Patient Information Leaflet

Alprazolam Sandoz 0.25 mg Tablets EFG

Alprazolam Sandoz 0.50 mg Tablets EFG

Alprazolam Sandoz 1 mg Tablets EFG

Alprazolam Sandoz 2 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 similar symptoms to 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.

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

2. What you need to know before you start taking Alprazolam Sandoz

3. How to take Alprazolam Sandoz

4. Possible side effects

5. Storage of Alprazolam Sandoz

6. Contents of the pack and additional information

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

Alprazolam 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 Sandoz

• 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 related or unrelated to sleep (sleep apnea),
• if you have a condition called myasthenia gravis characterized by muscle weakness,
• if you have severe liver damage.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alprazolam Sandoz:

• 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, there may be a loss of effectiveness (tolerance),
• there is a risk of developing addiction or 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),
• treatment with benzodiazepines, including alprazolam, can cause dependence, mainly after taking the medication continuously for a long time.

To minimize the risk of dependence, consider the following precautions:

• bendazepine use should only be under medical prescription (never because they have worked in other patients) and never recommend 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 treatment,
• do not combine several benzodiazepines regardless of their indication,

• stopping treatment with alprazolam may cause symptoms similar to those that led you to start treatment with alprazolam (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 Sandoz”),
• using alprazolam with opioid-type medications can cause deep sedation, respiratory depression, coma, and death.
• bendazepines can 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.

Children and adolescents (under 18 years)

Alprazolam is not recommended for children and adolescents under 18 years. Benzodiazepines should not be administered to children unless 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 their instructions carefully (see section “How to take Alprazolam Sandoz”).

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

Special populations

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.

Other medications and Alprazolam Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 for the treatment of depression,
• medications used for the treatment of epilepsy (antiepileptics),
• opioid analgesics and narcotics (morphine derivatives), as they may increase the feeling of euphoria, leading to increased psychological dependence,
• anxiety medications (anxiolytics/sedatives),
• anesthetics,
• sedating antihistamines (allergy medications),
• the concomitant use of alprazolam and opioids (potent analgesics, medication for opioid addiction treatment, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may be potentially fatal. Due to this, 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 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 interact with alprazolam and, in some cases, increase its activity. Some of the medications that interact with alprazolam are:

• medications used for the treatment of 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,
• gastroprotective medications such as cimetidine,
• dextropropoxyphene (narcotic analgesic),
• oral contraceptives,
• diltiazem (anti-hypertensive),
• macrolide antibiotics such as erythromycin, troleandomycin, clarithromycin, and telithromycin,
• medications used for the treatment of AIDS such as ritonavir, etc,
• digoxin (medication used to suppress or prevent heart rhythm disturbances).

Taking Alprazolam Sandoz with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may potentiate sedation, and this may affect your alertness (see section “Driving and operating 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 is not recommended during pregnancy or breastfeeding, unless, in the doctor's opinion, the benefits outweigh the risks for the baby.

If, by the doctor's decision, alprazolam is administered during a late stage of pregnancy or during delivery, certain effects may occur in the newborn, 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.

Driving and operating machines

Alprazolam may affect your ability to drive or operate machines, 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 increasing the dose. Do not drive or operate machines if you experience any of these effects. These effects may be potentiated if you consume alcohol simultaneously.

Alprazolam Sandoz 0.25 mg, Alprazolam Sandoz 0.5 mg, Alprazolam Sandoz 1 mg, and Alprazolam Sandoz 2 mg contain sodium

These medications contain less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Alprazolam Sandoz 0.25 mg tablets and Alprazolam Sandoz 2 mg tablets contain lactose

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

Alprazolam Sandoz 0.50 mg tablets contain lactose and yellow orange S (E110)

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

It may cause allergic reactions.

Alprazolam Sandoz 1 mg tablets contain lactose and amaranth (E123).

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

It may cause allergic reactions.

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 tablet or its part will be ingested without chewing, with the help of a little liquid. The groove is only used to break the tablet if it is difficult to swallow it whole. Your doctor will prescribe the Alprazolam Sandoz 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.Each individual dose should not 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 to 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 stop 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 finish 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 Sandoz 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 itself by different degrees of depression of the central nervous system, 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 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 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 take Alprazolam Sandoz

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 Sandoz

Alprazolam treatment can cause dependence, so when stopping 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 convulsions. 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)

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

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

Unknown frequency (cannot be estimated from available data)

With the use of benzodiazepines, the following may occur:

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 leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://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.

This medication does not require special conditions for conservation.

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 collection point at the 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 Sandoz 0.25 mg Tablets

• The active ingredient is alprazolam. Each tablet contains 0.25 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato) and magnesium stearate.

Composition of Alprazolam Sandoz 0.50 mg Tablets

• The active ingredient is alprazolam. Each tablet contains 0.5 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, Yellow S (E110) and Quinoline Yellow (E104).

Composition of Alprazolam Sandoz 1 mg Tablets

• The active ingredient is alprazolam. Each tablet contains 1 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, Patent Blue V (E131) and Amaranth (E123).

Composition of Alprazolam Sandoz 2 mg Tablets

• The active ingredient is alprazolam. Each tablet contains 2 mg of alprazolam.
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, talc, sodium carboxymethylcellulose (type A) (from potato) and magnesium stearate.

Appearance of the Product and Contents of the Package

Alprazolam Sandoz 0.25 mg are round, flat, scored on one side and white in color.

Alprazolam Sandoz 0.50 mg are round, flat, scored on one side and salmon-colored.

Alprazolam Sandoz 1 mg are round, flat, scored on one side and light blue in color.

Alprazolam Sandoz 2 mg are round, flat, scored in the form of a cross on one side and white in color.

Alprazolam Sandoz 0.25 mg is available in a blister pack containing 30 tablets.

Alprazolam Sandoz 0.50 mg is available in a blister pack containing 30 tablets.

Alprazolam Sandoz 1 mg is available in a blister pack containing 30 tablets.

Alprazolam Sandoz 2 mg is available in a blister pack containing 30 or 50 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

c/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

LACER, S.A.

C/ Boters nº 5; Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès, Barcelona

Spain

Last Review Date of this Leaflet: March 2022

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