Anelor

Italy
Brand name Anelor
Form drops, oral solution
Active substance / Dosage
ALPRAZOLAM
Prescription type Prescription only
ATC code
N05BA12
Registration number 035857
Manufacturer ERREKAPPA CONSUMER S.R.L.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

ANELOR 0.750 mg/ml Oral drops, solution

Alprazolam
Generic Medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 ANELOR is and what it is used for

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

2. What you should know before taking ANELOR

Do not take ANELOR

  • if you are allergic to the active substance (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 nerve disease called closed-angle glaucoma;
  • if you suffer from a disease causing muscle weakness and fatigue (myasthenia gravis);
  • if you have severe breathing difficulties (severe respiratory insufficiency);
  • if you have serious liver problems (severe hepatic insufficiency);
  • if you suffer from breathing problems during sleep (sleep apnea syndrome);
  • if you are in the first three months of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine may reduce or even abolish consciousness, may cause a significant reduction in spontaneous breathing ability, coma, and death if taken together with other medicines acting on the brain and mind (e.g., 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 medical supervision in the following cases:

  • if you are elderly and/or debilitated. In this case, your doctor may decide to reduce the dose; remember to use this medicine carefully, as it may cause sedation and/or musculoskeletal weakness, increasing your risk of falls, which may have serious consequences;
  • if you have chronic respiratory problems (chronic respiratory insufficiency); your doctor will prescribe a lower dose of this medicine, as it may 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. Your doctor will not prescribe benzodiazepines alone, as this may lead to suicidal thoughts and mood changes;
  • if you suffer from psychosis, a serious mental illness affecting behavior and making it difficult to interact with others. ANELOR is not recommended as the primary treatment for this condition;
  • if you are being treated with other medicines acting on the brain and mind, because ANELOR may enhance the effects of these medicines (see section “Other medicines and ANELOR”);
  • if you have or have had a history of alcohol, drug, or medicine abuse and dependence, as you have a higher risk of developing dependence on ANELOR (see section “Development of dependence”).

Memory disturbances
A few hours after taking ANELOR, you may experience difficulty remembering events that occurred after taking the medicine.
Paradoxical reactions
ANELOR may cause effects opposite to those expected (paradoxical effects) (see section 4 “Possible side effects”). These effects are more common in children and elderly patients. If you experience such effects, consult your doctor, as treatment with ANELOR should be discontinued.
Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: ANELOR is addictive, meaning you may develop an increasing desire to take the medicine or may experience physical symptoms that only improve or disappear after taking the medicine. The likelihood of developing dependence increases with higher doses and longer treatment duration. Therefore, your doctor will prescribe the most appropriate treatment based on your condition, using the lowest effective dose for the shortest possible duration.
Your doctor will also advise you on when to schedule follow-up visits to monitor your health during ANELOR therapy.
Once physical dependence has developed, sudden discontinuation of treatment may lead to withdrawal symptoms.
Incorrect use of ANELOR
You must take this medicine ONLY if prescribed by a doctor and purchased from a pharmacy.
Some individuals tend to abuse alprazolam and other similar medicines known as benzodiazepines.
Moreover, some people obtain these medicines illegally (e.g., black market, internet, friends, family, etc.), sometimes to resell them. DO NOT take ANELOR if it has not been prescribed to you by a doctor. DO NOT take ANELOR if you are unsure whether the medicine was purchased from a pharmacy.
Children and adolescents
The efficacy and safety of ANELOR in children and adolescents under 18 years of age are unknown.
Your doctor will decide whether ANELOR can be administered to children and adolescents based on their individual condition.
Other medicines and ANELOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of ANELOR and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes ANELOR together with opioids, the dose and duration of combined therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Caution is required when ANELOR is taken with the following medicines, as the effects of ANELOR may be altered or may affect these medicines:

  • pain-relieving medicines (analgesics) and cough suppressants (cough sedatives) containing opium or its derivatives; these medicines may depress your respiratory function;
  • medicines used for certain mental health conditions (antipsychotics), sleep-promoting medicines (hypnotics), anxiety-reducing medicines (anxiolytics, sedatives), antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine, imipramine, and desipramine), strong painkillers (narcotic analgesics, opioids), epilepsy treatments (antiepileptics), anaesthetics used during surgery, and allergy medicines (sedating antihistamines), as they may enhance the central nervous system depressant effect (slowing down of functions). If you take ANELOR together with one or more of these medicines or with alcoholic beverages, these substances may contribute to reduced brain and mental function, potentially leading to reduced spontaneous breathing, coma, and death (see section “Warnings and precautions”);
  • cimetidine, a medicine used to reduce stomach acidity;
  • propoxyphene, a medicine used for pain relief;
  • oral contraceptives;
  • diltiazem, a medicine used to lower blood pressure;
  • digoxin (a medicine used to increase the heart’s contraction strength). If you are elderly, taking ANELOR may increase the likelihood of digoxin-related toxic effects.

