Selincro 18mg Comp Pell 7 X 18mg

Talk to your doctor or pharmacist before taking Selincro. Tell your doctor about any other medical conditions you may have, such as depression, seizures, liver or kidney disease.

If you and your doctor have decided that abstinence (not drinking alcohol at all) is your immediate goal, you should not take Selincro because Selincro is used to reduce alcohol consumption.

If you need urgent medical attention, tell your doctor that you are taking Selincro. Your doctor will need to take your treatment with Selincro into account when choosing your emergency treatment.

If you are planning to have surgery, consult your doctor at least one week before the procedure. You may need to temporarily stop taking Selincro.

If you do not feel like yourself, if you see or hear things that are not there, and if this situation continues for several days, stop taking Selincro and talk to your doctor.

The risk of suicide, which is increased by alcohol and substance abuse, whether or not associated with depression, is not reduced by taking nalmefene.

If you are 65 years of age or older, tell your doctor or pharmacist before taking Selincro.

Children and adolescents

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

Other medicines and Selincro

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

If you take opioid medications while taking Selincro, the effects of these medications will be reduced, or these medications may not work at all. These medications include certain types of cough and cold medications, some antidiarrheals, and strong pain relievers.

Selincro with food and alcohol

Selincro does not prevent the intoxicating effects of alcohol.

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 taking Selincro is safe during pregnancy and breastfeeding.

Selincro is not recommended if you are pregnant.

If you are breastfeeding, you and your doctor should decide whether to discontinue breastfeeding or to discontinue treatment with Selincro, taking into account the benefit of breastfeeding for your child and the benefit of treatment for you.

Driving vehicles and using machines

Side effects such as disturbance in attention, visual disturbances, feeling abnormal, nausea, dizziness, drowsiness, insomnia, and headache may occur when starting treatment with Selincro. The majority of these effects were mild or moderate; they occurred at the beginning of treatment and lasted from a few hours to a few days. These side effects may affect your ability to drive or do any activity requiring alertness, including operating machinery.

Selincro contains lactose

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

Réduction de la consommation d'alcool chez les patients adultes ayant une dépendance à l'alcool avec une consommation d'alcool à risque élevé, ne présentant pas de symptômes physiques de sevrage et ne nécessitant pas un sevrage immédiat.

Chaque comprimé pelliculé contient 18,06 mg de nalméfène (sous forme de chlorhydrate dihydrate).

Excipient à effet notoire

Chaque comprimé pelliculé contient 60,68 mg de lactose.

Pour la liste complète des excipients, voir rubrique 6.1.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Caution should be exercised if you are taking other medicines such as diclofenac (an anti-inflammatory medicine used, for example, to treat muscle pain), fluconazole (a medicine used to treat infections caused by certain types of fungi), omeprazole (a medicine used to block the production of acid in the stomach), or rifampicin (an antibiotic used to treat infections caused by certain types of bacteria) with Selincro. If you take opioid medications while taking Selincro, the effects of these medications will be reduced, or these medications may not work at all. These medications include certain types of cough and cold medications, some antidiarrheals, and strong pain relievers.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects of seeing, hearing, or smelling things that are not there, or feeling like you are not yourself, 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 are mostly mild or moderate. If they occur, they occur early in treatment and last from a few hours to a few days. If you continue treatment with Selincro, or if you restart it after stopping it, you will probably not experience side effects. In some cases, you may have difficulty distinguishing side effects from the symptoms you may experience when you reduce your alcohol consumption. The following side effects have been reported with Selincro: Very common (may affect more than 1 in 10 people) to feel sick feeling of dizziness inability to sleep headaches Common (may affect up to 1 in 10 people) loss of appetite difficulty sleeping, confusion, feeling like you can't sit still, decreased libido drowsiness, tremors, decreased attention, strange sensations on the skin such as tingling, reduced sense of touch very fast heart rate, feeling of fast, pounding, or irregular heartbeats vomiting, dry mouth, diarrhea excessive sweating muscle contractions feeling tired, weak, unwell, feeling out of sorts weight loss. Other adverse reactions (frequency cannot be estimated from the available data) visual disturbances (usually transient) swelling of the face, lips, tongue, or throat urticaria itching rash skin redness 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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine. Belgium: Federal Agency for Medicines and Health Products www.afmps.be Vigilance Division: Website: www.notifieruneffetindesirable.be e-mail: adr@fagg-afmps.be Luxembourg: Regional Pharmacovigilance Centre of Nancy or Pharmacy and Medicines Division of the Health Directorate Website: www.guichet.lu/pharmacovigilance

Never 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 medications containing opioids, such as methadone or buprenorphine or certain pain relievers (such as morphine, oxycodone or other opioids); - if you are addicted or have recently been addicted to opioids. You may experience acute opioid withdrawal symptoms (such as nausea, vomiting, tremors, sweating, and anxiety); - if you experience or think you may experience withdrawal symptoms; - if your liver or kidneys are not functioning properly; - if you are experiencing or have recently experienced several symptoms of alcohol withdrawal (such as seeing, hearing, or feeling things that are not there, seizures, or tremors).

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 taking Selincro is safe during pregnancy and breastfeeding.

Selincro is not recommended if you are pregnant.

If you are breastfeeding, you and your doctor should decide whether to discontinue breastfeeding or to discontinue treatment with Selincro, taking into account the benefit of breastfeeding for your child and the benefit of treatment for you.

Adultes

• Chaque jour où le patient perçoit le risque de boire de l'alcool: 1 comprimé
• Si le patient a commencé à boire de l'alcool avant la prise de Selincro, il devra prendre un comprimé dès que possible
• Dose maximale: 1 comprimé par jour

Mode d'administration

• De préférence 1 à 2 heures avant le moment où le patient anticipe une consommation d'alcool
• Peut être pris pendant ou en dehors des repas