Package leaflet: Information for the patient

Control 1 mg tablets, 2.5 mg tablets

lorazepam
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as 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:

What Control is and what it is used for
What you need to know before taking Control
How to take Control
Possible side effects
How to store Control
Contents of the pack and other information

1. What Control is and what it is used for

Control contains the active substance lorazepam, which belongs to a group of medicines called benzodiazepines. It acts on the central nervous system by reducing anxiety (anxiolytic effect), promoting sleep similar to normal sleep (hypnotic effect), improving mood, and reducing the intensity of emotional responses to psychological stress (tranquilizing effect).
Benzodiazepines are indicated only when the condition is severe, disabling, or causes severe distress, and only for short-term treatment.
This medicine is prescribed to treat:

anxiety and symptoms related to anxiety states;
insomnia.

2. What you need to know before taking Control

Do not take Control

if you are allergic to lorazepam, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
if your muscles are always very weak or fatigued (myasthenia gravis);
if you have serious breathing problems (respiratory failure);
if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea syndrome); P. 1 | 13
if you have serious liver problems (hepatic failure);
if you have an eye condition characterized by high eye pressure and visual impairment (narrow-angle glaucoma);
if you are pregnant, planning to become pregnant, or suspect you may be pregnant (see "Pregnancy, breastfeeding and fertility");
if you are breastfeeding (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
The duration of treatment with Control 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 time needed for gradual dose reduction (see section 3 “How to take Control”).
Talk to your doctor or pharmacist before taking Control if:

you have or have ever had breathing problems (chronic respiratory failure, COPD - Chronic Obstructive Pulmonary Disease - or sleep apnea syndrome), 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 interrupted breathing for several seconds during sleep (sleep apnea).

If you have any of these conditions and need to start treatment with Control,
your doctor will schedule regular medical check-ups.

you suffer from or have ever had 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 stop taking lorazepam-containing medicines 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 Control may also cause dependence (see section “Development of dependence”) or personality disorders;
you have breathing problems, or suffer from heart problems (heart failure), or have low blood pressure;
you have or have ever had liver problems (hepatic failure), because this medicine could worsen your condition. Your doctor will recommend the most suitable dosage for your condition;
you have or have ever had kidney problems (renal failure). Your doctor will recommend the most suitable dosage for your condition;
you have a serious brain disease (hepatic encephalopathy);
you suffer from or have ever suffered from depression, because this medicine may worsen your condition and increase suicidal thoughts;
you suffer from 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. Control is not recommended as the primary treatment for this condition.

Memory disturbances
After taking Control, you may experience difficulty remembering events that occurred after
taking the medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after
taking this medicine.
Paradoxical reactions
Control may cause mental reactions and effects opposite to those expected (paradoxical effects) (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, consult your doctor, who will advise you on the correct way to discontinue taking this medicine.
Tolerance development
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance). Control is recommended for short-term treatment only.
In addition, treatment with this medicine increases sensitivity to the effects of alcohol and other medicines that depress brain function. Therefore, when taking Control, the simultaneous intake of alcohol and such medicines should be avoided or reduced.
Dependence development
The use of benzodiazepines, including Control, may lead to dependence, which may manifest as an increasing need, desire, or excessive urge to take the medicine (psychological dependence), or the development of physical symptoms that decrease or disappear only after taking the medicine (physical dependence). The likelihood of developing psychological and physical dependence on this medicine increases with higher doses and longer treatment duration.
You are more likely to develop dependence on Control if:

you have previously or currently used drugs;
you have previously or currently consumed alcohol frequently and/or in large quantities;
you have previously or currently had a desire to take medicines in excessive amounts;
you suffer from 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.

If treatment with Control is abruptly stopped after dependence has developed, you may experience withdrawal symptoms such as:

severe symptoms (more likely after long-term use of Control at high doses): feeling detached or estranged from oneself or the external world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise, and physical touch, hallucinations, delirium, epileptic seizures, convulsions.
Epileptic seizures and convulsions may occur more easily if you are taking antidepressant medicines together with Control;
other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability, dizziness, nausea, diarrhea, loss of appetite, mood changes with a tendency toward sadness, depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary body movements, vomiting, tingling sensations, altered perception, abdominal and muscle cramps, tremor, agitation, heightened awareness of heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, vertigo, exaggerated reflexes, inability to remember recent events, significant increase in body temperature;
rebound symptoms: insomnia and anxiety. These symptoms are the same ones for which you were advised to take Control, but if treatment is abruptly stopped, they may temporarily reappear in a more severe form than before starting treatment with this medicine. In addition, you may experience mood changes, restlessness, anxiety, and sleep disturbances.

