Lorazepam Tecnigen

Package leaflet: Information for the user

Lorazepam Tecnigen 1 mg tablets, 2.5 mg tablets

Lorazepam
Generic medicine
Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Lorazepam Tecnigen contains the active substance lorazepam. Lorazepam belongs to a group of medicines called benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect), promoting sleep that closely resembles natural sleep (hypnotic effect), improving mood, and reducing the intensity of emotional responses to psychological stress (tranquillizing effect).
Lorazepam Tecnigen is used for the short-term treatment of the following conditions when they are severe and cause distress in normal daily life:

• Anxiety and emotional tension states associated with anxiety
• Insomnia

2. What you should know before taking Lorazepam Tecnigen

Do not take Lorazepam Tecnigen

• if you are allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have serious breathing problems (respiratory failure);
• if you have serious liver problems (hepatic failure);
• if you suffer from episodes of breathing interruption for several seconds during sleep (sleep apnea);
• if you suffer from increased pressure inside the eye (narrow-angle glaucoma);
• if you are or think you may be pregnant (See section “Pregnancy and breastfeeding”).

Warnings and precautions
The duration of treatment with Lorazepam Tecnigen should be as short as possible. It is recommended
not to exceed 4 weeks for the treatment of insomnia and 8–12 weeks for the treatment of anxiety. The
recommended treatment duration includes the period necessary for gradual dose reduction. See section 3 “How to take Lorazepam Tecnigen”.
Talk to your doctor or pharmacist before taking Lorazepam Tecnigen if you think any of the following conditions apply to you (also see section 4 “Possible side effects”):

• you have or have ever had breathing problems, because this medicine may reduce your natural ability to breathe. Breathing problems may also be associated with the following conditions:
  • you suffer from heart problems (heart failure);
  • you suffer from low blood pressure;
  • you suffer from general breathing difficulties, chronic inability to breathe adequately and regularly, either during exertion or at rest;
  • you suffer from episodes of breathing interruption for several seconds during sleep (sleep apnea). If you have any of these conditions and need to start treatment with Lorazepam Tecnigen, your doctor will monitor you regularly;
• you suffer or have ever suffered from allergic reactions to benzodiazepines. This medicine may cause severe and rapidly occurring allergic reactions (anaphylactic reactions) or swelling of the face, tongue, and throat with difficulty swallowing and breathing (angioedema). Sometimes, these reactions can be fatal. If one or more of these symptoms occur, go immediately to the nearest emergency room. In such cases, your doctor will advise you to avoid taking lorazepam-containing medicines again and to continue treatment of your condition with other medicines;
• you have or have had problems with alcohol, drug, or medicine abuse and dependence, because Lorazepam Tecnigen may also cause dependence (see section “Development of dependence”);
• you suffer or have ever suffered from depression, because Lorazepam Tecnigen may worsen your condition and increase suicidal tendencies;
• you suffer or have ever suffered from difficulties in relating to other people or to various life situations, even if you have not always been aware of these difficulties. Lorazepam Tecnigen is not recommended as the primary treatment for this condition;
• you have or have ever had liver problems (hepatic failure), because this medicine could worsen your condition. Your doctor will advise you on the most appropriate dosage for your condition;
• you have or have ever had kidney problems (renal failure). Your doctor will advise you on the most appropriate dosage for your condition.

Memory disturbances
After taking Lorazepam Tecnigen, you may experience difficulty remembering events that occurred after taking the medicine. Therefore, it is advisable to ensure you can sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Lorazepam Tecnigen may cause mental disturbances and effects opposite to those expected (paradoxical effects) (see section 4 “Possible side effects”). These effects are more common in children and elderly patients.
If you experience these effects, consult your doctor, who will advise you on the correct way to discontinue this medicine.

Development of tolerance and dependence, withdrawal reactions, and drug abuse
Reduced effectiveness (tolerance) of this medicine may occur after prolonged use. This medicine is recommended for short-term treatment only.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines affecting brain function. Therefore, talk to your doctor if you are taking alcohol or such medicines.
The use of benzodiazepines, including Lorazepam Tecnigen, may lead to dependence. The risk of dependence increases with higher doses and prolonged use. The risk of dependence is also higher in individuals with a history of alcohol or drug abuse and in patients with significant personality disorders.
Talk to your doctor if:

• you have taken or are currently taking illegal substances;
• you regularly consume alcohol or have previously consumed large amounts of alcohol frequently;
• you have previously or currently have a desire to take large quantities of medicines;
• you have personality disorders, e.g., difficulties interacting with others or difficulties in certain life situations, even if you were not aware of these problems.

