ADEPEND 50 MG FILM-COATED TABLETS

Active substance: NALTREXONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Adepend 50 mg filmcoated tablets
(Naltrexone hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it onto others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Adepend 50 mg filmcoated tablets are and what they are used for
2.
Before you take Adepend 50 mg filmcoated tablets
3.
How to take Adepend 50 mg filmcoated tablets
4.
Possible side effects
5.
How to store Adepend 50 mg filmcoated tablets
6.
Further 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 filmcoated 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 filmcoated tablets do not cause dependency.

2.

BEFORE YOU TAKE ADEPEND 50 MG FILMCOATED TABLETS

Do not take Adepend 50 mg filmcoated tablets
if you are allergic (hypersensitive) to Naltrexone hydrochloride or any of the other ingredients of
Adepend 50 mg filmcoated tablets
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
Take special care with Adepend 50 mg filmcoated tablets
Your treatment should be started and supervised by a physician experienced in treatment of
alcohol addiction.
You must inform every doctor treating you that you are taking Adepend 50 mg filmcoated tablets.
Adepend 50 mg filmcoated tablets may cause life-threatening withdrawal symptoms to opioidaddicted patients
Please inform your doctor if you are suffering from liver or kidney diseases.
Liver function tests should be conducted before and during therapy.
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If you go for any blood tests, inform your doctor that you are taking Adepend 50 mg filmcoated
tablets as these tablets can affect the results of liver function tests.
During treatment with Adepend 50 mg filmcoated tablets painful conditions should not be treated
with opioids.
After treatment with Adepend 50 mg filmcoated 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 opioid-addiction:
Do not take opioids after use of Adepend 50 mg filmcoated tablets.
Although Adepend 50 mg filmcoated tablets inhibit the opioid-effect there might be opioids in
your body when efficacy of Adepend 50 mg filmcoated tablets has already decreased.
Accidentially overdosages might have severe or fatal consequences (respiratory depression).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
During treatment with Adepend 50 mg filmcoated 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 a close attention by an experienced physician is strictly required because respiratory
depression, circulatory disturbance and other symptoms (itching and other skin manifestations) might be
stronger and longer lasting.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The doctor has to decide whether Adepend 50 mg filmcoated tablets can be taken during pregnancy and
lactation considering the risk for mother and child.
Driving and using machines
Driving vehicles should be avoided.
Do not use any tools or machines since Adepend 50 mg filmcoated tablets may impair the mental and
physical abilities.
Important information about some of the ingredients of Adepend 50 mg filmcoated tablets
This medicine contains 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 FILMCOATED TABLETS

Use in adults and elderly
Always take Adepend 50 mg filmcoated tablets exactly as your doctor has told you. Please ask 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 filmcoated 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 diseases. He has to decide whether
the dosage of Adepend 50 mg filmcoated tablets will be adjusted or the treatment discontinued.

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Method of administration
Adepend 50 mg filmcoated tablets are taken with a liquid under fasting conditions.
Duration of treatment
The duration of treatment with Adepend 50 mg filmcoated tablets is determined by your doctor. Usually
Adepend 50 mg filmcoated tablets should be taken for at least 3 months, in certain cases prolonged
administration may be necessary.
If you take more Adepend 50 mg filmcoated 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 filmcoated tablets
Do not use a double dosage if you forgot to take Adepend 50 mg filmcoated tablets. Continue as
prescribed.
If you stop taking Adepend 50 mg filmcoated 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, Adepend 50 mg filmcoated tablets can cause side effects, although not everybody
gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
The possible side effects are ranked according to their frequency:
very common: affects more than 1 user in 10
common:

affects 1 to 10 users in 100

uncommon:

affects 1 to 10 users in 1,000

rare:

affects 1 to 10 users in 10,000

very rare:

affects less than 1 user in 10,000

not known:

frequency cannot be estimated from the available data

The following side effects may appear:
Very common:
Anxiety, sleeplessness, headache, sleep disorders, restlessness, nervousness, abdominal pain, abdominal
cramps, nausea, inclination to vomit, joint and muscle pain, feebleness
Common:
Loss of appetite, mental disorder, fatigue, stupor, palpitations, anomalies in the ECG, breathlessness,
dermatitis, libido disorders, thirst, dizziness, increased tear secretion, pain in the chest, diarrhoea,
constipation, urinary retention, rash, pruritus, delayed ejaculation, decreased potency, increased energy,
irritability, weight loss, weight gain, fever, pain, sensation of cold in extremities, hot flashes, heart
palpitations, dyspnoe

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Uncommon:
Oral herpes, athlete’s foot, disease of the lymph nodes, hallucination, confusion, despondency,
depression, paranoia, disorientation, nightmares, restlessness, abnormal dreams, shaking, vision
disorders, irritation and swelling of the eye, photophobia, eye pain or tiredness, colour asthenopia,
oedema, high blood pressure, blood pressure changes, flushing, nasal congestion, nasal disorders,
rinorrhoea, sneezing, disorders of the mouth and throat, increased sputum, sinus disorders, disorders of
the voice, coughing, yawning, flatulence, haemorrhoids, ulcus, mouth dryness, hepatic disorders,
increased bilirubin levels, hepatitis, seborrhea, acne, hair loss, groin pain, abnormally frequent urination,
painful urination, tinnitus, tremor, vertigo, ear pain
Rare:
Decreased number of blood platelets, unconsciousness, speech disorders, ,depression, suicidal ideation,
attempted suicide
Very rare:
Breakdown of skeletal muscle tissue

5.

HOW TO STORE ADEPEND 50 MG FILMCOATED TABLETS

Keep out of the reach and sight of children.
Do not store above 25 °C.
Store in the original package in order to protect from light.
Do not use Adepend 50 mg filmcoated tablets after the expiry date which is stated on the blister and
carton.
If you notice any defects in the tablets such as chipped or broken tablets, ask your doctor or pharmacist
for advice before taking them.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Adepend 50 mg filmcoated tablets contain
The active substance is naltrexone hydrochloride.
Each tablet contains 50 mg naltrexone hydrochloride.
The other ingredients are
Core of tablet
Lactose monohydrate, powdered cellulose, microcrystalline cellulose, silica colloidal anhydrous,
crospovidone, magnesium stearate
Cover of tablet
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 filmcoated tablets look like and contents of the pack
Beige filmcoated tablets with a break-score on each side.
The tablet can be divided into equal halves.
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Adepend 50 mg filmcoated 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
Manufacturer:
Haupt Pharma GmbH, 82515 Wolfratshausen, Germany.
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 Film-coated tablets
The leaflet was last approved in 12/2011
The following information is intended for medical or healthcare professionals only:
In case of overdosage patients should be supervised permanently and treated symptomatically.

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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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