Do not stop taking Control suddenly. Consult your doctor or pharmacist, who will advise you on the correct way to discontinue treatment with this medicine (see section 3 “If you stop taking Control”).
If you are elderly, debilitated, and/or suffer from specific health conditions
If you are elderly or debilitated (your general health condition is very weak), the effects of benzodiazepines, such as lorazepam contained in this medicine, may increase the risk of falls due to inability to perform coordinated movements (ataxia), muscle weakness, feeling of instability, drowsiness, fatigue (see “Use in elderly or debilitated patients”).
If you suffer from significant brain diseases (you have vascular lesions, especially cerebral arteriosclerosis), you are more sensitive to the effects of Control.
If you suffer from low blood pressure, this medicine may cause an increase in episodes of low blood pressure.
Therefore, it is recommended to use this medicine at the lowest possible dose or to avoid its use altogether.
If you have severe liver problems.
If you suffer from severe liver problems, with or without neurological symptoms such as mental confusion, altered level of consciousness, or coma, Control must not be used because it could worsen your condition (see also section 2 “Do not take Control”).
Children and adolescents
The efficacy and safety of Control in children under 12 years of age are unknown.
This medicine should not be used in children unless strictly necessary and under medical supervision. The duration of treatment will be determined by the doctor and should be as short as possible.
Other medicines and Control
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Control with the following medicines unless prescribed by your doctor:

Medicines that cause strong reduction of all brain functions, such as:
other medicines acting on the central nervous system, such as neuroleptics (used to treat psychiatric disorders), hypnotics (used to treat insomnia), anxiolytics/sedatives or barbiturates (used to treat anxiety), antidepressants (used to treat depression), antiepileptics such as phenobarbital or hydantoin (used to treat epilepsy), anesthetics (used for anesthesia), as they may enhance the effects of this medicine; taking these substances together with lorazepam should be avoided;
antihistamines (used to treat allergies), as they may enhance the effects of this medicine;
narcotic analgesics (used for pain), as they may cause euphoria and increase the risk of dependence;
Control, when administered together with anesthetic medicines, may cause euphoria, increasing the likelihood of developing psychological dependence;
the concomitant use of Control 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 has prescribed Control together with opioids, the dose and duration of concomitant therapy must be limited by the doctor. Inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s recommendations regarding the prescribed dose. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if such symptoms occur;
clozapine (used to treat schizophrenia), as it may cause strong sedation, excessive salivation, and loss of movement coordination (ataxia);
valproate (used to treat epilepsy), as it increases the amount of Control in the blood. If concomitant use is necessary, your doctor will reduce the dose of lorazepam you must take by half;
probenecid (used to treat gout), as it may enhance the effects of this medicine. If concomitant use is necessary, your doctor will reduce the dose of lorazepam you must take by half;
cisapride (used to treat gastroesophageal reflux), as it may enhance the effects of this medicine;
lofexidine (used to control opioid withdrawal symptoms), as it may enhance the effects of this medicine;
nabilone (used to treat nausea and vomiting during chemotherapy), as it may enhance the effects of this medicine;
disulfiram (used in the treatment of alcoholism), as it may enhance the effects of this medicine;
muscle relaxants, such as baclofen or tizanidine (used to reduce muscle spasms causing pain), as they may enhance the effects of this medicine;
sodium oxybate (used to treat narcolepsy), as its effect may be increased by concomitant intake of lorazepam;
theophylline or aminophylline (used to treat asthma), as they reduce the effects of this medicine;
loxapine (mainly used in the treatment of schizophrenia), as together with Control it may cause excessive loss of cognitive functions (stupor), a state characterized by excessive passivity and inertia toward events and people (e.g., inability to move and mutism), reduced breathing rate, and low blood pressure (hypotension).
caffeine (a substance mainly contained in coffee, but also in many energy drinks), as it may reduce the effects of Control.

Substances that affect liver enzymes (particularly cytochrome P450) may also increase benzodiazepine activity; however, unlike many other benzodiazepines, pharmacokinetic interactions between the P450 system and Control have not been demonstrated.
Control with food, drinks, and alcohol
Do not drink alcohol while taking Control 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 using machines”).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
This medicine must not be taken during pregnancy, especially during the first 3 months, because it may cause congenital malformations in the fetus.
If you take this medicine during the late stages of pregnancy or during labor, the newborn may have lower body temperature (hypothermia) with resulting metabolic disturbances, muscle weakness (hypotonia), markedly reduced motor activity, breathing difficulties (moderate respiratory depression), breathing pauses lasting several seconds (apnea), feeding difficulties, or yellowish discoloration of the skin and eyes due to increased bilirubin (neonatal jaundice).
If you have regularly taken this medicine during the late stages of pregnancy, your baby may develop physical dependence or withdrawal symptoms after birth (see section “Development of dependence”).
Breastfeeding
Do not take this medicine if you are breastfeeding. The lorazepam contained in this medicine passes into breast milk and may cause sedation and inability to suckle in the infant.
Fertility
If you are a woman of childbearing age, you should contact your doctor both if you plan to become pregnant and if you suspect you are pregnant, regarding discontinuation of the medicine.
Driving and using machines
This medicine may cause deep relaxation (sedation), memory loss (amnesia), may affect your ability to concentrate and control muscles, and may cause dizziness and visual disturbances. All these effects may impair your ability to drive vehicles or operate machinery.
Avoid driving even if your sleep duration is insufficient (less than 7–8 hours of uninterrupted sleep), as you are likely to be less alert.
Control contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Control

