What it is and what it is used for

for

This medicine has been prescribed for you for

• Symptomatic short-term treatment of anxiety and sleep disorders caused by anxiety where the anxiety is severe, disabling or subjecting the individual to unacceptable distress.
• Sedation prior to diagnostic procedures, as well as before surgical interventions This medicine contains lorazepam which belongs to a class of medicines called benzodiazepines. It has been prescribed to you or your child, and should not be given to anyone else. Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. 2.

What you need to know before you take it

e Lorazepam Aristo

Do not take Lorazepam Aristo

• if you are allergic to lorazepam, benzodiazepines or any of the other ingredients of this medicine (listed in section 6)
• if you have, or have ever had, an addiction to any medicines, alcohol or drugs
• if you have severe breathing problems, e.g. chronic obstructive pulmonary disease
• if you have abnormal muscle weakness (myasthenia gravis)
• if you have serious liver problems
• if you suffer from breathing problems when you are asleep (sleep apnoea syndrome)

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in case of acute poisoning with alcohol or depressants affecting the Central Nervous System (CNS) (e.g. sleeping pills or painkillers, medicines for the treatment of mental disorders, such as antipsychotics, antidepressants and lithium) if you are under 6 years of age.

Warnings and precautions Talk to your doctor or pharmacist before taking Lorazepam Aristo if:

• you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake
• you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• you feel you need to take more of Lorazepam Aristo to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication
• you have problems with controlling your movements (spinal or cerebellar ataxia)
• you suffer from breathing problems, e.g. chronic obstructive lung disease
• you have kidney or liver problems
• you are suffering from an eye problem called glaucoma e.g. high pressure within the eye
• you have a personality disorder; it may mean you have a greater chance of becoming dependent upon Lorazepam
• you have suffered from depression before, as it might come back during Lorazepam treatment
• you are suffering from depression, as Lorazepam may increase any suicidal feelings or thoughts you may have
• you are elderly, you may be more likely to fall
• you have low blood pressure. Some patients have experienced suicidal thoughts whilst taking medicines containing lorazepam, particularly if they are already depressed. If you are depressed, have irrational fears and obsessions, have started experiencing thoughts of suicide or harm towards yourself, please tell your doctor immediately. Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body). Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

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Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. At the start of therapy, your doctor will monitor your individual response to this medicine, so that a potential overdose can be detected as quickly as possible. If you are a child, an older or debilitated patient, you may show a more sensitive response to the effects of Lorazepam Aristo. Therefore, your therapy should be monitored more frequently. If you suffer from kidney or liver dysfunction, have existing heart failure and/or low blood pressure (hypotension), you may have greater sensitivity to the effects of this medicine; the same applies if you are elderly. You may be at greater risk of falls, especially when you get up at night. Hepatic encephalopathy (brain disease due to liver damage) may occur with the use of lorazepam. Lorazepam must therefore not be used in patients with severely impaired liver function and/or hepatic encephalopathy. You may observe memory loss during treatment with lorazepam. When used as a sleeping tablet, you should ensure that you get a sufficient amount of sleep (about 7 to 8 hours). If you follow this recommendation, the after-effects the next morning can usually be avoided (e.g. tiredness, impaired reaction skills). Please ask your doctor to give you more detailed instructions on how to go about your everyday life, taking your particular lifestyle into account (e.g. occupation). There have been uncommon reports of paradoxical reactions occurring with the use of benzodiazepines such as anxiety, states of agitation, delusion, excitability, aggressive behaviour sleep disorders, sexual arousal, hallucinations, psychoses (see section 4.). Such reactions are more likely if you are a child or an elderly patient. Treatment with lorazepam should be stopped if paradoxical reactions occur. Potentially fatal respiratory depression may occur with use of benzodiazepines including lorazepam. Severe allergic reactions have been reported with benzodiazepine use. Cases of swelling of the skin and/or mucous membranes involving the tongue, larynx or vocal cord region (angioedema) have been reported in patients after taking the first dose or subsequent doses of benzodiazepines. Some patients have experienced other symptoms while taking benzodiazepines, such as shortness of breath (dyspnoea), swelling of the throat or feeling and being sick. Some patients had to be treated as a medical emergency. If these symptoms occur, please tell your doctor immediately or go to hospital straight away. The airways can become blocked, which may prove fatal. Children and adolescents Children and adolescents under 18 years should not be treated with Lorazepam unless it is urgently required for sedation before surgery or before diagnostic procedures. For children under 6 years, Lorazepam is contraindicated. Further information can be found in section 3. Other medicines and Lorazepam Aristo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially: • • • • • • •

