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ADEPEND 50 MG FILM-COATED TABLETS

Active substance(s): NALTREXONE HYDROCHLORIDE

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Adepend 50 mg
United Kingdom
package leaflet
09.12.2015
renewal (for MHRA submission)

Art.Nr.: xxxxxx GBx
Weber-Code: xx
Format: 148 x 420 mm
Black

PACKAGE LEAFLET: INFORMATION FOR THE USER
Adepend® 50 mg film-coated tablets
(Naltrexone hydrochloride)
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 onto 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.
In this leaflet:
1. What Adepend® 50 mg film-coated tablets are and what they are used for
2. What you need to know before you take Adepend® 50 mg film-coated tablets
3. How to take Adepend® 50 mg film-coated tablets
4. Possible side effects
5. How to store Adepend® 50 mg film-coated tablets
6. Contents of the pack and other information
1. WHAT ADEPEND® 50 MG FILMCOATED TABLETS ARE AND
WHAT THEY ARE USED FOR
Adepend® is used as part of a
comprehensive
programme
of
treatment
against
alcoholism
to
reduce the risk of relapse, as support
treatment in abstinence and to reduce
the craving for alcohol.
Adepend® 50 mg film-coated tablets
diminish alcohol-intake extensively
because the desire for alcohol is
reduced. More patients are able to
maintain their abstinence and stay
relapse-free.
Adepend® 50 mg film-coated tablets
do not cause dependency.
2. What you need to know
BEFORE YOU TAKE ADEPEND®
50 MG FILM-COATED TABLETS
Do not take Adepend® 50 mg filmcoated tablets
- if you are allergic to Naltrexone
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
- if you are taking opioid-containing
drugs
- if you are opioid-addicted (without
successful withdrawal)
- if you experience acute symptoms of
opioid withdrawal
- if your urine test is positive for opioids
- if
you
experience
withdrawal
symptoms after a naloxone injection
- if you have severe liver problems or
acute hepatitis (inflammation of the
liver)
- if you have severe kidney problems
Warnings and precautions
- Your treatment should be started and
supervised by a physician experienced
in the treatment of alcohol addiction.
- You must inform every doctor treating
you that you are taking Adepend®
50 mg film-coated tablets.
50
mg
film-coated
- Adepend®
tablets may cause life-threatening
withdrawal symptoms to opioidaddicted patients
- Please inform your doctor if you are
suffering from liver or kidney disease.
Liver function tests should be
conducted before and during therapy.
- If you go for any blood tests, inform
your doctor that you are taking
Adepend® 50 mg film-coated tablets
as these tablets can affect the results
of liver function tests.
- During treatment with Adepend®
50 mg film-coated tablets painful
conditions should not be treated
with opioids.
- After treatment with Adepend®
50 mg film-coated tablets you might
be more sensitive to opioid containing
medicines. (e.g. opioid containing
cough medication, opioid containing
medication
for
symptomatic
treatment of common cold or opioid
containing medication for diarrhea
etc.).
- Please inform your doctor if you
become pregnant.
- For patients with additional opioidaddiction:
Do not take opioids after use of
Adepend® 50 mg film-coated tablets.
Although Adepend® 50 mg film-coated
tablets inhibit the opioid-effect there
might be opioids in your body when
efficacy of Adepend® 50 mg filmcoated tablets has already decreased.
Accidental overdoses might have
severe
or
fatal
consequences
(respiratory depression).
Other medicines and Adepend®
film-coated tablets
Tell your doctor or pharmacist if you
are taking/using, have recently taken/

used or might take/use any other
medicines.
During treatment with Adepend® 50 mg
film-coated tablets opioid containing
medicines should be avoided as the
effect might be decreased. Please
inform your doctor if you take drugs
against cough, common cold, diarrhoea
or pain. He will prescribe non-opioid
containing medicines.
If you need opioid analgesia in
emergency situations the dose needed
may be higher than normal.
In this situation close attention
by an experienced physician is
strictly required because respiratory
depression, circulatory disturbance
and other symptoms (itching and other
skin manifestations) might be more
pronounced and longer lasting.
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.
The doctor has to decide whether
Adepend® 50 mg film-coated tablets
can be taken during pregnancy and
lactation considering the risk to mother
and child.
Driving and using machines
Driving vehicles should be avoided.
Do not use any tools or machinery
since Adepend® 50 mg film-coated
tablets may impair your mental and
physical abilities.
50
mg
film-coated
Adepend®
tablets contain lactose. If you have
been told by your doctor that you have
intolerance to some sugars, please
contact your doctor before taking this
medicinal product.
3. HOW TO TAKE ADEPEND® 50 MG
FILM-COATED TABLETS
Use in adults and elderly
Always take Adepend® 50 mg filmcoated tablets exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Unless prescribed by your doctor, the
usual dose is 1 tablet per day.
Use in children and adolescents
(below 18 years).
Adepend® 50 mg film-coated tablets
should not be used in children and
adolescents below 18 years.
Use in patients with liver or kidney
diseases
Please inform your doctor if you are
suffering from liver or kidney disease.
He has to decide whether the dosage
of Adepend® 50 mg film-coated tablets
should be adjusted or the treatment
discontinued.
Method of administration
Adepend® 50 mg film-coated tablets
are taken with some liquid under
fasting conditions.
Duration of treatment
The duration of treatment with
Adepend® 50 mg film-coated tablets
is determined by your doctor. Usually
Adepend® 50 mg film-coated tablets
should be taken for at least 3 months, in
certain cases prolonged administration
may be necessary.
If you take more Adepend® 50 mg
film-coated tablets than you should
In case of overdosage please inform
your doctor. Other side effects as
mentioned below are not known.
If you forget to take Adepend®
50 mg film-coated tablets

