AXILIUM 2.5 mg/ml Roztwór doustny

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1. AXILIUM 2.5 mg/ml oral drops, solution
   1. What is AXILIUM and what is it used for
   2. What you need to know before you take AXILIUM
   3. How to take AXILIUM
   4. Possible side effects
   5. How to store AXILIUM
   6. Contents of the pack and other information

AXILIUM 2.5 mg/ml oral drops, solution

Lormetazepam

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as 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 other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is AXILIUM and what is it used for

AXILIUM contains the active ingredient 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 significant distress to the person.

2. What you need to know before you take 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 that causes muscle weakness and fatigue;
• if you suffer from loss of muscle coordination which therefore makes it difficult to perform certain movements following damage to the spinal cord and cerebellum (spinal and cerebellar ataxia);
• if you suffer from severe respiratory failure (e.g. severe chronic obstructive pulmonary disease);
• if you have trouble breathing during sleep (sleep apnea);
• if you have a disease of the optic nerve called narrow-angle glaucoma;
• if you have severe liver problems (hepatic insufficiency);
• if you have alcohol intoxication or other medicines that depress the nervous system (hypnotics, analgesics, antidepressants, lithium);
• if you are pregnant or if you are 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 the control of your doctor 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, fatigue, tiredness, progressive loss of muscle coordination (ataxia), which can increase the risk of falls and fractures (see section 3 How to take AXILIUM - Use in the elderly); Pag. 1to 7
• if you have breathing 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 if you have abused alcohol or drugs in the past;
• if you have low blood pressure or have heart problems (heart failure). In this case, the doctor may decide to subject you to regular checks.

AXILIUM is not indicated for the primary treatment of psychotic illnesses.
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 you feel that the medicine is not working as well as it did at the beginning of
treatment, see your doctor.

Dependence:when you take this medicine there is a risk of dependence, i.e. the need to
continue taking the medicine. The risk increases with the dose and duration of treatment. It is
higher if you have abused drugs or alcohol in the past.

Withdrawal:when you stop taking AXILIUM you may experience withdrawal or rebound symptoms,
even if you have taken the medicine at the recommended doses and for a short period of time (see section
If you stop taking AXILIUM). To minimize these symptoms, it is recommended to gradually reduce
the dose.
Withdrawal symptoms may also appear 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), make sure you get an uninterrupted 7-8 hours of sleep.

Behavioral reactions:if you experience behavioral disturbances, such as restlessness, agitation,
irritability, aggression, delirium, delusion, anger, rage, nightmares, hallucinations, psychosis, inappropriate
behavior, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more common in children and the elderly.

Duration of treatment:the duration of treatment should be as short as possible. It generally varies
from a few days to two weeks, up to a maximum of four weeks, including a period of
gradual withdrawal (see section 3 How to take AXILIUM)

Children and adolescents
In children and adolescents under 18 years of age, AXILIUM should only be used in cases of absolute
necessity and the duration of treatment 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 tell your doctor if you are taking the following medicines:

• antipsychotics and antidepressants (e.g. clozapine), used to treat mental disorders; the concomitant use of clozapine and AXILIUM may produce marked sedation, excessive salivation, progressive loss of muscle coordination (ataxia);
• hypnotics, medicines used to promote sleep;
• anxiolytics, tranquilizers and sedatives, used to treat anxiety;

Pag. 2to 7

• some strong painkillers and cough suppressants (opioids), which can cause depression of respiratory function and an 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 operations;
• antihistamines with a sedative effect, used to treat allergies;
• theophylline, aminophylline and methylxanthines, used to treat asthma or other respiratory diseases;
• some medicines used to treat high blood pressure (beta-blockers);
• medicines used for irregular heartbeat (cardiac glycosides);
• oral contraceptives;
• some antibiotics (medicines for infections);
• medicines that inhibit certain liver enzymes (such as Cytochrome P450). The concomitant use of AXILIUM and opioids (strong analgesics, medicines for substitution therapy for dependence and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes AXILIUM together with opioids, the dose and duration of treatment
concomitantly must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow the
doctor's recommendation on the dose. It may be helpful to inform friends or relatives to pay attention
to the signs and symptoms listed above. See your doctor if you experience these symptoms.

AXILIUM with alcohol
Avoid drinking alcohol during treatment with this medicine, as it may increase the
sedative effect of the medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take AXILIUM during pregnancy, as it may cause harm to the fetus.
If your doctor believes you should take AXILIUM in the late stages of pregnancy or during labour
your baby may experience low body temperature, loss of muscle tone, low blood pressure, difficulty
sucking and breathing (“infant hypotonia”).
If AXILIUM has been taken regularly in the late 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 in your childbearing years, consult your doctor, whether you intend to become pregnant
or suspect you are pregnant, as the administration of the medicine will need to be stopped.

