Package Insert: Information for the Patient

Lorazepam Normon 0.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains the active ingredient lorazepam, a sedative and anxiolytic (tranquilizer) medication that belongs to a group of medications called “benzodiazepines”.

What is it used for:

• Short-term symptomatic treatment of anxiety and sleep disorders caused by the same, when anxiety is severe, incapacitating or subjects the individual to unbearable anguish.
• Precursor sedation for diagnostic procedures, as well as before surgical interventions.

Do not take Lorazepam Normon 0.5 mgmg

Warnings and Precautions

Consult your doctor or pharmacist before starting this medication if:

• you have difficulty controlling your movements (spinal or cerebellar ataxia)
• you experience respiratory problems, for example, chronic obstructive pulmonary disease.
• you have altered liver or kidney function.
• you have a condition called glaucoma, for example, high pressure inside the eye.
• you abuse or have abused drugs or alcohol.
• you have a personality disorder; this may mean you are more likely to become dependent on lorazepam.
• you have previously experienced depression, as it may recur during treatment with lorazepam.
• you are depressed, as lorazepam may increase feelings or thoughts of suicide you may have.
• you are an elderly patient, as you are more likely to experience falls.
• you have low blood pressure.

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

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

If you have kidney or liver dysfunction, heart failure, and/or low blood pressure (hypotension), you may be more sensitive to the effects of this medication; the same applies if you are an elderly patient. You may be at greater risk of falls, especiallywhen getting up at night.

You may experience 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 observe memory loss during treatment with lorazepam.

When you take the tablet before sleeping, you should ensure that you can sleep uninterrupted for 7-8 hours after taking the tablet. If you follow this recommendation, you will normally avoid morning after effects (for example, fatigue, altered reaction capacity).

Ask your doctor to give you more detailed instructions on how to manage your daily life, taking into account your individual lifestyle (for example, profession).

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

The use of benzodiazepines, including lorazepam, may cause potentially fatal respiratory depression.

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

If after a few weeks you observe that the medication is not working as well as it did at the start of treatment, you should consult your doctor.

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

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

Children and Adolescents

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

Other Medications and Lorazepam Normon 0.5 mgmg

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially:

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

If you use this medication at the same time as other central nervous system depressants (for example, psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid analgesics, antihistamines, antiepileptic drugs), you may experience additive depressant effects on the central nervous system.

The concomitant use of this medication and opioids (for example, strong analgesics, some cough medications, and medication for opioid substitution) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, 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 the opioid medications you are taking and follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members to be aware of the symptoms mentioned above. Contact your doctor when you experience such symptoms.

The effect of medications to reduce muscle tension (muscle relaxants) and analgesics 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 valproate/sodium valproate may increase lorazepam levels in the blood. If valproate/sodium valproate is used at the same time, the dose of this medication 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 medication 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 alter and increase the effects of lorazepam in an unpredictable manner.

You should avoid grapefruit juice and drinks containing caffeine, as they may affect the way lorazepam acts.

Pregnancy and Breastfeeding

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

Pregnancy

This medication 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 to discontinue treatment.

The prolonged use of lorazepam in pregnant women may cause withdrawal symptoms in the newborn. Administration of lorazepam at the end of pregnancy or during delivery may cause the newborn to have reduced activity, reduced muscle tone, decreased body temperature (hypothermia), and/or decreased blood pressure (hypotension), respiratory insufficiency, apnea, and difficulty feeding (known as "floppy baby syndrome"). In addition, cases of malformation and mental retardation in children exposed prenatally to lorazepam have been reported after overdose or intoxication.

Breastfeeding

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

Driving and Operating Machines

Even if you take this medication as directed, you should wait for your reaction abilities 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. Do not work without a secure support point. In particular, remember that alcohol will further impair your reaction ability.

The decision on how far you can drive or perform other hazardous activities will be made 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 certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as 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, the indication, and the 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 act correctly.

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

Treatment of anxiety states and sleep disorders caused by anxiety

The usual daily dose for adults is 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 can 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 offered.

If the main 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 half an hour before bedtime; for this case, pharmaceutical forms with a higher individual dose are also offered.

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

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

Premedication before diagnostic procedures or before surgical interventions
For 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 for the treatment of anxiety or insomnia in children and adolescents under 18 years old.

