SELINCRO 18 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Selincro 18 mg Film-Coated Tablets

nalmefene

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 on to 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.

Contents of the pack

1. What is Selincro and what is it used for
2. What you need to know before you take Selincro
3. How to take Selincro
4. Possible side effects
5. Storage of Selincro
6. Contents of the pack and other information

1. What is Selincro and what is it used for

Selincro contains the active substance nalmefene.

Selincro is used to reduce alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after the initial assessment by their doctor.

Alcohol dependence occurs when a person has a physical or psychological dependence on drinking alcohol.

A high level of alcohol consumption is defined as drinking more than 60 grams of pure alcohol per day for men and more than 40 grams of pure alcohol per day for women. For example, a bottle of wine (750 ml; 12% vol.) contains approximately 70 grams of alcohol and a bottle of beer (330 ml; 5% vol.) contains approximately 13 grams of alcohol.

Your doctor has prescribed Selincro because you have not been able to reduce your alcohol consumption on your own. Your doctor will give you advice to help you comply with the treatment and, thereby, help you reduce your alcohol consumption.

Selincro works by acting on the brain processes responsible for your desire to continue drinking alcohol.

A high level of alcohol consumption is associated with a greater risk of health and social problems.

Selincro can help you reduce your alcohol consumption and maintain a reduced level of alcohol consumption.

2. What you need to know before you take Selincro

Do not take Selincro:

• If you are allergic to nalmefene or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines that contain opioids, such as methadone, buprenorphine, or painkillers (such as morphine, oxycodone, or other opioids).
• If you have or have recently had opioid dependence, as you may experience acute opioid withdrawal symptoms (such as nausea, vomiting, tremors, sweating, and anxiety).
• If you are experiencing or suspect you are experiencing opioid withdrawal symptoms.
• In case of liver or kidney function impairment (liver or kidney malfunction).
• If you are experiencing or have recently experienced several symptoms of alcohol withdrawal (such as seeing, hearing, or feeling things that do not exist, convulsions, and tremors).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Selincro. Inform your doctor about any other illness you suffer from, such as depression, seizures, liver or kidney disease.

If you and your doctor have decided that your immediate goal is abstinence (not drinking any alcohol), you should not take Selincro as it is indicated for reducing alcohol consumption.

If you require urgent medical attention, inform your doctor that you are taking Selincro. The use of Selincro may influence the choice of emergency treatment.

If you are scheduled to undergo surgery, consult your doctor at least 1 week before the procedure. You may need to temporarily discontinue treatment with Selincro.

If you feel strange, see or hear things that do not exist, and this happens repeatedly over several days, discontinue Selincro and consult your doctor.

The increased risk of suicide in people with excessive alcohol consumption or drug addiction, with or without depression, is not reduced by taking nalmefene.

If you are 65 years of age or older, consult your doctor or pharmacist before starting to take Selincro.

Children and adolescents

Selincro should not be used in children or adolescents under 18 years of age as Selincro has not been evaluated in this age group.

Taking Selincro with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Caution is advised when taking medicines such as diclofenac (an anti-inflammatory medicine used to treat, for example, muscle pain), fluconazole (a medicine used to treat diseases caused by some types of fungi), omeprazole (an agent used to block acid production in the stomach), or rifampicin (an antibiotic used to treat diseases caused by some types of bacteria) with Selincro.

If you take medicines that contain opioids, their effect may be reduced or they may not have any effect if taken with Selincro. These types of medicines include some types of cough and cold preparations, certain medicines for diarrhea, and potent painkillers.

Taking Selincro with food and alcohol

Selincro does not prevent the effects of alcohol intoxication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if the use of Selincro is safe during pregnancy and breastfeeding.

If you are pregnant, it is not recommended to take Selincro.

If you are breastfeeding, you and your doctor must decide whether to discontinue breastfeeding or discontinue Selincro treatment, considering the benefit of breastfeeding to the child and the benefit of treatment to you.

Driving and using machines

Side effects such as attention disorders, visual disturbances, abnormal sensations, nausea, dizziness, drowsiness, insomnia, and headache may occur at the start of treatment with Selincro. Most of these reactions were mild or moderate, occurred at the start of treatment, and lasted from a few hours to a few days. These side effects may affect your ability to drive or perform any activity that requires you to be alert, including the use of machines.

Selincro contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Selincro

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Posology

• The recommended dose is one tablet per day when you perceive a risk of alcohol consumption.
• The maximum dose is one tablet per day.

How and when to take it

• Selincro is for oral use.
• You should take the tablet 1-2 hours before alcohol consumption.

• Swallow the tablet whole. Do not break or crush it because Selincro may cause skin sensitization when it comes into direct contact with the skin.
• You can take Selincro with or without food.
• You may expect to be able to reduce your alcohol consumption during the first month after starting treatment with Selincro.
• Your doctor will regularly monitor you, for example, monthly from the start of treatment with Selincro; the actual frequency will depend on your progress. Together, you will decide how to proceed.

If you take more Selincro than you should

If you think you have taken more Selincro tablets than you should, inform your doctor or pharmacist.

If you forget to take Selincro

If you have started drinking alcohol without taking Selincro, take a tablet as soon as possible.

If you stop taking Selincro

When you stop taking Selincro, you may be less sensitive to the effects of medicines that contain opioids for a few days.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Selincro can cause side effects, although not everybody gets them.

Side effects related to seeing, hearing, or feeling things that are not there or feeling strange are uncommon (may affect up to 1 in 100 people). If you experience any of these side effects, consult your doctor.

The side effects reported with Selincro were mainly mild or moderate, occurred at the start of treatment, and lasted from a few hours to a few days.

If you continue treatment with Selincro or resume it after an interruption, it is likely that you will not experience side effects.

In some cases, it may be difficult to distinguish between side effects and symptoms you may experience when reducing alcohol consumption.

The following side effects have been observed with Selincro:

Very common (may affect more than 1 in 10 people):

• dizziness
• dizziness
• sleeplessness
• headache

Common (may affect up to 1 in 10 people):

• loss of appetite
• difficulty sleeping, confusion, restlessness, reduced libido
• drowsiness, body tremors, feeling less alert, strange sensation in the skin such as tingling, reduced sense of touch
• rapid heartbeat, sensation of rapid or irregular heartbeat
• vomiting, dry mouth, diarrhea
• excessive sweating
• muscle spasms
• feeling of fatigue, weakness, discomfort, or restlessness, feeling of strangeness
• weight loss

Other side effects of unknown frequency (frequency cannot be estimated from the available data):

• visual disturbance (mainly transient)
• facial swelling, lips, tongue, or throat
• urticaria
• itching
• rash
• redness of the skin
• muscle pain
• prolonged erection (priapism)

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Selincro

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the blister and carton after EXP or CAD. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any visible signs of deterioration of the tablets, such as cracked or broken tablets.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Selincro

• Each film-coated tablet contains 18.06 mg of nalmefene (as dihydrochloride dihydrate).
• The other ingredients are:

Core of the tablet: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.

The film coating contains: hypromellose, macrogol 400, titanium dioxide (E171).

Appearance and packaging

Selincro is a white, oval, biconvex film-coated tablet, 6.0 x 8.75 mm in size.

The tablet is engraved with "S" on one side.

Selincro is available in packs of 7, 14, 28, 42, 49, or 98 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder

• Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

Denmark

Manufacturer

• Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

Denmark

Elaiapharm

2881, Route des Crêtes

Z.I. Les Bouillides

Sophia Antipolis

06560 Valbonne

France

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Date of last revision of this leaflet: 01/2025