Axilium: detailed information

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

AXILIUM 2.5 mg/ml oral drops, solution

Lormetazepam
Generic Medicine
Please read this leaflet carefully before taking 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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AXILIUM is and what it is used for
What you need to know before taking AXILIUM
How to take AXILIUM
Possible side effects
How to store AXILIUM
Package contents and other information

1. What AXILIUM is and what it is used for

AXILIUM contains the active substance lormetazepam, which belongs to a group of medicines called benzodiazepines.
This medicine is indicated for the short-term treatment of sleep disorders (insomnia), in cases where the disorder is severe, disabling, and causes severe distress to the person.

2. What you should know before taking AXILIUM

Do not take AXILIUM

if you are allergic to lormetazepam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from myasthenia gravis, a disease causing muscle weakness and fatigue;
if you suffer from loss of muscle coordination making certain movements difficult due to damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
if you suffer from severe respiratory insufficiency (e.g. severe chronic obstructive pulmonary disease);
if you have breathing problems during sleep (sleep apnea);
if you have a nerve of the eye disorder called narrow-angle glaucoma;
if you have severe liver problems (hepatic insufficiency);
if you have intoxication from alcohol or other medicines that depress the nervous system (hypnotics, analgesics, antidepressants, lithium);
if you are pregnant or breastfeeding (see section Pregnancy, breastfeeding and fertility).

Warnings and precautions
Talk to your doctor or pharmacist before taking AXILIUM.
Take this medicine with caution and always under medical supervision in the following cases:

if you are elderly. In this case, the doctor may decide to reduce the dose to avoid unwanted effects such as muscle weakness, dizziness, drowsiness, tiredness, fatigue, progressive loss of muscle coordination (ataxia), which may increase the risk of falls and fractures (see section 3 How to take AXILIUM - Use in the elderly);
if you have respiratory problems (respiratory insufficiency). In this case, the doctor may decide to reduce the dose;
if you have severe kidney problems (severe renal insufficiency);
if you suffer from depression or have previously abused alcohol or drugs;
if you have low blood pressure or heart problems (heart failure). In this case, the doctor may decide to carry out regular check-ups.

AXILIUM is not indicated for the primary treatment of psychotic disorders.
Benzodiazepines should not be used alone to treat depression or sleep disorders associated with depression, as suicidal thoughts may occur.
Taking this medicine may cause:
Tolerance: if after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: when taking this medicine, there is a risk of dependence, i.e. the need to continue taking the medicine. The risk increases with dose and duration of treatment. It is higher if you have previously abused drugs or alcohol.
Withdrawal: when stopping AXILIUM, you may experience withdrawal or rebound symptoms, even if you have taken the medicine at the recommended doses and for a short period (see section If you stop taking AXILIUM). To minimize these symptoms, it is recommended to gradually reduce the dose.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Amnesia: to reduce the risk of amnesia (memory loss), ensure uninterrupted sleep of 7-8 hours.
Behavioural reactions: if you experience behavioural disturbances such as restlessness, agitation, irritability, aggression, delirium, delusion, anger, rage, nightmares, hallucinations, psychosis, inappropriate behaviour, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children and the elderly.
Duration of treatment: treatment duration should be as short as possible. It usually ranges from a few days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period (see section 3 How to take AXILIUM).
Children and adolescents
In children and adolescents under 18 years of age, AXILIUM should be used only in cases of absolute necessity and the treatment duration should be as short as possible.
Other medicines and AXILIUM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

