered with a
transparent protective foil. Carefully
peel off one part of the foil. Try
not to touch the sticky part of the
transdermal patch.

Elderly patients
No dosage adjustment is needed for elderly patients.
Patients with kidney disease / dialysis patients
In patients with kidney disease and in dialysis patients, no dosage adjustment
is necessary.
Patients with liver disease
In patients with liver disease, the intensity and duration of action of
Carlosafine may be affected. If this applies to you, your doctor will check on
you more closely.

- 
Step 3: Stick the transdermal patch onto
the area of skin you have chosen and
remove the remaining foil.

Use in children and adolescents
Carlosafine should not be used in persons below the age of 18 years, because
no experience has so far been gained in this age group.
Route of administration
The patch is for transdermal use.
When the transdermal patch is applied to the skin, the active substance
buprenorphine passes through the skin into the blood.
Method of administration
Before applying the transdermal patch
- C
 hoose an area of skin
which is flat, clean, free
from cuts or scars and
hairless on your upper
body, preferably on the
chest below the collarbone or on the upper part
of the back (see adjacent
illustrations). Call
assistance if you cannot
apply the transdermal
patch yourself.

Front
OR

- 
Step 4: Press the transdermal patch
against your skin with the palm of your
hand for about 30 to 60 seconds. Make
sure that the whole transdermal patch is
in contact with your skin, especially at
the edges.

Back
OR

- I f the chosen area has hairs, cut them off with a pair of scissors. Do not
shave them off!
- Avoid skin which is red, irritated or has any other blemishes, for instance
large scars.
- The area of skin you choose must be dry and clean. If necessary, wash it
with cold or lukewarm water. Do not use soap or other detergents. After
a hot bath or shower, wait until your skin is completely dry and cool.
Do not apply lotion, cream or ointment to the chosen area. This might
prevent your transdermal patch from sticking properly.

- 
Step 5: Wash your hands after using the transdermal patch. Do not use
any cleansing products.
Wearing the transdermal patch
You may wear the transdermal patch for up to 4 days. Provided that you have
applied the transdermal patch correctly, there is little risk of it coming off.
You may shower, bathe or swim while wearing it. However, do not expose
the transdermal patch to extreme heat (e.g. sauna baths, infra-red lamps,
electric blankets, hot water bottles).
In the unlikely event that your transdermal patch falls off before it needs
changing, do not use the same transdermal patch again. Stick a new one on
straight away (see “Changing the transdermal patch” below).

Changing the transdermal patch
- Take the old transdermal patch off.
- Fold it in half with the sticky side inwards.
- Throw it away carefully.
- Stick a new transdermal patch on a different skin site (as described
above). Wait at least one week before using the same site again.
Duration of treatment
Your doctor will tell you how long you may use Carlosafine. Do not stop
using Carlosafine on your own account, because pain may return and you
may feel unwell (see also “If you stop using Carlosafine” below).
If you have the impression that the effect of the Carlosafine transdermal
patch is too weak or too strong, tell your doctor or pharmacist.
If you use more Carlosafine than you should
If this happens there may be signs of an overdose of the substance
buprenorphine. An overdose may intensify the side effects of buprenorphine
such as drowsiness, nausea, and vomiting. You may get pin-point pupils
and breathing may become slow and weak. You may also get cardiovascular
collapse.
As soon as you discover that you have used more transdermal patches than
you should, remove the excess transdermal patches and talk to a doctor or
pharmacist.
If you forget to use Carlosafine
If you forget an application, stick a new transdermal patch on as soon as you
remember. You will then need to change your routine, e.g. if you usually
apply your transdermal patches on Mondays and Thursdays, but you forget
and don’t stick on a new transdermal patch until Wednesday, you will need
to change your transdermal patches on Wednesdays and Saturdays from
then on. Make a note of the new pair of days on the calendar on the outer
packaging. If you are very late changing your transdermal patch, pain may
return. In this case please contact your doctor.
Never apply twice the number of transdermal patches to make up for the
forgotten application!
If you stop using Carlosafine
If you interrupt or finish using Carlosafine too soon, pain may return. If you
wish to stop use on account of unpleasant side effects, please consult your
doctor. He/she will tell you what can be done and whether you can be treated
with other medicines.
Some people may experience withdrawal-effects when they have used strong
pain relievers for a long time and stop using them. The risk of having effects
after you stop using Carlosafine is very low. However, if you feel agitated,
anxious, nervous or shaky, if you are overactive, have difficulty sleeping or
digestion problems, tell your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you experience swelling of the hands, feet, ankles, face, lips, mouth,
or throat which may cause difficulty in swallowing or breathing, hives,
fainting, yellowing of the skin and eyes (also called jaundice), remove the
transdermal patch and call your doctor immediately or seek help at the
casualty department of the nearest hospital. These can be symptoms of a
very rare serious allergic reaction.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people):
• nausea (feeling sick)
• redness, itching
Common (may affect up to 1 in 10 people):
• dizziness, headache
• shortness of breath
• vomiting, constipation
• skin changes (exanthema, generally on repeated use), sweating
• oedema (e.g. swelling of the legs), tiredness

