Xanor 0.25 mg, 0.5 mg, 1 mg, and 2 mg tablets/ Xanor Depot 0.5 mg, 1 mg, 2 mg, and 3 mg prolonged-release tablets.
alprazolam
What Xanor/Xanor Depot is and what it is used for
Xanor/Xanor Depot contains the active substance alprazolam and belongs to a group of medicines called benzodiazepines (anti-anxiety medicines).
Xanor/Xanor Depot is used in adults to treat severe anxiety symptoms, disabling, or cause the patient great discomfort. This medicine is intended for short-term treatment only.
What you need to know before using Xanor/Xanor Depot
Do not take Xanor/Xanor Depot:
- if you are allergic to the active substance, other benzodiazepines, or any other ingredient in this medicine (listed in section 6)
- if you have sleep apnea (breathing pauses that occur during sleep)
- if you have the muscle disease myasthenia gravis
- if you have severe breathing problems
- if you have severe liver problems
- if you have an acute intoxication caused by alcohol or other drugs that affect the central nervous system
Warnings and precautions
Talk to your doctor or pharmacist before taking Xanor/Xanor Depot. Take special care with Xanor/Xanor Depot:
- if you have impaired kidney function
- if you have impaired liver function
- if you have a reduced general condition
- if you are elderly as there is a risk of drowsiness and muscle weakness which can lead to fall accidents
- if you are taking other medicines for mental illnesses
- if you are taking painkillers containing dextropropoxyphene. This combination should be avoided as it may affect breathing
- if you abuse or have abused alcohol, drugs, or medicines
- if you have been taking Xanor/Xanor Depot for a long time as the effect may be reduced.
Dependent
Use of Xanor/Xanor Depot can lead to physical and psychological dependence on the drug. If you find it difficult to stop taking this medicine, you may be psychologically dependent on it. Physical dependence means that withdrawal symptoms occur when treatment with this medicine is stopped suddenly (see section 3 “If you stop taking Xanor/Xanor Depot”). The risk of addiction increases with the dose and length of treatment. To reduce the risks, the dose should be as low as possible and the duration of treatment as short as possible. Follow your doctor’s dosage recommendations (see section 3). The risk is also greater in patients who abuse or have abused alcohol and drugs.
Abuse
Drug abuse is a known risk with this medicine (see also section 4). If this medicine is abused, it can lead to overdose and death. Always follow your doctor’s dosage recommendations. This drug may be desirable for people who abuse prescription medications and should be kept out of the reach of other people.
Memory impact
During treatment with Xanor/Xanor Depot, your memory may deteriorate. This usually happens several hours after you have taken the medicine. Contact your doctor if you experience such symptoms.
Effect on mood
Use of Xanor/Xanor Depot may increase the risk of episodes of hypomania (a milder form of mania) and mania (overactive mental state, excessively excited and energetic) in patients with depression. Contact your doctor immediately if you develop signs of hypomania or mania.
Treatment with Xanor/Xanor Depot may increase the risk of developing thoughts of harming yourself or committing suicide if you have depression. Ask your doctor before starting treatment with Xanor/Xanor Depot.
If treatment with Xanor/Xanor Depot is necessary and you are depressed or have previously had suicidal thoughts or thoughts of harming yourself, your doctor may monitor your treatment closely. Contact a doctor or the nearest hospital immediately if you develop thoughts of harming yourself or committing suicide.
Risk of tooth damage
It is important to brush your teeth with fluoride toothpaste twice a day because Xanor/Xanor Depot can in rare cases cause dry mouth, which can lead to tooth damage if oral hygiene is not taken care of.
Other medicines and Xanor/Xanor Depot
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take Xanor or Xanor Depot at the same time as other medicines used to treat certain conditions (see examples below), treatment with these medicines or Xanor/Xanor Depot may be affected. Your doctor may then need to adjust your dose.
- severe pain, some type of addiction, or cough (opioid drugs). Increases the risk of drowsiness, breathing difficulties ( respiratory depression ), and coma, and can be life-threatening. Because of this, concomitant use should only be considered by the physician when other treatment options are not possible. Contact a doctor if you experience symptoms such as drowsiness or difficulty breathing ( respiratory depression ).
- mental health problems (antipsychotic drugs including clozapine)
- sleep disorders (sleeping pills)
- allergy or hay fever (certain antihistamines )
- if you undergo a major operation (anesthesia)
- severe pain (narcotic analgesics such as dextropropoxyphene )
- problems such as anxiety or depression, including certain antidepressants containing fluoxetine, fluvoxamine, or nefazodone
- heart failure ( digoxin )
- infection ( antibiotics containing erythromycin, clarithromycin, or telithromycin)
- fungal infections (itraconazole, fluconazole, ketoconazole, voriconazole)
- medicines to treat angina and high blood pressure, such as diltiazem
- HIV and AIDS, so-called HIV protease inhibitors
- heartburn and stomach ulcers, such as cimetidine
- asthma and bronchial catarrh, such as theophylline
- epilepsy, such as carbamazepine
- muscle relaxant drugs. When used together with alprazolam, the muscle relaxant effect can be increased, which entails the risk of fall injuries.
