ORFIDAL 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Orfidal 1 mg Tablets

lorazepam

Contents of the Package Leaflet:

1. What is Orfidal and what is it used for
   1. What you need to know before taking Orfidal
   2. How to take Orfidal

1. Possible side effects
2. Storage of Orfidal
3. Contents of the pack and other information

1. What is Orfidal and what is it used for

Orfidal is a tranquilizer-anxiolytic (prevents nervousness and anxiety) that acts without influencing the normal activities of the individual. It complements antidepressant therapy and can be combined with antidepressant medications and other psychotropic drugs.

Orfidal is used in the following cases:

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

2. What you need to know before taking Orfidal

Do not take Orfidal

• If you are allergic to the active substance or to any of the other ingredients of this medicine (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 failure (difficult or troublesome breathing).
• If you have sleep apnea (breathing stops for short periods of time while sleeping).
• If you have severe liver disease.

Warnings and precautions

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

• If you have altered liver function.

• If your doctor has prescribed you prolonged treatment, it is advisable to have periodic blood tests and liver function tests.
• If you become pregnant during treatment, you must inform your doctor.
• It is not recommended for use in children under 6 years of age.

Children

Benzodiazepines are not recommended in children under 6 years of age unless strictly necessary; the duration of treatment should be as short as possible.

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

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

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

The use of benzodiazepines, including Orfidal, can lead to 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 drugs;
• you regularly consume alcohol or have frequently consumed large amounts of alcohol in the past;
• you have had or currently have a desire to take large amounts of medication;
• you suffer from a personality disorder (e.g., difficulty interacting with others or facing certain life situations, even if you were not always aware of these problems).

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

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

Some withdrawal reactions can be potentially fatal.

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

Other withdrawal reactions have been described: headache, anxiety, restlessness, tension, confusion, and irritability, depressed mood, dizziness, feeling of detachment or alienation from oneself and the outside world, excessive perception of noise, ringing in the ears, tingling and numbness in the limbs, 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, increased perception of heartbeat (palpitations), faster 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 medicine may also reappear during a brief period (rebound phenomenon).

Do not give Orfidal to family or friends. Keep this medicine in a safe place so that it does not harm others.

Amnesia

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

Psychiatric and paradoxical reactions

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

Other medicines and Orfidal

Taking Orfidal with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

It should be noted that all benzodiazepines produce depressant effects on the central nervous system (CNS), if administered together with barbiturates or alcohol.

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

• Medicines used to treat mental disorders (antipsychotics, neuroleptics, hypnotics, anxiolytics/sedatives, antidepressants).
  • Medicines used to relieve strong pain and potent analgesics, drugs for substitution therapy (treatment of opioid addiction), and some cough medicines (narcotic analgesics and opioids). The use of Orfidal with opioid-type medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.
  • However, if your doctor prescribes Orfidal with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
  • Inform your doctor about all opioid medicines you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family so they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

• Medicines used to treat seizures/epileptic seizures (antiepileptic drugs).
• Anesthetic medicines.
• Barbiturate medicines (sedatives).
• Medicines used to treat allergies (antihistamines).

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

• Clozapine (treatment of schizophrenia).
• Valproate (treatment of epilepsy and bipolar disorders).
• Probenecid (treatment of gout).
• Theophylline or aminophylline (anti-asthmatics, bronchodilators).

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, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

Tell your doctor if you are or plan to become pregnant.

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

If, on medical advice, the product is administered during late pregnancy or at high doses during labor, it is foreseeable that effects on the newborn may appear, such as hypoactivity, 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 from cold.

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

Breastfeeding

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

Elderly and debilitated patients

Elderly and debilitated patients should receive a lower dose since they are more susceptible to the effects of the drug.

Use in patients with respiratory failure

Lower doses are recommended in patients with chronic respiratory failure due to the associated risk of respiratory depression, such as in patients with chronic obstructive pulmonary disease (COPD) or sleep apnea syndrome.

Driving and using machines

Orfidal may alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Orfidal contains lactose

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

3. How to take Orfidal

The dose and duration of treatment should be adjusted to your individual situation. Your doctor will advise you on the dose and number of times a day you should take the medicine and the duration of your treatment with Orfidal, so that you take the lowest possible dose for the shortest possible time. Do not change or exceed the dose that has been prescribed for you. To stop treatment, the dose should be gradually reduced after consulting your doctor. This reduces the risk of withdrawal reactions, which can be potentially fatal in some cases (see section 2).

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 stop treatment before, 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.

Duration of treatment

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

The discontinuation of treatment or reduction of the dose will be done progressively and under the supervision of your doctor to avoid the appearance of withdrawal reactions (see section 2).

If you take more Orfidal than you should

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

The most frequent symptoms of intoxication are: excessive drowsiness, confusion, or coma.

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

If you forget to take Orfidal

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Orfidal

Do not stop taking this medicine suddenly unless you suspect a serious side effect, as the doses should be reduced gradually. Your doctor will indicate how to stop treatment. If you think you are experiencing a serious side effect, talk to your doctor immediately.

If you stop taking Orfidal or reduce the dose suddenly, you may experience withdrawal symptoms or temporary rebound symptoms (see section 2).

When stopping the administration, the symptoms that led you to take the medicine may reappear, as well as restlessness, muscle pain, anxiety, tension, confusion, and irritability, insomnia, lack of concentration, headache, sweating, depression, rebound phenomena, derealization (unreal or unfamiliar perception of the immediate environment), 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 body temperature), so your doctor will indicate precisely how to gradually reduce the dose.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects are described according to their frequency of occurrence in treated patients:

Very common At least 1 in 10 patients

Common At least 1 in 100 patients

Uncommon At least 1 in 1,000 patients

Rare At least 1 in 10,000 patients

Very rare Less than 1 in 10,000 patients

Frequency not known Cannot be estimated from the available data

Disorders of the Blood and Lymphatic System

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

Disorders of the Immune System

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

Endocrine Disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Disorders of Metabolism and Nutrition

Frequency not known: Hyponatremia (lack of sodium).

Psychiatric Disorders

Common: Confusion, depression, unmasking of depression

Uncommon: Change in libido (sexual desire), decreased orgasms.

Frequency not known: Disinhibition, euphoria, suicidal thoughts 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.

Disorders of the Nervous System

Very common: Feeling of suffocation.

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

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

Ocular Disorders

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

Disorders of the Ear and Labyrinth

Frequency not known: Vertigo.

Vascular Disorders

Frequency not known: Hypotension (decrease in blood pressure).

Respiratory, Thoracic, and Mediastinal Disorders

Frequency not known: Respiratory failure, 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: Jaundice (yellowing of the whites of the eyes and skin).

Disorders of the Skin and Subcutaneous Tissue

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

Musculoskeletal and Connective Tissue Disorders

Common: Muscle weakness.

Disorders of the Reproductive System and Breast

Uncommon: Impotence.

General Disorders and Administration Site Conditions

Very common: Feeling of suffocation.

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 previously indicated, withdrawal of the product may cause the reappearance of certain symptoms as a consequence of dependence.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects

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

5. Storage of Orfidal 1 mg Tablets

Keep out of the reach and sight of children.

Store below 25°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Orfidal

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

Appearance of the Product and Package Contents

Orfidal is presented in boxes containing 25 or 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer:

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

Date of the Last Revision of this Prospectus: March 2023

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