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Adepend 50 Mg Film-Coated Tablets

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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

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1.    WHAT ADEPEND® 50 MG FILM-COATED 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 film-coated 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.

-    Adepend®    50 mg film-coated

tablets may cause life-threatening withdrawal symptoms to opioid-addicted 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 opioid-addiction:

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 film-coated 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.

Adepend®    50 mg film-coated

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 film-coated 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

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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.

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.

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 break-score 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

Potahovana 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 obalena tableta

Slovenia Adepend® 50 mg Filmsko oblozena tableta

United

Kingdom Adepend® 50 mg Film-coated tablets

The leaflet was last approved in 05/2015

The following information is intended for medical or healthcare professionals only:

In case of overdosage patients should be supervised permanently and treated symptomatically.

xxxxxx GBx