1 mg tablets
lorazepam
What Lorazepam Orion is and what it is used for
Lorazepam Orion is a sedative and anti-anxiety drug. The active substance is lorazepam which belongs to the group of benzodiazepines.
Lorazepam Orion is used for short-term treatment of severe and inhibitory anxiety, which can have various causes, in adults.
Lorazepam contained in Lorazepam Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Lorazepam Orion
Do not use Lorazepam Orion
- if you are allergic to lorazepam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
- if you have irregular breathing with respiratory arrest in sleep ( sleep apnea )
- if you have a lung disease that causes difficulty breathing
- if you have myasthenia gravis (severe muscle weakness)
- if you have severe liver disease.
Warnings and cautions
Talk to your doctor before using Lorazepam Orion:
- if you have impaired kidney function
- if you have impaired liver function
- if you are fragile or elderly
- if you have chronic breathing difficulties
- if you have acute narrow-angle glaucoma
- if you have or have had problems related to illicit drugs, drug abuse or alcohol
- if you have had seizures.
Use of Lorazepam Orion may lead to addiction
The use of benzodiazepines may lead to physical and mental dependence. To reduce the risk of addiction, the lowest effective dose of Lorazepam Orion should be used and the treatment time should be as short as possible. Generally, the treatment time should not exceed 4 weeks. The need for further treatment should be evaluated if the treatment time exceeds 4 weeks. Continued treatment should then be evaluated regularly and preferably by the same doctor who initiated the treatment. The treatment time should not exceed a maximum of 2-3 months.
Children and young people
Lorazepam Orion should not be used by children and adolescents under 18 years of age.
Other medicines and Lorazepam Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take special care with any of the following medicines while you are using Lorazepam Orion:
- other drugs that suppress the central nervous system (eg antipsychotics, anti-anxiety drugs , antidepressants, hypnotics ( hypnotics ), sedatives ( sedatives ), anesthetics (anesthetics), narcotic analgesics (painkillers), sedative antihistamines .
- antiepileptics (eg phenobarbital, hydantoin, barbiturates and valproate )
- drugs used in addiction (lofexidine and disulfiram )
- medicines used to treat stomach upset (cisapride)
- antibiotics (rifampicin)
- muscle relaxants (baclofen and tizanidine)
- asthma medications (theophylline and aminophylline) and caffeine
- blood pressure medications, blood vessel and diuretic preparation
- nabilon (anti-nausea medicine)
- probenecid (anti- gout )
Concomitant use of these drugs with lorazepam may increase or decrease the effect of lorazepam or increase the risk of side effects.
Concomitant use of Lorazepam Orion with opioids (strong painkillers, opioid dependence 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 Lorazepam Orion at the same time as an opioid medicine, 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 dosing 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.
Lorazepam Orion with food, drink and alcohol
Take the tablets together with some liquid. The tablets can be taken with or without food.
Alcohol:
Do not drink alcohol while using this medicine, as alcohol can alter and potentiate the effects of Lorazepam Orion unpredictably.
Pregnancy and breastfeeding
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 taking this medicine.
Lorazepam Orion should not be used during pregnancy, especially during the first and last trimester. The drug can have a detrimental effect on the fetus.
If you become pregnant during treatment with Lorazepam Orion, tell your doctor immediately so that your doctor can decide if to stop treatment.
The active substance in Lorazepam Orion passes into breast milk. Therefore, the drug should not be used during breastfeeding unless the expected benefits of treatment outweigh the risk to the baby.
Driving and using machines
Lorazepam Orion has a moderate to large effect on the ability to drive and perform tasks that require sharpened attention, as the drug affects the ability to react, causes drowsiness, drowsiness, and muscle relaxation. In addition, Lorazepam Orion may cause side effects such as dizziness and visual disturbances. Do not drive or use machines after taking lorazepam.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Lorazepam Orion contains lactose
This medicine 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 Lorazepam Orion
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one and the treatment time is individual.
The recommended dose is:
- For the treatment of anxiety, the usual daily dose of 2-3 mg is divided into several doses. However, the daily dose may vary from 1 to 7.5 mg. Take the highest dose one at bedtime.
