LORAZEPAM NORMON 0.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Lorazepam Normon 0.5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lorazepam Normon and what is it used for
2. What you need to know before you take Lorazepam Normon
3. How to take Lorazepam Normon
4. Possible side effects
5. Storage of Lorazepam Normon
6. Contents of the pack and other information

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

This medicine contains the active substance lorazepam, a sedative and anxiolytic (tranquilizing) medicine belonging to the group of medicines called “benzodiazepines”.

What it is used for:

• Short-term symptomatic treatment of anxiety and sleep disorders caused by anxiety, when anxiety is severe, disabling, or subjects the individual to unacceptable distress.
• Sedation before diagnostic procedures, as well as before surgical interventions.

2. What you need to know before you take Lorazepam Normon

Do not take Lorazepam Normon 0.5 mg

• if you are allergic to lorazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had an addiction to any medicine, alcohol, or drugs.
• if you have severe respiratory problems, e.g., chronic obstructive pulmonary disease;
• if you have abnormal muscle weakness (myasthenia gravis);
• if you have problems with movement coordination (spinal and cerebellar ataxias),
• if you have severe liver problems;
• if you suffer from respiratory problems when you are asleep (sleep apnea syndrome);
• in case of acute intoxication with alcohol or central nervous system depressants (e.g., sleeping pills or analgesics, medicines for the treatment of mental disorders, such as antipsychotics, antidepressants, and lithium).
• if you are under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• you have problems controlling your movements (spinal or cerebellar ataxia)
• you suffer from respiratory problems, e.g., chronic obstructive pulmonary disease.
• you have altered liver or kidney function.
• you have an eye problem called glaucoma, e.g., high pressure inside the eye.
• you abuse or have abused in the past drugs or alcohol.
• you have a personality disorder; this may mean you have a higher probability of becoming dependent on lorazepam.
• you have previously suffered from depression, as it could reappear during treatment with lorazepam.
• you suffer from depression, as lorazepam may increase suicidal thoughts or feelings you may have.
• you are an elderly patient, as you are more likely to suffer from falls.
• you have low blood pressure.

Some patients have experienced suicidal thoughts while taking medicines containing lorazepam, especially if they are already depressed. If you are depressed, have irrational fears or obsessions, have started to experience suicidal thoughts or self-harm, inform your doctor immediately.

At the start of therapy, your doctor will monitor your individual response to this medicine, so that a possible overdose can be detected as soon as possible. If you are a child, or an elderly or debilitated patient, you may show a more sensitive response to the effect of lorazepam. Therefore, therapy should be monitored more frequently.

If you suffer from kidney or liver dysfunction, have heart failure and/or low blood pressure (hypotension), you may have a greater sensitivity to the effect of this medicine; the same applies if you are an elderly person. You may be at a higher risk of suffering from falls, especially when getting up at night.

You may suffer from hepatic encephalopathy (brain disease due to liver damage) with the use of lorazepam. Therefore, lorazepam should not be used in patients with severe liver failure and/or hepatic encephalopathy.

You may experience memory loss during treatment with lorazepam.

When you take the tablet before sleeping, you should make sure you will be able to sleep uninterrupted for 7-8 hours after taking the tablet. If you follow this recommendation, you will normally avoid the side effects the next morning (e.g., fatigue, altered reaction capacity).

Ask your doctor to give you more detailed instructions on how to manage your daily life, taking into account your particular lifestyle (e.g., your profession).

Rare cases of paradoxical reactions have been reported with the use of benzodiazepines, such as anxiety, agitation states, delirium, irritability, aggressive behavior, sleep disorders, sexual excitement, hallucinations, psychosis (see section 4). These reactions are more likely if you are a child or an elderly patient. Treatment with lorazepam should be discontinued if paradoxical reactions occur.

With the use of benzodiazepines, including lorazepam, potentially life-threatening respiratory depression may occur.

When taking this medicine, there is a risk of dependence, which increases with the dose and duration of treatment and also in patients with a history of alcoholism and drug abuse. Therefore, you should take this medicine for the shortest possible time (see section 4).

If after a few weeks you notice that the medicine is not working as well as at the start of treatment, you should consult your doctor.

Treatment with lorazepam should be gradually discontinued to avoid withdrawal symptoms. See section 3 "If you stop taking Lorazepam Normon".

