Leaflet: information for the user

Orfidal 1 mg tablets

lorazepam

1.What is Orfidal and for what it is used

1. What you need to know before taking Orfidal
2. How to take Orfidal

4.Possible side effects

5.Storage of Orfidal

6.Contents of the pack and additional information

Orfidal is an anxiolytic (prevents nervousness and anxiety) that acts without influencing normal activities of the individual. It complements antidepressive therapy appropriately and can be combined with antidepressant medications and other psychopharmaceuticals.

Orfidal is used in the following cases:

- Short-term treatment of all states of anxiety and tension, associated or not with functional or organic disorders, including anxiety associated with depression and that linked to surgical and/or diagnostic procedures, and in preanesthesia.

- Sleep disorders.

Do not take Orfidal

• If you are allergic to the active ingredient in benzodiazepines (a group of medications that includes lorazepam) or to any of the other components of this medication (listed in section 6).
• If you have been diagnosed with Myasthenia gravis (an autoimmune neuromuscular disease characterized by very weak or tired muscles).
• If you have severe respiratory insufficiency (difficult breathing or severe chest discomfort).
• If you have sleep apnea (temporary stoppage of breathing while sleeping).
• If you have a severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Orfidal 1 mg tablets.

• If you have liver function impairment.

-If your doctor has prescribed a long-term treatment, it is recommended that they perform periodic blood tests and liver function tests (liver function).

-If you become pregnant during treatment, inform your doctor.

-Do not recommend its use in children under 6 years old.

Children

Benzodiazepines are not recommended for children under 6 years old unless strictly necessary; the duration of treatment should be the minimum possible.

Development of tolerance and dependence, withdrawal reactions and drug/medication abuse

You may experience a reduction in the effectiveness of this medication (tolerance) after continuous use. This medication is recommended for short-term treatments.

The treatment with this medication also increases sensitivity to the effects of alcohol and other medications that affect brain activity. Therefore, consult your doctor if you drink alcohol or are using this type of medication.

The use of benzodiazepines, including Orfidal, can cause dependence. The risk of dependence increases with higher doses and continuous use. It also increases if you have a history of alcohol or drug abuse and in patients with significant personality disorders.

You must inform your doctor if:

-You have taken or are currently taking any drug;

-You regularly consume alcohol, or in the past you have consumed large amounts of alcohol frequently;

-You have had in the past or have in the present a strong desire to take large amounts of medication;

-You have a personality disorder (e.g., difficulty interacting with others or facing certain situations in life, even if you were not always aware of these problems).

In principle, benzodiazepines should only be used for short periods of time and should be discontinued gradually. You and your doctor should agree on how long you will take the medication before starting treatment.

If you stop taking the medication suddenly or reduce the dose quickly, withdrawal reactions may occur. Do not stop taking this medication suddenly. Ask your doctor for advice on how to discontinue treatment.

Some withdrawal reactions can be potentially fatal.

Withdrawal reactions can vary from mild depressive mood and insomnia to a severe syndrome with muscle cramps and abdominal cramps, vomiting, sweating, tremors, and convulsions. The most severe signs and symptoms of withdrawal, including potentially fatal reactions, may include: delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidal tendencies. Seizures/epileptic crises may be more frequent in patients with pre-existing seizure disorders or those taking other medications that lower the seizure threshold, such as antidepressants.

Other withdrawal reactions have also been described: headache, anxiety, restlessness, tension, confusion, and irritability, depressed mood, dizziness,feeling of detachment or alienation from oneself and the world, excessive perception of noise, ringing in the ears, tingling and numbness in the extremities, increased sensitivity to light, noise, and physical contact/changes in perception, involuntary movements, nausea, loss of appetite, diarrhea, panic attacks, muscle pain, states of excitement,exaggerated perception of heartbeats (palpitations), rapid heartbeats (tachycardia), feeling of losing balance, exaggerated reflexes, loss of ability to remember recent events, and increased body temperature.

The symptoms for which you were prescribed this medication may also reappear for a short period of time (rebound phenomenon).

You must not give Orfidal to family members or friends. Keep this medication in a safe place to prevent harm to others.

Amnesia

Benzodiazepines can induce amnesia. This occurs more frequently several hours after administration of the medication, so patients should ensure they sleep uninterrupted for 7-8 hours after taking the tablet.

Psychiatric and paradoxical reactions

In the treatment with benzodiazepines, pre-existing depressions may reappear or the depressive state may worsen. Additionally, the suicidal tendencies of depressed patients may be masked, which should be monitored in these patients.