In principle, benzodiazepines should only be used for short periods and discontinued gradually. Before starting treatment, you and your doctor should agree on how long you will take the medicine.
If you stop taking the medicine abruptly or reduce the dose too quickly, withdrawal reactions may occur. Do not stop this medicine abruptly. Consult your doctor on how to discontinue treatment.
Some withdrawal reactions may be life-threatening.
Withdrawal symptoms may range from mild depression and insomnia to a more severe syndrome with muscle and abdominal cramps, vomiting, sweating, tremors, and seizures. More severe withdrawal signs and symptoms, including life-threatening reactions, may include delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicide. Seizures/epileptic fits may occur more frequently in patients with pre-existing seizure disorders or in patients taking other medicines that lower the seizure threshold, such as antidepressants.
Other withdrawal reactions may include: headache, anxiety, restlessness, tension, confusion and irritability, depressed mood, dizziness, feelings of detachment, increased sensitivity to noise, tinnitus, tingling sensations, numbness or tingling in the limbs, altered sensory perception, involuntary movements, stomach pain, loss of appetite, diarrhea, panic attacks, muscle pain, states of excitement, increased awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), sensation of loss of balance, exaggerated reflexes, inability to recall recent events, and increased body temperature.
The symptoms for which this medicine was prescribed may also temporarily reappear (rebound phenomena).
Do not give Lorazepam Tecnigen to family members or friends. Store this medicine securely so it cannot harm others.

If you are elderly and/or have specific health conditions
If you are elderly and/or your general health condition is very weak, or if you suffer from significant brain diseases (especially cerebral arteriosclerosis), you are more sensitive to the effects of Lorazepam Tecnigen.
If you suffer from low blood pressure, this medicine may increase episodes of blood pressure drop.
Therefore, it is recommended to use the lowest possible dose of this medicine or avoid its use altogether.

If you have severe liver problems
If you suffer from severe liver problems, with or without brain-related symptoms such as mental confusion, altered consciousness, or coma, Lorazepam Tecnigen must not be used because it could worsen your condition (see also section 2 “Do not take Lorazepam Tecnigen”).

Children and adolescents
The efficacy and safety of Lorazepam Tecnigen in children under 12 years of age are unknown. Your doctor will decide whether Lorazepam Tecnigen can be administered to children based on their condition. The duration of treatment should be as short as possible.

Other medicines and Lorazepam Tecnigen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Concomitant use of Lorazepam Tecnigen and opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Lorazepam Tecnigen together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Contact your doctor if such symptoms occur.
Inform your doctor or pharmacist if you are taking any of the following medicines together with Lorazepam Tecnigen, as caution is required:

• medicines causing strong reduction of all brain functions, such as:
  • sedatives and sleep-inducing medicines (barbiturates, hypnotics/sedatives);
  • medicines for treating certain mental illnesses (antipsychotics);
  • medicines for treating anxiety (anxiolytics);
  • medicines for treating acute or chronic severe pain (narcotic analgesics, opioids);
  • medicines used to treat epileptic seizures (antiepileptics);
  • anaesthetics;
  • medicines used to counteract allergic manifestations (sedating antihistamines). Lorazepam Tecnigen, when taken together with anaesthetic medicines, may cause euphoria, increasing the likelihood of developing psychological dependence;
• clozapine (a medicine used for thought disorders), because taking it together with Lorazepam Tecnigen may cause marked sedation, increased salivation, and loss of movement coordination;
• valproate (a medicine used for epileptic seizures), because it may enhance the effects of Lorazepam Tecnigen. In this case, your doctor may decide to halve the dose of Lorazepam Tecnigen;
• probenecid (a medicine used for gout), because it may enhance the effects of Lorazepam Tecnigen. In this case, your doctor may decide to halve the dose of Lorazepam Tecnigen;
• theophylline and aminophylline (medicines used for bronchial asthma), because they may reduce the effects of Lorazepam Tecnigen;
• loxapine (a medicine used for thought disorders), because taking it together with Lorazepam Tecnigen may cause a state characterized by excessive passivity and inertia towards events and people (e.g., immobility and mutism), marked reduction in breathing rate, and low blood pressure;
• baclofen (a medicine used as a muscle relaxant);
• caffeine (a substance mainly found in coffee, but also in many energy drinks), because it may reduce the effects of Lorazepam Tecnigen.

Lorazepam Tecnigen and alcohol
Do not drink alcohol while taking Lorazepam Tecnigen, because alcohol increases drowsiness and reduced consciousness caused by this medicine.
This may also severely impair your ability to drive vehicles and operate machinery (see section “Driving and use of machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine must not be taken during pregnancy, especially during the first three months, as it may cause congenital malformations in the fetus.