Severe allergic reactions have been reported with the use of benzodiazepines. Cases of skin and/or mucous membrane swelling affecting the tongue, larynx, or vocal cord area (angioedema) have been reported in some patients after taking the first or subsequent doses of benzodiazepines. Some patients have experienced other symptoms while taking benzodiazepines, such as difficulty breathing (dyspnea), throat swelling, or feeling nauseous and vomiting. Some patients had to be treated urgently. If these symptoms occur, inform your doctor immediately or go to the hospital immediately. The airways may become blocked, which can be fatal.

Children and adolescents

As with other benzodiazepines, lorazepam should not be administered to children under 18 years of age, unless it is urgently necessary as sedation before surgery or before diagnostic procedures. Lorazepam Normon 0.5 mg is contraindicated in children under 6 years of age. You will find more information in the following section.

Other medicines and Lorazepam Normon 0.5 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially:

• medicines for narcolepsy (excessive daytime sleepiness and sleep attacks) with cataplexy (e.g., sodium oxybate)
• medicines for treating delusions or hallucinations (e.g., chlorpromazine, loxapine, or clozapine)
• medicines to aid digestion (e.g., antacids or omeprazol)
• a medicine to control nausea and vomiting induced by chemotherapy called nabilone
• medicines for addiction treatment (e.g., lofexidine)
• strong painkillers (e.g., methadone, tramadol, codeine, morphine)
• medicines used to treat tuberculosis, such as isoniazid
• antibiotics, such as erythromycin
• medicines used to treat high blood pressure (e.g., ACE inhibitors, alpha-blockers, angiotensin II receptor antagonists, calcium channel blockers, adrenergic neuron blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside, and diuretics)
• medicines used to treat asthma (e.g., theophylline)
• muscle relaxants (e.g., baclofen and tizanidine)
• other sedatives (e.g., barbiturates or antihistamines)
• other medicines used to treat anxiety
• medicines used to treat depression
• antihistamines for allergies
• medicines for Parkinson's disease, e.g., Levodopa
• medicines for epilepsy (e.g., phenobarbital or valproate/sodium valproate)
• a medicine for gout called probenecid
• medicines that affect liver enzymes (e.g., cimetidine, esomeprazol, rifampicin, ketoconazole, itraconazole).

If you use this medicine at the same time as other central nervous system depressant medicines (e.g., psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid-type painkillers, sedating antihistamines, antiepileptics), an interaction may occur, producing additive depressive effects on the central nervous system.

The concomitant use of this medicine and opioids (e.g., strong painkillers, some cough medicines, and substitution therapy medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Lorazepam Normon 0.5 mg together with opioids, the dose and duration of concomitant treatment should be limited by your doctor. Inform your doctor about all opioid medicines you are taking and follow your doctor's dosage recommendation carefully. It may be useful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

The effect of muscle relaxants and painkillers may be increased.

If lorazepam is used at the same time as clozapine, intense sedation, excessive salivation, and altered movement coordination may occur.

The administration of lorazepam at the same time as valproic acid/sodium valproate may increase lorazepam levels in the blood. If valproic acid/sodium valproate is used at the same time, the dose of this medicine should be reduced to approximately half.

The administration of lorazepam at the same time as probenecid may accelerate the onset of action or prolong the effect of lorazepam. If probenecid is used at the same time, the dose of this medicine should be reduced to half.

The use of theophylline or aminophylline may reduce the sedative effect of lorazepam.

Taking Lorazepam Normon 0.5 mg with food, drinks, and alcohol

You should avoid drinking alcohol, as alcohol may unpredictably alter and increase the effects of lorazepam.

Grapefruit juice and drinks containing caffeine should be avoided, as they may affect the way lorazepam works.

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.

Pregnancy

This medicine should not be taken during pregnancy.

Inform your doctor immediately if you become pregnant during treatment with Lorazepam Normon 0.5 mg, who will decide whether you should stop treatment.

Prolonged use of lorazepam in pregnant women may cause withdrawal symptoms in the newborn. Administration of lorazepam at the end of pregnancy or during childbirth may cause the baby to have reduced activity, reduced muscle tone, decreased body temperature (hypothermia), and/or decreased blood pressure (hypotension), respiratory failure, apnea, and difficulty feeding (known as "floppy baby syndrome"). Additionally, cases of malformation and mental retardation in children with prenatal exposure after lorazepam overdose or intoxication have been reported.

Breastfeeding

Because the active substance of this medicine, lorazepam, passes into breast milk, it should not be taken during breastfeeding. Taking this medicine during breastfeeding may cause sedation and inability to feed in the infant.

