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RECIVIT 400 MCG SUBLINGUAL TABLETS

Active substance(s): FENTANYL CITRATE

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Package leaflet: Information for the user
Recivit® 67 micrograms, sublingual tablets
Recivit® 133 micrograms, sublingual tablets
Recivit® 267 micrograms, sublingual tablets
Recivit® 400 micrograms, sublingual tablets
Recivit® 533 micrograms, sublingual tablets
Recivit® 800 micrograms, sublingual tablets
Fentanyl
Read all of this leaflet carefully before you start taking 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 Recivit is and what it is used for
2. What you need to know before you take Recivit
3. How to take Recivit
4. Possible side effects
5. How to store Recivit
6. Contents of the pack and other information
1. What Recivit is and what it is used for
Recivit contains the active ingredient fentanyl, which belongs to a group
of strong pain-relieving medicines called opioids.
Recivit is used to treat breakthrough pain in adult patients with cancer
who are already taking other opioid pain medicines for their persistent
(around-the-clock) cancer pain.
Breakthrough pain is additional, sudden pain that occurs even though
you have taken your usual opioid pain-relieving medicines.
2. What you need to know before you take Recivit
Do not take Recivit:
• if you are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6);
• if you are not regularly using a prescribed opioid medicine (e.g
codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine),
every day on a regular schedule, for at least a week, to control your
persistent pain. If you have not been using these medicines you must
not use Recivit, because it may increase the risk that breathing could
become dangerously slow and/or shallow, or even stop (see section
4 “Possible side effects”).
• if you have severe breathing problems or severe lung disorder;
• if you are currently taking monoamine-oxidase (MAO) inhibitor medicines
for severe depression (or have taken them in the past 2 weeks).
• if you suffer from short-term pain other than breakthrough pain.
Warnings and precautions
Recivit contains an active ingredient in an amount that can be
fatal to a child, and therefore keep all tablets out of the sight and
reach of children and non-patients at all times.
Keep the tablets in a locked storage space and do not store the tablets
once removed from the blister package.
Talk to your doctor or pharmacist before taking Recivit.
Tell your doctor before treatment if you have or have recently had any
of the following, as your doctor will need to take account of these when
prescribing your dose:
• your other opioid pain medicine taken for your persistent (aroundthe-clock) cancer pain is not stabilized yet;
• you are suffering from any condition that has an effect on your
breathing (such as asthma, wheezing, or shortness of breath);
• you have a head injury;
• you have problems with your heart, especially slow heart rate,
irregular heartbeat, low blood volume or low blood pressure;
• you have liver or kidney problems, as these organs have an effect on
the way in which your system breaks down the medicine.
• If you take antidepressants or antipsychotics, please refer to the
section ‘Other medicines and Recivit’
Children and adolescents
Recivit shall not be used by children and adolescents below 18 years.
Other medicines and Recivit
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, especially:
• Monoamine-oxidase (MAO) inhibitors (used for severe depression),
see “Do not take Recivit” above. Tell your doctor if you have taken this
type of medicine within the last two weeks,
• Sleeping pills, medicines to treat anxiety, antihistamines,
tranquillisers, some muscle relaxants or any medicines which might
normally make you sleepy (have a sedative effect),
• The risk of side effects increases if you are taking medicines such as
certain antidepressants or antipsychotics. Recivit may interact with
these medicines and you may experience mental status changes
(e.g. agitation, hallucinations, coma), and other effects such as body
temperature above 38˚C, increase in heart rate, unstable blood
pressure, and exaggeration of reflexes, muscular rigidity, lack of
coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting,
diarrhoea). Your doctor will tell you whether Recivit is suitable for you.
• Any medicines that might influence the effect of Recivit (by effecting
the way in which your body breaks down Recivit), such as:
– medicines that help control HIV infection (such as ritonavir, indinavir,
nelfinavir, saquinavir),