Possibly, the treatment effect could also be affected in combination with the following drugs: birth control pills, rifampicin (against infection ), or St. John’s wort.
Use of Xanor/Xanor Depot with alcohol
You should avoid alcohol in connection with treatment with Xanor/Xanor Depot, as the combination can increase certain side effects of the medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You must tell your doctor immediately if you are pregnant or plan to become pregnant. Observations in humans have shown that alprazolam can be harmful to the fetus (increased risk of malformation ( cleft palate )). During pregnancy, alprazolam may only be used after a doctor has decided whether the benefit of the treatment outweighs the risk to the unborn child and whether the medicine is suitable for you.
If you use Xanor/Xanor Depot until birth, tell your doctor because your newborn baby may have withdrawal symptoms after birth.
Breast-feeding
Do not use Xanor/Xanor Depot if you are breastfeeding. Alprazolam passes into breast milk.
Driving ability and use of machinery
Treatment with Xanor/Xanor Depot may impair your ability to react and concentrate by making you feel drowsy and/or forgetful. Do not drive or use machinery if you are affected in this way.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Xanor/Xanor Depot contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Xanor contains sodium benzoate (E 211) and sodium
Xanor 0.25 mg, 0.5 mg, and 1 mg tablets contain 0.11 mg sodium benzoate (E 211) per tablet. Xanor 2 mg tablets contain 0.23 mg sodium benzoate (E 211) per tablet.
Xanor tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. are almost “sodium-free”.
How to take Xanor/Xanor Depot
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor, who adjusts it individually for you. The treatment should preferably be started, followed up, and ended by the same doctor. The treatment is often started with a low dose which can then be increased if necessary according to the doctor’s prescription. With Xanor tablets, the effect is obtained after 1-2 hours, while it takes 5-11 hours to get the full effect with Xanor Depot depot tablets. Once the appropriate maintenance dose has been established, Xanor tablets are taken 2-3 times daily and Xanor Depot prolonged-release tablets are taken 1-2 times daily.
Please note that Xanor Depot prolonged-release tablets must be swallowed whole, they must not be split, chewed, or crushed! If Xanor Depot is taken once daily, it is preferable to take one dose in the morning. Never change the prescribed dose yourself.
Length of treatment: The risk of dependence and abuse may increase with the dose and length of treatment. Therefore, the doctor should prescribe the lowest possible effective dose and duration of treatment and reassess the need for continued treatment frequently (see section 2 “Warnings and precautions”).
The maximum treatment time should not exceed 2-4 weeks. Long-term treatment is not recommended.
Use for children and adolescents
Safety and efficacy have not been established in patients under 18 years of age. The use of alprazolam is therefore not recommended.
If you have taken too much Xanor/Xanor Depot
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose may be:
- dizziness
- somnolence
- breathing problems
- confusion
- unconsciousness
- muscle weakness
- difficulty coordinating body movements ( ataxia )
- reactions such as aggressiveness, agitation, hallucinations, and restlessness.
If you forget to take Xanor/Xanor Depot
If you forget to take your medicine at the usual time, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a missed dose. If you are unsure, ask your doctor or pharmacist.
If you stop taking Xanor/Xanor Depot
You should not stop taking Xanor or Xanor Depot without first talking to your doctor. You must taper off the treatment slowly in consultation with your doctor.
If the treatment is stopped suddenly, it can lead to withdrawal symptoms such as headache, muscle pain, severe anxiety, restlessness, confusion, irritation, and sleep disturbances. In severe cases, the following symptoms may occur: altered perception of reality, altered personality experience (a feeling that you are outside your own body), loss of sensation and tingling in the arms and legs, hypersensitivity to light, sound and touch, hallucinations and epileptic seizures (seizures). . These symptoms may occur several days after you stop taking the tablets. When treatment with alprazolam stops, symptoms that were originally the reason for treatment with Xanor/Xanor Depot may return with greater intensity than before. In addition to the symptoms listed above, mood swings may also occur.
Your doctor will therefore reduce the dose gradually when treatment ends. Dose reduction is done according to individual needs, as the tapering depends on several factors (e.g. length of treatment and your daily dose ). Ask your doctor how to reduce the dose gradually.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Xanor/Xanor Depot and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Angioedema has been observed but the frequency is not known
Stop taking Xanor/Xanor Depot and contact your doctor as soon as possible if you experience any of the following side effects:
- yellow discoloration of the whites of the eyes or skin (jaundice)
- reactions such as restlessness, agitation, irritability, aggressiveness, delusions, tantrums, nightmares, insomnia, hallucinations, or mental illness characterized by the disturbed perception of reality ( psychosis ), inappropriate behavior, and other behavioral disturbances. These reactions happen more often if you are older.
