Package Insert: Information for the User

Alprazolam Alter 0.50 mg Tablets EFG

Alprazolam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Alprazolam Alter is and for what it is used

2. What you need to know before starting to take Alprazolam Alter

3. How to take Alprazolam Alter

4. Possible adverse effects

5. Storage of Alprazolam Alter

6. Contents of the package and additional information

Alprazolam Alter contains the active ingredient alprazolam. It belongs to a group of medicines called benzodiazepines (anxiolytic medicines).

Alprazolam Alter is used in adults for the treatment of severe, debilitating, or highly distressing anxiety symptoms. This medicine is only for short-term use.

Do not take Alprazolam Alter

• if you are allergic to alprazolam, benzodiazepines in general, or any of the other components of this medication (listed in section 6).
• if you have severe respiratory failure or lung diseases.
• if you have severe liver damage.
• if you have Myasthenia gravis (a form of muscle weakness).
• if you have sleep apnea (a condition where breathing stops during sleep).
• if you have glaucoma (increased eye pressure that can cause blindness).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Alter.

• if you have or have had liver or kidney disease, or chronic respiratory failure, inform your doctor.
• if you have depression or anxiety associated with depression, as alprazolam may increase any suicidal feelings you may have.
• if during treatment you notice symptoms of mania (a state of overexcitement, feeling of euphoria, or irritability) or hypomania (a state of excitement and excessive activity).
• after prolonged use of alprazolam, tolerance may develop.
• if you notice any change in your personality, as alprazolam, and benzodiazepines in general, have been associated with rare reactions such as restlessness, agitation, irritability, aggression, confusion, anger attacks, nightmares, hallucinations, psychosis, and inappropriate behavior. If this occurs, consult your doctor immediately.

• When stopping treatment with alprazolam, withdrawal symptoms similar to those that led to starting treatment with Alprazolam Alter may occur (rebound effect). To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose, as instructed by your doctor (see section “If you stop taking Alprazolam Alter”).
• The use of alprazolam with opioid-type medications may cause deep sedation, respiratory depression, coma, and death.
• Benzodiazepines may cause memory loss and reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, discontinue treatment and consult your doctor.
• It is very important to inform your doctor if you have a history of drug and alcohol use.

• There is a risk of developing addiction/dependence when using Alprazolam Alter.

The use of this medication, and all benzodiazepines in general, may lead to dependence. This occurs mainly after uninterrupted use of the medication for a prolonged period, or by increasing the dose. To prevent these risks, please note the following:

• Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients) and never advise others to take them.

• Do not increase the prescribed dose, or prolong treatment longer than recommended.

• Consult your doctor regularly to decide if treatment should continue.

• The consumption of abused drugs or alcohol may increase the risk of dependence.

Since this medication should not be discontinued abruptly, but rather gradually, follow your doctor's instructions strictly for the end of treatment.

Children and adolescents (under 18 years)

The efficacy and safety of use in children have not been established. Therefore, Alprazolam Alter is not recommended for use in children and adolescents (under 18 years).

Use in elderly patients (over 65 years)

Alprazolam Alter may affect this group of patients more than young patients. If you belong to this group, your doctor may reduce the dose and check your response to treatment. Please follow their instructions carefully (see section “How to take Alprazolam Alter”).

Benzodiazepines and related products should be used with caution in elderly patients, due to the risk of sedation and/or muscle weakness that may cause falls, often with serious consequences in this population.

Special patient groups

If your liver or kidneys do not function well, consult your doctor, who may advise you to use a lower dose of Alprazolam Alter.

If you have respiratory problems, inform your doctor.

