ANELOR 750 MICROGRAMMI/ML Oral drops, solution

Зміст інструкції

1. ANELOR 0.750 mg/ml Oral drops, solution
   1. What is ANELOR and what is it used for
   2. What you need to know before you take ANELOR
   3. How to take ANELOR
   4. Possible side effects
   5. How to store ANELOR
   6. Contents of the pack and other information

ANELOR 0.750 mg/ml Oral drops, solution

Alprazolam

Generic Medicine
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 pass it on to others, even if their symptoms are the same as yours, 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 ANELOR is and what it is used for
• 2. What you need to know before you take ANELOR
• 3. How to take ANELOR
• 4. Possible side effects
• 5. How to store ANELOR
• 6. Contents of the pack and other information

1. What is ANELOR and what is it used for

ANELOR contains the active ingredient alprazolam which belongs to a group of medicines called “benzodiazepines”, used to relieve severe states of anxiety.
ANELOR is indicated in adult patients for the treatment of anxiety symptoms when the disorder is severe, disabling or subjects the individual to severe distress. This medicine is indicated only for short-term use.

2. What you need to know before you take ANELOR

Do not take ANELOR

• if you are allergic to the active ingredient (alprazolam), to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside the eye due to a disease of the optic nerve called closed-angle glaucoma;
• if you suffer from a disease that causes muscle weakness and fatigue (myasthenia gravis);
• if you suffer from severe breathing difficulties (severe respiratory failure);
• if you have severe liver problems (severe hepatic failure);
• if you have trouble breathing during sleep (sleep apnea syndrome);
• if you are in the first three months of pregnancy or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine can reduce to cancel consciousness, can cause a significant reduction in the spontaneous ability to breathe, coma and death if taken together with other medicines that act on the brain and mind (for example opioids, antipsychotics and hypnotic-sedatives) (see section “Other medicines and ANELOR”).
Talk to your doctor or pharmacist before taking ANELOR.
Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are elderly and/or debilitated. In this case the doctor may decide to reduce the dose; remember to use this medicine with caution because it can cause sedation and/or musculoskeletal weakness and expose you to falls, often with serious consequences;
• if you have chronic respiratory problems (chronic respiratory failure) the doctor will prescribe you a lower dose of this medicine because it can worsen your condition;
• if you have kidney problems (renal insufficiency) or mild to moderate liver problems (mild to moderate hepatic insufficiency);
• if you suffer from severe depression. The doctor will not prescribe you only benzodiazepines because you may experience suicidal thoughts and cause mood changes;
• suffer from psychosis, a serious mental illness that alters behavior and causes difficulty relating to others. ANELOR is not recommended as the primary treatment for this condition;
• you are being treated with other medicines that act on the brain and mind, because ANELOR can increase the effects of these medicines (see section “Other medicines and ANELOR”);
• you have or have had in the past problems of alcohol, drug or other medicine abuse and dependence, because there is a greater risk of developing dependence on ANELOR (see section “Development of dependence”).

Memory problems
A few hours after taking ANELOR, you may have difficulty remembering what happened after taking the medicine.

Paradoxical reactions
ANELOR can cause effects opposite to those expected (paradoxical effects) (see section 4 “Possible side effects”). These effects are more common in children and the elderly. If you experience these effects, see your doctor because treatment with ANELOR should be discontinued.

Tolerance: if after a few weeks you feel that the medicine is not working as well as at the beginning of treatment, see your doctor.

Dependence: ANELOR causes dependence, i.e. you may experience a growing desire to take the medicine or you may develop physical disorders that decrease or disappear only after taking the medicine). The probability of developing dependence increases with increasing dose and duration of treatment. Therefore, the doctor will prescribe you the most appropriate treatment based on your disorders and conditions, using the lowest effective dose to be taken for the shortest possible period.
The doctor will also indicate when to undergo check-up visits to assess the progress of your health in relation to therapy with ANELOR.

Once you have developed physical dependence, sudden discontinuation of treatment can manifest withdrawal symptoms.
Incorrect use of ANELOR
You must take this medicine ONLY if prescribed by your doctor and after purchasing it at the pharmacy.
Some people tend to abuse alprazolam and other similar medicines, called benzodiazepines.
In addition, some people obtain these medicines illegally (e.g. black market, internet, friends, family, etc.), sometimes with the aim of reselling them to others. DO NOT take ANELOR if this medicine has not been prescribed by your doctor. DO NOT take ANELOR if you are not sure that this medicine has been purchased from a pharmacy.

Children and adolescents
The efficacy and safety of ANELOR in children and adolescents under 18 years of age are not known.
The doctor will decide whether ANELOR can be given to children and adolescents based on their conditions.

