Selincro
nalmefene
nalmefene
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.
What Selincro is and what it is used for
What you need to know before you take Selincro
How to take Selincro
Possible side effects
How to store Selincro
Contents of the pack and other information
Selincro contains the active substance nalmefene.
Selincro is used for the reduction of alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after the first consultation with their doctor.
Alcohol dependence occurs when a person has a physical or psychological dependence on the consumption of alcohol.
A high level of alcohol consumption is defined as drinking more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women. For example, a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Your doctor has prescribed Selincro because you were not able to reduce your alcohol consumption on your own. Your doctor will provide you with counselling to help you keep to your treatment and thereby reduce your alcohol consumption.
Selincro works by affecting processes in the brain that are responsible for your urge to continue drinking.
A high level of alcohol consumption is associated with an increased risk of health and social problems. Selincro can help you reduce the amount of alcohol you drink, and keep the reduced level of alcohol consumption.
if you are allergic to nalmefene or any of the other ingredients of this medicine (listed in section 6)
if you are taking medicines containing opioids, for example, methadone or buprenorphine or pain killers (such as morphine, oxycodone or other opioids)
if you are or have recently been dependent on opioids. You may experience acute opioid withdrawal symptoms (such as feeling sick, vomiting, shakiness, sweating and anxiety)
if you experience, or suspect you are experiencing opioid withdrawal symptoms
if your liver or kidney function is poor
if you are experiencing or have recently experienced several alcohol withdrawal symptoms (such as seeing, hearing or sensing things that are not there, seizures and shakiness)
Talk to your doctor or pharmacist before taking Selincro. Inform your doctor about any other diseases you may have, for example, depression, seizure, 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 because Selincro is indicated for reduction of alcohol consumption.
If you require emergency medical attention, tell your doctor that you are taking Selincro. Your use of Selincro may affect your doctor’s choice of emergency treatment.
If you are going to have a surgical procedure, talk to your doctor at least 1 week before the procedure. You may need to stop taking Selincro temporarily.
If you feel detached from yourself, see or hear things that are not there, and this continues to recur for more than a few days, stop taking Selincro and talk to your doctor.
The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.
If you are 65 years old or above, talk to your doctor or pharmacist before taking Selincro.
Selincro should not be used in children or adolescents below the age of 18 years because Selincro has not been tested in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Caution should be excercised when taking medicines such as diclofenac (antiinflammatory medicine used to treat, for example, muscle pain), fluconazole (antibiotic used to treat diseases caused by some types of fungus), omeprazole (medicine used to block the production of acid in the stomach), or rifampicin (antibiotic used to treat diseases caused by some types of bacteria) together with Selincro.
If you take medicines containing opioids, the effects of these medicines will be reduced, or the medicines may not work at all if you take them together with Selincro. These medicines include certain types of cough and cold medicines, certain medicines for diarrhoea and strong pain killers.
Selincro does not prevent the intoxicating effects of alcohol.
If you are pregnant or breast-feeding, 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 breast-feeding. Selincro is not recommended if you are pregnant.
If you are breast-feeding, you and your doctor should make a decision whether to discontinue breast- feeding or to discontinue Selincro therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to you.
Side effects such as disturbance in attention, visual impairment, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur when beginning Selincro treatment. The majority of these reactions were mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days. These side effects may affect your skills when driving or doing anything that requires you to be alert, including operating machinery.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet on days when you think there is a risk you will drink alcohol
The maximum dose is one tablet per day.
Selincro is for oral use.
You should take the tablet 1-2 hours before you start drinking alcohol.
Swallow the tablet whole, do not crush or divide the tablet because Selincro may cause skin sensitisation when in 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 you start treatment with Selincro.
Your doctor will follow up with you on a regular basis, for example, monthly after you start
treatment with Selincro; the actual frequency will depend on your progress. Together you will decide how to continue.
If you believe you have taken too many Selincro tablets, contact your doctor or pharmacist.