Taking Alprazolam Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

•Central nervous system depressants, as they may potentiate the sedative effect of Alprazolam Alter:

• major tranquilizers (antipsychotics)
• sleep inducers (hypnotics)
• medications used to treat depression
• medications for epilepsy treatment (antiepileptics)
• narcotic analgesics and opioids (morphine derivatives) due to the potential to increase euphoria, leading to increased psychological dependence
• anxiety medications (anxiolytics/sedatives)
• anesthetics
• sedating antihistamines (allergy medications)
• However, if your doctor prescribes Alprazolam Alter with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• There are some groups of medications that, due to their action in the body (inhibitors of cytochrome P450), may increase the activity of Alprazolam Alter, such as:

• antifungal medications like ketoconazole, itraconazole, posaconazole, or voriconazole
• the following antidepressants: nefazodone, fluvoxamine, and fluoxetine
• gastric protectors like cimetidine
• dextropropoxyphene (narcotic analgesic)
• oral contraceptives
• diltiazem (anti-hypertensive)
• macrolide antibiotics like erythromycin, troleandomycin, clarithromycin, and telithromycin
• protease inhibitors for HIV treatment, such as ritonavir
• digoxin (medication used to suppress or prevent heart rhythm alterations).

If you need to undergo surgery where general anesthesia will be administered, inform your doctor that you are taking Alprazolam Alter.

Taking Alprazolam Alter with food, drinks, and alcohol

During treatment, avoid consuming alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see also the section “Driving and using machines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Alprazolam Alter is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefits outweigh the risks for the baby.

If you take alprazolam regularly during the last 3 months of pregnancy, your baby may develop dependence on alprazolam and be at risk of experiencing withdrawal symptoms after birth.

If, by the doctor's decision, alprazolam is administered at the end of pregnancy or during delivery, the baby may experience effects such as decreased body temperature (hypothermia), decreased muscle tone (hypotonia), and moderate respiratory depression.

Benzodiazepines pass into breast milk, so their use is not recommended in breastfeeding women.

Driving and using machines

This medication may cause drowsiness, sedation, difficulty concentrating, and decreased reflexes, which may be potentiated if you consume alcohol at the same time. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medication.

Alprazolam Alter contains yellow orange S (E110)

This medication may cause allergic reactions because it contains yellow orange S. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Alprazolam Alter contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Alprazolam Alter sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

If your doctor has indicated that you have a sodium intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

The Alprazolam Alter tablets should be swallowed whole without chewing with a sufficient amount of liquid (for example, a glass of water). The tablet groove may help you break it if you have difficulty swallowing it whole. If you are to take it once a day, it is preferable to take the dose in the morning.

Your doctor will prescribe the Alprazolam Alter presentation most suitable for you, according to the dose you need.

The usual doses are as follows:

• The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.
• The usual dose ranges from 0.5 mg to a maximum of 4 mg per day divided into 2 or 3 doses.

In elderly patients, with chronic respiratory insufficiency, liver or kidney impairment, the recommended initial dose is 0.25 mg of alprazolam, 2 or 3 times a day, with the amount of alprazolam ingested per day ranging from 0.5 mg to 0.75 mg in divided doses, which can be gradually increased as needed and well tolerated.

No individual dose should exceed the indicated limits, and the total daily dose should not either, unless your doctor indicates otherwise.

Duration and discontinuation of treatment

The maximum duration of treatment should not exceed 2-4 weeks. Long-term treatment is not recommended. If your doctor considers that in your case it is necessary to prolong the treatment, they will do so for limited periods and will frequently monitor your situation.

You should never discontinue treatment abruptly. Your doctor will indicate the duration of treatment depending on the evolution of your disease and will explain how to gradually reduce the dose until you complete your treatment.

If you estimate that the action of alprazolam is too strong or too weak, inform your doctor or pharmacist.

If you take more Alprazolam Alter than you should

If you have taken more alprazolam than you should, consult your doctor or pharmacist immediately or go to the nearest hospital with this leaflet.

Benzodiazepine overdose generally manifests by different degrees of central nervous system depression, ranging from drowsiness to coma.

