0.25 mg, 0.5 mg, 1 mg and 2 mg alprazolam tablets
1. What Alprazolam Krka dd is and what it is used for
Alprazolam Krka dd contains the active substance alprazolam. It belongs to a group of medicines called benzodiazepines.
Alprazolam Krka dd tablets are used for short-term treatment of:
- generalized anxiety disorder
- anxiety disorder associated with depression
- panic disorder, with or without agoraphobia (fear of certain situations or fear of squares)
Alprazolam Krka dd should only be prescribed if the anxiety is severe, disabling, or causing great discomfort.
Alprazolam contained in Alprazolam Krka dd may also be approved for the treatment of other conditions not mentioned in this information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Alprazolam Krka dd
Do not use Alprazolam Krka dd
- if you are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6)
- if you have myasthenia gravis muscle disease
- if you have severe breathing problems (eg chronic bronchitis or emphysema ).
- if you have sleep apnea (irregular breathing or paused breathing while sleeping)
- if you have severe liver problems
- if you have an acute poisoning caused by alcohol or other drugs that affect the central nervous system
Warnings and cautions
Talk to your doctor or pharmacist before taking Alprazolam Krka dd if you:
- have been depressed and had thoughts of committing suicide.
- have had a mental illness that required hospitalization.
- have problems with the lungs, kidneys, or liver.
- have previously abused drugs or alcohol or have had difficulty stopping taking drugs, alcohol, or drugs (See section 4 “Possible side effects”). Your doctor may give you special help when you stop taking this medicine.
- previously used drugs for severe anxiety, because your body can get used to this type of drug so that you no longer get the effect of them.
Benzodiazepines and similar drugs should be used with caution in the elderly due to the risk of drowsiness and/or muscle weakness that can lead to falls, which can have serious consequences.
Be aware that the effect of the tablets may decrease after you have used them for a few weeks (tolerance).
Use of Alprazolam Krka dd may lead to physical and mental dependence on the drug. The risk of addiction increases with a higher dose and longer treatment time. The risk is also greater in patients who abuse or have abused alcohol or drugs (see also section 3 “If you stop taking Alprazolam Krka dd”).
During treatment with Alprazolam Krka dd, your memory may be impaired. This usually occurs several hours after you have taken the medicine. Contact your doctor if you experience such symptoms.
Use of Alprazolam Krka dd may increase the risk of episodes of hypomania and mania in patients with depression. Contact a doctor as soon as possible if you develop hypomania or mania.
Treatment with Alprazolam Krka dd may increase the risk of developing thoughts of harming yourself or committing suicide if you suffer from severe depression or anxiety associated with major depression. Ask your doctor before starting treatment with Alprazolam Krka dd
If treatment with Alprazolam Krka dd is necessary and you are severely depressed or have previously had suicidal thoughts or thoughts of harming yourself, your doctor may monitor your treatment closely. Contact a doctor as soon as possible or go to the nearest hospital if you develop thoughts of harming yourself or committing suicide.
Children and young people
Alprazolam is not recommended for children and adolescents under 18 years of age.
Other medicines and Alprazolam Krka dd
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially medicines listed below as the side effects of Alprazolam Krka dd may change when taken at the same time:
- other medicines to treat anxiety or depression (eg nefazodone, fluvoxamine, fluoxetine ), or sleeping pills
- certain strong painkillers (eg morphine, codeine, dextropropoxyphene )
- medicines to treat mental illnesses such as schizophrenia (antipsychotics, including clozapine)
- epilepsy drugs (eg carbamazepine)
- medicines to relieve allergies ( antihistamines )
- medicines to treat fungal infections (eg ketoconazole, itraconazole, fluconazole, voriconazole)
- birth control pills
- certain antibiotics to treat infections (eg erythromycin, clarithromycin, telithromycin)
- cimetidine (to treat stomach ulcers )
- diltiazem (used to treat angina and high blood pressure )
- digoxin (used for several heart problems)
- certain medicines to treat HIV (eg ritonavir)
- rifampicin, a medicine used to treat tuberculosis
- drugs to treat asthma and bronchitis (eg theophylline).
- muscle relaxants (as these are used together with alprazolam, there is a risk of an increased muscle relaxant effect which may lead to falls)
- St. John’s wort (a traditional herbal medicine).