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Depending on your condition and illness, your doctor will advise you on the appropriate dose, how many times a day to take the medicine, and the duration of treatment with Control, so that you take the lowest possible dose for the shortest possible time.
If you need to increase the dose of this medicine, your doctor will advise you on how to do so gradually to avoid unwanted effects. When increasing the dose of Control, the evening dose should be increased first, followed, if necessary, by an increase in the morning dose.

Treatment of anxiety
Treatment should be as short as possible. Your doctor will regularly monitor your condition.
The recommended dose is 1 tablet of 1 mg, or ½ - 1 tablet of 2.5 mg, 1 - 3 times daily.
The duration of treatment generally should not exceed 8 - 12 weeks, including a period of gradual discontinuation. In certain cases, your doctor may decide to extend the treatment after evaluating your health status.

Treatment of insomnia
The duration of treatment should be as short as possible.
The recommended dose is 1 - 2.5 mg.
It is recommended to take the medicine in the evening, before going to bed.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
The duration of treatment generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation.
In certain cases, your doctor may decide to extend the treatment after evaluating your health status.

Method of administration
The tablets can be taken at any time of day, regardless of meals.
The evening dose should be increased before the daytime dose.

Use in elderly or debilitated patients
In elderly patients and in debilitated patients, your doctor will consider administering a reduced dose.

Use in patients with kidney or liver problems
In patients with severe kidney or liver problems (renal or hepatic insufficiency), your doctor will evaluate whether a reduced dose is necessary and will subject you to frequent monitoring.

If you take more Control than you should
If you take a dose of Control higher than prescribed, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine’s packaging with you, even if empty.
Symptoms of overdose, in mild cases, may include:

blurred vision, drowsiness, disorientation, and reduced sensory function;
speech articulation disorders;
mental confusion;
continuous 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 reduce consciousness and major brain functions, symptoms may include:

loss of ability to coordinate movements;
reduced muscle tone;
low blood pressure;
excessive drowsiness;
paradoxical reactions opposite to the expected effects of this medicine (paradoxical symptoms);
reduced function of the central nervous system;
reduced heart function;
reduced breathing;
coma;
death.

Contact your doctor immediately or go to the nearest emergency department if you take more Control 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 the absorption of Control, or flumazenil, a medicine that counteracts the effects of Control.

If you forget to take Control
Do not take a double dose to make up for a missed tablet.
If you forget to take a dose, take it as soon as you remember, but ensure that you can rest immediately afterwards for a sufficient period (7–8 hours).
If you think you have missed more than one dose, consult your doctor.

If you stop taking Control

At the end of treatment with this medicine, your doctor will decide whether you need to continue therapy.
The dose and frequency of administration of this medicine should be gradually reduced before stopping treatment. This allows your body to adapt to the absence of the medicine and reduces the risk of unpleasant effects when stopping treatment. Your doctor will advise you on how to do this.
Do not stop treatment abruptly, otherwise the symptoms for which you were being treated may return even more intensely than before (rebound insomnia and anxiety) (see also “Development of dependence”). When stopping treatment, you may experience withdrawal symptoms such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, depressed and nervous mood (dysphoria), dizziness, nausea, diarrhea, and loss of appetite. In more severe cases, the following symptoms may occur: loss of sense of reality (derealization), altered perception of self (depersonalization), increased sensitivity to sound (hyperacusis), numbness or tingling sensations in hands and feet, increased sensitivity to light, noise, and physical contact, hallucinations up to delirium, epileptic seizures or convulsions (violent, involuntary muscle contractions). Other symptoms include: depression, insomnia, sweating, ringing in the ears (tinnitus), involuntary movements, vomiting, widespread tingling (paresthesia), altered perceptions (perceptual disturbances), abdominal and muscle pain (abdominal and muscular cramps), tremor, muscle pain (myalgia), agitation, awareness of heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, balance disorders (dizziness), exaggerated muscle reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).
Even the insomnia or anxiety that required treatment with this medicine may reappear in a more severe form (rebound phenomena with mood changes, anxiety, restlessness, or sleep disturbances). If you experience these symptoms, consult your doctor.
If you suffer from epilepsy or convulsions, or are taking medicines for depression (antidepressants), be cautious, as your risk of experiencing seizures when stopping treatment with this medicine is higher.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