- depression/depressive thoughts.
The following side effects may occur during treatment with Xanor/Xanor Depot:
Very common (may affect more than 1 in 10 users)
- Depression
- sedation
- drowsiness
- coordination difficulties
- impaired memory
- speech difficulties
- dizziness
- headache
- constipation
- dry mouth
- fatigue
- irritability
Common (may affect up to 1 in 10 users)
- decreased appetite
- anorexia
- increased appetite
- state of confusion
- disorientation
- decreased sexual desire ( libido )
- concern
- sleep difficulties
- nervousness
- increased sexual desire ( libido )
- balance disorders
- coordination difficulties
- extreme fatigue
- tremors
- concentration difficulties
- blurred vision
- nausea
- vomiting
- skin inflammation
- sexual dysfunction
- weight change
Uncommon (may affect up to 1 in 100 users)
- mania (overactive mental state, excessively excited and energetic)
- hallucinations
- anger
- bodily anxiety
- drug dependence (see section 2 “Warnings and precautions”)
- memory loss
- feeling of intoxication
- muscle weakness
- incontinence
- irregular menstruation
- withdrawal syndrome (see section 2 “Warnings and precautions”)
Has been reported (occurring in an unknown number of users)
- overproduction of the hormone et prolactin
- hypomania (a milder form of mania)
- aggressiveness
- hostility
- delusions
- restlessness
- drug abuse (see section 2 “Warnings and precautions”)
- autonomic nervous system imbalance (such as palpitations, increased salivation, and nasal congestion)
- involuntary muscle contractions
- reduced responsiveness
- speech difficulties
- low blood pressure
- stomach and intestinal problems
- trouble swallowing
- inflammation of the liver ( hepatitis )
- problems with liver function
- jaundice (causes yellowing of the skin and the whites of the eyes)
- swelling of the body ( edema )
- skin reactions caused by sunlight
- difficulty urinating
- increased fluid pressure in the eye
Previously undetected depression may become apparent when using benzodiazepines such as Xanor/Xanor Depot.
Physical and psychological dependence may develop during treatment. Therefore, if treatment is stopped suddenly, certain symptoms may occur (see section 3 “If you stop taking Xanor/Xanor Depot”).
Impairment of memory may occur which may lead to inappropriate behavior (see section 2 “Warnings and precautions”).
How Xanor/Xanor Depot should be stored
Xanor tablets: No special storage instructions.
Xanor Depot prolonged-release tablets 0.5 mg and 2 mg: Store in the original packaging. Light-sensitive (tablets stored in too bright light may change color).
Xanor Depot prolonged-release tablets 1 mg and 3 mg: No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Xanor tablets
- The active substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg, 1 mg or 2 mg of alprazolam.
- Other ingredients are lactose monohydrate 96 mg (tablets 0.25, 0.5, and 1 mg) and 192 mg (tablets 2 mg), microcrystalline cellulose, corn starch, magnesium stearate, docusate sodium with sodium benzoate (E 211), colloidal silicon dioxide. See section 2 “Xanor/Xanor Depot contains lactose” and “Xanor contains sodium benzoate and sodium” for further informationDyes: erythrosine E127 (only tablets 0.5 and 1 mg), indigo carmine E132 (only tablets 1 mg).
Xanor Depot prolonged-release tablet
- The active substance is alprazolam. Each prolonged-release tablet contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam.
- Other ingredients are lactose monohydrate 222 mg, hypromellose, magnesium stearate, and colloidal silicon dioxide. See section 2 “Xanor/Xanor Depot contains lactose” for further information. Dyes: indigo carmine E132 (only prolonged-release tablets 0.5 and 2 mg).
Appearance and package sizes of the medicine
Xanor tablets
0.25 mg: white, oval, 9.0×5.5 mm, scored, embossed UPJOHN 29
0.5 mg: pink, oval, 9.0×5.5 mm, scored, embossed UPJOHN 55
1 mg: violet, oval, 9.0×5.6 mm, scored, embossed UPJOHN 90
2 mg: white, oblong, 15.0×4.6 mm, scored, embossed U94
Tablets 0.25 mg, 0.5 mg, and 1 mg: pressure packs containing 20 and 100 tablets. Glass jars containing 200 tablets.
Tablets 2 mg: Glass jars containing 20, 100, and 200 tablets.
Xanor Depot prolonged-release tablet
0.5 mg: blue, diameter 9.3 mm, embossed P&U 57
1 mg: white, diameter 9.3 mm, embossed P&U 59
2 mg: blue, pentagonal, embossed P&U 66
3 mg: white, triangular, embossed P&U 68
Prolonged-release tablets 0.5 mg, 1 mg, 2 mg, and 3 mg: pressure packs containing 20 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local Representative
Viatris AB
Box 23033
104 35 Stockholm