If you are going to have an operation and need to be put to sleep, tell your doctor that you are taking Alprazolam Krka dd
Concomitant use of Alprazolam Krka dd and opioid drugs (strong painkillers, opioid-dependent drugs, and certain cough medicines) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Alprazolam Krka dd at the same time as opioid medicines, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any opioid medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
Alprazolam Krka dd with food, drink, and alcohol
You can take the tablet with or without food. Swallow the tablet together with a small amount of liquid. It is important to avoid alcohol in connection with treatment with Alprazolam Krka dd, as the combination may potentiate the effect of the drug.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Human observations have shown that alprazolam may be harmful to the fetus (increased risk of malformation ( cleft palate )). Alprazolam Krka dd should not be used during pregnancy unless clearly necessary by your doctor. The doctor will assess whether the benefit of the treatment outweighs the risk to the unborn child. If you are taking Alprazolam Krka dd until birth, tell your doctor as the newborn may experience withdrawal symptoms when it is born.
Breast-feeding
Do not use Alprazolam Krka dd if you are breast-feeding. Alprazolam passes into breast milk.
Driving and using machines
Alprazolam Krka dd can cause side effects such as drowsiness, memory loss, muscle weakness, and impaired concentration. Your ability to react may therefore be affected, especially if you do not get enough sleep. These effects can be exacerbated if you drink alcohol. You should not drive or use machines during treatment with Alprazolam Krka dd
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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Alprazolam Krka dd contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Alprazolam Krka dd
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine the appropriate dose of Alprazolam Krka dd for you, depending on your symptoms and the development of tolerance. The treatment is often started with a low dose which can then be increased if necessary according to the doctor’s prescription. If you experience serious side effects after your first dose, your dose may be reduced. Never change the prescribed dosage yourself.
Treatment of anxiety syndrome
The recommended starting dose is 0.25 – 0.5 mg three times daily.
Your doctor may increase the dose as needed. The recommended maintenance dose is 0.5 – 3 mg daily, divided into several doses.
Treatment of anxiety disorders associated with depression
When treating anxiety disorders associated with depression, your doctor will prescribe a maintenance dose of up to 3 mg per day, spread over several dosing occasions.
Treatment of the panic disorder
The recommended starting dose is 0.5 – 1 mg before bedtime.
Your doctor may adjust the dose as needed. Dose one can be increased by a maximum of 1 mg every 3-4 days, to a maximum dose of 10 mg.
Elderly and patients who are sensitive to the hypnotic effect of alprazolam
The starting dose is 0.25 mg two to three times daily for the treatment of anxiety disorders. The doctor may increase the dose gradually if necessary. In the treatment of the panic disorder, the doctor may increase the dose, if necessary, to a maximum dose of 4.5 mg daily, divided into several doses.
Treatment time
Alprazolam Krka dd should only be used for short-term treatment (maximum 12 weeks, including slow tapering of dose one when treatment is to be stopped). The duration of treatment will be determined by the doctor.
The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
An overdose of alprazolam causes dizziness, drowsiness, breathing problems, confusion, unconsciousness, muscle weakness, ataxia (difficulty coordinating body movements), feeling cold, slurred speech, drop in blood pressure, aggression, hallucinations, and upset.
If you forget to use Alprazolam Krka dd
If you forget to take your dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Alprazolam Krka dd
You should not stop taking Alprazolam Krka dd without first talking to your doctor as it is important that you, in consultation with your doctor, gradually reduce your treatment. If treatment is stopped abruptly or if the dose is lowered rapidly, it may lead to relapse symptoms which may lead to increased anxiety, restlessness, or difficulty sleeping. Some patients may experience withdrawal symptoms (see section 4 “Possible side effects”). These symptoms will go away as your body adjusts.
Doctors will therefore reduce the dose gradually when treatment is stopped. The dose reduction takes place according to individual needs, as the downsizing depends on several factors (eg the length of the treatment time and your daily dose ). Generally, the dose should be gradually reduced by 0.5 mg alprazolam every three days. For some people, the dose may need to be reduced even more slowly. Your doctor will explain how to reduce your dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, talk to your doctor immediately as your treatment needs to be stopped:
- Sudden wheezing, difficulty swallowing or breathing, swollen eyelids, face or lips, rash or itching (especially affecting the whole body).
Tell your doctor as soon as possible if you experience the following symptoms, as your dose or treatment may need to be changed:
- Yellow discoloration of the whites of the eyes or the skin (jaundice).
- In very rare cases, treatment with this drug may cause reactions such as restlessness, agitation, irritability, aggression, delusions, outbursts of rage, nightmares, hallucinations, or mental illness characterized by a disturbed perception of reality ( psychosis ), inappropriate behavior, and other behavioral disorders. These reactions occur more often if you are older.
- Depression / depressive thoughts.