Do not take a double dose to make
up for a forgotten dose. Continue as
prescribed.
If you stop taking Adepend® 50 mg
film-coated tablets
Do not stop the treatment without
consulting your doctor.
If you have further questions on the
use of this product, please ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
If any of side effects become serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
The following side effects may appear:
Very common (may affect more than 1
in 10 people):
Anxiety,
sleeplessness,
headache,
restlessness, nervousness, abdominal
pain, nausea, vomiting, joint and
muscle pain, feebleness
Common (may affect up to 1 in 10
people):
Decreased appetite, heart palpitations,
increased heart rate, anomalies in the
ECG, libido disorders, thirst, dizziness,
increased tear secretion, pain in
the chest, diarrhoea, constipation,
rash, delayed ejaculation, erectyle
dysfunction,
increased
energy,
irritability,
increased
sweating,
affective disorder
Uncommon (may affect up to 1 in 100
people):
Oral herpes, athlete’s foot, disease
of the lymph nodes, hallucination,
confusion, despondency, depression,
paranoia, disorientation, nightmares,
agitation, abnormal dreams, shaking,
drowsiness, vision disorders, irritation
and swelling of the eye, photophobia,
eye
pain
or
tiredness,
colour
asthenopia, blood pressure changes,
hot flushes, nasal congestion, nasal
discomfort,
rinorrhoea,
sneezing,
disorders of the mouth and throat,
increased sputum, sinus disorders,
disorders of the voice, coughing,
breathlessness, yawning, flatulence,
haemorrhoids, ulcers, mouth dryness,
hepatic disorders, increased bilirubin
levels, hepatitis, seborrhea, acne, hair
loss, itching, groin pain, abnormally
frequent urination, painful urination,
tinnitus, vertigo, ear pain, ear
discomfort, increased appetite, weight
loss, weight gain, fever, pain, sensation
of cold in arms and legs
Rare (may affect up to 1 in 1,000
people):
Decreased number of blood platelets,
suicidal ideation, attempted suicide
Very rare (may affect up to 1 in 10,000
people):
Breakdown of skeletal muscle tissue
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.

6. contents of the pack and
other INFORMATION
What Adepend® 50 mg film-coated
tablets contain
The active substance is naltrexone
hydrochloride.
Each tablet contains 50 mg naltrexone
hydrochloride.
The other ingredients are
Tablet core
Lactose
monohydrate,
powdered
cellulose, microcrystalline cellulose,
silica colloidal anhydrous, crospovidone,
magnesium stearate
Film-coat
Lactose-monohydrate, hypromellose,
titanium dioxide (E 171), macrogol
4000, black ferric oxide
(E 172), red ferric oxide (E 172), yellow
ferric oxide (E 172)
What Adepend® 50 mg film-coated
tablets look like and contents of
the pack
Beige film-coated tablets with a breakscore on each side.
The tablet can be divided into equal
doses.
Adepend® 50 mg film-coated tablets
are available in packs of 7, 14, and 28
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Orpha-Devel Handels und Vertriebs GmbH,
3002 Purkersdorf, Austria
Manufacturer:
Haupt Pharma GmbH,
82515 Wolfratshausen, Germany
Amomed Pharma GmbH,
1050 Vienna, Austria
This medicinal product is authorised in
the Member States of the EEA under
the following names:
Austria Ethylex 50 mg Filmtabletten
Czech
Republic Adepend® 50 mg
Potahovaná tableta
Denmark Adepend® 50 mg
Filmovertrukket tablet
Germany Adepend® 50 mg
Filmtablette
Hungary Adepend® 50 mg
Filmtabletta
Poland
Adepend® 50 mg Tabletka
powlekana
Slovakia Adepend® 50 mg Filmom
obalená tableta
Slovenia Adepend® 50 mg Filmsko
obložena tableta
United
Kingdom Adepend® 50 mg Filmcoated tablets
The leaflet
05/2015

was

last

approved

in

The following information is intended
for medical or healthcare professionals
only:
In case of overdosage patients should
be supervised permanently and treated
symptomatically.

5. HOW TO STORE ADEPEND®
50 MG FILM-COATED TABLETS
Keep out of sight and reach of children.
Do not use Adepend® 50 mg film-coated
tablets after the expiry date which is
stated on the blister and carton.
Do not store above 25°C.
Store in the original package in order
to protect from light.
If you notice any defects in the tablets
such as chipped or broken tablets, ask
your doctor or pharmacist for advice
before taking them.
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.

xxxxxx GBx

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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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