LORAZEPAM NORMOGEN 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lorazepam Normogen 2 mg Tablets EFG

Lorazepam

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 pack

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

1. What is Lorazepam Normogen 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”.

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 Normogen

Do not take Lorazepam Normogen

• If you are allergic to the active substance, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had 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 or 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 lorazepam if:

• You have problems controlling your movements (spinal or cerebellar ataxia).
• You suffer from respiratory problems, e.g., chronic obstructive pulmonary disease.
• If 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; it may mean that 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 weakened 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 that 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.

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 dose 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 is contraindicated in children under 6 years of age. You will find more information in the following section.

Other medicines and Lorazepam Normogen

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 delirium or hallucinations (e.g., chlorpromazine, loxapine, or clozapine).
• Medicines to aid digestion (e.g., antacids or omeprazole).
• A medicine to control nausea and vomiting induced by chemotherapy called nabilone.
• Medicines for the treatment of addiction (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/valproic acid).
• A medicine for gout called probenecid.
• Medicines that affect liver enzymes (e.g., cimetidine, esomeprazole, 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 depressant 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 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 to be 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/valproate sodium may increase lorazepam levels in the blood. If valproic acid/valproate sodium 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 Normogen 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, breastfeeding, and fertility

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, who will decide whether you should 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 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 breastfeeding (known as "floppy infant 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 breastfeed in the infant.

Driving and using machines

Even if you take this medicine as prescribed, you should expect 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 or machines. Do not work without a secure support. In particular, remember that alcohol will further impair your reaction ability.

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 Normogen contains lactose

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

3. How to Take Lorazepam Normogen

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

Unless your doctor has prescribed lorazepam in a different way, the following information will apply:

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 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 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 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 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

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

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 Normogen 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, altered movement coordination, apathy, and, in severe cases, loss of consciousness.

If you forget to take Lorazepam Normogen

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 Normogen

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, the 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 adverse effects

Like all medications, this medication can cause adverse 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 states, delirium, excitability, aggressive behavior (hostility, aggression, anger), sleep disorders/insomnia, sexual excitement, hallucinations, psychosis. If such reactions occur, treatment with lorazepam should be discontinued.
• Low blood pressure (hypotension), mild drop in blood pressure.
• Respiratory failure (severity depends on the 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 depression of the central nervous system.

Dependence/abuse

Even after daily treatment with this medication for a few days, withdrawal syndromes (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 states, palpitations, rapid pulse, panic attacks, dizziness, increased reflexes, short-term memory loss, and fever. Abrupt interruption 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 the 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 adverse effects?

Many of the adverse effects mentioned above will disappear during treatment or when the dose is reduced. If adverse 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Lorazepam Normogen

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of 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 Normogen

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

Appearance of the product and package contents

Yellow, round, biconvex tablets, serigraphed with "LZ" on one face and scored on the other, with a diameter of 6.6 mm ± 10%.

Presented in aluminum/PVC-PVDC blisters (120).

Packaging of 30 and 60 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 prospectus:July 2023

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/)