18 mg film-coated tablets
nalmefene
What Selincro is and what it is 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 two weeks after the first appointment with their doctor.
Alcohol dependence occurs when a person has a physical or mental dependence on consuming alcohol.
High alcohol consumption is defined as drinking more than 60 g / day of pure alcohol for men and more than 40 g / day for women. As an example, a bottle of wine (750 ml; 12% alcohol volume) contains about 70 g of alcohol and a bottle of beer (330 ml; 5% alcohol volume) contains about 13 g of alcohol.
Your doctor has prescribed Selincro because you were unable to reduce your alcohol consumption on your own. Your doctor will give you the advice to help you complete your treatment and thus reduce your alcohol consumption.
Selincro works by influencing processes in the brain that control your desire to continue drinking.
High alcohol consumption is associated with increased health risks and social problems. Selincro can help you reduce the amount of alcohol you drink and keep your alcohol consumption at a lower level.
What you need to know before using Selincro
Do not use 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, e.g. methadone or buprenorphine or painkillers (such as morphine, oxycodone, or other opioids )
- if you are or have recently been addicted to opioids. You may experience acute withdrawal symptoms (such as nausea, vomiting, tremors, sweating, and anxiety) from opioids.
- if you experience or suspect that you are experiencing withdrawal symptoms from opioids
- if your liver or kidney function is impaired
- if you experience or have recently experienced symptoms of alcohol withdrawal (such as visual, auditory, or sensory hallucinations, seizures, and tremors)
Warnings and cautions
Talk to your doctor or pharmacist before taking Selincro. Inform your doctor about any additional illnesses you have, e.g. depression, seizures, liver or kidney disease.
If you and your doctor have decided that your immediate goal is abstinence (not drinking alcohol at all), do not take Selincro, as Selincro is used to reduce alcohol consumption.
If you need immediate medical attention, tell your doctor that you are taking Selincro. Your treatment with Selincro may affect your doctor’s choice of emergency medical care.
If you are going to have a surgical procedure, you should contact your doctor at least one week before the procedure. You may need to temporarily stop taking Selincro.
If you feel absent, see or hear things that do not exist and this recurs for longer than a few days, stop taking Selincro and talk to your doctor.
The increased risk of suicide among alcohol and drug addicts, with or without concomitant depression, is not reduced by taking nalmefene.
If you are 65 years of age or older, talk to your doctor or pharmacist before taking Selincro.
Children and young people
Selincro should not be used by children or adolescents under 18 years of age, as Selincro has not been tested for this age group.
Other drugs and Selincro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Caution should be exercised when using drugs such as diclofenac (an anti-inflammatory drug that treats eg muscle pain), fluconazole ( antibiotics that treat diseases caused by certain types of fungi), omeprazole (drugs that stop the production of acid in the stomach) or rifampicin ( antibiotics ). which treats diseases caused by certain types of bacteria), together with Selincro.
If you are taking opioid-containing medicines, the effects of these medicines will be reduced, or not at all, if you take them with Selincro. These medicines include certain types of medicines for coughs and colds, certain medicines for diarrhea, and strong painkillers.
Selincro with food, drink, and alcohol
Selincro does not prevent the intoxicating effects of alcohol.
Pregnancy, breastfeeding, and fertility
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 Selincro is safe to use during pregnancy and lactation.
Selincro is not recommended if you are pregnant.
If you are breastfeeding, you and your doctor should decide whether to stop breastfeeding or stop treatment with Selincro and then weigh the benefits of breastfeeding your baby against the benefits of your treatment.
Driving and using machines
Side effects such as attention deficit, visual impairment, abnormal feeling, nausea, dizziness, drowsiness, insomnia, and headache may occur at the beginning of treatment with Selincro. The majority of these reactions were mild or moderate and occurred at the beginning of treatment and lasted from a few hours to a few days. These side effects can affect your ability to drive or do things that require your attention, including the use of machinery.
Selincro contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Selincro
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
- The recommended dose is one tablet on those days when you think there is a risk that you will drink alcohol.
- The maximum dose is one tablet a day.
How and when to take the medicine
- Selincro should be taken orally.
- You should take the tablet 1-2 hours before you start drinking alcohol.
- Do not swallow the tablet whole, crush or divide it as Selincro may cause skin sensitization by direct contact with the skin.
- You can take Selincro with or without food.
- You can expect to be able to reduce your alcohol consumption within the first month after starting treatment with Selincro.
- Your doctor will regularly evaluate the treatment with you, e.g. monthly after you start with Selincro, how often depends on your progress. You will decide together how to proceed.
If you use more Selincro than you should
If you think you have taken too many Selincro tablets, contact your doctor or pharmacist or go to the nearest emergency department immediately.
If you forget to use Selincro
If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
If you stop using Selincro
You may be less sensitive to the effects of opioid-containing medicines for a few days after stopping treatment with Selincro.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A few cases with side effects such as vision, hearing or sensory hallucinations, or a feeling of being absent have been reported. However, the frequency of these adverse reactions cannot be calculated from the available data.
The side effects reported with Selincro were mainly mild or moderate, occurring at the beginning of treatment and lasting from a few hours to a few days. If you continue treatment with Selincro or start again after stopping treatment, you will probably not get any side effects. In some cases, it can be difficult to distinguish between side effects and the symptoms you may feel 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)
- nausea
- dizziness
- insomnia
- headache
Common (may affect up to 1 in 10 people)
- loss of appetite
- difficulty sleeping, confusion, restlessness, decreased sexual drive
- drowsiness, twitching in the body, impaired attention, strange feeling in the skin such as numbness and tingling, decreased sensitivity to touch
- rushing heart, a feeling of a fast, powerful, or irregular pulse
- vomiting, dry mouth, diarrhea
- excessive sweating
- muscle spasms
- fatigue, weakness, discomfort or worry, uneasy feeling
- weight loss
Other side effects (can not be calculated from the available data)
- vision, hearing, or sensory hallucinations
- absent feeling
- swelling of the face, lips, tongue, or throat
- hives
- itching
- rash
- reddening of the skin
- muscle pain
- a prolonged erection (priapism)
- Visual impairment (mostly transient)
How to store Selincro
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
- This medicine does not require any special storage instructions.
- Do not use this medicine if you notice any defect in the tablets, e.g. if the tablets are edge-supported or broken.
- 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 to protect the environment.
Contents of the packaging and other information
Content declaration
- Each film-coated tablet contains 18.06 milligrams of nalmefene (as hydrochloride dihydrate).
- Other ingredients are Tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), and magnesium stearate. The film coating consists of hypromellose, macrogol 400, and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Selincro is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet.
The tablet is marked with an “S” on one side.
Selincro is available in packs of 7, 14, 28, 42, 49, or 98 tablets – in blister cards.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
DK-2500 Valby
Denmark
Manufacturer
H. Lundbeck A / S
Ottiliavej 9
DK-2500 Valby
Denmark
Elaiapharm
2881, Route des Crêtes
ZI Les Bouillides
Sophia Antipolis
06560 Valbonne
France