Other medications and Orfidal

Taking Orfidal with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another medication.

You should be aware that all benzodiazepines produce depressive effects on the CNS (central nervous system) when administered with barbiturates or alcohol.

When Orfidal is taken with other medications that act on the CNS, the combination may make you feel more drowsy than usual. These medications include:

-Medications used to treat mental disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).

• Medications used to relieve strong pain and potent analgesics, medications for substance therapy (treatment of opioid addiction) and some medications for cough (narcotic analgesics and opioids). The use of Orfidal with opioid medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.
• However, if your doctor prescribesOrfidalwith opioids, the dose and duration of concomitant treatment should be limited by your doctor.
• Inform your doctor about all opioid medications you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

-Medications used to treat seizures/epileptic crises (antiepileptic medications).

-Anesthetic medications.

-Barbiturate medications (sedatives).

-Medications used to treat allergies (antihistamines).

Similarly, the concomitant administration of Orfidal with other medications may alter the effect of Orfidal, prolonging or reducing its activity. These medications include:

-Clozapine (treatment of schizophrenia).

-Valproate (treatment of epilepsy and bipolar disorders).

-Probenecid (treatment of gout).

-Theophylline or aminophylline (antiasmatic, bronchodilator medications).

Taking Orfidal with food, drinks, and alcohol

Orfidal can be taken with or without food.

Alcohol increases the sedative effect of this medication, so it is recommended to avoid consuming alcoholic beverages.

Pregnancy, lactation, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy:

Inform your doctor if you are or intend to become pregnant.

The use of benzodiazepines appears to be related to a possible increase in the risk of congenital malformations in the first trimester of pregnancy. Benzodiazepines and their derivatives have been detected passing through the placenta.

If, on medical recommendation, the product is administered during a late stage of pregnancy, or at high doses during delivery, it is predictable that they may appear effects on the newborn such as hyporeactivity, hypothermia (decrease in body temperature), hypotonia (decrease in muscle tone), apnea (period of lack of breathing), moderate respiratory depression, feeding problems, and metabolic response imbalance to stress by cold.

Newborns born to mothers who take benzodiazepines chronically for several weeks of pregnancy or during the last period of pregnancy may develop physical dependence and trigger withdrawal syndrome in the postnatal period.

Lactation

This medication should not be used during lactation, as benzodiazepines are excreted in breast milk. Cases of sedation and inability to breastfeed have been detected in neonates whose mothers were under treatment with benzodiazepines. These newborns should be monitored to detect any of the pharmacological effects mentioned (sedation and irritability).

Older adults and debilitated patients

Older adults and debilitated patients should receive a lower dose, as they are more susceptible to the effects of the medication.

Use in patients with respiratory insufficiency

It is recommended to use lower doses in patients with chronic respiratory insufficiency due to the associated risk of respiratory depression, such as in patients with chronic obstructive pulmonary disease (COPD) or sleep apnea syndrome.

Driving and operating machinery

Orfidal may impair your ability to drive or operate machinery, as it may cause drowsiness, decrease your attention, or decrease your reaction time. The appearance of these effects is more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Orfidal contains lactose

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

The dose and duration of treatment should be adjusted according to your individual situation. Your doctor will advise you on the dose and the number of times a day you should take the medication and the duration of your treatment with Orfidal, so that you take the lowest possible dose for the shortest time possible. Do not change or exceed the dose that has been prescribed for you. To discontinue treatment, the dose should be gradually reduced after consulting with your doctor. This reduces the risk of withdrawal reactions, which can be potentially fatal in some cases (see section2).

Follow exactly the administration instructions indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment. Do not discontinue treatment prematurely, as it may not have the desired effect.

The recommended dose in adults is ½ or 1 tablet (0.5 or 1 mg of lorazepam) 2 to 3 times a day, which means a maximum of 3 mg of lorazepam, administered orally, with or without food.

Treatment duration

Your doctor will determine the duration of treatment. You will be prescribed the most effective dose at the lowest possible dose for the shortest time possible, as you are at risk of becoming addicted (dependent). Your doctor will evaluate your treatment frequently.

Treatment suspension or dose reduction will be made progressively and supervised by your doctor to avoid the appearance of withdrawal reactions (see section2).

If you take more Orfidal than you should

Although benzodiazepine intoxication is very rare, if you have taken more Orfidal than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915 620 420.

The most common symptoms of intoxication are: excessive somnolence, confusion, or coma.

