Package Leaflet: Information for the User

Alprazolam Cinfa 1 mg Tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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 you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient of this medication is alprazolam. It belongs to a group of medications called benzodiazepines (anxiolytic medications).

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

Do not take alprazolam cinfa

• If you are allergic to alprazolam, benzodiazepines, or any of the other ingredients in this medication (listed in section 6).
• If you have breathing difficulties, whether or not related to sleep (sleep apnea).
• If you have a condition called myasthenia gravis, which is characterized by muscle weakness.
• If you have severe liver damage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take alprazolam cinfa.

• If you have any lung, kidney, or liver problems.
• If you have felt or feel so depressed that you have had thoughts or ideas of suicide.
• After long-term use of alprazolam, tolerance may be detected.
• There is a risk of developing addiction/dependence when using alprazolam.
• 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).
• The treatment with benzodiazepines, including alprazolam, may cause dependence, mainly after taking the medication continuously for a long time.

To minimize the risk of dependence, the following precautions should be taken:

• The use of benzodiazepines should only be under medical prescription (never because they have worked in other patients) and should never be recommended to others.
• Do not increase the prescribed doses, or prolong the treatment longer than recommended.
• Consult your doctor regularly to decide if you should continue with the treatment.
• Do not combine several benzodiazepines, regardless of their indication.
• When stopping treatment with alprazolam, rebound-like symptoms may appear. To avoid this, it is recommended not to stop treatment abruptly, but to gradually reduce the dose, as instructed by your doctor (see section 3 “If you stop taking alprazolam cinfa”).
• The use of alprazolam with opioid 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 consumption.

Other medications and alprazolam cinfa

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

Alprazolam may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

• Central nervous system depressants, as they may potentiate the sedative effect of alprazolam:
• Major tranquilizers (antipsychotics).
• Sleep inducers (hypnotics).
• Medications used to treat depression.
• Medications used to treat epilepsy (antiepileptics).
• Opioid analgesics and narcotics (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence.
• Medications used to treat anxiety (anxiolytics/sedatives).
• Anesthetics.
• Sedating antihistamines (allergy medications).
• The concomitant use of alprazolam and opioids (powerful analgesics, addiction treatment medications, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribes alprazolam 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 dosage recommendations 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 interact with alprazolam and, in some cases, increase its activity. Some of the medications that may interact with alprazolam are:
• Medications used to treat fungal infections such as ketoconazole, itraconazole, posaconazole, or voriconazole. It is not recommended to take them at the same time as alprazolam.
• The following antidepressants: nefazodone, fluvoxamine, and fluoxetine.
• Gastric protectors such as cimetidine.
• Dextropropoxyphene (narcotic analgesic).
• Oral contraceptives.
• Diltiazem (anti-hypertensive).
• Macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin.
• Medications used to treat HIV/AIDS such as ritonavir, etc.
• Digoxin (medication used to suppress or prevent heart rhythm disturbances).

Alprazolam cinfa with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your ability to drive or operate machinery (see section 2 “Driving and operating machines”).

Pregnancy and breastfeeding

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

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

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

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which may trigger a withdrawal syndrome in the postnatal period.

Children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years old. Benzodiazepines should not be administered to children unless it is strictly necessary and prescribed by a doctor. The efficacy and safety of alprazolam in children under 18 years have not been established.

Older adults (over 65 years)

Alprazolam 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 your doctor's instructions carefully (see section 3 “How to take alprazolam cinfa”).

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

Special groups of patients

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

If you have respiratory problems, inform your doctor.

Driving and operating machines

Alprazolam may affect your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects. These effects may be potentiated if you consume alcohol at the same time.

Alprazolam cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Alprazolam cinfa contains sodium benzoate

This medication contains 0.224 mg of sodium benzoate per tablet.

Alprazolam cinfa contains sodium

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

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

Swallow the tablet or its part without chewing with the help of water or another non-alcoholic beverage. If necessary, and as indicated by your doctor or pharmacist, you can break the tablet along the groove.

The tablet can be broken into equal doses.

Your doctor will prescribe the alprazolam presentation most suitable for you according to the dose you need.

The recommended doses are as follows:

The initial dose is 0.25 mg to 0.5 mg of alprazolam three times a day.

The recommended 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 initial recommended dose is 0.25 mg of alprazolam 2 or 3 times a day, with a total daily dose of 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 it necessary to prolong 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 based 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 effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take morealprazolam cinfathan 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 (prolonged and deep sleep), muscle tone decrease (hypotonia), blood pressure decrease, 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 your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takealprazolam cinfa

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 alprazolamcinfa

Treatment with alprazolam can cause dependence, so when discontinuing alprazolam administration abruptly, withdrawal symptoms may appear.

The withdrawal symptoms that may occur are: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, general feeling of disgust (dysphoria), insomnia, intolerance to light, sounds, and physical contact, paresthesias and cramps in the extremities and abdomen, vomiting, sweating, tremors, depersonalization, hallucinations, and seizures. If 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 medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur during treatment with alprazolam predominantly occur at the beginning of treatment and generally disappear with continued administration or after a dose reduction.

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

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

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

• Sensation 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.

Rare side effects (may affect up to 1 in 100 people):

• 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.
• Withdrawal 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:

• Drowsiness, 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 elderly patients.
• The administration of the product (even at usual doses) may lead to the development of physical dependence. Stopping treatment may lead to the development of withdrawal or rebound phenomena. It may cause psychological dependence. 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 possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of alprazolam cinfa

• The active ingredient is alprazolam. Each tablet contains 1 mg of alprazolam.
• The other components are: lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium (type A) (from potato), cornstarch, povidone, magnesium stearate, anhydrous colloidal silica, sodium docusate, sodium benzoate (E-211), hydrated aluminum oxide, and indigotin (E-132).

Appearance of the product and contents of the packaging

Blue sky-colored tablets, cylindrical, biconvex, scored on one face and marked with the code “A1C” on the other face.

It is presented in PVC-PVDC/ALU blisters. Each package contains 30 tablets.

Other presentations:

alprazolam cinfa 0.25 mg tablets EFG, package with 30 tablets.

alprazolam cinfa 0.5 mg tablets EFG, package with 30 tablets.

alprazolam cinfa 2 mg tablets EFG, package with 30 and 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: June 2022

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/62790/P_62790.html

QR code to:https://cima.aemps.es/cima/dochtml/p/62790/P_62790.html