Medicine for narcolepsy with cataplexy (e.g. sodium oxybate) Medicine for treating HIV (e.g. zidovudine) Medicine to treat delusions or hallucinations (e.g. chlorpromazine, loxapine or clozapine) Medicine to help with indigestion (e.g. antacids, cisapride or omeprazole) A medicine to control nausea and vomiting induced by chemotherapy called nabilone Medicines for addiction treatment (e.g. lofexidine and disulfiram) Strong pain killers (e.g. methadone, tramadol, codeine, morphine) 3

• • • • • • • • • • • • • •

Medicines used to treat tuberculosis such as isoniazid Antibiotics such as erythromycin Medicines to treat high blood pressure (e.g. ACE-inhibitors, alpha-blockers, angiotensin-II receptor antagonists, calcium channel blockers, adrenergic neurone 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 allergy Medicines for Parkinson's disease e.g. levodopa Medicines for epilepsy (e.g. phenobarbital or valproate/valproic acid) Medicine for gout called probenecid Oestrogen-containing contraceptives Medicines which affect liver enzymes (e.g. cimetidine, esomeprazole, rifampicin, ketoconazole, itraconazole).

If Lorazepam Aristo is used at the same time as other medicines that depress the central nervous system (e.g. psychotropic agents, sleeping tablets, sedatives, anaesthetics, beta-blockers, opiate-type painkillers, sedative antihistamines, antiepileptics), there may be some interaction, causing additive depressant effects on the central nervous system. Concomitant use of Lorazepam Aristo and opioids (e.g. strong pain killers, some cough medicines and medicines for substitution therapy) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Lorazepam Aristo together with opioids, the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. The effect of medicines to reduce muscle tension (muscle relaxants) and painkillers may be increased. If lorazepam is used at the same time as clozapine, marked sedation, excessive salivation and impaired movement coordination may occur. Administration of Lorazepam Aristo at the same time as valproic acid/sodium valproate can increase the levels of lorazepam in the blood. If valproic acid/sodium valproate is used at the same time, the dose of Lorazepam Aristo should be reduced by about a half. Administration of Lorazepam Aristo at the same time as probenecid may speed up the onset of action or prolong the effect of lorazepam. If used at the same time as probenecid, the dose of Lorazepam Aristo should be halved. The use of theophylline or aminophylline can reduce the sedative effect of Lorazepam Aristo. Lorazepam Aristo with food, drink and alcohol You should avoid drinking alcohol, as alcohol can alter and increase the effects of Lorazepam Aristo in an unpredictable way. Grapefruit juice and drinks containing caffeine should be avoided as they can affect the way that Lorazepam works.

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Pregnancy and breast-feeding Pregnancy If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Lorazepam Aristo should not be taken during pregnancy. Your doctor will decide if the treatment should be discontinued. If you take Lorazepam during late pregnancy or during labour, your baby may be less active than other babies, have lower muscular tone, low body temperature (hypothermia) and/or low blood pressure (hypotension), respiratory depression, apnoea and drinking difficulties ("floppy infant syndrome"). Your baby may also develop withdrawal symptoms after birth, if you take Lorazepam Aristo for a prolonged time in the late stages of your pregnancy. Breast-feeding As Lorazepam passes into breast milk and might cause sedation and inability to suckle in your baby, you should not take Lorazepam Aristo during breast-feeding. Driving and using machines Even when Lorazepam Aristo is used as directed, you should expect your reaction skills to be impaired, especially during the first few days of treatment. In this case, you will no longer be able to react quickly enough to unexpected and sudden events. Do not drive a car or any other vehicle. Do not use any hazardous electrical tools or machines. Do not work without a secure foothold. In particular, please remember that alcohol will further impair your ability to react. The decision as to what extent driving or other hazardous activities are possible will be taken by your treating doctor, taking your individual response and dosage into consideration. Lorazepam Aristo contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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How to take it

