SELINKRO  18 mg  tablets

What Selincro and what it is used
Selincro contains active substance nalmefene .
Selincro used to reduce alcohol consumption in adult patients with alcohol dependence who continue to consume large amounts of alcohol two weeks after their first consultation with their doctor.
Alcohol dependence occurs when a person has a physical or psychological dependence on alcohol consumption.
High level of alcohol consumption was 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% of alcohol - volume) contains about 70 g of alcohol and a bottle of beer (330 ml, 5% alcohol content - volume) contains about 13 g of alcohol.
Your doctor has prescribed Selincro, because you did yourself to reduce your alcohol intake . Your doctor will advise to help you stick to the treatment and thus to reduce alcohol consumption.
Selincro helps reduce alcohol consumption by influencing the processes in the brain that are responsible for the desire that makes you continue to drink .
Drinking large amounts of alcohol is associated with an increased risk of health and social problems .
Selincro can help to reduce the amount of alcohol you consume, and will help to keep consumption of less alcohol than before.
No risk to become dependent on Selincro.

2 . What you should know before taking Selincro
Do not take Selincro:
if you are allergic to nalmefene or any other ingredients of this medicine (listed in Section 6) ;
if you are taking medicines containing opioids , such as painkillers ( such as morphine , oxycodone or other opioids ) ;
if you are or have recently been dependent on opioids. You may feel acute withdrawal symptoms (feeling sick , vomiting , tremors , sweating , and anxiety) ;
If you have or suspect you have symptoms of opioid withdrawal ;
if you have liver problems or kidney problems ;
if you have or have recently had a few symptoms of alcohol withdrawal (such as seeing, hearing or feeling things that are not there , twitching and shivering).
Warnings and Precautions
Talk to your doctor or pharmacist before taking Selincro. Tell your doctor about all other diseases you may have , such as depression , seizures, liver or kidney disease .
You should not take Selincro, if you and your doctor have decided that your immediate goal is abstinence ( no alcohol consumption) because Selincro shown to reduce alcohol consumption.
If you need urgent medical attention , tell your doctor that Selincro. That take Selincro can affect the choice of your doctor for emergency treatment .
If you are surgery , talk with your doctor at least one week before. You may need to temporarily stop taking Selincro.
If you feel not yourself , seeing or hearing things that are , and this is repeated more than a few days , stop taking Selincro and contact your doctor.
If you are over 65 years of age , talk to your doctor or pharmacist before you start taking Selincro.

Children and adolescents
Selincro should not be used in children or adolescents under the age of 18 because Selincro was not tested for this age group.

Other medicines and Selincro
Tell your doctor or pharmacist if you are taking , have recently taken or taking other medicines, including medicines obtained without a prescription . Caution must be taken drugs such as diclofenac ( anti-inflammatory drug that is used , e.g., for the treatment of muscle pain) , fluconazole ( an antibiotic used for the treatment of diseases caused by certain types of fungi) , omeprazole ( a drug used to block the production of stomach acid ) or rifampicin ( antibiotic used to treat diseases caused by certain types of bacteria ) with Selincro.
If you are taking medicines containing opioids , their effect will be reduced or might not take effect, if taken together with Selincro. These drugs include certain types of medicines for coughs and colds , certain anti-diarrheal drugs and strong painkillers.

Selincro with food and alcohol
Selincro intoxicated not prevent the effect of the alcohol.

Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine uses .
It is not known whether the use of Selincro is safe during pregnancy and lactation . Selincro not recommended if you are pregnant .
If you are breastfeeding , you and your doctor should decide whether to discontinue nursing or to discontinue therapy Selincro taking into account the benefit of breastfeeding to the child and the benefit of therapy for you.

Driving and using machines
Not explored the effects of this drug on the ability to drive and use machines.
Selincro can cause side effects such as nausea, dizziness, insomnia and headache. The majority of these reactions were mild or moderate , occurred early in treatment and lasted from several hours to several days. These side effects can affect your skills while driving or doing anything that requires you alert , 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.

3 . How to take Selincro
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

What dose Selincro taking
The recommended dose is one tablet on days when you feel you are at risk of alcohol use .
The maximum dose is 1 tablet per day .

How and when to take Selincro
Tablets should be taken 1-2 hours before you start drinking alcohol.
Swallow the tablet whole , do not crush it or divide .
You can take Selincro with or without food.
You can expect to be able to reduce your alcohol intake during the first month after starting treatment with Selincro.
Your doctor will monitor you regularly , such as once a month after starting treatment with Selincro; How often do you check in practice will depend on your progress. Together we will decide how to proceed.

If you take more dose Selincro
If you think you have taken too many tablets Selincro, contact your doctor immediately or go to the nearest emergency department .

If you forget to take Selincro
If you started drinking alcohol without taking Selincro, take one tablet as soon as possible .

If you stop taking Selincro
After discontinuation of Selincro for a few days you may have less sensitivity to the effects of drugs containing opioids.

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

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Have been few reported cases of adverse effects such as seeing, hearing or feeling things that are not there or feeling that you are not yourself . However, the incidence of these side effects can not be estimated from available data.
Adverse reactions reported to and Selincro, were generally mild or moderate, occurred at the start of treatment and lasted from several hours to several days. If you continue treatment Selincro or renew it after a break , you probably will not experience these side effects .
In some cases, you may find it difficult to distinguish adverse events from symptoms that you may experience when you reduce alcohol consumption.

In Selincro the following adverse effects:
Very common , which may affect more than 1 in 10 people :
feeling of nausea ;
dizziness ;
insomnia ;
headache.
Frequent , which may affect up to 1 in 10 people :
loss of appetite ;
sleep problems , confusion, anxiety, decreased libido ;
drowsiness, twitching body , decreased alertness , strange body sensations like pins and needles , decreased sensitivity to touch ;
rapid heart beat , feeling fast, pounding or irregular heartbeat ;
vomiting , dry mouth ;
excessive sweating ;
muscle spasms ;
feeling of exhaustion , weakness , discomfort or inconvenience , you feel strange ;
weight loss.
Other adverse reactions :
seeing, hearing or feeling things that are ;
feeling that you're not yourself .
At present , the available data to determine the incidence of these adverse reactions.

If you get any side effects, tell your doctor or pharmacist. These include all possible side effects not listed in this leaflet .

5 . How to store Selincro
Keep out of reach of children .
Do not use this medicine after the expiry date ( " EXP" ) stated on the blister and carton. The expiry date refers to the last day of that month.
Selincro does not require any special storage conditions .
Do not use this medicine if you notice defects in tablets , such as nicks or broken tablets.
Do not dispose of medications in wastewater or household waste . Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does Selincro
Each tablet contains 18,06 mg of nalmefene (as hydrochloride dihydrate) .

Other ingredients are:
The tablet core : microcrystalline cellulose , anhydrous lactose, crospovidone ( type A), magnesium stearate.
The tablet coating contains hypromellose , macrogol 400, titanium dioxide ( E171 ) .

Selincro looks like and contents of pack
Selincro white, oblong , biconvex tablet with dimensions 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 and 98 tablets.
Not all pack sizes may be marketed.