Prospecto: Information for the User

Lorazepam Normon 1 mg TabletsEFG

lorazepam

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they 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 prospect. See section 4.

Lorazepam Normon belongs to the group of medications known as “short-acting benzodiazepines”. It is indicated for the treatment of:

• all anxiety states
• neurosis
• psychic tensions and hyperemotivity
• sleep disorders
• psychosomatic disorders
• adjunct in all medical processes in which anxiety components exist

Do not take Lorazepam Normon if

• You are allergic to lorazepam, other benzodiazepines, or any of the other components of this medication (listed in section 6).
• You have myasthenia gravis.
• You have severe respiratory insufficiency.
• You have sleep apnea syndrome (interruption of breathing during sleep).
• You have severe liver insufficiency.
• You have narrow-angle glaucoma (increased intraocular pressure).

Warnings and precautions

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

• If you have had or have any liver or kidney alterations.
• 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 can 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, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormal sharpness of hearing), paresthesia, and cramps 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, depending on the indication (see section 3); never prolong treatment without your doctor's indication.
• Benzodiazepines can induce an alteration of recent memory; this occurs more frequently after several hours after taking the medication, so, to reduce the associated risk, ensure that you can sleep uninterrupted for 7-8 hours (see section 4).
• Benzodiazepines can produce psychiatric and paradoxical reactions, such as restlessness, agitation, irritability, aggression, delirium, anger attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. If this occurs, treatment should be suspended. These reactions are more frequent in children and the elderly.
• Benzodiazepines should not be used alone for the treatment of 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.

Use of Lorazepam Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Lorazepam may interact with some medications, especially with central nervous system depressants. A potentiation of the depressive effect on the central nervous system may occur when administering medications for psychiatric problems (neuroleptics), insomnia (hypnotics), anxiety (anxiolytics/sedatives), depression (antidepressants), severe pain (narcotic analgesics), epilepsy (antiepileptics), and allergy (antihistamines), as well as some anesthetics.

In the case of narcotic analgesics, an increase in the sensation of euphoria may also occur, which can increase psychological dependence.

Use in elderly patients

Elderly patients may be more sensitive to the effects of Lorazepam than other adults, so they should take a lower dose.

Use of Lorazepam Normon with food, drinks, and alcohol

Lorazepam should not be administered in combination with alcoholic beverages, as these may potentiate the sedative effect of the medication, which may affect the ability to drive or operate machinery.

Pregnancy and lactation

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

Pregnancy

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

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

Lactation

Due to the fact that benzodiazepines pass into breast milk, this medication should not be administered during lactation.

Driving and operating machinery

Lorazepam may alter the 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 an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will indicate the duration of your treatment with lorazepam. Do not discontinue treatment beforehand, as it may worsen your condition.

This medication is administered orally. Swallow the tablets with a sufficient amount of liquid.

Anxiety:

The recommended dose is 1 to 3 tablets per day, divided into 2 or 3 doses. The highest dose should be taken before bedtime. In psychiatry, in acute agitation states, higher doses may be administered.

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

The duration of treatment should be as short as possible. Your doctor should reevaluate your situation regularly. In general, the total duration of treatment 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.

Insomnia:

The dose for adults is 1 tablet at bedtime. In elderly patients and patients with renal and/or hepatic insufficiency, the recommended dose is ½ tablet per day, which may be adjusted gradually if necessary.

The duration of treatment should be as short as possible. In general, the duration of treatment can vary from a few days to two weeks; it should not exceed four weeks, including gradual withdrawal of the medication.

Treatment should begin with the lowest recommended dose. Do not exceed the maximum dose.

Use in children and adolescents

Lorazepam should not be administered to children unless strictly necessary. The duration of treatment should be as short as possible.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Lorazepam Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount ingested. Bring the lorazepam packaging with you to show it to your doctor or pharmacist. The symptoms of benzodiazepine overdose generally manifest as different degrees of depression of the central nervous system, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy (drowsiness); in more serious cases, ataxia (disruption of nervous system functions), hypotonia (abnormal muscle tone), hypotension, respiratory depression, rarely coma, and very rarely death.

If you forgot to take Lorazepam Normon

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

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

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

The use of lorazepam in the treatment of insomnia may produce drowsiness the next day. It may also appear as emotional numbness, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disruption of the nervous system functions) or diplopia (double vision). These reactions appear predominantly 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 greater with increased dosage. Amnestic effects may be associated with inappropriate behavior (see section 2).
• Depression: the use of benzodiazepines may unmask an 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 dependence (withdrawal or rebound phenomena upon discontinuing treatment); (see section 2) 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 Medicinal Products for Human Use: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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

The active principle is lorazepam. Each tablet contains 1 mg of lorazepam.

The other components are lactose monohydrate, microcrystalline cellulose, potassium polacrilex, magnesium stearate, and partially substituted hydroxypropyl cellulose (E.463).

Appearance of the product and content of the packaging

Lorazepam Normon 1 mg are white, round, biconvex tablets, printed “LZ” on one face and a breaking bar on the other, presented in packs of 25 or 50 tablets. The tablet can be divided into equal doses.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:August 2023

The detailed and updated information on 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/64972/P_64972.html