The following medicines may increase the effects of ANELOR:

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

ANELOR with food and drinks
Avoid drinking alcohol during treatment with ANELOR, as alcohol may enhance the sedative effect of this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during the first three months of pregnancy, as it may cause congenital malformations in the fetus.
Your doctor will assess whether you can take this medicine during the second and third trimesters of pregnancy.
If your doctor considers it necessary for you to 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), feeding difficulties leading to poor weight gain, and withdrawal symptoms (see section 3 “If you stop taking ANELOR”).
These effects are reversible and may last from a few days up to 1–3 weeks after birth.
If you start ANELOR treatment while of childbearing age, consult your doctor if you plan to become pregnant or suspect you are pregnant, as the medicine must be discontinued. Your doctor will inform you about the potential risks to the fetus associated with ANELOR use.
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, during treatment with ANELOR, you experience loss of concentration or muscle control, or if you feel drowsy or dizzy. These effects are enhanced if you have not slept enough or have consumed alcohol.
ANELOR 0.75 mg/ml oral drops, solution contains ethanol
This medicine contains 43.3 mg of alcohol (ethanol) per 10-drop dose and 87 mg of alcohol (ethanol) per 20-drop dose.
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 equals 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 0.25 mg dose (equivalent to 10 drops) and 466 mg per 20-drop dose.
The maximum daily dose allowed for anxiety treatment, equal to 4 mg of alprazolam (equivalent to 160 drops), contains approximately 3.7 g of propylene glycol. Do not take this medicine if you are pregnant or suffer from liver or kidney disease, unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
If the child is under 5 years of age, consult your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine is not contraindicated in patients with celiac disease.

3. How to take ANELOR

Take this medicine exactly as directed by 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 0.25 mg to 0.50 mg (10–20 drops) three times daily. The dose may be
increased by your doctor up to a maximum of 4 mg per day, taken in divided doses. You should first increase
the evening dose, followed by the daytime doses.
Use in elderly patients, patients with severe liver or kidney problems and/or debilitating organic diseases
The recommended initial dose for the treatment of anxiety is 0.25 mg (10 drops) two or three times daily.
The duration of treatment with ANELOR should be as short as possible.
The maximum duration of treatment should not exceed 2–4 weeks. Prolonged treatment is not recommended.
Your doctor will decide whether treatment may be continued beyond the recommended maximum period.
Instructions for use
Press on the plastic cap and simultaneously unscrew it.

Schematic drawing of a hand pressing down and rotating the cap of a bottle downward, with a curved arrow indicating the unscrewing motion

To close, screw the cap back on tightly.
If you take more ANELOR than you should
If you accidentally ingest or take an excessive dose of ANELOR, contact your doctor immediately or go to the nearest hospital.
In mild cases of overdose, you may experience: impaired sensory functions (drowsiness),
mental confusion and lethargy. In more severe cases, you may experience: profound depression of the central nervous system with symptoms such as drowsiness, confusion, muscle problems (ataxia, hypotonia), low blood pressure, breathing difficulties, 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 for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking ANELOR
Do not stop treatment with ANELOR suddenly and without first discussing it with your doctor.
Your doctor will gradually reduce your dose (by no more than 0.50 mg every 3 days) to minimize:

  • withdrawal symptoms such as: ₋ severe symptoms: feeling detached from oneself or the external world, numbness and tingling in the arms or legs, increased sensitivity to light, sound and physical contact, hallucinations, epileptic 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 as those for which ANELOR was prescribed, and may temporarily reappear more intensely after abrupt discontinuation of treatment.

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 everybody will experience them.

Contact your doctor immediately if you experience any of the following side effects, because treatment with ANELOR must be discontinued:

  • effects opposite to those expected ( paradoxical effects ) (see section 2 “Paradoxical disturbances”) such as:
    ₋ restlessness
    ₋ agitation
    ₋ irritability
    ₋ aggression
    ₋ feelings of disappointment
    ₋ anger
    ₋ nightmares
    ₋ hallucinations
    ₋ disturbances in thinking
    ₋ behavioural changes.

Contact your doctor immediately if you experience any of the following side effects, because they may be serious:

  • swelling of the face, tongue and throat, leading to difficulty in swallowing and breathing ( angioedema )
  • difficulty remembering events occurring after taking the medicine (see section 2 “Memory disturbances”)
  • unmasking of pre-existing depression
  • dependence (see section 2 “Development of dependence”)
  • withdrawal symptoms and 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 ability to coordinate movements
  • memory disturbances
  • 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, decreased or increased body weight
  • confusion, disorientation
  • decreased sexual desire (libido), sexual dysfunction
  • anxiety
  • nervousness
  • balance problems, coordination problems
  • loss of attention and concentration
  • excessive drowsiness (lethargy)
  • insomnia, excessive sleepiness
  • tremors
  • vertigo
  • slurred speech
  • blurred vision
  • nausea
  • dermatitis
  • fatigue, irritability.

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

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

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

  • increased levels of prolactin (a natural hormone) in the blood
  • mood changes
  • hostile behaviours, abnormal thoughts
  • impulsiveness and motor hyperactivity
  • disturbances of the autonomic nervous system responsible for bodily functions that cannot be voluntarily controlled (e.g. internal organs and gland functions)
  • involuntary muscle contractions causing unnatural postures
  • stomach and intestinal disorders
  • inflammatory liver diseases (hepatitis)
  • altered liver function
  • yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
  • skin reactions due to exposure to sunlight
  • inability to completely empty the bladder
  • swelling of the hands and feet due to fluid retention
  • increased pressure inside the eye
  • misuse of this medicine (tendency to excessive or inappropriate use of ANELOR).

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 ANELOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store the medicine below 25°C.
Keep the medicine in the original packaging to protect it from light.
The shelf life after first opening the bottle is 4 months, and any unused product should 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. Package contents and other information

What ANELOR contains
1 ml of solution:

  • The active substance is: alprazolam 0.750 mg;
  • The other components are: Propylene glycol, Ethyl alcohol, Sodium saccharin, Black cherry flavour, Purified water.

Description of the appearance of ANELOR and contents of the pack
Oral drops, solution: 20 ml bottle.
Marketing Authorization Holder
Errekappa Consumer S.r.l. – Via Ciro Menotti 1A - 20129 Milan
Manufacturer
Genetic S.p.A., Contrada Canfora – Fisciano 84084 (SA)
This leaflet was last updated on March 2025