Driving and using machines

Even if you take this medicine as prescribed, you should expect your reaction skills to be affected, especially during the first few days of treatment. In this case, you will not be able to react quickly enough to unexpected and sudden events. Do not drive a car or any other vehicle. Do not use hazardous electrical tools or machines. Do not work without a secure support. In particular, remember that alcohol will further impair your reaction skills.

The decision on how far it is possible to drive or perform other hazardous activities will be taken by your doctor, taking into account your individual response and dose.

Lorazepam Normon tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

3. How to take Lorazepam Normon

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again. The dose and duration of treatment should be adjusted to the individual response to treatment, indication, and severity of the disease. As a basic rule, the dose should be as low as possible, and the duration of treatment should be as short as possible.

Dosage

Follow exactly the administration instructions, as otherwise, this medication may not work correctly.

Unless your doctor has prescribed Lorazepam Normon 0.5 mg in a different way, the following information will be applied:

Treatment of anxiety states and sleep disorders caused by anxiety

The daily dose for adults is usually 0.5 to 2.5 mg of lorazepam divided into 2 or 3 doses or as a single dose at night. In isolated cases, especially in hospitalized patients, the daily dose may be increased up to a maximum of 7.5 mg of lorazepam, taking into account all precautions. For the administration of higher doses, pharmaceutical forms with a higher individual dose are available.

If the primary focus involves sleep disorders that require treatment, the daily dose (0.5 to 2.5 mg of lorazepam) can be administered as a single dose approximately 30 minutes before bedtime; for this case, pharmaceutical forms with a higher individual dose are also available.

When used for sleep, it should be taken approximately 30 minutes before bedtime; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, will likely cause more severe side effects the next morning.

If you take the full dose at night, do not take it with a full stomach.

Pre-medication before diagnostic procedures or before surgical interventionsFor adults, 1 to 2.5 mg of lorazepam the night before and/or 2 to 4 mg approximately 1 to 2 hours before the procedure.

Use in children and adolescents

Lorazepam should not be used to treat anxiety or insomnia in children and adolescents under 18 years of age.

Under 6 years:

Children under six years of age should not be treated with lorazepam.

From 6 to 12 years of age:

Before diagnostic procedures or before surgical interventions: the recommended dose is between 0.5 and 1 mg, depending on the child's weight (the dose should not exceed 0.05 mg/kg of body weight), taken at least one or two hours before the operation.

From 13 to 18 years of age:

Before diagnostic procedures or before surgical interventions: the recommended dose is 1 mg to 4 mg, taken one or two hours before the operation.

Use in elderly or debilitated patients

In elderly or debilitated patients, as well as in patients with organic brain changes, the initial dose should be reduced by approximately 50%. The doctor should adjust the dose according to need and tolerability in each individual case.

Use in patients with renal insufficiency

Patients with kidney problems may receive lower doses. The initial dose is usually half of the normal recommended dose for adults. Your doctor will see how you respond to the medication and adjust the dose if necessary.

Use in patients with hepatic insufficiency

Patients with moderate to mild liver problems may receive lower doses. The initial dose is usually half of the normal recommended dose for adults.

Lorazepam is contraindicated in patients with severe hepatic insufficiency

Method of administration

Oral route.

Swallow the tablets whole with a little liquid (e.g., with half a glass or a full glass of water). The tablets can be taken with or without food.

When used for sleep, it should be taken approximately 30 minutes before bedtime; otherwise, it will likely take longer to take effect and, depending on the duration of sleep, will likely cause more severe side effects the next morning.

Duration of use

The duration of treatment is determined by your doctor. In acute diseases, the use of this medication should be limited to single doses or for a few days. In chronic diseases, the duration of treatment depends on the evolution of the disease. After two weeks of daily intake, the doctor should weigh the need to continue treatment with lorazepam and gradually reduce the dose, if treatment is still indicated.

It should be noted that after prolonged treatment (more than 1 week) and abrupt interruption of the medication, a transient increase in sleep disorders, anxiety, and tension, restlessness, and agitation may occur. Therefore, treatment should not be interrupted abruptly, but with a gradual reduction of the dose.

If you take more Lorazepam Normon than you should

Inform a doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20 if you suspect that you have suffered intoxication after taking quite large quantities of this medication. Follow the first aid instructions received by phone. Do not induce vomiting unless the doctor expressly indicates it.

The signs of overdose are: drowsiness, confusion, lethargy, shallow breathing, alteration of movement coordination, apathy, and in severe cases, loss of consciousness.

If you forget to take Lorazepam Normon

If you forget to take a tablet, take the next dose as usual. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Lorazepam Normon

Never interrupt or suspend treatment on your own unless you suspect a serious adverse effect. In this case, contact your doctor immediately.