• If, for serious reasons, you take this medicine at high doses during the last three months of pregnancy, during the period before childbirth (labour), or during delivery, the newborn may show the following symptoms:
  • excessive reduction in motor activity;
  • poor muscle tone;
  • moderate reduction in breathing rate;
  • low body temperature;
  • breathing pauses lasting several seconds (apnea);
  • feeding difficulties;
  • reduced cold tolerance and consequent metabolic disturbances;
  • yellowish/yellow skin and mucous membrane discoloration (jaundice).
• If you take this medicine for a prolonged period during the final stage of pregnancy, the newborn may develop physical dependence or withdrawal symptoms immediately after birth (see section “Development of dependence”).

Breastfeeding
This medicine passes into breast milk. Your doctor will decide whether you can take Lorazepam Tecnigen while breastfeeding.
If you breastfeed while taking this medicine, the newborn may experience drowsiness and reduced ability to suckle breast milk.

Driving and use of machines
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Lorazepam Tecnigen. Lorazepam Tecnigen may also cause amnesia, impaired concentration, and altered muscle function. Your alertness may be impaired, especially if you have not slept long enough after taking Lorazepam Tecnigen.

Lorazepam Tecnigen contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Lorazepam Tecnigen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Lorazepam Tecnigen

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The dose and duration of treatment must be adjusted according to your individual condition. Your doctor will advise you on the appropriate dose, the number of daily administrations, and the duration of treatment with Lorazepam Tecnigen, ensuring that you take the lowest possible dose for the shortest possible time.
Do not change or exceed the prescribed dose. To discontinue treatment, the dose must be gradually reduced under medical supervision. This reduces the risk of withdrawal reactions, which in some cases may be life-threatening (see section 2).
If you need to increase the dose of this medicine, your doctor will advise you on how to do so gradually to avoid undesirable effects. When increasing the dose of Lorazepam Tecnigen, the evening dose should be increased first, followed if necessary by an increase in the morning dose.
Lorazepam Tecnigen must be taken orally.

• Treatment of anxiety
  The recommended duration of treatment should not exceed 8–12 weeks. This period includes the time needed to gradually reduce the dose of Lorazepam Tecnigen before stopping. Your doctor will decide whether treatment can continue beyond the maximum recommended period.
  It is advised not to exceed the maximum daily dose.
  The recommended dose is 2 or 3 tablets of 1 mg per day. In severe cases, the recommended dose is 3 or 4 tablets of 2.5 mg per day.

• Treatment of insomnia
  The recommended duration of treatment ranges from a few days up to a maximum of 4 weeks. This period includes the time required to gradually reduce the dose of Lorazepam Tecnigen before stopping. Your doctor will decide whether treatment can continue beyond the maximum recommended period. It is advised not to exceed the maximum daily dose.
  The recommended dose is 1 or 2 tablets of 1 mg, taken at bedtime.
  In cases of persistent insomnia, the recommended dose is 1 or 2 tablets of 2.5 mg, taken at bedtime.

If you are elderly and/or your general health condition is very weak
The recommended initial dose is 1 mg or 2 mg per day, divided into several doses.
If you suffer from kidney or liver problems (renal or hepatic insufficiency)
Your doctor will determine the most appropriate dose for you on a case-by-case basis and will monitor you frequently.

• Preparation of patients awaiting surgery
  Major surgical procedures: the recommended dose is 2 mg–4 mg of Lorazepam Tecnigen, taken the evening before surgery.
  Minor surgical procedures: the recommended dose is 2 mg–4 mg, taken 1–2 hours before surgery.

Duration of treatment
The duration of treatment is determined by your doctor. You will be prescribed the lowest effective dose for the shortest possible time, as there is a risk of becoming dependent on this medicine. Your doctor will regularly review your treatment.
It is necessary to stop taking this medicine or to reduce the dose gradually and under medical supervision to prevent withdrawal reactions (see section 2).

If you take more Lorazepam Tecnigen than you should
It is important that you never take more medicine than prescribed. Generally, there is no life-threatening risk if you accidentally take a higher dose than prescribed, unless you also consume alcohol or other medicines at the same time.
Symptoms
In mild cases, symptoms may include:

• blurred vision, drowsiness, disorientation, and reduced sensory function;
• difficulty in speaking;
• mental confusion;
• prolonged sleep and reduced response to normal stimuli;
• inability to completely empty the bladder;
• changes in sexual desire.

In more severe cases, such as when large quantities are taken with suicidal intent, or when this medicine is taken together with alcoholic beverages or other medicines that depress consciousness and major brain functions, symptoms may include:

• loss of motor coordination;
• reduced muscle tone;
• low blood pressure;
• excessive drowsiness;
• effects opposite to those expected from this medicine (paradoxical symptoms);
• depression of all functions of the central nervous system;
• reduced heart function;
• reduced breathing;
• coma;
• death.

Treatment
Contact your doctor immediately or go to the nearest emergency department if you take more Lorazepam Tecnigen than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if you are unconscious, gastric lavage will be performed. If these measures are insufficient, activated charcoal may be administered to reduce absorption of Lorazepam Tecnigen, or flumazenil, a medicine that counteracts the effects of Lorazepam Tecnigen.