Lorazepam Aristo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose and duration of treatment must be adjusted to your individual response to therapy, the therapeutic indication (i.e. the illness for which this medicine has been prescribed) and the severity of your illness. As a basic rule, the dose should be kept as low as possible and the duration of treatment as short as possible. Your prescriber should have discussed with you how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Dose Please follow the directions for use at all times, as Lorazepam Aristo may otherwise not work properly. The following information applies, unless Lorazepam Aristo has been prescribed otherwise by your doctor: Treatment of anxiety and sleep disorders caused by anxiety:

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The daily dose for adults is generally 0.5 to 2.5 mg lorazepam, divided into 2 to 3 single doses or as a single evening dose. In individual cases, especially in a hospital setting, the doctor may increase the daily dose to a maximum of 7.5 mg lorazepam, taking all precautions into consideration. If the main focus involves sleep disorders requiring treatment, the daily dose (0.5 to 2.5 mg lorazepam) can be taken as a single dose approximately half an hour before bedtime. When used as a sleeping tablet, you should take it about half an hour before bedtime; otherwise, it will probably take longer for it to take effect and – depending on the length of sleep – will probably cause more severe after-effects the next morning. If you take your whole dose in the evening, it should not be taken on a full stomach. Sedation prior to diagnostic procedures, as well as before surgical interventions: For adults, 1 to 2.5 mg lorazepam in the evening before surgery and/or 2 to 4 mg lorazepam approximately 1 to 2 hours before the procedure. The orodispersible tablets can be taken with or without meals. Use in elderly or debilitated patients In elderly or debilitated patients, as well as in patients with organic brain changes, the initial total daily dose should be reduced by approximately 50 %. These patients should preferably use preparations with a lower active substance content. The dose must be adjusted by the doctor, depending on the required effect and tolerability in each individual case. Use in patients with impaired renal function Patients with kidney problems may be given lower doses. The starting dose is usually half of the recommended normal adult dose. Your doctor will see how you respond to the medicine and alter the dose if needed. Use in patients with impaired hepatic function Patients with moderate to mild liver problems may be given lower doses. The starting dose is usually half of the recommended normal adult dose. Lorazepam is contraindicated in patients with severe liver insufficiency (see section 4.3). Use in children and adolescents Lorazepam Aristo should not be used for the treatment of anxiety or insomnia in children and adolescents under 18 years of age. Aged less than 6 years: Children under the age of six must not be treated with Lorazepam. Aged 6 – 12 years: Before diagnostic procedures or before surgical interventions: The recommended dose is between 0.5 mg to 1 mg, depending upon the weight of the child (0.05 mg/kg body weight dose should not be exceeded), taken at least one to two hours before the operation. Aged 13 – 18 years of age: Before diagnostic procedures or before surgical interventions: The recommended dose is between 1 mg to 4 mg, taken one to two hours before the operation. Method of administration Lorazepam Aristo is for oral use. The orodispersible tablets dissolve instantly in the mouth. They can, if desired, be swallowed and washed down with some liquid. The tablet can be divided into equal doses. 6

If you take more Lorazepam Aristo than you should Tell a doctor immediately if you suspect that intoxication has occurred after quite large amounts of this medicine have been taken. You must call a doctor for first-aid instructions, which you must then apply. Do not induce vomiting unless expressly told to do so. Signs of an overdose are: drowsiness, confusion, somnolence, shallow breathing, impaired movement coordination, apathy and, in severe cases, unconsciousness. If you forget to take Lorazepam Aristo If you forget to take an orodispersible tablet, take it as normal at your next time. Do not take a double dose to make up for a forgotten dose. If you stop taking Lorazepam Aristo Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Withdrawal symptoms may include headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Possible side effects

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

Possible side effects

are to be expected especially at the start of treatment, if the dose is too high and in the patient groups mentioned in "Warnings and precautions" (see section 2). Very common: may affect more than 1 in 10 patients treated

