Package Insert: Information for the Patient

Lorazepam NORMON 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Lorazepam NORMON belongs to a group of medicines called “short-acting benzodiazepines”.It is indicated for the short-term treatment of anxiety states associated with insomnia, depression, and emotional disturbances.

Do not take Lorazepam NORMON.

• She is allergic to lorazepam or any of the other components of this medication (listed in section 6).
• She has had an allergic reaction (hypersensitivity) after taking benzodiazepines (a group of medications to which lorazepam belongs).
• She has been diagnosed with Myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or tired muscles).
• She has severe respiratory insufficiency (difficult breathing or severe chest discomfort).
• She has sleep apnea (temporary stoppage of breathing while sleeping).
• She has a severe liver disease.
• She is being treated simultaneously with opioids, barbiturates, neuroleptics, or similar medications.

Warnings and precautions

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

• if he has had or has any liver or kidney impairment,
• if he has angle-closure glaucoma,
• after continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected,
• like other benzodiazepines, treatment may cause physical and psychological dependence; the risk of dependence increases with dose and duration of treatment and is higher in patients who have consumed or consume drugs or alcohol. Once physical dependence has developed, abrupt discontinuation of treatment may cause withdrawal symptoms, such as headaches, muscle aches, anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormal sharpness of hearing), paresthesia (tingling and numbness in the extremities), intolerance to light, sounds, and physical contact, hallucinations, or convulsions,
• after withdrawal of the medication, especially if it is stopped abruptly, rebound insomnia and anxiety, mood changes, and restlessness may appear; therefore, it is recommended to gradually reduce the dose before discontinuing treatment,
• the duration of treatment should be as short as possible (see 3. How to take Lorazepam NORMON); it should never be prolonged without your doctor's indication,
• benzodiazepines may cause alterations in recent memory; this occurs more frequently after several hours after taking the medication, so to minimize the associated risk, ensure that you can sleep uninterrupted for 7-8 hours (see 4. Possible adverse effects),
• benzodiazepines may cause psychiatric and paradoxical reactions, such as anxiety, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, treatment should be discontinued. These reactions are more frequent in children and the elderly,
• benzodiazepines should not be used alone to treat anxiety associated with depression (suicide risk),
• benzodiazepines should be used with maximum caution in patients who have consumed or consume drugs or alcohol,
• it is recommended to use lower doses in patients with chronic respiratory insufficiency

Children

Like other benzodiazepines, Lorazepam NORMON should not be administered to children, unless absolutely necessary. The duration of treatment should be as short as possible.

Older adults

Like other benzodiazepines, older adults may be more sensitive to the effects of Lorazepam NORMON than other adults, so they should take a lower dose.

Taking Lorazepam NORMON with other medications

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

Like other benzodiazepines, Lorazepam NORMON may interact with some medications, especially those that depress the central nervous system.

A potentiation of the depressive effect on the central nervous system may occur when administering benzodiazepines together with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedating antihistamines.

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

Compounds that inhibit certain liver enzymes (particularly cytochrome P 450) may potentiate the activity of benzodiazepines.

Inform your doctor or pharmacist if you are taking, or have taken recently, any other medication, even those acquired without a prescription.

Taking Lorazepam NORMON with food, drinks, and alcohol

Lorazepam NORMON should not be taken in combination with alcoholic beverages, as these may potentiate the sedative effect of the medication.

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

If you are taking Lorazepam NORMON and plan to become pregnant or have confirmed pregnancy, you should contact your doctor to proceed with withdrawal of the treatment.

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

Breastfeeding

Due to the fact that benzodiazepines pass into breast milk, it is recommended to avoid taking this medication during breastfeeding.

Driving and operating machinery

Lorazepam NORMON may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease attention, or decrease reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Lorazepam NORMON contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Lorazepam NORMON.

The recommended dose for anxiety states is 1 to 4 tablets per day, divided into 2 or 3 doses. The highest dose should be taken before sleeping.

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

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

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

In elderly patients and patients with renal and/or hepatic insufficiency, the recommended dose is 0.5 mg per day, which can be gradually adjusted if necessary.

The tablet can be divided into equal doses.

Lorazepam NORMON is administered orally. Take the tablets with a sufficient amount of liquid.

If you take more Lorazepam NORMON than you should

If you have taken more Lorazepam NORMON than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service. Phone 91 562 04 20.

Like other benzodiazepines, overdose does not represent a life-threatening situation, unless taken with other central depressants (including alcohol).

In case of accidental overdose, induce vomiting (within an hour) if the patient is conscious.

Benzodiazepine overdose generally manifests as different degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy; in more serious cases, ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death may occur.

If you forget to take Lorazepam NORMON

Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The use of Lorazepam NORMON, like other benzodiazepines, may produce drowsiness, emotional numbness, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disruption of the nervous system functions) or diplopia (double vision).

These reactions predominantly appear at the beginning of treatment and generally disappear with continued administration. Occasionally, other adverse effects may occur, such as gastrointestinal alterations, changes in libido or skin reactions.

Other adverse effects that may occur:

• Anterograde amnesia (recent memory disorder): the risk is higher with increased dosage. Amnestic effects may be associated with inappropriate behavior (see Warnings and Precautions).
• Depression: the use of benzodiazepines may unmask existing depression.
• Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other conduct alterations. These reactions may be severe and occur more frequently in children and elderly patients.
• Dependence: physical (withdrawal or rebound phenomena upon discontinuing treatment) and/or psychological dependence may occur. Cases of abuse have been reported.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You may also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (Website:www.notificaRAM.es).

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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 pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Lorazepam NORMON 5 mg tablets

• The active ingredient is lorazepam. Each tablet contains 5 mg of lorazepam.

• The other components of the tablet are: lactose monohydrate, microcrystalline cellulose, potassium polacrilex, magnesium stearate, red iron oxide (E-172), and partially substituted hydroxypropyl cellulose (E-463).

Appearance of the product and contents of the packaging

Lorazepam NORMON 5 mg film-coated tablets are presented in packs of 20 tablets.

Pink, round, biconvex tablets, engraved with “LZ” on one face and a breaking bar on the other.

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:August 2023

Detailed and updated 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/77785/P_77785.html