Lorazepam Normon 5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Lorazepam NORMON 5 mg tablets EFG
Read the entire leaflet carefully before you start taking 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Lorazepam NORMON is and what it is used for.
- What you need to know before taking Lorazepam NORMON.
- How to take Lorazepam NORMON.
- Possible side effects.
- How to store Lorazepam NORMON.
Pack contents and additional information
1. What Lorazepam NORMON is and what it is used for
Lorazepam NORMON belongs to the group of medicines known as "short-acting benzodiazepines". It is indicated for the short-term treatment of anxiety states associated with insomnia, depression, and emotional disturbances.
2. What you need to know before taking Lorazepam NORMON
Do not take Lorazepam NORMON if:
- You are allergic to lorazepam or to any of the other ingredients of this medicine (listed in section 6).
- You have had an allergic reaction (hypersensitivity) after taking benzodiazepines (a group of medicines to which lorazepam belongs).
- You have been diagnosed with myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or fatigued muscles).
- You have severe respiratory insufficiency (difficulty breathing or severe chest discomfort).
- You have sleep apnea (temporary cessation of breathing during sleep).
- You have a severe liver disease.
- You are receiving concomitant treatment with opioids, barbiturates, neuroleptics, or similar medicines.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lorazepam NORMON:
- If you have had or currently have any liver or kidney problems,
- If you have narrow-angle glaucoma,
- After continuous use for several weeks, you may notice a certain degree of reduced effectiveness regarding hypnotic effects,
- As with other benzodiazepines, treatment may lead to physical and psychological dependence; the risk of dependence increases with dose and duration of treatment and is higher in patients who have used or currently use drugs or alcohol. Once physical dependence has developed, abrupt discontinuation of treatment may cause withdrawal symptoms such as headaches, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormally acute hearing), tingling and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or seizures,
- After stopping the medicine, especially if treatment is discontinued abruptly, rebound insomnia and anxiety, mood changes, and restlessness may occur; therefore, it is recommended to gradually reduce the dose before stopping treatment,
- The duration of treatment should be as short as possible (see section 3. How to take Lorazepam NORMON); never extend treatment without your doctor's instruction,
- Benzodiazepines may cause impairment of recent memory; this occurs more frequently several hours after taking the medicine, so to reduce the associated risk, you should ensure you can sleep uninterrupted for 7–8 hours (see section 4. Possible side effects),
- Benzodiazepines may cause psychiatric and paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse behavioral effects. If this occurs, treatment should be discontinued. These reactions are more frequent in children and elderly patients,
- Benzodiazepines should not be used alone to treat anxiety associated with depression (risk of suicide),
- Benzodiazepines should be used with extreme caution in patients who have used or currently use drugs or alcohol,
- Lower doses are recommended in patients with chronic respiratory insufficiency.
Children
As with other benzodiazepines, Lorazepam NORMON should not be administered to children unless strictly necessary. The duration of treatment should be as short as possible.
Elderly patients
As with other benzodiazepines, elderly individuals may be more sensitive to the effects of Lorazepam NORMON than younger adults and should therefore take a lower dose.
Taking Lorazepam NORMON with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
As with other benzodiazepines, Lorazepam NORMON may interact with certain medicines, especially central nervous system (CNS) depressants.
The CNS depressant effect may be enhanced when antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedating antihistamines are administered concomitantly.
With narcotic analgesics, there may also be an increased feeling of euphoria, which could increase psychological dependence.
Substances that inhibit certain liver enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines.
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine, including those obtained without a prescription.
Taking Lorazepam NORMON with food, drinks, and alcohol
Lorazepam NORMON must not be taken in combination with alcoholic beverages, as alcohol may enhance the sedative effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
If you are taking Lorazepam NORMON and plan to become pregnant or have confirmed you are pregnant, you should contact your doctor to arrange for discontinuation of treatment.
Infants born to mothers who take benzodiazepines chronically during the last stage of pregnancy may develop physical dependence and may experience a withdrawal syndrome in the postnatal period.
Breastfeeding
Since benzodiazepines pass into breast milk, this medicine should be avoided during breastfeeding.
Driving and using machines
Lorazepam NORMON may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or impair reaction capacity. These effects are 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.
Lorazepam NORMON contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.
3. How to take Lorazepam NORMON
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will indicate the duration of your treatment with Lorazepam NORMON.
The recommended dose for anxiety states is 1 to 4 tablets daily, divided into 2 or 3 doses. The highest dose should be taken before going to bed.
It is advisable to start treatment with the lowest recommended dose, gradually increasing it until effective doses are achieved.
The duration of treatment should be as short as possible. Your doctor should regularly reevaluate your condition. In general, the total duration of treatment should not exceed 8–12 weeks, including gradual withdrawal.
In certain cases, it may be necessary to extend treatment beyond the recommended period. This decision can only be made by your doctor after assessing your progress.
In elderly patients and in patients with renal and/or hepatic impairment, the recommended dose is 0.5 mg per day, with gradual dose adjustment if necessary.
The tablet may be divided into equal doses.
Lorazepam NORMON is administered orally. Swallow the tablets with a sufficient amount of liquid.
If you take more Lorazepam NORMON than you should
If you have taken more Lorazepam NORMON than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20.
As with other benzodiazepines, overdose is not life-threatening unless taken together with other central depressants (including alcohol).
In case of accidental overdose, vomiting should be induced (within one hour) if the patient is conscious.
Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy; in more severe cases, ataxia (impaired coordination due to nervous system dysfunction), hypotonia (reduced muscle tone), hypotension, respiratory depression, and rarely coma or even death may occur.
If you forget to take Lorazepam NORMON
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The use of Lorazepam NORMON, as with other benzodiazepines, may cause drowsiness, emotional blunting, reduced level of alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disturbance of nervous system functions), or diplopia (double vision).
These reactions occur predominantly at the beginning of treatment and usually disappear with continued administration. Occasionally, other adverse effects may occur, such as gastrointestinal disturbances, changes in libido, or skin reactions.
Other possible adverse effects include:
- Anterograde amnesia (impairment of recent memory): the risk increases with higher doses. Amnesic effects may be associated with inappropriate behaviors (see Warnings and precautions).
- Depression: benzodiazepines may unmask pre-existing depression.
- Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances. These reactions may be severe and occur more frequently in children and elderly patients.
- Dependence: physical dependence (withdrawal or rebound phenomena upon discontinuation of treatment) and/or psychological dependence may occur; see Warnings and precautions). Cases of abuse have been reported.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es).
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lorazepam NORMON
Keep this medicine out of sight and reach of children.
Do not store above 30°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lorazepam NORMON 5 mg tablets
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The active substance is lorazepam. Each tablet contains 5 mg of lorazepam.
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The other components of the tablet are: lactose monohydrate, microcrystalline cellulose, polacriline potassium, magnesium stearate, red iron oxide (E-172) and low-substituted hydroxypropyl cellulose (E-463).
Appearance of the product and contents of the pack
Lorazepam NORMON 5 mg film-coated tablets are presented in packs of 20 tablets.
Pink, round, biconvex tablets, printed with "LZ" on one side and a break line on the other.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of the most recent review of this leaflet: August 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/77785/P_77785.html