Leaflet: information for the user

Lorazepam Normon 2 mg tablets EFG

Lorazepam

Read this leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them..
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Lorazepam Normon

4. Possible side effects

5. Storage of Lorazepam Normon

6. Contents of the pack and additional information

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

What it is 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

• If you are allergic to the active ingredient, other benzodiazepines, or any of the other components of this medication (listed in section 6).
• If you have or have had addiction to any medication, 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 coordination problems with movement (spinal and cerebellar ataxias).
• If you have severe liver problems.
• If you suffer from respiratory problems while sleeping (sleep apnea syndrome).
• In case of acute intoxication with alcohol or central nervous system depressants (e.g. sleeping pills or analgesics, medications for 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 lorazepam if:

• You have difficulty controlling your movements (spinal or cerebellar ataxia).
• You suffer from respiratory problems, e.g. chronic obstructive pulmonary disease.
• Your liver or kidney function is impaired.
• You have a eye problem called glaucoma, e.g. 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 had depression previously, as it may recur during treatment with lorazepam.
• You are depressed, as lorazepam may increase suicidal thoughts or feelings you may have.
• You are an elderly patient, as you are more likely to fall.
• You have low blood pressure.

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

At the beginning 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 effect 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 effect of this medication; the same applies to elderly patients. You may be at greater risk of falling, especially when getting up at night.

You may develop 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 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 (e.g. fatigue, altered reaction capacity).

Ask your doctor to give you more detailed instructions on how to lead your daily life, taking into account your individual lifestyle (e.g. 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. Lorazepam treatment should be discontinued if paradoxical reactions occur.

With the use of benzodiazepines, including lorazepam, there is a potential for 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 notice that the medication is not working as well as it did at the start of treatment, you should consult your doctor.

Lorazepam treatment should be discontinued gradually to avoid withdrawal symptoms. See section 3.

Rare cases of severe allergic reactions have been reported with the use of benzodiazepines. Some patients have experienced swelling of the skin and/or mucous membranes affecting the tongue, larynx, or vocal cord region (angioedema) after taking the first 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, report them immediately to your doctor 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 is necessary urgently as sedation before surgery or before diagnostic procedures. Lorazepam is contraindicated in children under 6 years old. You will find more information in the next section.

Other medications and Lorazepam Normon

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 (e.g. sodium oxybate).
• Medications for treating delirium or hallucinations (e.g. chlorpromazine, loxapine, or clozapine).
• Medications to promote digestion (e.g. antacids or omeprazole).
• A medication to control chemotherapy-induced nausea and vomiting called nabilone.
• Medications for addiction treatment (e.g. lofexidine).
• Strong analgesics (e.g. methadone, tramadol, codeine, morphine).
• Medications used to treat tuberculosis, such as isoniazid.
• Antibiotics, such as erythromycin.
• Medications 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, nitroprusside sodium, and diuretics).
• Medications used to treat asthma (e.g. theophylline).
• Muscle relaxants (e.g. baclofen and tizanidine).
• Other sedatives (e.g. barbiturates or antihistamines).
• Other medications used to treat anxiety.
• Medications used to treat depression.
• Antihistamines for allergies.
• Medications for Parkinson's disease, e.g. levodopa.
• Medications for epilepsy (e.g. phenobarbital or valproate/sodium valproate).
• A medication for gout called probenecid.
• Medications that affect liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If you use this medication at the same time as other central nervous system depressants (e.g. psychotropic agents, sleeping pills, sedatives, anesthetics, beta-blockers, opioid analgesics, antihistamines, antiepileptic drugs), there may be an interaction, producing additive depressive effects on the central nervous system.

The concomitant use of this medication and opioids (e.g. 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 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 dosage recommendations closely. It may be helpful to inform friends or family members about the signs and 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, there may be intense sedation, excessive salivation, and altered movement coordination.

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 about 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 with food, drinks, and alcohol

You should avoid drinking alcohol, as alcohol may alter and increase the effects of lorazepam in an unpredictable way.

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

Pregnancy, breastfeeding, and fertility

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, who will decide whether to discontinue 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 delivery may cause the baby to have reduced activity, reduced muscle tone, decreased body temperature (hypothermia), and/or decreased blood pressure (hypotension), respiratory insufficiency, apnea, and difficulty breastfeeding (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 ingredient 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 breastfeed 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 contains 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 treatment duration must 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 treatment duration 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 in a different way, 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 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 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

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

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.

Treatment duration

The treatment duration 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 treatment duration 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 abrupt 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 from intoxication after taking fairly large quantities of this medication. Follow the first aid instructions received by phone. Do not induce vomiting unless the doctor explicitly instructs you to do so.

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 unless 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 discontinued 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.

It is expected that adverse reactions will occur 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, drowsiness.

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

• Unstable movements and gait (ataxia).
• Confusion.
• Depression, onset of depression.
• Feeling dizzy.
• Weakness of the muscles, 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 state of 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 (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/crisis.
• Memory lapses (amnesia).
• Disinhibition, euphoria.
• Coma.
• Thoughts/intents of suicide.
• Decreased attention/concentration.
• 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 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.
• Icterus, 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).
• Decreased body temperature (hypothermia).

Benzodiazepines cause dose-dependent depression of the central nervous system.

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 when 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, states of agitation, palpitations, rapid pulse, panic attacks, dizziness, increased reflexes, short-term memory loss, and fever. Abrupt discontinuation may cause an increase in convulsions in the case of chronic lorazepam administration 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 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 abuse 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 rash, 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 the Vigilance 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.

Store below 30°C. Store in the original packaging to protect it from light.

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.

Medications 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 at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lorazepam Normon

• The active ingredient is lorazepam. Each tablet contains 2 mg of lorazepam.
• The other components (excipients) are:yellow iron oxide (E-172), potassium polacrilex, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and contents of the packaging

Yellow, round, biconvex, tablets with “LZ” printed on one side and scored on the other, with a diameter of 6.6 mm ± 10%.

Presented in Aluminio/PVC-PVDC blister packs (120).

Packs of 30 and 60 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:July 2023

Detailed information about this medication 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 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/88965/P_88965