Other medicines and ANELOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The concomitant use of ANELOR and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) 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 the doctor prescribes ANELOR together with opioids, the dose and duration of concomitant therapy must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or relatives to make them aware of the signs and symptoms above. Contact your doctor if these symptoms occur.
Caution is required when ANELOR is taken together with the following medicines because the effects of ANELOR may be affected or affect the following medicines:

• medicines to reduce pain (analgesics) and medicines that reduce the cough reflex (cough sedatives) based on opium and its derivatives; these medicines can depress your respiratory function;
• medicines used for some mental health problems (antipsychotics), medicines that promote sleep (hypnotics), medicines to reduce anxiety (anxiolytics, sedatives), medicines to treat depression (antidepressants e.g. nefazodone, fluvoxamine, fluoxetine, imipramine and desipramine), medicines for the treatment of severe pain (narcotic analgesics, opioids), medicines used during surgical operations (anaesthetics) and medicines used to treat allergies (sedative antihistamines) because they can increase the depressive (slowing) effect on the central nervous system. If you take ANELOR together with one or more of these medicines or together with alcoholic beverages, these substances can contribute to decreasing the functions of your brain and mind up to causing a reduction in the spontaneous ability to breathe, coma and death (see section “Warnings and precautions”);
• cimetidine, a medicine used to reduce stomach acidity;
• propoxyphene, a medicine used against pain;
• oral contraceptives;
• diltiazem, a medicine used to lower blood pressure;
• digoxin (a medicine used to increase the force of heart contraction). If you are elderly, taking ANELOR may increase the likelihood of developing toxic effects due to digoxin.

The following medicines can increase the effects of ANELOR:

• medicines used to treat fungal infections (ketoconazole, itraconazole, posaconazole, voriconazole), administration with ANELOR is not recommended
• erythromycin, clarithromycin, telithromycin, troleandomycin (antibiotics used against bacterial infections), co-administration should be carried out with caution and a substantial dose reduction should be considered
• some medicines used to treat AIDS (known as “HIV protease inhibitors”, for example ritonavir, saquinavir, indinavir). During therapy with these medicines it may be necessary to reduce the dose of ANELOR or discontinue its administration.

ANELOR with food and drink
Avoid drinking alcohol during treatment with ANELOR as alcohol can increase the sedative effect of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 this medicine in the first 3 months of pregnancy, as it can cause congenital malformations in the fetus.
The doctor will assess whether you can take this medicine during the second and third trimesters of pregnancy.
If the doctor believes that you must necessarily take ANELOR in the late stages of pregnancy or during labor, your baby may develop the so-called “floppy infant” syndrome, characterized by low body temperature (hypothermia), loss of muscle tone (axial hypotonia), breathing difficulties (respiratory depression or apnea), difficulty taking milk with consequent reduced weight gain, withdrawal symptoms (see section 3 “If you stop taking ANELOR”).
These effects are reversible and can last from a few days to 1-3 weeks after the birth of the child.
If you start treatment with ANELOR in fertile age, consult your doctor, whether you intend to start a pregnancy or suspect you are pregnant, because it will be necessary to stop taking the medicine. Your doctor will inform you of the potential danger to the fetus, with the use of ANELOR
Breastfeeding
Do not take ANELOR if you are breastfeeding, as this medicine passes into breast milk.

Driving and using machines
Do not drive or operate machinery if you experience loss of concentration or muscle control during treatment with ANELOR or if you feel drowsy or dizzy. These effects are increased if you have not slept enough or if you have consumed alcoholic beverages.

ANELOR 0.75 mg/ml oral drops, solution contains ethanol
This medicine contains 43.3 mg of alcohol (ethanol) in each dose of 10 drops and 87 mg of alcohol (ethanol) in each dose of 20 drops.
The amount in 10 drops of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine, the amount in 20 drops is equivalent to less than 3 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

ANELOR 0.75 mg/ml oral drops, solution contains propylene glycol
This medicine contains approximately 233 mg of propylene glycol per dose of 0.25 mg (corresponding to 10 drops) and 466 mg per dose of 20 drops.
The maximum daily dose allowed for the treatment of anxiety, equal to 4 mg of alprazolam (corresponding to 160 drops), contains approximately 3.7 g of propylene glycol. If you are pregnant or suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform further checks during therapy.
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.
The medicine is not contraindicated in patients with celiac disease.

3. How to take ANELOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
10 drops of ANELOR contain 0.25 mg of alprazolam; 20 drops of ANELOR contain 0.50 mg of
alprazolam.

Treatment of anxiety:
The recommended initial dose is from 0.25 mg to 0.50 mg (10-20 drops) 3 times a day. The dose may be
increased by the doctor up to 4 mg per day to be taken in divided doses. You should first increase the dose
to be taken in the evening and then the dose to be taken during the day.
Use in the elderly, in patients with severe liver or kidney problems and/or with debilitating organic diseases
The recommended initial dose for the treatment of anxiety is 0.25 mg (10 drops) 2 or 3 times a day.

