Adepend

Adepend, 50 mg, film-coated tablets
Naltrexoni hydrochloridum
Please read the following leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Adepend 50 mg film-coated tablets are and what they are used for
2. Important information before taking 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 package and other information

1. WHAT ARE ADEPEND 50 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
Adepend 50 mg film-coated tablets are used as part of a comprehensive treatment program for alcoholism to reduce the risk of relapse, support abstinence, and reduce the craving for alcohol ("desire to drink").
Adepend 50 mg film-coated tablets significantly reduce alcohol consumption by decreasing the urge to drink. A greater number of patients are able to maintain abstinence and remain relapse-free.
Adepend 50 mg in the form of film-coated tablets does not cause dependence.

2. IMPORTANT INFORMATION BEFORE TAKING ADEPEND 50 MG FILM-COATED TABLETS

When not to 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 currently taking opioid medicines
• if you are opioid-dependent (withdrawal has not been successful)
• if you have severe opioid withdrawal symptoms
• if opioid presence is detected in urine tests
• if you experience withdrawal symptoms 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 supervised by a physician experienced in managing alcohol dependence.
• Inform any treating physician that you are taking Adepend 50 mg film-coated tablets.
• Adepend 50 mg film-coated tablets may cause life-threatening withdrawal symptoms in patients dependent on opioids.
• Inform your doctor if you have liver or kidney disease. Liver function tests should be performed before and during treatment.
• If undergoing blood tests, inform your doctor that you are taking Adepend 50 mg film-coated tablets, as they may affect liver function test results.
• Do not use opioid painkillers while taking Adepend 50 mg.
• After treatment with Adepend 50 mg film-coated tablets, patients may experience increased sensitivity to opioid-containing medicines (e.g., opioid-containing cough medicines, opioid-containing cold remedies, or opioid-containing antidiarrheal agents).
• Inform your doctor if you become pregnant.
• For patients with additional opioid dependence: Do not take opioids after using Adepend 50 mg film-coated tablets. Although Adepend 50 mg blocks the effects of opioids, opioids may still be present in the body when the effectiveness of Adepend 50 mg film-coated tablets has decreased. Accidental overdose may lead to severe complications (respiratory depression) or death.

Taking other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During treatment with Adepend 50 mg film-coated tablets, avoid medicines containing opioids, as they may reduce its effectiveness. Inform your doctor if you are taking cough, cold, or antidiarrheal medicines.
Your doctor will prescribe non-opioid alternatives.
If opioid painkillers are required in emergency situations, a higher than normal dose may be needed.
In such cases, strict supervision by an experienced physician is essential, as respiratory depression, circulatory disturbances, and other symptoms (such as itching and other skin reactions) may be more severe and prolonged.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The decision to use Adepend 50 mg film-coated tablets during pregnancy or breastfeeding is made by the physician after weighing the potential risks and benefits for both mother and child.

Driving and operating machinery
Do not drive or operate machinery, as Adepend 50 mg film-coated tablets may impair psycho-physical abilities.

Adepend 50 mg film-coated tablets contain lactose.
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ADEPEND 50 MG FILM-COATED TABLETS

Use in adults and elderly patients
Always take Adepend 50 mg film-coated tablets exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Unless otherwise directed by your doctor, the usual dose is 1 tablet daily.

Use in children and adolescents (under 18 years of age)
Adepend 50 mg film-coated tablets should not be used in children and adolescents under 18 years of age.

Use in patients with liver or kidney disease
Inform your doctor if you have liver or kidney disease. Your doctor must decide whether the dose of Adepend 50 mg film-coated tablets should be adjusted or if treatment should be discontinued.

Method of administration
Adepend 50 mg film-coated tablets should be taken with liquid on an empty stomach.

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

Taking more than the recommended dose of Adepend 50 mg film-coated tablets
In case of overdose, inform your doctor immediately. Other adverse effects not mentioned below are not known.

Missed dose of Adepend 50 mg film-coated tablets
Do not take a double dose to make up for a missed dose. Continue taking the prescribed dose as directed.

Stopping Adepend 50 mg film-coated tablets
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Adepend 50 mg coated tablets can cause adverse reactions, although not everyone experiences them.
If any of the adverse symptoms worsen, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
The following adverse reactions 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, disturbances in sexual desire, thirst, dizziness, increased lacrimation, chest pain, diarrhoea, constipation, rash, delayed ejaculation, erectile dysfunction, increased energy, irritability, cold sensation in limbs, increased sweating, affective disorders.

Uncommon (may affect up to 1 in 100 people):
Cold sores, interdigital fungal infection, lymph node disease, hallucinations, confusion, depressed mood, depression, paranoia, disorientation, nightmares, agitation, disturbances in sexual desire, unusual dreams, hand tremor, somnolence, visual disturbances, eye irritation and swelling, photophobia, eye fatigue or pain, disturbances in colour vision, changes in blood pressure, hot flushes, nasal congestion, nasal discomfort, watery nasal discharge, sneezing, oral and throat disorders, increased salivation, sinus disorders, hoarseness, cough, dyspnoea, yawning, bloating with flatulence, haemorrhoids, ulcers, dry mouth, liver disorders, increased bilirubin concentrations, hepatitis, seborrhoea, acne, alopecia, pruritus, groin pain, frequent urination, painful urination, tinnitus, vertigo of labyrinthine origin, ear pain, ear discomfort, increased appetite, weight loss, weight gain, fever, pain, cold sensation in hands and feet.

Rare (may affect up to 1 in 1,000 people):
Thrombocytopenia, suicidal thoughts, suicide attempts

Very rare (may affect up to 1 in 10,000 people):
Rhabdomyolysis

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE ADEPEND 50 MG FILM-COATED TABLETS

Keep the medicine out of the 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 stated month.
Store below 25°C.
Keep in the original packaging to protect from light.
If any damage to the tablet is noticed, such as a chipped or broken tablet, consult a doctor or pharmacist before taking it.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Adepend 50 mg film-coated tablets contain
The active substance is naltrexone hydrochloride.
Each tablet contains 50 mg of naltrexone hydrochloride.
Other ingredients are:
Tablet core
Lactose monohydrate, powdered cellulose; microcrystalline cellulose, colloidal anhydrous silica,
crospovidone, magnesium stearate
Tablet 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 film-coated tablets look like and contents of the pack
Beige film-coated tablets with a division line on both sides.
The tablet can be divided into equal doses.
Adepend 50 mg film-coated tablets are available in packs of 7, 10, 14, 28, 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Walter Ritter GmbH + Co. KG
Spaldingstraße 110 B
20097 Hamburg
Germany
Manufacturer:
Walter Ritter GmbH + Co. KG
Brüder-Grimm-Straße 121
36396 Steinau an der Straße
Germany
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria
This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

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