Other side effects that may occur are :
Very common: may affect more than 1 user in 10
- Depression
- drowsiness, drowsiness
- difficulty coordinating body movements ( ataxia )
- memory problems
- slurred speech ( dysarthria )
- dizziness, intoxication
- headache
- constipation
- dry mouth
- fatigue
- irritability
Common side effects: may affect up to 1 in 10 people
- decreased appetite
- confusion
- disorientation (difficulty or inability to locate)
- changes in sexual desire (decreased libido, increased libido )
- nervousness, anxiety
- insomnia or disturbed sleep (insomnia)
- balance difficulties and instability (such as feeling drunk) especially during the day
- abnormal coordination
- decreased alertness or concentration
- difficulty staying awake, inertia
- shaking or trembling
- Tamsyn
- nausea
- dermatitis ( dermatitis )
- sexual dysfunction
- weight changes
Uncommon side effects: may affect up to 1 in 100 people
- elevated mood or overexcitement (mania)
- hallucinations (seeing or hearing things that do not exist)
- feel upset or angry
- memory loss ( amnesia )
- vomiting, diarrhea
- muscle weakness
- incontinence (urine leakage)
- irregular menstruation
Has been reported: occurs in an unknown number of users
- in women; irregular menstruation or overproduction of the hormone et prolactin(a hormone that stimulates milk production)
- increased appetite
- decreased appetite ( anorexia )
- hypomania
- feel hostile or aggressive
- abnormal thoughts
- hyperactivity
- imbalance in the nervous system. Symptoms may include a fast pulse and unstable blood pressure (feeling dizzy, drunk, or fainting).
- involuntary twisting or sharp movements ( dystonia )
- upset stomach
- difficulty swallowing
- inflammation of the liver ( hepatitis )
- liver problems (this is shown in blood tests)
- yellow discoloration of the whites of the eyes or the skin (jaundice)
- the severe allergic reaction that causes swelling of the face or throat
- skin reactions caused by sensitivity to sunlight
- difficulty urinating or controlling the bladder
- swollen ankles, feet, or fingers
- increased fluid pressure in the eye, which can affect your vision
Previously undetected depression may become apparent in sensitive individuals.
Addiction and withdrawal symptoms
There is a risk of developing an addiction when using drugs such as Alprazolam Krka dd, this increases the risk of developing withdrawal symptoms when treatment is stopped.
Withdrawal symptoms are more common if you:
- ends the treatment suddenly
- have used high doses of the medicine
- have been using the drug for a long time
- has a history of alcohol or drug abuse
This can cause side effects such as headaches and muscle aches, severe anxiety and tension, restlessness, confusion, mood swings, difficulty sleeping, and irritation. In severe cases, the following symptoms may occur: feelings of unreality, depersonalization, hypersensitivity to light, sound and touch, numbness and tingling in the hands and feet, hallucinations (that, when awake, see or hear things that do not exist), tremors and epileptic seizures. Tell your doctor if the withdrawal symptoms get worse or do not go away.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Alprazolam Krka dd
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is alprazolam. Each tablet contains 0.25 mg, 0.5 mg, 1 mg or 2 mg of alprazolam.
- The other ingredients in the 0.25 mg tablet are lactose monohydrate, corn starch, crospovidone (type A), povidone K 25, magnesium stearate (E470b), polysorbate 80.
- The other ingredients in the 0.5 mg tablet are lactose monohydrate, maize starch, crospovidone (type A), povidone K 25, carmines (E120), magnesium stearate (E470b), polysorbate 80.
- The other ingredients in the 1 mg tablet are lactose monohydrate, maize starch, crospovidone (type A), povidone K 25, patent blue V (E131), magnesium stearate (E470b), polysorbate 80.
- The other ingredients in the 2 mg tablet are lactose monohydrate, maize starch, crospovidone (type A), povidone K 25, magnesium stearate (E470b), polysorbate 80.
- See section 2: “Alprazolam Krka dd contains lactose”.
What the medicine looks like and the contents of the pack
0.25 mg tablets: white to off-white, round, biconvex tablets with beveled edges. The tablet has a score line on one side and is marked with 0.25 on the other side, 7 mm in diameter. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
0.5 mg tablets: light pink, marbled, round, biconvex tablets with beveled edges. The tablet has a score line on one side and is marked with 0.5 on the other side, 7 mm in diameter. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
1 mg tablets: light blue-green to light blue, marbled, round, biconvex tablets with beveled edges. The tablet has a score line on one side and is marked with 1 on the other side, 7 mm in diameter. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
2 mg tablets: white to off-white, round, biconvex tablets with beveled edges and a score line on both sides. The tablet is marked with 2 on both sides of the tablet, on one side of the breaker notch, 9 mm in diameter. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
Alprazolam Krka dd is available in cartons of 10, 20, 30, 50, 60, 100 tablets in blisters.
Alprazolam Krka dd is available in cartons of 10×1, 20×1, 30×1, 50×1, 60×1, 100×1 tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.