paradoxical reactions (opposite to expected effects) (see section 2 "Paradoxical disturbances"), such as:
depression or unmasking of pre-existing depression
restlessness
agitation
irritability
aggression
feelings of disappointment
anger
nightmares
hallucinations
difficulty correctly interpreting reality and thought disturbances
behavioral 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 behavioral changes (see section 2 "Memory disturbances")
physical dependence on the medicine (see section 2 "Development of dependence")
psychological dependence on the medicine (see section 2 "Development of dependence")
withdrawal symptoms (see section 2 "Development of dependence")
rebound symptoms (see section 2 "Development of dependence")
coma
suicidal thoughts, suicide attempts
excessive use of Control (abuse) or of other similar medicines (benzodiazepines)
severe decrease in the number of white blood cells in the blood, which may increase susceptibility to infections.

If the dose is incorrect, an excessive state of "calm" (sedation) and excessive muscle relaxation may occur, manifesting as the following side effects:

drowsiness, loss of emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, inability to perform coordinated movements (ataxia), double vision (diplopia). These effects are more frequent at the beginning of treatment and tend to disappear as therapy continues.

Side effects may be:

Very common (may affect more than 1 in 10 people)

daytime drowsiness and excessive calm (sedation), fatigue.

Common (may affect up to 1 in 10 people)

tremors, dizziness, confusion
muscle weakness, loss of energy (asthenia)
loss of ability to coordinate movements
depression and unmasking of pre-existing depressive state

Uncommon (may affect up to 1 in 100 people)

nausea
changes in libido including alterations

Rare (may affect up to 1 in 1,000 people)

loss of emotions, disinhibition, euphoria, sleep disturbances, decreased orgasm;
headache, reduced alertness, difficulty in speech articulation (dysarthria), loss of recent memory (transient anterograde amnesia) or memory disturbances;
visual disturbances, double vision (diplopia), blurred vision;
reduced blood pressure (hypotension);
respiratory problems (respiratory depression, apnea, worsening of nocturnal apnea, worsening of obstructive lung disease);
constipation, altered salivation;
increased bilirubin, yellowing of the skin and eyes (jaundice), increased liver enzymes (transaminases and alkaline phosphatase);
skin allergic reactions (allergic dermatitis), hair loss (alopecia);
reduced sexual potency in men (impotence).

Very rare (may affect up to 1 in 10,000 people)

changes in the number of certain blood cells (thrombocytopenia, leucopenia, agranulocytosis, pancytopenia);
generalized allergic reactions (hypersensitivity including anaphylaxis and anaphylactoid reactions);
a hormonal disorder called SIADH (syndrome of inappropriate antidiuretic hormone secretion);
decreased sodium levels in the blood (hyponatremia);
extrapyramidal symptoms, coma;
excessive decrease in body temperature (hypothermia).

Not known (frequency cannot be estimated from available data)

dependence, withdrawal syndrome, suicide attempts, behavioral changes;
agitation, aggression, anger, nightmares, hallucinations, disappointment, irritability, restlessness;
disorientation;
reduced ability to experience emotions;
seizures/epileptic fits;
changes in skin color, blood pressure, heart rate, salivation, and other autonomic nervous functions not under voluntary control, as manifestations that may accompany an epileptic seizure;
reduced attention and/or reduced concentration ability;
balance disturbances;
sensation of instability;
stomach and intestinal problems;
inability to completely empty the bladder (urinary retention);
changes in appetite
Angioedema, dermatological symptoms including even very severe reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist.
You may also report side effects directly via the website:
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 Control

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
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 Control contains
Control 1 mg tablets

The active substance is lorazepam. Each tablet contains 1 mg of lorazepam.
The other components are microcrystalline cellulose, monohydrate lactose, maize starch, magnesium stearate, amberlite IRP 88.

Control 2.5 mg tablets

The active substance is lorazepam. Each tablet contains 2.5 mg of lorazepam.
The other components are microcrystalline cellulose, monohydrate lactose, maize starch, magnesium stearate, amberlite IRP 88.

Description of the appearance of Control and package contents
Control 1 mg tablets are supplied in a pack containing two blisters in PVC/Aluminum, each blister containing 15 tablets. Pack size: 30 tablets.
Control 2.5 mg tablets are supplied in a pack containing two blisters in PVC/Aluminum, each blister containing 10 tablets. Pack size: 20 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)