Alcover

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALCOVER 175 mg/ml oral solution

Sodium oxybate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Alcover is and what it is used for
2. What you need to know before taking Alcover
3. How to take Alcover
4. Possible side effects
5. How to store Alcover
6. Contents of the pack and other information

1. WHAT ALCOVER IS AND WHAT IT IS USED FOR

Alcover contains the active substance sodium oxybate, a substance that belongs to a group of medicines
used to treat alcohol dependence.
This medicine is used as an additional treatment in the following therapies:

• management of acute ethanol withdrawal syndrome.

2. WHAT YOU NEED TO KNOW BEFORE TAKING ALCOVER

Do not take Alcover

• if you are allergic to sodium oxybate or to any of the other ingredients of this medicine (listed in section 6);
• if you have succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder);
• if you suffer from major depression;
• if you are being treated with opioid or barbiturate medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alcover:

• if you have breathing or lung problems (especially if you are obese), because Alcover may potentially cause breathing difficulties;
• if you currently have or have previously had depression;
• if you have heart failure, high blood pressure, or liver or kidney problems, as your dose may need to be adjusted;
• if you have previously abused medicines;
• if you have epilepsy, as the use of Alcover is not recommended in this condition;
• if you have porphyria (an uncommon metabolic disorder). If any of these apply to you, tell your doctor before taking Alcover.

If, while taking Alcover, you experience bedwetting or incontinence (either urinary or fecal), confusion, hallucinations, sleepwalking episodes, or abnormal thoughts, you must inform your doctor immediately. Although these side effects are not common, if they occur, they are usually mild to moderate in severity.
Elderly patients
If you are elderly, your doctor will closely monitor your condition to assess whether Alcover is producing the desired effects.
Abuse, dependence, misuse, and illicit use
You should be aware that Alcover has a well-known potential for abuse, dependence, misuse, and illicit use. Cases of dependence have occurred following illicit use of sodium oxybate. Your doctor will closely monitor you for these risks.
Before starting and during treatment with this medicine, your doctor will ask whether you have ever abused medicines or experienced psychiatric disorders.
Your doctor will carry out periodic checks and will discontinue treatment if misuse is suspected.
Patients with liver disease
If you have liver disease due to excessive alcohol consumption, including liver cirrhosis, your doctor will advise starting treatment at the lowest possible dose and will monitor you for any need for subsequent dose adjustments.
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Alcover
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Alcover must not be taken together with medicines that induce sleep or medicines that reduce the activity of the central nervous system (the central nervous system is the part of the body related to the brain and spinal cord).
Also inform your doctor or pharmacist if you are taking any of the following types of medicines:

• medicines that increase central nervous system activity and antidepressants
• medicines that may be metabolized similarly by the body (e.g. valproate, phenytoin or ethosuximide used to treat epilepsy)
• topiramate used to treat epilepsy
• if you are taking valproate, your daily dose of Alcover will need to be adjusted, as this may lead to interactions (see section 3).

Alcover with food, drinks and alcohol
You must not drink alcohol while taking Alcover, as its effects may be increased.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Very few women have taken sodium oxybate during pregnancy, and some of these experienced spontaneous abortions. The risk of using Alcover during pregnancy is unknown; therefore, the use of Alcover is not recommended in pregnant women or in women planning pregnancy.
It is not known whether Alcover passes into breast milk. Patients taking Alcover should stop breastfeeding.
Driving and using machines
Alcover will affect your ability to drive or operate tools or machinery.
Do not drive, operate tools or machinery, or perform any activity that is dangerous or requires mental alertness for at least 6 hours after taking Alcover.
When you first start taking Alcover, and until you determine whether this medicine causes drowsiness the following day, exercise extreme caution when driving, operating complex machinery, or performing any other activity that could be dangerous or require full attention.
Alcover contains methyl para-hydroxybenzoate, propyl para-hydroxybenzoate and sorbitol
Alcover contains methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, which may cause allergic reactions, including delayed reactions.
Alcover contains sorbitol; if your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. HOW TO TAKE ALCOVER

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:

• 50 mg per kg of body weight per day, divided into 3 doses administered at least four hours apart (e.g. morning, afternoon, and evening).

Alcover contains 175 mg of active substance per ml of solution, which can be administered using the oral dosing syringe provided in the package.
Suggested daily dosing schedule (corresponding to a dosage of 50 mg per kg of body weight):
Body weight  ml
50 kg      5
75 kg      7.5  to be repeated 3 times as indicated
100 kg     10

Duration of treatment:

• 7–10 days.

If you take more Alcover than you should
Symptoms of Alcover overdose may include agitation, confusion, difficulty in movement, breathing difficulties, blurred vision, excessive sweating, headache, vomiting, decreased level of consciousness leading to coma, and epileptic seizures.
If you take more Alcover than prescribed, or take it accidentally, seek immediate emergency medical help. You must bring the medicine bottle with its label, even if it is empty.

If you forget to take Alcover
Do not take a double dose to make up for the missed dose.

If you stop taking Alcover
Do not stop treatment without first consulting your doctor.
If the medicine is discontinued, you may experience insomnia, headache, anxiety, dizziness, sleep disturbances, drowsiness, hallucinations, and abnormal thoughts.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. These are generally mild to moderate. If you experience any of the following adverse reactions, inform your doctor immediately.

Very common (may affect more than 1 in 10 people):
Nausea, dizziness, headache.

Common (may affect up to 1 in 10 people):
Sleep disorders including insomnia, blurred vision, awareness of heartbeat, vomiting, stomach pain, diarrhoea, anorexia, decreased appetite, weight loss, weakness, abnormal dreams, fatigue, feeling of drunkenness, sleep paralysis, somnolence, tremor, confusion/disorientation, nightmares, sleepwalking, bedwetting, sweating, depression, muscle cramps, swelling, falls, joint pain, back pain, excessive daytime sleepiness, balance disorders, attention disorders, sensory disturbances especially to touch, abnormal sense of touch, sedation, taste disturbances, anxiety, difficulty falling asleep in the middle of the night, nervousness, spinning sensation (vertigo), urinary incontinence, breathing difficulties, snoring, nasal congestion, rash, sinusitis, inflammation of the nose and throat, increased blood pressure.

Uncommon (may affect up to 1 in 100 people):
Psychosis (a mental disorder that may include hallucinations, disorganized or incoherent speech, and agitated behaviour), paranoia, abnormal thoughts, hallucinations, agitation, suicide attempt, difficulty falling asleep, restless legs, memory loss, myoclonus (involuntary muscle contractions), involuntary faecal incontinence, hypersensitivity.

Not known (frequency cannot be estimated from the available data):
Seizures, decreased depth or frequency of breathing, urticaria, suicidal thoughts, brief interruption of breathing during sleep, euphoria, dry mouth, facial swelling (angioedema), dehydration, nocturia, excessive nighttime urination.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALCOVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after Exp. The expiry date refers to the last day of the month.
After opening the bottle, any unused contents remaining after 30 days from opening must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Alcover contains

• The active substance is sodium oxybate. Each ml contains 175 mg of sodium oxybate.
• The excipients are sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, cherry flavor, citric acid, purified water.

Description of the appearance of Alcover and contents of the pack

• Plastic bottle with a child-resistant closure cap, supplied with a dosing syringe. Bottle containing 140 ml of oral solution.
• Plastic bottle with a child-resistant closure cap. Carton containing 12 bottles of 10 ml oral solution.

Marketing Authorization Holder and Manufacturer
LABORATORIO FARMACEUTICO C.T. S.r.l.
Via Dante Alighieri, 71 - Sanremo