antipsychotics and antidepressants (e.g. clozapine), used to treat psychiatric disorders; concomitant use of clozapine and AXILIUM may cause marked sedation, excessive salivation, and progressive loss of muscle coordination (ataxia);
hypnotics, medicines used to promote sleep;
anxiolytics, tranquillisers, and sedatives, used to treat anxiety;
certain strong painkillers and cough suppressants (opioids), which may cause respiratory depression and increased sense of well-being when taken with AXILIUM. This may increase your desire to continue taking these medicines (dependence);
antiepileptics, used for epilepsy;
anaesthetics, used during surgical procedures;
sedating antihistamines, used to treat allergies;
theophylline, aminophylline, and methylxanthines, used to treat asthma or other respiratory diseases;
certain medicines used to treat high blood pressure (beta-blockers);
medicines used for irregular heartbeat (cardiac glycosides);
oral contraceptives;
certain antibiotics (medicines for infections);
medicines that inhibit certain liver enzymes (such as Cytochrome P450). Concomitant use of AXILIUM and opioids (strong analgesics, medicines for opioid dependence replacement therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes AXILIUM together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
AXILIUM with alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take AXILIUM during pregnancy, as it may harm the unborn baby.
If your doctor considers that you need to take AXILIUM in the later stages of pregnancy or during labour, your baby may show low body temperature, loss of muscle tone, low blood pressure, difficulty sucking and breathing (“infant hypotonia”).
If AXILIUM has been taken regularly during the later stages of pregnancy, your baby may experience withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as lormetazepam passes into breast milk.
Fertility
If you start treatment with AXILIUM and are of childbearing age, consult your doctor, whether you intend to become pregnant or suspect you are pregnant, as it will be necessary to discontinue the medicine.
Driving and using machines
The use of AXILIUM may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or have muscle tone problems. These effects are worse if you have not slept enough. If this happens, avoid driving or using machinery.
Consuming alcohol during treatment with this medicine negatively affects your ability to drive and use machinery.
AXILIUM contains propylene glycol, ethanol (alcohol), and sodium
This medicine contains 705 mg of propylene glycol per ml (1 ml corresponds to 25 drops).
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may carry out additional monitoring during treatment.
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per ml (1 ml corresponds to 25 drops).
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially ‘sodium-free’.

3. How to take AXILIUM

Take this medicine exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to.
The recommended single dose in adults ranges from 1 mg (10 drops) to 2 mg (20 drops).

Use in children and adolescents (under 18 years of age)
This medicine should only be used when absolutely necessary. The recommended dose, determined by the
doctor, depends on the patient's age, weight, and medical condition. The duration of treatment should be as
short as possible.

Use in the elderly
In elderly patients, the recommended dose is 0.5–1 mg (5–10 drops).

Use in patients with kidney, liver, or respiratory problems
In patients with kidney problems, the doctor may consider reducing the dose. In patients with mild to
moderate respiratory impairment or hepatic impairment, a dose reduction should be considered.

Instructions for administration
Take this medicine half an hour before going to bed.
The drops should be diluted with a small amount of water or another beverage.

Duration of treatment
Treatment duration should be as short as possible and generally ranges from a few days to 2 weeks, up to a
maximum of 4 weeks, including a gradual withdrawal period.
In certain cases, the doctor may decide to extend the treatment after evaluating your health status.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment and may reduce the dose or
frequency of administration if necessary.

If you take more AXILIUM than you should
If you (or someone else) have taken an excessive dose of AXILIUM, or if you suspect that a child may have
ingested this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause profound depression of the central nervous system, with symptoms such as drowsiness,
fatigue, confusion, visual disturbances, deep sleep progressing to unconsciousness, progressive loss of
muscle coordination (ataxia), reduced muscle tone (hypotonia), low blood pressure (hypotension),
respiratory depression, temporary loss of sensory and intellectual functions (obnubilation), which may
worsen to coma and, very rarely, death.
Bring this leaflet, the bottle, and its packaging with you to the hospital or doctor so they know which
medicine has been taken.

If you forget to take AXILIUM
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do
not take a double dose to make up for the missed dose.

If you stop taking AXILIUM
Do not stop treatment with AXILIUM suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal
symptoms, such as:

headache, muscle pain, tension;
severe anxiety, confusion, restlessness, irritability;
in severe cases of withdrawal, derealization (feeling that things are unreal), depersonalization (feeling of detachment from the surrounding environment), intolerance to sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that are not real), or epileptic seizures.

