LORAZEPAM NORMON 5 mg TABLETS

2. What you need to know before taking Lorazepam NORMON

Do not take Lorazepam NORMON.

• If you are allergic to lorazepam or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction (hypersensitivity) after taking benzodiazepines (the group of medicines to which lorazepam belongs).
• If you have been diagnosed with myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or tired muscles).
• If you have severe respiratory failure (difficult breathing or severe chest discomfort).
• If you have sleep apnea (pauses in breathing for short periods while sleeping).
• If you have severe liver disease.
• If you are being treated simultaneously with opioids, barbiturates, neuroleptics, or similar medicines.

Warnings and precautions

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

• if you have had or have liver or kidney problems,
• if you have narrow-angle glaucoma,
• after continuous use for several weeks, a certain degree of loss of efficacy with respect to hypnotic effects may be detected,
• as with other benzodiazepines, treatment may cause physical and psychological dependence; the risk of dependence increases with the dose and duration of treatment and is greater in patients who have consumed or consume drugs or alcohol. Once physical dependence has developed, sudden interruption of treatment can cause withdrawal symptoms, such as headaches, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms may occur: depersonalization, hyperacusis (abnormal acuteness of hearing), paresthesia, and muscle cramps, intolerance to light, sounds, and physical contact, hallucinations, or convulsions,
• after withdrawal of the medicine, especially if the medication 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 (see 3. How to take Lorazepam NORMON); it should never be prolonged without your doctor's advice,
• benzodiazepines may cause impairment of recent memory; this occurs more frequently after several hours after taking the medicine, so, to minimize the associated risk, you should ensure that you will be able to sleep uninterrupted for 7-8 hours (see 4. Possible side effects),
• benzodiazepines may cause psychiatric and paradoxical reactions, such as restlessness, agitation, irritability, aggression, delirium, rage, 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 for the treatment of anxiety associated with depression (risk of suicide),
• benzodiazepines should be used with extreme caution in patients who have consumed or consume drugs or alcohol,
• lower doses are recommended in patients with chronic respiratory failure

Children

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

Elderly patients

As with other benzodiazepines, elderly patients 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 medicines

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

As with other benzodiazepines, Lorazepam NORMON may interact with some medicines, especially central nervous system depressants (CNS).

A potentiation of the depressant effect on the CNS may occur when administered concomitantly with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedating antihistamines.

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

Compounds that inhibit certain liver enzymes (particularly cytochrome P450) may potentiate the activity of benzodiazepines.

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Taking Lorazepam NORMON with food, drinks, and alcohol

Lorazepam NORMON should not be administered in combination with alcoholic beverages, as they may potentiate the sedative effect of the medicine.

Pregnancy and breastfeeding

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

Pregnancy

If you are taking Lorazepam NORMON and plan to become pregnant or have confirmed that you are pregnant, you should contact your doctor to discontinue 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

Since benzodiazepines pass into breast milk, this medicine should be avoided during breastfeeding.

Driving and using machines

Lorazepam NORMON may affect your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or reduce your reaction time. The occurrence of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Lorazepam NORMON contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Lorazepam NORMON

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

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

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

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

The duration of treatment should be as short as possible. Your doctor should reassess 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.

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. Swallow 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 Toxicology Information Service. Telephone 91 562 04 20.

As with other benzodiazepines, overdose is not life-threatening, unless taken with other central depressants (including alcohol).

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

Overdose with benzodiazepines is generally manifested by various degrees of central nervous system depression, ranging from drowsiness to coma. In moderate cases, symptoms may include drowsiness, confusion, and lethargy; in more severe 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 make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of Lorazepam NORMON, like other benzodiazepines, may cause drowsiness, emotional bluntness, decreased alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or diplopia.

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

Other side effects that may occur:

• Anterograde amnesia (recent memory disorder): the risk is greater with increasing dose. 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, rage, nightmares, hallucinations, psychosis, inappropriate behavior, and other adverse effects on behavior. These reactions are more frequent in children and the elderly.
• Dependence: physical dependence (withdrawal or rebound phenomena when treatment is stopped) and/or psychological dependence may occur. Cases of abuse have been reported.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es.

By reporting side 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Lorazepam NORMON 5 mg tablets

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

• The other ingredients of the tablet are: lactose monohydrate, microcrystalline cellulose, potassium polacrylate, magnesium stearate, red iron oxide (E-172), and hypromellose (E-463).

Appearance and packaging of the product

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

Tablets are pink, round, biconvex, and engraved with "LZ" on one side and a score line on the other.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:August 2023

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

You can access detailed and updated information on 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/77785/P_77785.html