– medicines used for treatment of fungal infections (such as
ketoconazole, itraconazole, or fluconazole),
– medicines for treatment of bacterial infections (such as
clarithromycin, erythromycin, telithromycin) including tuberculosis
(such as rifabutin, rifampin),
– medicines used against severe nausea (such as aprepitant,
dronabinol),
– medicines for treatment of high blood pressure or heart diseases
(such as diltiazem and verapamil),
– medicines used for depression (such as fluoxetin or St. John’s wort),
– medicines used for heartburn and indigestion (such as cimetidin),
– sleeping pills or sedatives (such as phenobarbital),
– medicines to control epileptic convolutions/seizures (such as
carbamazepine, phenytoin, oxcarbazepine),
– anti-viral medicines (such as efavirenz, nevirapine),
– anti-inflammatory or immunosuppressive medicines (such as
glucocorticoids),
– medicines for the treatment of diabetes (such as pioglitazone),
– psycho-stimulating medicines (such as modafinil).
• Other types of strong pain killers (such as buprenorphine,
pentazocine or nalbuphine). These medicines may reduce or reverse
the effect of Recivit.
Recivit with food, drink and alcohol
• Recivit may be used before or after, but not during, meals. You may
drink some water before using Recivit to help moisten your mouth,
but you should not drink or eat anything while taking the medicine.
• You should not drink grapefruit juice while using Recivit because it
may affect the way your body breaks down Recivit.
• Do not drink alcohol while using Recivit. It can increase the risk of
experiencing dangerous side effects.
Pregnancy and breast-feeding
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.
Recivit should not be used during pregnancy unless you have discussed
this with your doctor. You should not use Recivit during childbirth
because fentanyl may cause respiratory depression and withdrawal
symptoms in the foetus or in the new-born child.
Fentanyl can get into breast milk and may cause side effects in the
breast-fed infant. Do not use Recivit if you are breast-feeding. You
should not start breast-feeding within 48 hours after the last dose of
Recivit.
Driving and using machines
You should discuss with your doctor whether it is safe for you to drive,
or operate machinery after taking Recivit. Do not drive or operate
machinery if you: are feeling sleepy or dizzy; have blurred or double
vision; or have difficulty in concentrating. It is important you know how
you react to Recivit before driving or operating machinery.
The medicine can affect your ability to drive as it may make you sleepy
or dizzy.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
– The medicine has been prescribed to treat a medical or dental
problem and
– You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
– It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
Recivit contains sodium
This medicinal product contains 0.651 mg sodium per tablet. To be
taken into consideration by patients on a controlled sodium diet.
3. How to take Recivit
This medicine should be taken by placing the tablet under your tongue
(sublingual use).
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
If your doctor switched you to Recivit, you must not use the previous
medicine containing fentanyl concurrently for the treatment of your
breakthrough pain. Dispose of the previous medicine. However, keep
using the opioid pain medicine you take for your persistent (aroundthe-clock) cancer pain during your Recivit treatment.
Initial Phase – Finding the most appropriate dose
For Recivit to work successfully, your doctor will need to identify the
most appropriate dose for treating a single episode of breakthrough
pain. Recivit sublingual tablets are available in a range of strengths. You
may need to try different strengths of Recivit sublingual tablets over a
number of episodes of breakthrough pain to find the most appropriate
dose. Your doctor will help you do this and will work with you to find the
best strength of tablet to use.
If you do not get adequate pain relief from one tablet your doctor may
ask you to take two tablets to treat an episode of breakthrough pain.

SCHWARZ
Name:

GI RECIVIT TABLETTEN
9 pt

Größe:

150 X 315 MM

Sprache:

EN

Faserlauf:

315 MM

Code:



SCHWARZ

Datum:

17.04.2014

Artikel-Nr.:

93018686

Druckfarbe:

Klass.-Nr.:

50/000/23

Flattermarken:

Bez. der Vorgängerdatei:

93017612

Vorgängerdatei gelöscht:



Leistungsindex:



RZ geprüft:

‒/X3

Mazur

V2

Do not take a second tablet unless your doctor tells you to as this may
result in overdose. Your doctor will advise you which strength of tablet
to use.
You must always use the dose of Recivit as prescribed by your
doctor – this may be a different dose from that which you have used
with other medicines for breakthrough pain.
Maintenance Phase - Once you have found the most appropriate
dose
Once you and your doctor have found a dose of Recivit tablets that controls
your breakthrough pain you should not take this dose more than four times
a day. A dose of Recivit may consist of more than one tablet.
If you think that the dose of Recivit that you are using is not controlling
your breakthrough pain satisfactorily tell your doctor, as he may need
to adjust your dose.
You must not change your dose of Recivit unless directed by your doctor.
Taking the medicine
Recivit should be used sublingually. This means that the tablet should
be placed under the tongue where it dissolves rapidly in order to allow
fentanyl to be absorbed across the lining of the mouth.
When you get an episode of breakthrough pain, take the dose advised
by your doctor as follows:
• If your mouth is dry, take a sip of water to moisten it. Spit out or
swallow the water.
• Remove the tablet(s) from the blister pack immediately before use.
• Peel back the tab of the foil top of one blister and gently remove the
tablet. Do not try to push Recivit sublingual tablets through the foil top.
• Place the tablet under your tongue as far back as you can and let it
dissolve completely.
• Recivit will dissolve rapidly under the tongue and be absorbed in order
to provide pain relief. It is therefore important that you do not suck,
chew or swallow the tablet.
• After 30 minutes, if pieces of the tablet remain, they may be swallowed.
• You should not drink or eat anything until the tablet has completely
dissolved under your tongue.
If you take more Recivit than you should
• remove any remaining tablets from your mouth,
• tell your caregiver or another person what has happened,
• you or your caregiver should immediately contact your doctor,
pharmacist or local hospital and discuss what action to take.
Symptoms of overdose include altered mental status, loss of
consciousness, extreme drowsiness, slow and shallow breathing. If
these occur, seek emergency medical help immediately.
Note to caregivers
While waiting for the doctor:
– keep the person awake by talking to or shaking her/him now and then,
– make sure the person has free airways and is breathing.
If you think someone has taken Recivit by accident seek emergency
medical help immediately.
If you forget to take Recivit
Do not take a double dose to make up for a forgotten tablet.
If you stop using Recivit
You should discontinue Recivit when no longer required. You should
continue to take your usual opioid medicine to treat your persistent pain
and you may contact your doctor to confirm its correct dose.
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.
The most serious side effects are
• severe breathing problems (uncommon, may affect up to 1 in
100 people),
• low or extremely low blood pressure and shock.
If you become very sleepy and/or experience any of the above
mentioned side effects, you should stop taking Recivit and you or
your caregiver should contact your doctor immediately and call for
emergency help.
Very common (may affect more than 1 in 10 people):
• nausea,
• constipation,
• sleepiness,
• sedation,
• dizziness.
Common (may affect up to 1 in 10 people):
• confusion, anxiety, seeing or hearing things that are not really there
(hallucinations), abnormal thinking,
• asthenia (weakness),
• headache, muscle jerks, feeling of dizziness or “spinning”, loss of
consciousness,
• dry mouth, taste alteration,
• low blood pressure,
• vomiting, abdominal pain, indigestion,
• sweating, itchy skin,
• accidental injury (for example, falls).
Uncommon (may affect up to 1 in 100 people):
• decreased appetite, wind, abdominal bloating, tooth decay, blockage
of the gut (ileus),
• malaise
• tingling or numbness, difficulty coordinating movements, convulsion
(fits), coma,
• abnormal dreams, feeling detached, depression, mood swings,
excessive feeling of well being,
• shortness of breath,
• blurred or double vision,