Symptoms include drowsiness (somnolence), speech disorders (dysarthria), coordination disturbances, confusion, lethargy (a state of deep and prolonged somnolence), muscle tone decrease (hypotonia), blood pressure drop, respiratory depression, rarely coma, and very rarely death. Serious sequelae are rare, unless alprazolam is taken with other medications or alcohol.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Alprazolam Alter

Do not take a double dose to compensate for the missed doses. If the missed dose is recent, take your dose immediately, and if not, wait for the next dose, without taking a double dose to compensate.

If you interrupt treatment with Alprazolam Alter

Alprazolam treatment can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

Withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of discontent (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. In case this occurs, you should consult your doctor immediately.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Alprazolam Alter may cause side effects, although not everyone will experience them.

The following side effects have been produced during treatment with alprazolam:

•Very common side effects(may affect more than 1 in 10 patients)

• Depression.
• Sedation, drowsiness, coordination disorder (ataxia), memory alteration, difficulty articulating words (dysarthria), dizziness, headache.
• Constipation, dry mouth.
• Fatigue, irritability.

•Common side effects(may affect between 1 and 10 in 100 patients)

• Feeling of confusion, disorientation, alteration of sexual desire (libido), anxiety, difficulty sleeping (insomnia), nervousness.
• Abnormal coordination, balance alteration, difficulty concentrating, excessive sleep (hypersomnia), deep and prolonged somnolence (lethargy), tremor.
• Nausea, decreased appetite.
• Blurred vision.
• Dermatitis.
• Sexual dysfunction.
• Weight changes.

•Uncommon side effects(may affect between 1 and 10 in 1,000 patients)

• Mental and behavioral disorders (mania), hallucinations, anger reactions, agitation, dependence.
• Memory loss (amnesia).
• Loss of muscle strength.
• Inability to retain urine in the bladder (urinary incontinence).
• Irregular menstruation.
• Abstinence symptoms.

•Unknown frequency(cannot be estimated from available data)

• Increased levels of prolactin in the blood (hormone responsible for stimulating and maintaining lactation after childbirth).
• Mental and behavioral disorders (hypomania), aggression, hostility, abnormal thinking, psychomotor hyperactivity, drug abuse.
• Autonomic nervous system imbalance, involuntary muscle contractions (dystonia).
• Gastrointestinal disorder, hepatitis, liver function alteration, yellowing of the skin and white of the eyes (jaundice).
• Peripheral edema.
• Angioedema (swelling under the skin's surface).
• Photosensitivity (exaggerated response to light).
• Urinary retention in the bladder.
• Increased intraocular pressure.

With the use of benzodiazepines, the following may occur:

• Somnolence, lack of reaction to emotional stimuli (emotional numbing), reduced state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. These phenomena occur predominantly at the beginning of treatment and generally disappear with continued administration. Occasionally, gastrointestinal alterations, changes in sexual desire, or skin reactions may occur.
• A loss of memory (amnesia) may develop, which may be associated with inappropriate behavior.
• The use of benzodiazepines may unmask an existing depression.
• When using benzodiazepines or similar compounds, reactions such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations may occur. These reactions can be severe and occur more frequently in children and the elderly.
• The administration of the product (even at usual doses) may lead to the development of physical dependence. Stopping treatment may lead to withdrawal or rebound phenomena. Psychological dependence may develop. Cases of abuse have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Alprazolam Alter after the expiration date that appears on the packaging after “Exp”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alprazolam Alter 0.50 mg tablets

The active ingredient is alprazolam. Each tablet contains 0.50 mg of alprazolam.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, carboxymethylcellulose sodium (Type A), magnesium stearate, quinoline yellow (E104), and orange yellow S (E110).

Appearance of the product and contents of the packaging

Orange-colored, scored, circular tablets. The score is for fracturing and facilitating swallowing, but not for dividing into exactly equal doses. Packaging with 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

LABORATORIOS ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

Responsible for manufacturing

LACER, S.A.

C/. Boters, 5 -Parc Tecnològic del Vallès-

08290 Cerdanyola del Vallès (Barcelona, Spain)

This leaflet was approved in June 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/