Driving and using machines
The use of AXILIUM may affect your ability to drive and operate machinery because you may feel
confused, forgetful, drowsy, with problems with muscle tone. These effects are increased if you have not
had enough sleep. If this happens, avoid driving or using machinery.
Drinking alcohol during treatment with this medicine negatively affects your ability to
drive and operate machinery.

AXILIUM contains propylene glycol, ethanol (alcohol) and sodium
Pag. 3to 7
This medicine contains 705 mg of propylene glycol per ml (1ml corresponds to 25 drops).
If the child is under 5 years of age, talk to your doctor or pharmacist before giving 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
recommended by your doctor. The doctor may perform further checks during therapy.
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per ml (1ml 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
You must continue to take this medicine until your doctor tells you to stop.
The single recommended dose in adultsis from 1 mg (10 drops) to 2 mg (20 drops).

Use in children and adolescents (under 18 years of age)
This medicine should be used only in cases of absolute necessity. The recommended dose, established
by the doctor, depends on the age, weight and condition of the person. The duration of treatment should
be as short as possible.

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

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

Method of administration
Take this medicine half an hour before going to bed.
The drops must be diluted with a little water or other beverage.

Duration of treatment
The duration of treatment 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 period of gradual discontinuation.
In certain cases, the doctor may decide to prolong the treatment, after assessing your
health conditions.
Treatment should be started with the lowest recommended dose. The maximum dose should not be
exceeded.
The doctor will regularly check your condition at the beginning of treatment to decrease, if necessary,
the dose or frequency of intake.

If you take more AXILIUM than you should
If you (or someone else) have taken an excessive dose of AXILIUM or if you think a child may have
taken this medicine, immediately notify your doctor or go to the Emergency Room of the nearest
hospital.
An overdose can cause severe depression of the nervous system with symptoms such as drowsiness,
fatigue, confusion, visual disturbances, from deep sleep to unconsciousness, progressive loss of
muscle coordination (ataxia), decreased muscle tone (hypotonia), lowering of blood pressure
Pag. 4to 7
(hypotension), respiratory depression, temporary loss of sensory and
intellectual abilities (obnubilation) which can worsen to coma and, very rarely, to death.
Bring this leaflet, the bottle and its container to the hospital or doctor so they know
which medicine has been consumed.

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

If you stop taking AXILIUM
Donot stop treatment with AXILIUM suddenly or without first agreeing with
your doctor, because withdrawal symptomsmay occur.
If the doctor has decided to stop the treatment, he will gradually reduce the dose to minimize the
withdrawal symptoms, such as:

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

Other symptoms are: depression, insomnia, sweating, persistent tinnitus, involuntary movements, vomiting,
paresthesia, perceptual changes, abdominal and muscle 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 greater when you suddenly stop taking AXILIUM. You may also
experience changes in mood, anxiety, restlessness and sleep disturbances.
If you have any doubts about 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.
At the beginning of treatment, drowsiness during the day, emotional disturbances,
awareness of being depressed, confusion, fatigue, headache, dizziness, muscle weakness or
double vision may occur; these reactions usually subside after repeated administrations.
The adverse reactions most frequently observed in patients taking AXILIUM are headache,
sedation and anxiety.
The more serious adverse reactions observed in patients taking AXILIUM are angioedema, suicide or
suicide attempt associated with unmasking of pre-existing depression.
Contact your doctor immediately if you experience:

• depression and mental disorders, such as restlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations (seeing and hearing things that do not exist), psychosis (a serious condition of the mind in which a person loses contact with reality and the ability to think and judge clearly), changes in behavior. If such undesirable effects occur, treatment should be discontinued. These reactions are more likely to occur in children and the elderly.

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

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

• headache. Page. 5to 7

Common(may affect up to 1 in 10 people)

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

Not known(frequency cannot be estimated based on available data)

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

Taking this medicine can also cause paradoxical reactions and amnesia (see sections
Warnings and precautions and If you stop taking AXILIUM).
Rarely, sudden, potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), jaundice (yellowing of the skin and whites of the eyes), increased
levels of liver enzymes, increased bilirubin, decreased platelets or white blood cells
(thrombocytopenia, agranulocytosis), decreased of all blood cells (pancytopenia), alterations
in the secretion of the antidiuretic hormone (SIAD) can also occur.

Reporting ofside effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Page 6to 7
The product must be used within 30 days of the first opening of the bottle. Excess product
must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AXILIUM contains

• The active ingredient is lormetazepam. 1 ml (25 drops) of solution contains 2.5 mg of lormetazepam.
• The other ingredients 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 a 20 ml bottle of solution.

Marketing Authorisation 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.
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