• sedation, tiredness, drowsiness Common: may affect up to 1 in 10 patients treated
• unsteady movements and gait (ataxia)
• confusion
• depression, onset of depression
• feeling dizzy
• muscle weakness, feeling weary (lassitude) Uncommon: may affect up to 1 in 100 patients treated
• altered sex drive, impotence, less intense orgasm
• feeling sick Rare: may affect up to 1 in 1,000 patients treated
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reduced alertness salivation changes

Very rare: may affect up to 1 in 10,000 patients treated

• leucopenia Not known: frequency cannot be estimated from the available data
• dependence and addiction (see section "How do I know if I am tolerant or addicted?" below).
• changes in blood counts (thrombocytopenia, agranulocytosis, pancytopenia)
• prolonged reaction times
• impaired movement coordination (extrapyramidal symptoms)
• tremor
• visual disturbances (double vision, blurred vision)
• difficulty in articulating/slurred speech
• headache
• convulsions/seizures
• memory gaps (amnesia)
• disinhibition, euphoria
• coma
• suicidal thoughts/attempt
• impaired attentiveness/concentration
• balance disorders
• vertigo
• paradoxical reactions such as anxiety, states of agitation, delusion, excitability, aggressive behaviour (hostility, aggression, rage), sleep disorders/insomnia, sexual arousal, hallucinations, psychoses. If such reactions occur, treatment with Lorazepam Aristo should be stopped.
• low blood pressure (hypotension), slight drop in blood pressure
• respiratory depression (dose-dependent in severity), breathlessness (apnoea), worsening of sleep apnoea (temporary cessation of breathing during sleep)
• worsening of obstructive pulmonary disease (airway constriction)
• constipation
• increased bilirubin
• jaundice, increase in liver enzymes (transaminases, alkaline phosphatase)
• allergic skin reactions
• hair loss
• hypersensitivity reactions, anaphylactic/anaphylactoid reactions, swelling of the skin and/or mucous membranes (angioedema)
• inappropriate antidiuretic hormone secretion (SIADH)
• low sodium blood levels (hyponatraemia)
• decrease in body temperature (hypothermia) Benzodiazepines cause dose-dependent depression of the central nervous system. Drug Withdrawal When you stop taking Lorazepam Aristo, you may experience drug withdrawal symptoms, which include: headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

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How do I know if I am tolerant or addicted? If you notice any of the following signs whilst taking Lorazepam Aristo, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again If you notice any of these signs, it is important you talk to your prescriber. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store it

Lorazepam Aristo

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package in order to protect from light and moisture. After dividing the orodispersible tablets: Store any remaining half-tablets in the original package in order to protect from light and moisture. Use within 24 hours. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Lorazepam Aristo contains • •

The active substance is lorazepam. Lorazepam Aristo 1 mg orodispersible tablets: each tablet contains 1 mg lorazepam Lorazepam Aristo 2.5 mg orodispersible tablets: each tablet contains 2.5 mg lorazepam The other ingredients are: Lorazepam Aristo 1 mg orodispersible tablets: lactose monohydrate, mannitol, microcrystalline cellulose, crospovidone, magnesium stearate [vegetable], Lorazepam Aristo 2.5 mg orodispersible tablets: lactose monohydrate, mannitol, microcrystalline cellulose, crospovidone, magnesium stearate [vegetable], yellow iron oxide

What Lorazepam Aristo looks like and contents of the pack Lorazepam Aristo 1 mg orodispersible tablets: White to off white, circular, flat faced, bevel edged, uncoated orodispersible tablet with a deep breakable score-line on one side and plain on the other side. The tablets can be divided into equal doses. Lorazepam Aristo 2.5 mg orodispersible tablets: Pale yellow, circular, flat faced, bevel edged, uncoated orodispersible, tablet with a deep breakable score-line on one side and plain on the other side. The tablets can be divided into equal doses.

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Lorazepam Aristo is available in packs of 20, 25, 28, 30, 40, 50, 60 and 500 orodispersible tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany Manufacturer Medinsa (Laboratorios Medicamentos Internacionales, S.A.) C/ Solana, 26, Torrejón de Ardoz, 28850 Madrid, Spain This leaflet was last revised in 01/2026.

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