If you suddenly interrupt treatment after prolonged use, withdrawal symptoms mentioned in section 4 may appear. To avoid these symptoms, treatment will be interrupted with a gradual reduction of the dose (see section 3).

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 all people experience them.

Adverse reactions can be expected especially at the start of treatment, with higher doses, and among the population described in "Warnings and precautions" (see section 2).

Very common (may affect more than 1 in 10 people):

• sedation, fatigue, drowsiness

Common (may affect up to 1 in 10 people):

• unstable movements and gait (ataxia)
• confusion
• depression, onset of depression
• dizziness
• muscle weakness, feeling of fatigue (lassitude)

Uncommon (may affect up to 1 in 100 people):

• change in libido, impotence, less intense orgasms
• feeling sick

Rare (may affect up to 1 in 1,000 people):

• rash
• reduced alertness
• changes in salivation

Very rare (may affect up to 1 in 10,000 people):

• leukopenia

Frequency not known (frequency cannot be estimated from available data):

• changes in blood counts (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction times
• alteration of movement coordination (extrapyramidal symptoms)
• tremor
• dizziness
• visual problems (double vision and blurred vision)
• difficulty articulating speech/difficulty speaking (stammering)
• headache
• seizures/convulsions
• memory lapses (amnesia)
• disinhibition, euphoria
• coma
• suicidal thoughts/attempts
• decreased attention/concentration
• balance disorders
• vertigo
• paradoxical reactions such as anxiety, agitation, delirium, excitability, aggressive behavior (hostility, aggression, anger), sleep disorders/insomnia, sexual excitement, hallucinations, psychosis. If such reactions occur, treatment with Lorazepam Normon should be discontinued
• low blood pressure (hypotension), mild drop in blood pressure
• respiratory failure (severity depends on dose), difficulty breathing (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep)
• worsening of chronic obstructive pulmonary disease (constriction of the airway)
• constipation
• increased bilirubin
• jaundice, increased liver enzymes (transaminases, alkaline phosphatase)
• allergic skin reactions
• hair loss
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema)
• inadequate secretion of antidiuretic hormone (SIADH)
• low sodium levels in the blood (hyponatremia)
• decreased body temperature (hypothermia)

Benzodiazepines cause dose-dependent central nervous system depression.

Dependence/abuse

Even after daily treatment with this medication for a few days, withdrawal symptoms (e.g., sleep disorders, increased sleep) may occur when treatment is discontinued, especially when it is discontinued abruptly. Anxiety, tension, as well as agitation and restlessness may reappear in an increased form. Other symptoms reported after discontinuation of benzodiazepine treatment include headaches, depression, confusion, irritability, sweating, low mood (dysphoria), dizziness, loss of sense of reality, behavioral disorders, exaggerated perception of noises, numbness and tingling in the limbs, hypersensitivity to light, sounds, and physical contact, distorted perception, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, seizures/convulsions, tremors, abdominal cramps, muscle pain, agitation, palpitations, rapid pulse, panic attacks, dizziness, increased reflexes, short-term memory loss, and fever. Abrupt discontinuation can cause an increase in seizures in case of chronic administration of lorazepam in epileptics or other medications that reduce the seizure threshold (e.g., antidepressants).

The risk of withdrawal symptoms increases with the duration of use and dose. These symptoms can usually be avoided by gradually reducing the dose.

There is evidence of tolerance development (dose increase due to habituation) with respect to the calming effect (sedative) of benzodiazepines.

There is a risk of abuse with lorazepam. Patients with a history of drug and/or alcohol abuse are at higher risk.

What measures should be taken in case of side effects?

Many of the side effects mentioned above will disappear during treatment or when the dose is reduced. If side effects persist, inform your doctor, who will decide whether to discontinue treatment. Inform your doctor immediately if you have an unexplained skin rash, discoloration, or swelling.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (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 mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/86665/P_86665.html

5. Storage of Lorazepam Normon

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Lorazepam Normon 0.5 mg:

• The active ingredient is lorazepam.
• The other components (excipients) are: Indigo Carmine (E-132), potassium polacrylate, lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and package contents

Lorazepam Normon 0.5 mg tablets EFG, are light blue, round, biconvex tablets, serigraphed with "LZ" on one face and smooth on the other.

They are presented in aluminum/PVC-ACLAR® (PCTFE) or aluminum/PVC-PVDC(120) blisters in packages of 50 tablets.

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:March 2022

Other sources of information

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