LORAZEPAM NORMON 1 mg TABLETS

Introduction

P: I

L

lorazepam

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Lorazepam Normon and what is it used for
2. What you need to know before taking Lorazepam Normon
3. How to take Lorazepam Normon
4. Possible side effects
5. Storage of Lorazepam Normon
6. Package contents and additional information

1. What is Lorazepam Normon and what is it used for

Lorazepam Normon belongs to the group of medications called "short-acting benzodiazepines". It is indicated for the treatment of:

• all anxiety states
• neurosis
• psychic tension and hyperemotionality
• sleep disorders
• psychosomatic disorders
• co-adjuvant in all medical processes where there are anxiety components

2. What you need to know before taking Lorazepam Normon

Do not take Lorazepam Normon if

• If you are allergic to lorazepam, other benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have myasthenia gravis.
• If you have severe respiratory failure.
• If you have sleep apnea syndrome (interruption of breathing during sleep).
• If you have severe liver failure.
• If you have narrow-angle glaucoma (increased intraocular pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lorazepam Normon:

• If you have or have had any liver or kidney disorders.
• After continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected.
• As with other benzodiazepines, treatment may cause physical and psychological dependence; the risk of dependence increases with the dose and duration of treatment and is greater in patients who have consumed or consume drugs or alcohol. Once physical dependence has developed, sudden interruption of treatment can cause withdrawal symptoms, such as headaches, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormal acuteness of hearing), paresthesia, and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or convulsions.
• After withdrawal of the medication, especially if it is stopped 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. Your doctor should re-evaluate your situation regularly. In general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal.
• Benzodiazepines may cause impairment of recent memory; this occurs more frequently after several hours after taking the medication, so to minimize the associated risk, you should ensure that you will be able to sleep uninterrupted for 7-8 hours (see section 4).
• Benzodiazepines may cause psychiatric and paradoxical reactions, such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, treatment should be discontinued. These reactions are more frequent in children and the elderly.
• Benzodiazepines should not be used alone for the treatment of anxiety associated with depression (risk of suicide).
• Benzodiazepines should be used with extreme caution in patients who have consumed or consume drugs or alcohol.
• Lower doses are recommended in patients with chronic respiratory failure.

Using Lorazepam Normon with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Lorazepam may interfere with some medications, especially central nervous system depressants. There may be an increase in the depressant effect on the central nervous system when administered together with medications for the treatment of psychiatric problems (neuroleptics), insomnia (hypnotics), anxiety (anxiolytics/sedatives), depression (antidepressants), severe pain (narcotic analgesics), epilepsy (antiepileptics), and allergies (antihistamines), as well as some anesthetics.

In the case of narcotic analgesics, there may also be an increase in the sensation of euphoria, which can increase psychological dependence.

Use in elderly patients

Elderly people may be more sensitive to the effects of Lorazepam than other adults, so they should take a lower dose.

Using Lorazepam Normon with food, drinks, and alcohol

Lorazepam should not be taken in combination with alcoholic beverages, as they can enhance the sedative effect of the medication, which can affect the ability to drive or operate machinery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

If you are taking lorazepam and plan to become pregnant or have confirmed that you are pregnant, you should contact your doctor to discontinue treatment.

Children born to mothers who take benzodiazepines chronically during the last period of pregnancy may develop physical dependence, which can trigger a withdrawal syndrome in the postnatal period.

Breastfeeding

Since benzodiazepines pass into breast milk, this medication should not be administered during breastfeeding.

Driving and using machines

Lorazepam may alter the ability to drive or operate machinery, as it can cause drowsiness, reduce attention, or reduce reaction capacity. The appearance of these effects is more likely at the start 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Lorazepam Normon

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will indicate the duration of your treatment with lorazepam. Do not stop treatment before, as it may worsen your disease.

This medication is administered orally. Take the tablets with a sufficient amount of liquid.

Anxiety:

The recommended dose is 1 to 3 tablets per day, divided into 2 or 3 doses. The highest dose should be taken before bedtime. In psychiatry, in cases of acute agitation, higher doses may be administered.

It is recommended to start treatment with the lowest recommended dose, gradually increasing until the effective doses are achieved.

The duration of treatment should be as short as possible. Your doctor should re-evaluate your situation regularly. In general, the total duration of treatment should not exceed 8-12 weeks, including gradual withdrawal.

In certain cases, it may be necessary to prolong treatment beyond the recommended period. This decision can only be made by your doctor, after weighing your progress.

Insomnia:

The dose for adults is 1 tablet at bedtime. In elderly patients and patients with renal and/or hepatic insufficiency, the recommended dose is ½ tablet per day, which can be gradually adjusted if necessary.

The duration of treatment should be as short as possible. In general, the duration of treatment can range from a few days to two weeks; it should not exceed four weeks, including gradual withdrawal of the medication.

Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.

Use in children and adolescents

Lorazepam should not be administered to children, unless it is strictly necessary. The duration of treatment should be as short as possible.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you take more Lorazepam Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount taken. Bring the lorazepam package with you to show it to the doctor or pharmacist. The symptoms of benzodiazepine overdose are generally characterized by different 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, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death may occur.

If you forget to take Lorazepam Normon

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The use of lorazepam in the treatment of insomnia may cause drowsiness the next day. It can also cause emotional numbing, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or diplopia. These reactions occur predominantly at the start of treatment and usually disappear with continued administration. Occasionally, other side effects may occur, such as gastrointestinal disorders, changes in libido, or skin reactions.

Other side effects that may occur:

• Anterograde amnesia (recent memory disorder); the risk is greater with increasing dose. Amnestic effects may be associated with inappropriate behavior (see section 2).
• Depression: the use of benzodiazepines may unmask existing depression.
• Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. These reactions can be severe and occur more frequently in children and elderly patients.
• Dependence: physical dependence (withdrawal or rebound phenomena when treatment is stopped) and/or psychological dependence may occur. Cases of abuse have been reported.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lorazepam Normon

Keep this medication out of the sight and reach of children.

Do not store above 30°C. Store in the original packaging.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

The active ingredient is lorazepam. Each tablet contains 1 mg of lorazepam.

The other ingredients are lactose monohydrate, microcrystalline cellulose, potassium polacrylate, magnesium stearate, and low-substituted hydroxypropyl cellulose (E.463).

Appearance of the product and package contents

Lorazepam Normon 1 mg are white, round, biconvex tablets, engraved with "LZ" on one side and a break line on the other, presented in packages of 25 or 50 tablets. The tablet can be divided into equal doses.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this leaflet:August 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/64972/P_64972.html