Nalmefen – Selincro tablets

Selincro is an oral medication containing nalmefene — an active substance used to reduce alcohol consumption in adult patients with alcohol dependence.

Selincro acts on processes in the brain responsible for the urge to continue drinking alcohol. As a result:

• Reduces the need to drink — the patient finds it easier to stop after one or two drinks
• Reduces the pleasure from alcohol — drinking no longer provides such intense satisfaction

Important: Unlike aversion therapies (e.g. Anticol), this medication does not enforce complete abstinence, but helps regain control over the amount of alcohol consumed.

Selincro does not prevent alcohol intoxication.

The main indication for Selincro is reducing alcohol consumption in adult patients with alcohol dependence who:

• Maintain a high drinking risk level (according to WHO definition):
  • Men: > 60 g of pure alcohol per day
  • Women: > 40 g of pure alcohol per day
• High consumption persists for 2 weeks after the initial medical consultation
• Do not have physical withdrawal symptoms that would require immediate detoxification
• Do not aim for immediate and complete abstinence

For reference: a bottle of wine (750 ml, 12%) contains approximately 70 g of alcohol; a bottle of beer (330 ml, 5%) contains approximately 13 g of alcohol.

Important: Nalmefene treatment should be conducted in parallel with ongoing psychosocial support, focused on maintaining treatment and reducing consumption.

Age restrictions

• Under 18 years: do not use (medication has not been studied in this age group)
• 65 years and older: consult a doctor before starting treatment

Note: Selincro should always be used strictly according to the prescribing doctor's instructions.

Method of administration

• The medication is taken orally, with or without food
• The tablet should be swallowed whole — do not crush, do not split! (Selincro may cause skin sensitisation upon direct skin contact)

Condition for starting treatment

Before prescribing the medication, the doctor assesses the patient's clinical condition and drinking patterns over approximately two weeks.

Dosage

The medication is taken as needed, not continuously every day:

• Take one tablet (18 mg) on days when the patient anticipates a risk of alcohol consumption
• The tablet should preferably be taken 1–2 hours before the anticipated time of drinking
• If the patient has already started drinking and did not take a tablet earlier, it should be taken as soon as possible
• Maximum dose: do not exceed one tablet per day

Treatment duration and effects

• Effect visible within the first month of treatment
• Regular follow-up visits (e.g. monthly) — frequency depends on progress

Missed dose

If the patient missed a dose and has started drinking, the tablet should be taken as soon as possible.

After stopping treatment

For several days after stopping, the patient may be less sensitive to the effects of opioid-containing medications (e.g. strong painkillers).

Use of the medication is contraindicated in the following cases:

• Hypersensitivity (allergy) to nalmefene or any of the excipients
• Taking opioid medications — methadone, buprenorphine, painkillers (morphine, oxycodone, other opioids), cough medicines, anti-diarrhoeal medicines
• Opioid dependence (current or recent) — acute withdrawal symptoms may occur: nausea, vomiting, tremor, sweating, anxiety
• Opioid withdrawal symptoms — or suspicion that symptoms are currently occurring
• Renal or hepatic impairment
• Alcohol withdrawal symptoms (current or recent) — seeing, hearing or feeling things that are not there, seizures and tremor

• Inform your doctor about all conditions: depression, seizures, liver or kidney disease
• If the goal is abstinence — DO NOT use Selincro (the medication is intended for consumption reduction, not for complete cessation of drinking)
• Emergency care / accident — tell medical personnel about taking Selincro (it affects treatment choices, especially painkillers)
• Before surgery — talk to your doctor at least 1 week before the procedure; temporary discontinuation may be necessary
• Hallucinations / derealisation — if the patient experiences a feeling of detachment from the body, sees or hears things that are not there and these states recur for more than a few days → stop the medication and consult your doctor
• Suicide risk — taking nalmefene does not reduce the elevated suicide risk in patients abusing alcohol and substances (with or without depression)
• Selincro does not prevent alcohol intoxication
• Psychosocial support — the medication's effectiveness is highest when it is part of a comprehensive therapeutic programme (more: Addiction therapy)
• Lactose intolerance — the medication contains anhydrous lactose and should not be used in patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome

Before starting treatment, inform your doctor about all medications being taken, including those available without prescription.