• skin rash, increased or altered sensitivity to touch,
• difficulty passing urine.
Not known (frequency cannot be estimated from the available data):
• flushing, feeling warm
• diarrhoea
• receding gums, tooth loss
• fatigue
• swelling of arms and legs.
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 the Yellow Card Scheme at:
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 Recivit
The pain-relieving medicine in Recivit is very strong and could
be life-threatening if taken accidentally by a child. 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
carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage
conditions.
Store in the original blister package, in order to protect from light.
Keep Recivit in a locked storage space.
Do not store the tablet once removed from the blister package.
Unused or partially used remaining products must not be disposed of
via wastewater or household waste. It should be taken, if possible, to
your pharmacist to be disposed of safely. This is a safety precaution
and it will also help protect the environment.
6. Contents of the pack and other information
What Recivit contains
• The active substance is: fentanyl.
Each sublingual tablet contains 67, 133, 267, 400, 533 or
800 micrograms of fentanyl (as citrate).
• The other ingredients (exipients) are: calcium hydrogen phosphate
anhydrous, microcrystalline cellulose, disodium phosphate anhydrous,
hypromellose, macrogol, magnesium stearate, maltodextrin, titanium
dioxide (E171), triacetin, printing ink (shellac, iron oxide black (E172)).
What Recivit looks like and contents of the pack
Recivit 67 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘0’ in black ink on one face.
Recivit 133 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘1’ in black ink on one face.
Recivit 267 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘2’ in black ink on one face.
Recivit 400 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘4’ in black ink on one face.
Recivit 533 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘5’ in black ink on one face.
Recivit 800 micrograms is a white, convex, triangular tablet, height of
5.6 mm, printed with ‘8’ in black ink on one face.
The Recivit sublingual tablets are available in a peelable, child resistant
blister, with pack sizes of 3, 4, 15 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Grünenthal Ltd
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex
UB11 1BD
United Kingdom
Manufacturer
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
This medicinal product is authorised in the Member States of the
EEA under the following names:
Sweden: Fentacan 67 mikrogram / 133 mikrogram / 267 mikrogram /
400 mikrogram / 533 mikrogram / 800 mikrogram
sublinguala resoribletter

Other formats of this leaflet
A service is available 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: Recivit 67 micrograms sublingual tablets
• Reference number: PL 21727/0057
• Product Name: Recivit 133 micrograms sublingual tablets
• Reference number: PL 21727/0058
• Product Name: Recivit 267 micrograms sublingual tablets
• Reference number: PL 21727/0059
• Product Name: Recivit 400 micrograms sublingual tablets
• Reference number: PL 21727/0060
• Product Name: Recivit 533 micrograms sublingual tablets
• Reference number: PL 21727/0061
• Product Name: Recivit 800 micrograms sublingual tablets
• Reference number: PL 21727/0062
This leaflet was last revised in April 2014

93018686

50/000/23

SCHWARZ
Name:

GI RECIVIT TABLETTEN
9 pt

Größe:

150 X 315 MM

Sprache:

EN

Faserlauf:

315 MM

Code:



SCHWARZ

Datum:

17.04.2014

Artikel-Nr.:

93018686

Druckfarbe:

Klass.-Nr.:

50/000/23

Flattermarken:

Bez. der Vorgängerdatei:

93017612

Vorgängerdatei gelöscht:



Leistungsindex:



RZ geprüft:

MINI/X3

Mazur

V2

Expand view ⇕

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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