If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
After you stop treatment with Selincro, you may be less sensitive to the effects of medicines containing opioids for a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Few cases of side effects of seeing, hearing or sensing things that are not there or feeling detached from oneself have been reported. However, the frequency of these side effects cannot be estimated from the available data.
The side effects reported with Selincro were mainly mild or moderate, occurred at the beginning of treatment and lasted for a few hours to a few days.
If you continue treatment with Selincro, or start again after a break in treatment, you will probably not
have side effects.
In some cases, it may be difficult for you to distinguish side effects from 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)
feeling sick
dizziness
inability to sleep
headache
Common (may affect up to 1 in 10 people)
loss of appetite
difficulty sleeping, confusion, feeling restless, reduced sex drive
drowsiness, body twitches, feeling less alert, peculiar sensation in the skin like pins and needles, reduced sense of touch
racing heart, a sensation of a rapid, forceful, or irregular beating of the heart
vomiting, dry mouth, diarrhoea
excessive sweating
muscle spasms
feeling of exhaustion, weakness, discomfort or uneasiness, feeling strange
weight loss
Uncommon (may affect up to 1 in 100 people)
seeing, hearing or sensing things that are not there
feeling detached from oneself
Other side effects (cannot be estimated from the available data)
visual impairment (mostly transient)
swelling of face, lips, tongue or throat
hives
itching
rash
redness of skin
muscle pain
prolonged erection (priapism)
If you get 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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) that is printed on the blister and carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice defects in the tablets, such as chipped or broken tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the
environment.
Each film-coated tablet contains 18.06 milligram nalmefene (as hydrochloride dihydrate)
The other ingredients are:
The tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.
The film-coating of the tablet contains: hypromellose, macrogol 400, titanium dioxide (E171).
Selincro is a white, oval, biconvex, film-coated tablet of 6.0 x 8.75 mm. The tablet is engraved with ‘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.
H. Lundbeck A/S Ottiliavej 9
DK-2500 Valby
Denmark
H. Lundbeck A/S Ottiliavej 9
DK-2500 Valby
Denmark
Elaiapharm
2881, Route des Crêtes
Z.I. Les Bouillides Sophia Antipolis 06560 Valbonne France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
H. Lundbeck A/S (Danija) Tel: + 45 36301311
Lundbeck Export A/S Representative Office
Teл.: +359 2 962 4696
Lundbeck S.A.
Tél/Tel: +32 2 535 7979
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600
Lundbeck Pharma A/S Tel: + 45 4371 4270
Charles de Giorgio Ltd Tel: +356 25600500
Lundbeck B.V.
Tel: +31 20 697 1901
Lundbeck Eesti AS Tel: + 372 605 9350
H. Lundbeck AS Tlf: + 47 91 300 800
Lundbeck Hellas S.A.
Τηλ: + 30 210 610 5036
Lundbeck Austria GmbH Tel: +43 1 253 621 6033
Lundbeck España S.A. Tel: +34 93 494 9620
Lundbeck Poland Sp. z o. o. Tel.: + 48 22 626 93 00
Lundbeck SAS
Tél: + 33 1 79 41 29 00
Lundbeck Portugal Lda Tel: +351 21 00 45 900
Lundbeck Croatia d.o.o. Tel: +385 1 644 8264
Lundbeck Romania SRL Tel: +40 21319 88 26
Lundbeck (Ireland) Limited Tel: +353 1 468 9800
Lundbeck Pharma d.o.o. Tel.: +386 2 229 4500
Vistor hf.
Sími: +354 535 7000
Lundbeck Italia S.p.A. Tel: +39 02 677 4171
Oy H. Lundbeck Ab Puh/Tel: + 358 2 276 5000
Lundbeck Hellas A.E
Τηλ.: + 357 22490305
H. Lundbeck AB
Tel: +46 40 699 82 00
H. Lundbeck A/S (Dānija)
Tel: + 45 36301311
Lundbeck (Ireland) Limited Tel: +353 1 468 9800