Treatment of overdoseincludes inducing vomiting or gastric lavage, general maintenance measures, adequate respiration, monitoring of vital signs, and proper patient control.Flumazenil may be used as an antidote. In patients taking benzodiazepines chronically, special care should be taken when administering flumazenil, as this association of medications may increase the risk of seizures.

If you forget to takeOrfidal

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withOrfidal

Do not stop taking this medication suddenly unless you suspect a severe adverse effect, as the doses should be gradually reduced. Your doctor will indicate how to discontinue treatment. If you believe you are experiencing a severe adverse effect, speak with your doctor immediately.

If you stop taking Orfidal or reduce the dose suddenly, you may experience withdrawal symptoms or temporary rebound symptoms (see section2).

Upon cessation of administration, the symptoms that led to the use of the medication may reappear, as well as restlessness, muscle pain, anxiety, tension, unease, confusion, and irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, derealization (perception of the immediate environment as unreal or unknown), dizziness, depersonalization (disconnection from reality), involuntary movements, nausea, vomiting, diarrhea, loss of appetite, tremors, abdominal cramps, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia (excessive stimulation), loss of short-term memory, and hyperthermia (increase in the body's internal temperature), so your doctor will indicate precisely how to gradually reduce the dose.

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

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

The following side effects are described according to their frequency of appearance in patients treated:

Very commonAt least 1 in 10 patients

CommonAt least 1 in 100 patients

UncommonAt least 1 in 1,000 patients

RareAt least 1 in 10,000 patients

Very rareLess than 1 in 10,000 patients

Frequency not known Cannot be estimated from available data

Blood and lymphatic system disorders

Frequency not known:Thrombocytopenia (decrease in blood platelets), agranulocytosis (decrease in neutrophils, a type of white blood cell), and pancitopenia (significant decrease in all blood cells).

Immune system disorders

Frequency not known: Hypersensitivity and anaphylactic/anaphylactoid reactions (allergic).

Endocrine disorders

Frequency not known:SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion).

Metabolism and nutrition disorders

Frequency not known:Hyponatremia (low sodium levels).

Mental and behavioral disorders

Common:Confusion, depression, depression unmasking

Uncommon:Change in libido (sex drive), decrease in orgasms.

Frequency not known:Disinhibition, euphoria, suicidal ideas and attempts, paradoxical reactions such as anxiety, agitation, excitement, hostility, aggression, fury, sleep disturbances/insomnia, sexual desire, and hallucinations,drug/medication abuse, drug/medication dependence.

Nervous system disorders

Very common:Feeling of choking.

Common:Ataxia (motor coordination and speech problems), dizziness.

Frequency not known:Extrapyramidal symptoms: tremor, dysarthria (difficulty articulating words), headache, convulsions, amnesia, coma, attention/concentration disturbances, balance disorder.

Eye disorders

Frequency not known:Visual disturbances (double vision and blurred vision).

Ear and labyrinth disorders

Frequency not known:Vestibular disorders.

Circulatory disorders

Frequency not known:Hypotension (low blood pressure).

Respiratory, thoracic, and mediastinal disorders

Frequency not known:Respiratory insufficiency, apnea, worsening of sleep apnea.

Worsening of chronic obstructive pulmonary disease (COPD).

Gastrointestinal disorders

Uncommon:Nausea.

Frequency not known:Constipation.

Hepatobiliary disorders

Frequency not known:Icterus (yellowing of the whites of the eyes and skin).

Skin and subcutaneous tissue disorders

Frequency not known:Angioedema (swelling under the skin of the tongue, glottis, or larynx that can cause respiratory tract obstruction that can be fatal), skin allergic reactions, alopecia (hair loss).

Musculoskeletal and connective tissue disorders

Common:Muscle weakness.

Reproductive and breast disorders

Uncommon:Impotence.

General disorders and administration site conditions

Very common:Feeling of choking.

Common:Asthenia (fatigue, tiredness).

Frequency not known:Hypothermia (decrease in body temperature), withdrawal syndrome.

Investigations

Frequency not known:Increased bilirubin, increased transaminases, and increased alkaline phosphatase (liver enzymes).

As mentioned earlier, withdrawal of the product may cause the reappearance of certain symptoms due to the development of dependence.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Store below 25°C.

Do not use Orfidal after the expiration date shown on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Orfidal

• The active ingredient is lorazepam.
• The other components are: lactose, microcrystalline cellulose, amberlite, and magnesium stearate.

Appearance of the product and content of the packaging

Orfidal is presented in boxes containing 25 or 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Responsible for manufacturing:

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge, Co. Kildare

W12 HX57

Ireland

Pfizer Logo

Last review date of this leaflet: March 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/