Other symptoms include: depression, insomnia, sweating, persistent tinnitus, involuntary movements, vomiting,
paresthesia, perceptual disturbances, abdominal and muscular cramps, tremor, myalgia, agitation, palpitations,
tachycardia, panic attacks, dizziness, hyperreflexia, short-term memory loss, hyperthermia.
Treatment should be discontinued gradually; otherwise, the symptoms for which you were being treated may
reappear, even more intensely than before (rebound insomnia and anxiety). The risk of developing these
symptoms is higher if you stop taking AXILIUM abruptly. You may also experience mood changes, anxiety,
restlessness, and sleep disturbances.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

At the beginning of treatment, daytime drowsiness, emotional disturbances, awareness of being depressed, confusion, fatigue, headache, dizziness, muscle weakness or double vision may occur; these reactions usually diminish with repeated administration.

The most frequently observed adverse reactions in patients taking AXILIUM are headache, sedation and anxiety.

The most serious adverse reactions observed in patients taking AXILIUM are angioedema, suicide or suicide attempt associated with unmasking of pre-existing depression.

Seek immediate medical advice if you experience:

depression and mental disorders such as restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, hallucinations (seeing or hearing things that are not real), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), behavioural changes. If any of these side effects occur, treatment must be discontinued. These reactions are more likely to occur in children and elderly patients.

Contact your doctor if you experience any of the following side effects:

Very common (may affect more than 1 in 10 people)

headache.

Common (may affect up to 1 in 10 people)

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, potentially life-threatening (Quincke's oedema);
anxiety;
decreased sexual desire;
dizziness, sedation, drowsiness, attention disturbances;
memory loss (amnesia) (see section Warnings and precautions);
vision problems and double vision (diplopia);
difficulty speaking;
altered taste (dysgeusia);
slowing of mental functions (bradypsychia);
increased heart rate (tachycardia);
vomiting, nausea, abdominal pain, constipation;
dry mouth;
itching;
urinary problems;
muscle weakness (asthenia);
increased sweating (hyperhidrosis).

Not known (frequency cannot be estimated from the available data)

unmasking of pre-existing depression with tendency to self-harm (suicide and attempted suicide), psychosis, hallucinations, dependence, depression (unmasking of pre-existing depression), delirium, delusion, withdrawal syndrome (rebound insomnia), agitation, aggressiveness, irritability, restlessness, rage, nightmares, abnormal behaviour, emotional disturbances (see sections Warnings and precautions and If you stop taking AXILIUM);
confusion, depressed level of consciousness, loss of muscle coordination (ataxia), muscle weakness;
skin irritations (urticaria, skin rash);
fatigue;
falls.

The use of this medicine may also cause paradoxical reactions and amnesia (see sections Warnings and precautions and If you stop taking AXILIUM).

Rarely, potentially fatal sudden allergic reactions (anaphylactic/anaphylactoid reactions), jaundice (yellowing of the skin and whites of the eyes), increased liver enzyme levels, increased bilirubin levels, decreased platelets or white blood cells (thrombocytopenia, agranulocytosis), decreased counts of all blood cells (pancytopenia), and disturbances in antidiuretic hormone secretion (SIADH) may also occur.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AXILIUM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
The product should be used within 30 days after the first opening of the bottle. Any remaining product
should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AXILIUM contains

The active substance is lormetazepam. 1 ml (25 drops) of solution contains 2.5 mg of lormetazepam.
The other components are: sodium saccharin, glycerol 85%, ethanol 96%, orange flavour, lemon essence, caramel flavour, propylene glycol.

Description of the appearance of AXILIUM and contents of the pack
Pack containing one 20 ml bottle of solution.
Marketing Authorization Holder
Dymalife Pharmaceutical Srl – Via Bagnulo, 95 – 80063 Piano di Sorrento (NA)
Manufacturer
ABC FARMACEUTICI S.p.A., Canton Moretti, 29 Località San Bernardo – 10090 Ivrea (TO) – Italy.