If you forget to take Lorazepam Tecnigen
If you forget to take a dose, take it as soon as you remember, but only if you are able to rest immediately afterwards for a sufficiently long period (7–8 hours). Do not take a double dose to make up for a missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Lorazepam Tecnigen
Do not stop taking this medicine suddenly unless you suspect a serious side effect, as doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment. If you think you are experiencing a serious side effect, contact your doctor immediately. If you stop taking Lorazepam Tecnigen or suddenly reduce the dose, temporary withdrawal symptoms or rebound symptoms may occur (see section 2).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Normally, side effects occur at the beginning of treatment and generally decrease in intensity or disappear with continuation of treatment or by reducing the dose.
Contact your doctor immediately if you experience any of the following side effects, as treatment with Lorazepam Tecnigen must be discontinued:

• paradoxical reactions (opposite effects to those expected) (see section 2 "Paradoxical disorders"), such as:
  • depression or unmasking of pre-existing depression
  • restlessness
  • agitation
  • irritability
  • aggression
• feelings of disappointment
• anger
• nightmares
• hallucinations
• difficulty in correctly interpreting reality and disturbances in thinking
• behavioural changes
• drowsiness, even during the day
• dizziness
• loss of ability to coordinate movements
• sleep disturbances, insomnia
• confusion
• changes in sexual desire
• anxiety states
• feelings of hostility
• general state of excitement
• sexual excitement
• reduced ability to reach the peak of sexual excitement (orgasm)
• fatigue
• impotence

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat leading to difficulty swallowing and breathing
• difficulty remembering events after taking the medicine (anterograde amnesia). This may also be accompanied by behavioural changes (see section 2 "Memory disturbances")
• drug abuse and physical dependence (see section 2 "Development of tolerance and dependence, withdrawal reactions and drug abuse")
• drug withdrawal symptoms (see section 2 "Development of tolerance and dependence, withdrawal reactions and drug abuse")
• rebound symptoms (see section 2 "Development of tolerance and dependence, withdrawal reactions and drug abuse")
• coma
• suicidal thoughts, suicide attempts
• excessive use of Lorazepam Tecnigen (abuse) or of similar medicines (benzodiazepines)
• severe decrease in white blood cell count, which may increase susceptibility to infections.

Contact your doctor if you experience any of the following side effects:
Common side effects (may affect up to 1 in 10 people):

• muscle weakness

Uncommon side effects (may affect up to 1 in 100 people):

• nausea

Side effects with frequency not known (frequency cannot be estimated from the available data):

• reduction in all blood cells
• decrease in blood platelet count
• hypersensitivity reactions
• condition characterised by excessive secretion of antidiuretic hormone, causing water retention in the body and reduced sodium levels in the blood
• changes in appetite
• decreased sodium levels in the blood
• disinhibition
• disorientation
• euphoria
• reduced capacity to experience emotions
• disturbance of nervous centres controlling instinctive movements, which may cause: tremors, dizziness, difficulty in speech articulation (extrapyramidal symptoms)
• seizures/epileptic fits
• amnesia
• reduced attention and/or reduced concentration ability
• reduced level of alertness
• changes in skin colour, blood pressure, heart rate, salivation and other nervous functions not under voluntary control, as manifestations that may accompany an epileptic seizure
• balance disorders
• sensation of instability
• headache
• visual disturbances such as double vision or blurred vision
• disturbances in eye function
• lowering of body temperature
• reduced blood arterial pressure
• respiratory depression
• temporary suspension of breathing for several seconds (apnoea)
• worsening of pre-existing sleep apnoea before taking the medicine
• worsening of chronic lung diseases with breathing difficulties
• stomach and intestinal problems
• constipation
• allergic skin reactions
• patchy hair loss (alopecia)
• yellow/yellowish discoloration of the skin and mucous membranes (jaundice)
• inability to completely empty the urinary bladder (urinary retention)
• increased blood levels of bilirubin, transaminases and alkaline phosphatase (substances produced by the liver).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lorazepam Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lorazepam Tecnigen contains
One Lorazepam Tecnigen tablet contains 1 mg of lorazepam.
One Lorazepam Tecnigen 2.5 mg tablet contains 2.5 mg of lorazepam.
The other ingredients are: maize starch, microcrystalline cellulose, sodium starch glycolate type A,
magnesium stearate, Ludipress (granules of monohydrate lactose, povidone and crospovidone).
Description of the appearance of Lorazepam Tecnigen and package contents
The tablets are available in PVC/aluminum blisters, pack size of 20 tablets.
Marketing Authorization Holder
Genetic SpA - Via della Monica, 26 - Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)
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