Uncommon (may affect up to 1 in 100 people):
• confusion, sleep disorder, restlessness
• various degrees of sedation (calmness), ranging from tiredness to
muzziness
• circulation disorders (such as low blood pressure or, rarely, even
circulatory collapse)
• dry mouth
• rash
• difficulty in passing water, urinary retention (less urine than normal)
• weariness

6. Contents of the pack and other information
What Carlosafine contains
- The active substance is buprenorphine.



[35 micrograms /h:]
Each transdermal patch of 25 cm2 contains 20 mg of buprenorphine and
releases 35 micrograms of buprenorphine per hour.




[52.5 micrograms /h:]
Each transdermal patch of 37.5 cm2 contains 30 mg of buprenorphine and
releases 52.5 micrograms of buprenorphine per hour.

Rare (may affect up to 1 in 1,000 people):
• loss of appetite
• illusions such as hallucinations, anxiety and nightmares, reduced sex
drive
• difficulties concentrating, speech disorder, muzziness, disturbed balance,
abnormal skin sensations (numbness, prickling or burning sensations)
• visual disturbance, blurred vision, swollen eyelids
• hot flushes
• difficulty breathing (respiratory depression)
• heartburn
• hives
• erection difficulties
• withdrawal symptoms (see below), administration site reactions




[70 micrograms /h:]
Each transdermal patch of 50 cm2 contains 40 mg of buprenorphine and
releases 70 micrograms of buprenorphine per hour.

Very rare (may affect up to 1 in 10,000 people):
• serious allergic reactions (see below)
• dependence, mood swings
• muscle twitching, taste disorders
• pin-point pupils
• ear pain
• abnormally rapid breathing, hiccups
• retching
• pustules, small blisters
• chest pain
If you notice any of the side effects listed above, tell your doctor as soon as
possible.
In some cases delayed allergic reactions occurred with marked signs of
inflammation. In such a case you should stop using Carlosafine after you
have talked to your doctor.
Some people may have withdrawal symptoms when they have used strong
pain relievers for a long time and stop using them. The risk of having
withdrawal effects when you stop using Carlosafine is low. However, if you
feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty
sleeping or digestion problems, tell your doctor.
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 Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store Carlosafine
• Keep this medicine out of the sight and reach of children.
• D
 o not use this medicine after the expiry date which is stated on the
carton and sachet after EXP. The expiry date refers to the last day of that
month.
• This medicine does not require any special storage conditions.
• A
 fter removing a patch, fold it in half with the sticky sides inwards and
press them together. Return the used patch to its sachet and carefully
dispose the transdermal patch.
• D
 o 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 other ingredients are:
Adhesive matrix (containing buprenorphine): povidone K90, levulinic
acid, oleyl oleate, Poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)
acrylate-co-vinylacetate] (5:15:75:5)


Adhesive matrix (without buprenorphine): Poly[(2-ethylhexyl)acrylateco-glycidylmethacrylate-co-(2-hydroxyethyl)acrylate-co-vinylacetate]
(68:0,15:5:27),



Separating foil between adhesive matrices with and without
buprenorphine: Polyethylene terephthalate film,



Backing foil: polyester,



Release liner: Polyethylene terephthalate film, siliconised



Blue printing ink

What Carlosafine looks like and contents of the pack
Each transdermal patch is rectangular beige coloured with rounded corners
and is imprinted
[35 μg/h:]
“Buprenorphin” and “35 μg/h”
[52.5 μg/h:]
“Buprenorphin” and “52.5 μg/h”
[70 μg/h:]
“Buprenorphin” and “70 μg/h”
Each transdermal patch is sealed in one child-resistant sachet. The patches
are available in packs containing
[For DE/H/5080/001-003/DC]
4, 5, 8, 10, 16 or 20 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2B Draycott Avenue
Kenton, Middlesex
HA3 0BU
United Kingdom
Manufacturer
Tesa Labtec GmbH
Heykenaukamp 10
21147 Hamburg
Germany
This leaflet was last revised in November 2015

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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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