Adepend

PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET: USER INFORMATION

Adepend, 50 mg, coated tablets

Naltrexone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Adepend 50 mg coated tablets are and what they are used for
• 2. Important information before taking Adepend 50 mg coated tablets
• 3. How to take Adepend 50 mg coated tablets
• 4. Possible side effects
• 5. How to store Adepend 50 mg coated tablets
• 6. Contents of the pack and other information

1. WHAT ARE ADEPEND 50 MG COATED TABLETS AND WHAT ARE THEY USED FOR

Adepend 50 mg coated tablets are used as part of a comprehensive treatment program for alcohol dependence to reduce the risk of relapse, as a supportive medication for abstinence, and to reduce the need to drink alcohol ("craving").
Adepend 50 mg coated tablets significantly reduce alcohol consumption by reducing the feeling of need to drink. A greater number of patients are able to maintain abstinence and remain relapse-free.
Adepend 50 mg in the form of coated tablets is not addictive.

2. IMPORTANT INFORMATION BEFORE TAKING ADEPEND 50 MG COATED TABLETS

When not to take Adepend 50 mg coated tablets:

• if the patient is allergic to naltrexone hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if the patient is currently taking opioid medications
• if the patient is dependent on opioids (has not been able to stop taking them)
• if severe opioid withdrawal symptoms are present
• if opioids are detected in the urine test
• if withdrawal symptoms occur after naloxone injection
• in case of severe liver disorders or acute hepatitis
• in case of severe kidney disorders

Warnings and precautions

• Treatment should be initiated and controlled by a doctor experienced in the treatment of alcohol dependence.
• The patient should inform any doctor treating them that they are taking Adepend 50 mg coated tablets.
• Adepend 50 mg coated tablets may cause life-threatening withdrawal symptoms in patients dependent on opioids.
• The patient should inform their doctor about any existing liver or kidney disease. Liver function tests should be performed before starting treatment and during its duration.
• If the patient is scheduled for any blood tests, they should inform their doctor that they are taking Adepend 50 mg coated tablets, as they may affect the results of liver function tests.
• During treatment with Adepend 50 mg, the patient should not be treated for pain with opioids.
• After treatment with Adepend 50 mg coated tablets, the patient may experience increased sensitivity to opioid-containing medications (e.g., cough medicines, cold medicines, or anti-diarrheal medicines, etc.).
• The patient should inform their doctor if they become pregnant.
• For patients with additional opioid dependence: Do not take opioids after taking Adepend 50 mg coated tablets. Although Adepend 50 mg coated tablets block the effects of opioids, they may still be present in the body when the effectiveness of Adepend 50 mg coated tablets is already reduced. Accidental overdose can lead to severe disorders (respiratory depression) or death.

Taking other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
During treatment with Adepend 50 mg coated tablets, the patient should avoid taking opioid-containing medications, as they may reduce the effectiveness of Adepend 50 mg coated tablets. The patient should inform their doctor about taking cough medicines, cold medicines, or anti-diarrheal medicines.
The doctor will then prescribe non-opioid medications.
In case of necessity to use opioid painkillers in emergency situations, a higher dose may be required than usual.
In this situation, absolutemonitoring by an experienced doctor is required, as respiratory failure, circulatory disorders, and other symptoms (itching and other skin changes) may be more severe and prolonged.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The decision to use Adepend 50 mg coated tablets during pregnancy and breastfeeding is made by the doctor, after considering the associated risks and benefits for the mother and child.

Driving and using machines

The patient should not drive vehicles, as Adepend 50 mg coated tablets may impair psychophysical abilities. The patient should not use any tools or operate any machines.

Adepend 50 mg coated tablets contain lactose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. HOW TO TAKE ADEPEND 50 MG COATED TABLETS

Use in adults and the elderly

Adepend 50 mg coated tablets should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Unless the doctor prescribes otherwise, the patient usually takes 1 tablet per day.

Use in children and adolescents (under 18 years of age)

Adepend 50 mg coated tablets should not be used in children and adolescents under 18 years of age.

Use in patients with liver or kidney disease

The patient should inform their doctor about any existing liver or kidney disease. The doctor must decide whether to adjust the dose of Adepend 50 mg coated tablets or discontinue treatment.

Method of administration

Adepend 50 mg coated tablets should be taken with a liquid, on an empty stomach.

Duration of treatment

The duration of treatment with Adepend 50 mg coated tablets is determined by the doctor. Adepend 50 mg coated tablets should usually be taken for at least 3 months, although in some cases, prolonged administration of the medicine may be necessary.

Taking a higher dose of Adepend 50 mg coated tablets than recommended

In case of overdose, the patient should inform their doctor. Other side effects, apart from those mentioned below, are not known.

Missing a dose of Adepend 50 mg coated tablets

The patient should not take a double dose to make up for a missed dose. The patient should continue taking the prescribed dose.

Stopping treatment with Adepend 50 mg coated tablets

The patient should not stop treatment without consulting their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Adepend 50 mg coated tablets can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if the patient notices any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
The following side effects may occur:
Very common (may affect more than 1 in 10 people):
Anxiety, insomnia, headache, restlessness, nervousness, abdominal pain, nausea, vomiting, joint and muscle pain, weakness.
Common (may affect up to 1 in 10 people):
Decreased appetite, palpitations, increased heart rate, ECG abnormalities, sexual dysfunction, craving, dizziness, increased lacrimation, chest pain, diarrhea, constipation, rash, delayed ejaculation, erectile dysfunction, increased energy, irritability, feeling of cold in the limbs, increased sweating, affective disorders.
Uncommon (may affect up to 1 in 100 people):
Cold sore, interdigital fungal infection, lymph node disease, hallucinations, confusion, depression, paranoia, disorientation, nightmares, agitation, sexual dysfunction, unusual dreams, hand tremors, somnolence, vision disturbances, eye irritation and swelling, photophobia, eye fatigue or pain, color vision disturbances, changes in blood pressure, hot flashes, nasal congestion, nasal discomfort, runny nose, sneezing, oral and pharyngeal diseases, increased salivation, sinusitis, hoarseness, cough, dyspnea, yawning, bloating with gas discharge, hemorrhoids, ulcers, dry mouth, liver disease, increased bilirubin levels, hepatitis, seborrhea, acne, hair loss, pruritus, groin pain, frequent urination, painful urination, tinnitus, vertigo, ear pain, ear discomfort, increased appetite, weight loss, weight gain, fever, pain, feeling of cold in the hands and feet.
Rare (may affect up to 1 in 1,000 people): Decreased platelet count, suicidal thoughts, suicide attempts
Very rare (may affect up to 1 in 10,000 people): Muscle tissue breakdown

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE ADEPEND 50 MG COATED TABLETS

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store in the original package to protect from light.
If the patient notices any damage to the tablets, such as a broken or split tablet, they should consult their doctor or pharmacist before taking it.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Adepend 50 mg coated tablets contain

The active substance is naltrexone hydrochloride.
Each tablet contains 50 mg of naltrexone hydrochloride.

Other ingredients

Core:
Lactose monohydrate, cellulose powder; microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate
Coating:
Lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172)

What Adepend 50 mg coated tablets look like and contents of the pack

Beige coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Adepend 50 mg coated tablets are available in packs of 7, 10, 14, 28, 30, and 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Walter Ritter GmbH +Co.KG
Spaldingstr. 110 B
20097 Hamburg
Germany
Manufacturer:
AOP Orphan Pharmaceuticals GmbH,
Leopold-Ungar-Platz 2
1190 Vienna
Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Information intended for healthcare professionals only:
In case of overdose, patients should be constantly monitored and treated symptomatically.