- for difficulty sleeping due to anxiety or transient temporary stress, the usual dose is 1 to 2 mg once daily, usually at bedtime.
- in elderly and weak patients, the recommended daily dose is 1 mg daily divided into two doses . Dose one should be adjusted and adjusted to the patient’s needs and tolerance.
The tablet can be divided into two equal doses.
Use for children and adolescents
The safety and efficacy of lorazepam in children and adolescents have not yet been established. Lorazepam Orion should not be used in children and adolescents under 18 years of age.
If you use more Lorazepam Orion than you should
You may experience symptoms such as drowsiness, mental confusion, apathy, speech disorders, unsteady movements, depression, low blood pressure, decreased muscle strength, impaired breathing, fainting with weak pulse, pallor, bluish lips, and nails. Unconsciousness has been observed in rare cases and very rare cases poisoning with Lorazepam Orion may result in death.
If you forget to use Lorazepam Orion
Do not take a double dose to make up for a forgotten tablet. Skip the missed dose one and take the next dose at the next regular dosing occasion.
If you stop using Lorazepam Orion
Discontinue medication only as directed by your doctor.
Your doctor may gradually reduce your dose, especially if you have used the medicine in high doses or for a long time.
If you suddenly stop taking Lorazepam Orion, you may experience withdrawal symptoms such as headache, muscle aches, anxiety, tension, restlessness, depression, insomnia, sweating, dizziness, confusion, and irritability. In addition, you may find that the symptoms that Lorazepam Orion decreased may increase in strength when you suddenly stop taking the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects to consider:
If you notice any of the following, stop taking Lorazepam Orion and contact your doctor immediately or go to the nearest emergency department: a severe allergic reaction.
Symptoms of a severe allergic reaction are:
- hives , itching .
- swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe.
This is a serious but very rare side effect that can affect up to 1 in 10,000 users. You may need immediate hospitalization or medical attention.
Other possible side effects are
Very common (may affect more than 1 user in 10)
- drowsiness, fatigue, drowsiness.
Common (may affect up to 1 in 10 people)
- difficulty coordinating movements ( ataxia ), confusion, depression, aggravated latent depression, dizziness
- muscle weakness, weakness
Uncommon (may affect up to 1 in 100 people)
- headache, lethargy, emotional numbness
- vision changes (including double vision and blurred vision)
- nausea, indigestion, change in appetite
- skin reactions
- libido change, impotence , decreased orgasm
Rare (may affect up to 1 in 1,000 people)
- changes in the blood picture (decreased number of red blood cells , white blood cells and platelets )
- transient memory gaps and memory disturbances
- increase in bilirubin , jaundice, elevated levels of liver enzymes ( transaminases , alkaline phosphatase)
Very rare (may affect up to 1 in 10,000 people)
- hypersensitivity reactions and anaphylactic reactions
- syndrome with insufficient antidiuretic hormone (SIADH) secretion , low blood sodium, low body temperature
- tremors, dizziness, slurred speech, seizures, loss of inhibition, euphoria , coma , suicidal ideation or suicide attempts, paradoxical reactions such as anxiety, agitation, agitation, hostility, aggression, rage, sleep disturbances / insomnia, sexual arousal, hallucinations
- low blood pressure , lowering of blood pressure et
- difficulty breathing, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease
- constipation
- allergic skin reactions, hair loss
Has been reported (occurs in an unknown number of users)
- withdrawal syndrome
- dependent
Läkemedelsverket
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se
How to store Lorazepam Orion
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 strip and the outer carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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.
Contents of the pack and other information
Content declaration
- The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
- The other ingredients are: lactose monohydrate , microcrystalline cellulose, polacrylic potassium and magnesium stearate.
What the medicine looks like and contents of the pack
White to off-white, round, flat with beveled edges, tablet marked with “1” on one side and a deep break notch on the other side.
Packaging: Strip with aluminum foil coated with PE film.
Pack sizes: 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Packaging: Aluminum / aluminum blister packaging.
Pack sizes: 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer:
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com