The duration of treatment with ANELOR must be as short as possible.
The maximum treatment duration should not exceed 2-4 weeks. Prolonged treatment is not
recommended. The doctor will decide if the treatment can be continued beyond the recommended maximum period.
Instructions for use
Press on the plastic cap and simultaneously unscrew.

To close, screw the cap back on tightly.

If you take more ANELOR than you should
In case of ingestion/accidental intake of an excessive dose of ANELOR, immediately inform
your doctor or go to the nearest hospital.
In mild cases of overdose you may experience: blurring of sensory functions (obnubilation),
mental confusion and lethargy. In more severe cases you may experience: severe depression of the nervous system
with symptoms such as drowsiness, confusion, muscle problems (ataxia, hypotonia), lowering of
blood pressure, difficulty breathing, coma, death.

If you forget to take ANELOR
If you forget to take a dose, 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 a missed dose.

If you stop taking ANELOR
Do not stop treatment with ANELOR suddenly and without first agreeing with your doctor.
The doctor will reduce the dose gradually (no more than 0.50 mg every 3 days) to minimize:

• withdrawal symptoms such as: ₋ severe symptoms: feeling of detachment from oneself or from the external world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, seizures, muscle and abdominal cramps, vomiting, sweating, tremors, convulsions; ₋ other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, mild depression of mood, insomnia;
• rebound symptoms, for example anxiety. These symptoms are the same for which you have been advised to take treatment with ANELOR and may reappear temporarily in a more intense way after abrupt discontinuation of treatment.

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.
Contact your doctor immediatelyif you experience any of the following side effects because the intake
of ANELOR must be stopped:

• opposite effects to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as: ₋ restlessness ₋ agitation ₋ irritability ₋ aggressiveness ₋ feeling of frustration ₋ anger ₋ nightmares ₋ hallucinations ₋ thought disorders ₋ behavioral changes.

Contact your doctor immediatelyif you experience any of the following side effects because they can be
serious:

• swelling of the face, tongue and throat resulting in inability to swallow and breathe (angioedema)
• difficulty rememberingwhat happened after taking the medicine (see section 2 “Memory problems”)
• unmasking of pre-existing depression
• dependence(see section 2 “Development of dependence”)
• withdrawal symptomsand rebound symptoms(see section 3 “If you stop taking ANELOR”).

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

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

• depression
• sedation
• drowsiness
• loss of coordination
• memory problems
• difficulty speaking
• dizziness
• headache
• constipation
• dry mouth due to lack of saliva
• fatigue
• irritability.

Common(may affect up to 1 in 10 people):

• decreased appetite, decrease or increase in body weight
• confusion, disorientation
• decreased sexual desire (libido), sexual dysfunction
• anxiety
• nervousness
• problems with balance, problems with coordination of movements;
• loss of attention and concentration
• excessive drowsiness (lethargy)
• insomnia, excessive sleepiness
• tremors
• vertigo
• slurred speech (dysarthria)
• blurred vision
• nausea
• dermatitis
• fatigue, irritability.

Uncommon(may affect up to 1 in 100 people):

• obsessive ideas and behaviors
• inability to remember current life events
• vomiting
• muscle weakness
• irregular menstrual cycle
• drug dependence
• drug withdrawal syndrome
• incontinence.

Frequency not known(the frequency cannot be estimated from the available data):

• increased levels of prolactin (a natural hormone) in the blood
• mood changes
• hostile behaviors, abnormal thoughts
• impulsivity and motor hyperactivity
• alterations of the nervous system responsible for the functions of the body that cannot be controlled voluntarily (e.g. the functions of internal organs and glands)
• involuntary muscle contractions that force you to assume unnatural positions
• stomach and intestinal diseases
• inflammatory liver diseases (hepatitis)
• impaired liver function
• yellowing/yellowish discoloration of the skin and mucous membranes (jaundice)
• skin reactions due to exposure to the sun
• inability to completely empty the bladder
• swelling of the hands and feet due to fluid accumulation
• increased pressure inside the eye
• abuse of this medicine (tendency to excessive or incorrect use of ANELOR).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 ANELOR

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 pack after “Scad.”. The expiry date refers to the last day of that month.
Store the medicine at a temperature below 25°C.
Keep the medicine in its original packaging to protect it from light.
The shelf life after first opening the bottle is 4 months and the unused product must be
discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ANELOR contains
1 ml of solution:

• the active ingredient is: alprazolam 0.750 mg;
• the other ingredients are: Propylene glycol, Ethyl alcohol, Sodium saccharin, Cherry aroma, Purified water.

Description of the appearance of ANELOR and contents of the pack
Oral drops, solution: bottle of 20 ml.

Marketing Authorisation Holder
Errekappa Consumer S.r.l. – via Ciro Menotti 1A - 20129 Milano

Manufacturer
Genetic S.p.A., Contrada Canfora – Fisciano 84084 (SA)

This leaflet was last updated inMarch 2025