Medications requiring special caution

Selincro may interact with:

• Diclofenac — anti-inflammatory drug (used for muscle pain)
• Fluconazole — antibiotic (used for fungal infections)
• Omeprazole — medication reducing stomach acid secretion
• Rifampicin — antibiotic (used for bacterial diseases)

Opioid medications — weakened or abolished effect

If the patient takes opioid-containing medications, their effect will be weakened or the medications will not work at all. This applies to:

• Medicines for cough and cold
• Medicines for diarrhoea
• Strong painkillers (morphine, oxycodone, other opioids)

Important: Use of opioids during Selincro treatment is contraindicated.

Like all medications, Selincro may cause adverse effects, although not everyone will experience them. Adverse effects were mainly mild to moderate, occurred at the start of treatment and lasted from a few hours to a few days. They are unlikely to occur upon continuation or resumption of treatment.

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 falling asleep, confusion, restlessness, decreased libido
• Drowsiness, body tremor, reduced alertness, tingling and prickling, reduced sense of touch
• Very fast heartbeat (tachycardia), sensation of rapid/strong/irregular heartbeats (palpitations)
• Vomiting, dry mouth, diarrhoea
• Excessive sweating
• Muscle cramps
• Feeling of exhaustion, weakness, discomfort or anxiety, unusual sensations
• Weight loss

Uncommon (may affect up to 1 in 100 people)

• Seeing, hearing or feeling things that are not there (hallucinations)
• Feeling of detachment from one's own body (derealisation)

Frequency not known (cannot be estimated from available data)

• Visual disturbances (usually transient)
• Swelling of face, lips, tongue or throat
• Urticaria (hives)
• Itching
• Rash
• Skin reddening
• Muscle pain
• Prolonged erection (priapism)

You should contact your doctor immediately or go to hospital if the following symptoms occur:

• Hallucinations or derealisation (seeing, hearing things that are not there, feeling of detachment from the body) recurring for more than a few days — stop the medication and talk to your doctor
• Swelling of face, lips, tongue or throat — may be a symptom of a severe allergic reaction
• Prolonged erection (priapism) — requires urgent medical attention
• Severe allergic reactions: urticaria, itching, rash, difficulty breathing

If the patient notices any worrying symptoms or symptoms not listed in the leaflet, they should tell their doctor or pharmacist.

Pregnancy

It is not known whether Selincro is safe during pregnancy. Use of the medication during pregnancy is not recommended.

Breastfeeding

It is not known whether Selincro is safe during breastfeeding. The patient should decide together with the doctor whether to stop breastfeeding or stop treatment, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery

Selincro may cause adverse effects that may affect the ability to drive and operate machinery:

• Attention disorders
• Visual disturbances
• Feeling unwell
• Nausea, dizziness, drowsiness
• Insomnia, headache

In most cases, these symptoms are mild to moderate, occur at the start of treatment and last from a few hours to a few days. Patients should exercise particular caution, especially during the first weeks of treatment.

Active substance

Nalmefene (Latin: Nalmefenum). Each film-coated tablet contains 18.06 mg of nalmefene (as nalmefene hydrochloride dihydrate).

Excipients

• Tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate
• Film coating: hypromellose, macrogol 400, titanium dioxide (E 171)

Form and packaging

• Form: white, oval, biconvex film-coated tablets (6.0 mm × 8.75 mm), with embossed "S"
• Pack sizes: 7, 14, 28, 42, 49 or 98 tablets in blisters

Important: The tablet should be swallowed whole — do not crush, do not split! Selincro may cause skin sensitisation upon direct skin contact.

Contains anhydrous lactose — patients with intolerance to certain sugars should consult their doctor before taking this medication.

The path to controlling your drinking starts with a medical consultation:

1. Medical consultation — the doctor will assess your health, monitor drinking patterns over 2 weeks and decide whether Selincro is the right choice (more: Contact)
2. Initial tests — the doctor may order liver and kidney tests
3. Receiving a prescription — if there are no contraindications, the doctor will issue a prescription for Selincro (e-prescription available)
4. Psychosocial support — alongside pharmacotherapy, addiction therapy is recommended (individual or group)
5. Follow-up visits — regular meetings with the doctor (e.g. monthly) to monitor progress

Schedule a consultation to find out whether Nalmefene is the right solution for you: E-registration or Contact.