Lorazepam Normon 1 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Lorazepam normon 1 mg tablets EFG

lorazepam

Read this entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Lorazepam Normon belongs to a group of medicines known as "short-acting benzodiazepines". It is indicated for the treatment of:

• all anxiety states
• neuroses
• psychological tension and hyperemotionality
• sleep disorders
• psychosomatic disorders
• as an adjunct in all medical conditions where anxiety components are present

2. What you need to know before taking Lorazepam Normon

Do not take Lorazepam Normon if

• You are allergic to lorazepam, to other benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6).
• You have the muscle disease myasthenia gravis.
• You have severe respiratory insufficiency.
• You have sleep apnoea 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 taking Lorazepam Normon:

• If you have had or currently have any liver or kidney problems.
• After continuous use for several weeks, a certain degree of reduced effectiveness regarding hypnotic effects may occur.
• As with other benzodiazepines, treatment may lead to physical and psychological dependence. The risk of dependence increases with dose and duration of treatment and is higher in patients who have used or currently use drugs or alcohol. Once physical dependence has developed, abruptly stopping treatment may cause withdrawal symptoms such as headache, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormally acute hearing), tingling and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or seizures.
• After discontinuation of the medicine, especially if treatment is stopped abruptly, rebound insomnia and anxiety, mood changes, and restlessness may occur; therefore, it is recommended to gradually reduce the dose before stopping treatment.
• The duration of treatment should be as short as possible, depending on the indication (see section 3); you should never prolong treatment without medical advice.
• Benzodiazepines may cause impairment of recent memory; this occurs more frequently several hours after taking the medicine, so to reduce the associated risk, you should ensure you are able to sleep uninterrupted for 7–8 hours (see section 4).
• Benzodiazepines may cause psychiatric and paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behaviour, and other adverse behavioural effects. If this occurs, treatment should be discontinued. These reactions are more common in children and elderly patients.
• Benzodiazepines should not be used alone for the treatment of anxiety associated with depression (risk of suicide).
• Benzodiazepines should be used with extreme caution in patients who have used or currently use drugs or alcohol.
• Lower doses are recommended in patients with chronic respiratory insufficiency.

Use of Lorazepam Normon with other medicines

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

Lorazepam may interact with certain medicines, particularly central nervous system depressants. The central nervous system depressant effect may be enhanced when lorazepam is taken together with medicines used to treat psychiatric disorders (neuroleptics), insomnia (hypnotics), anxiety (anxiolytics/sedatives), depression (antidepressants), severe pain (narcotic analgesics), epilepsy (antiepileptics), and allergies (antihistamines), as well as certain anaesthetics.

When used with narcotic analgesics, there may also be an increased feeling of euphoria, which could increase the risk of psychological dependence.

Use in elderly patients

Elderly patients may be more sensitive to the effects of Lorazepam than younger adults, and therefore should take a lower dose.

Use of Lorazepam Normon with food, drinks, and alcohol

Lorazepam should not be taken together with alcoholic beverages, as alcohol may enhance the sedative effect of the medicine, which could impair your ability to drive or operate machinery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are taking lorazepam and plan to become pregnant or have confirmed pregnancy, you should contact your doctor to gradually discontinue treatment.

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

Breastfeeding

Since benzodiazepines pass into breast milk, this medicine should not be used during breastfeeding.

Driving and using machines

Lorazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or slow reaction times. These effects are more likely at the start 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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Lorazepam Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine. Your doctor will indicate the duration of your treatment with lorazepam. Do not stop treatment prematurely, as this could worsen your condition.

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

Anxiety:

The recommended dose is 1 to 3 tablets daily, divided into 2 or 3 doses. The highest dose should be taken before going to sleep. In psychiatry, for acute agitation states, higher doses may be administered.

It is advisable 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 regularly re-evaluate your condition. In general, total treatment duration should not exceed 8–12 weeks, including gradual withdrawal of the medicine.

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

Insomnia:

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

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

Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.

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 feel that the effect of this medicine 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 915 62 04 20, indicating the medicine and the amount ingested. Take the lorazepam packaging with you to show the doctor or pharmacist. Symptoms of benzodiazepine overdose are generally manifested by varying degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy (drowsiness); in more severe cases, ataxia (disturbance of nervous system functions), hypotonia (muscle tone lower than normal), hypotension, respiratory depression, rarely coma, and very rarely death.

If you forget to take Lorazepam Normon

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

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

The use of lorazepam in the treatment of insomnia may cause next-day drowsiness. Emotional blunting, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia (disturbance of nervous system functions), or diplopia (double vision) may also occur. These reactions occur mainly at the beginning of treatment and usually disappear with continued administration. Occasionally, other adverse effects may occur, such as gastrointestinal disturbances, changes in libido, or skin reactions.

Other possible adverse effects include:

• Anterograde amnesia (impairment of recent memory); the risk increases with higher doses. Amnesic effects may be associated with inappropriate behaviors (see section 2).
• Depression: the use of benzodiazepines may unmask pre-existing depression.
• Psychiatric and paradoxical reactions: restlessness, agitation, irritability, aggressiveness, delirium, rage attacks, nightmares, hallucinations, psychosis, inappropriate behavior, and other behavioral disturbances. These reactions can be severe and occur more frequently in children and elderly patients.
• Dependence: physical dependence (withdrawal or rebound phenomena upon discontinuation) may occur (see section 2) and/or psychological dependence. Cases of abuse have been reported.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lorazepam Normon

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

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

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

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

Appearance of the product and contents of the pack

Lorazepam Normon 1 mg are white, round, biconvex tablets, printed with "LZ" on one side and a break line on the other, available in packs of 25 or 50 tablets. The tablet can be divided into equal doses.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: August 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/64972/P_64972.html