Under 6 years:

Children under six years old should not be treated with lorazepam.

6 to 12 years old:

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

13 to 18 years old:

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 cerebral organic changes, the initial dose should be reduced by approximately 50%. The doctor should adjust the dose according to need and tolerance in each individual case.

Use in patients with renal insufficiency

Patients with kidney problems may receive lower doses. The initial dose is usually half 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 the normal recommended dose for adults.

Lorazepam is contraindicated in patients with severe liver insufficiency.

Administration form

Oral route.

Swallow the tablets whole with a little liquid (for example, 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 half an hour before bedtime; otherwise, it will probably take longer to take effect, and depending on the duration of sleep, it will probably 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 use, 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 (over 1 week) and sudden discontinuation 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 rather with a gradual reduction in dose.

If you take more Lorazepam Normon than you should

Inform your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20 if you suspect you have suffered an overdose after taking large quantities of this medication. Follow the first aid instructions received by phone. Do not induce vomiting unless the doctor instructs you to do so explicitly.

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 compensate for the missed doses.

If you interrupt treatment with Lorazepam Normon

Never interrupt or discontinue treatment on your own, except when you suspect a severe adverse effect. In this case, contact your doctor immediately.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• drowsiness, fatigue, somnolence

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

• unstable gait and movement (ataxia)
• confusion
• depression, onset of depression
• feeling dizzy
• 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):

• eruption
• reduced alertness
• changes in salivation

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

• leucopenia

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

• changes in blood counts (thrombocytopenia agranulocytosis, pancitopenia)
• 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
• convulsions/crises
• memory lapses (amnesia)
• disinhibition, euphoria
• coma
• suicidal thoughts/intents
• attention/concentration deterioration
• balance disorders
• dizziness
• paradoxical reactions such as anxiety, agitation, delirium, excitability, aggressive behavior (hostility, aggression, rage), sleep disorders/insomnia, sexual excitement, hallucinations, psychosis. If such reactions occur, treatment with Lorazepam Normon should be interrupted.
• low blood pressure (hypotension), mild drop in blood pressure
• respiratory insufficiency (severity depends on dose), difficulty breathing (apnea), worsening of sleep apnea (temporary cessation of breathing during sleep)
• worsening of chronic obstructive pulmonary disease (airway constriction)
• constipation
• increased bilirubin
• jaundice, increased liver enzymes (transaminases, alkaline phosphatase)
• skin allergic reactions
• hair loss
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions, skin swelling and/or mucous membrane swelling (angioedema)
• inadequate secretion of antidiuretic hormone (SIADH)
• low sodium levels in the blood (hyponatremia)
• low body temperature (hypothermia)

Benzodiazepines cause dose-dependent central nervous system depression.

Dependence/abuse

Even after daily treatment with this medicine for a few days, withdrawal symptoms (e.g., sleep disturbances, increased sleep) may occur when treatment is stopped, especially if stopped abruptly. Anxiety, tension, as well as agitation and restlessness may reappear in increased form. Other symptoms reported after discontinuation of benzodiazepine treatment include headaches, depression, confusion, irritability, sweating, low mood (dysphoria), feeling dizzy, loss of sense of reality, behavioral disorders, exaggerated perception of sounds, numbness and tingling in the extremities, hypersensitivity to light, sounds, and physical contact, distorted perception, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/ cramps, tremors, abdominal cramps, muscle pain, agitation, palpitations, rapid pulse, panic attacks, dizziness, increased reflexes, short-term memory loss, and fever. Abrupt discontinuation may cause an increase in convulsions in patients with chronic lorazepam administration and epilepsy 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 dose tolerance (increased dose due to habituation) with respect to the calming (sedative) effect of benzodiazepines.

There is a risk of abuse with lorazepam. Patients with a history of medication 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 stop treatment. Inform your doctor immediately if you have an inexplicable skin eruption, discoloration, or swelling of the skin.

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 System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lorazepam Normon 0.5 mg:

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

Appearance of the product and contents of the packaging

Lorazepam Normon 0.5 mg tablets EFG, are blue clear, round, biconvex, tablets 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 packs of 50 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos

Madrid (SPAIN)

Last review date of this leaflet:March 2022

Other sources of information

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

You can access detailed and updated information about this medicine 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/86665/P_86665.html