Orfidal 1 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orfidal 1 mg tablets

lorazepam

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Orfidal is and what it is used for

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

2. Possible side effects

3. Storage of Orfidal

4. Contents of the pack and other information

1. What Orfidal is and what it is used for

Orfidal is a tranquilizer-anxiolytic (prevents nervousness and anxiety) that acts without interfering with the individual's normal activities. It appropriately 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, whether associated or not with functional or organic disorders, including anxiety associated with depression, anxiety related to surgical and/or diagnostic procedures, and 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, to benzodiazepines (a group of medicines to which lorazepam belongs), 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 fatigued muscles).
• If you have severe respiratory insufficiency (difficulty breathing or severe chest discomfort).
• If you have sleep apnea (temporary cessation of breathing during sleep).
• If you have a severe liver disease.

Warnings and precautions

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

• If you have impaired liver function.
• If your doctor has prescribed a long-term treatment, periodic blood tests and liver function tests are advisable.
• If you become pregnant during treatment, inform your doctor immediately.
• Use in children under 6 years of age is not recommended.

Children

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

Tolerance development, dependence, withdrawal reactions, and drug/medication abuse

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

Treatment with this medicine may also increase sensitivity to the effects of alcohol and other medicines affecting brain activity. Therefore, consult your doctor if you consume alcohol or are using such medicines.

The use of benzodiazepines, including Orfidal, may lead to dependence. The risk of dependence increases with higher doses and prolonged use. The risk is also higher in individuals with a history of alcohol or drug/medication abuse, and in patients with significant personality disorders.

You should inform your doctor if:

• you have taken or are currently taking any drugs;
• you regularly consume alcohol, or in the past frequently consumed large amounts of alcohol;
• you have previously or currently have urges to take large amounts of medication;
• you suffer from a personality disorder (e.g., difficulty interacting with others or coping with 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 the duration of treatment before starting.

If you stop taking the medicine suddenly or reduce the dose too quickly, withdrawal reactions may occur. Do not stop taking this medicine abruptly. Seek medical advice on how to discontinue treatment.

Some withdrawal reactions can potentially be life-threatening.

Withdrawal reactions may range from mild depression and insomnia to a severe syndrome including muscle and abdominal cramps, vomiting, sweating, tremors, and seizures. The most severe withdrawal signs and 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 also been reported: headache, anxiety, restlessness, tension, confusion, irritability, depressed mood, dizziness, feelings of detachment or alienation from oneself and the external world, heightened sensitivity to noise, tinnitus (ringing in the ears), tingling and numbness in the extremities, increased sensitivity to light, noise, and physical touch/perceptual changes, involuntary movements, nausea, loss of appetite, diarrhea, panic attacks, muscle pain, states of excitement, increased awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), sensation of losing balance, exaggerated reflexes, inability to recall recent events, and increased body temperature.

The symptoms for which this medicine was prescribed may also reappear briefly (rebound phenomenon).

Do not give Orfidal to family members or friends. Keep this medicine in a safe place to prevent harm to others.

Amnesia

Benzodiazepines may cause amnesia. This is more likely to occur several hours after taking the medicine; therefore, to reduce the associated risk, patients should ensure uninterrupted sleep of 7–8 hours after taking the tablet.

Psychiatric and paradoxical reactions

In treatment with benzodiazepines, pre-existing depression may reappear or worsen. Additionally, suicidal tendencies in depressed patients may be masked and should therefore be closely monitored.

Other medicines and Orfidal

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

It should be noted that all benzodiazepines produce central nervous system (CNS) depressant effects, especially when taken 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 usual. These medicines include:

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

  • Medicines used to relieve severe pain and strong analgesics, medicines for substitution therapy (treatment of opioid addiction), and some cough medicines (narcotic analgesics and opioids). The use of Orfidal together with opioid-type medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are available.
  • However, if your doctor prescribes Orfidal together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
  • Inform your doctor about all opioid medicines you are taking and closely follow your doctor’s dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• Medicines used to treat seizures/epileptic attacks (antiepileptic medicines).

• Anaesthetic medicines.

• Barbiturates (sedatives).

• Medicines used to treat allergies (antihistamines).

Likewise, 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-asthmatic, bronchodilators).

Taking Orfidal with food, drinks, and alcohol

Orfidal can be taken with or without food.

Alcohol enhances the sedative effect of this medicine; therefore, consumption of alcoholic beverages should be avoided.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

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

The use of benzodiazepines appears to be associated with a possible increased risk of congenital malformations during the first trimester of pregnancy. Passage of benzodiazepines and their metabolites across the placenta has been detected.

If, on medical advice, the product is administered during late pregnancy or at high doses during labor, effects on the newborn may be expected, such as hypoactivity, hypothermia (decreased body temperature), hypotonia (reduced muscle tone), apnea (periods of no breathing), moderate respiratory depression, feeding difficulties, and impaired metabolic response to cold stress.

Infants born to mothers who have chronically taken benzodiazepines for several weeks during pregnancy or during the final stages of pregnancy may develop physical dependence and experience 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 suckle have been reported in neonates whose mothers were being treated with benzodiazepines. These newborns should be monitored for any of the pharmacological effects mentioned (sedation and irritability).

Elderly and debilitated patients

Elderly and debilitated patients should receive a lower dose, as they are more susceptible to the drug's effects.

Use in patients with respiratory insufficiency

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

Driving and using machines

Orfidal may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce attention, or impair reaction capacity. These effects are 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 medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Orfidal

The dosage and duration of treatment should be adjusted according to your individual condition. Your doctor will advise you on the dose, how many times a day you should take the medicine, and how long you should continue treatment with Orfidal, so 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 should be gradually reduced after consulting your doctor. This reduces the risk of withdrawal reactions, which may be potentially fatal in some cases (see section 2).

Always follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the duration of your treatment. Do not stop treatment prematurely, as this may prevent the desired effect from being achieved.

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

Duration of treatment

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

Discontinuation of treatment or dose reduction must be done gradually and under medical supervision to avoid withdrawal reactions (see section 2).

If you take more Orfidal than you should

Although benzodiazepine poisoning is very rare, if you have taken more Orfidal than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420.

The most common symptoms of overdose are: excessive drowsiness, confusion, or coma.

Treatment of overdose includes inducing vomiting or gastric lavage, general supportive measures, adequate respiration, monitoring of vital signs, and appropriate patient management. Flumazenil may be used as an antidote. Special caution should be exercised when administering flumazenil to patients who have been taking benzodiazepines chronically, as this combination may increase the risk of seizures.

If you forget to take Orfidal

Do not take a double dose to make up for a missed dose.

If you interrupt treatment with Orfidal

Do not stop taking this medicine suddenly unless you suspect a serious adverse reaction, as doses must be gradually reduced. Your doctor will advise you on how to discontinue treatment. If you think you are experiencing a serious adverse reaction, speak 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 treatment, the symptoms that led you to start taking the medicine may reappear, along with restlessness, muscle pain, anxiety, tension, agitation, confusion, irritability, insomnia, difficulty concentrating, headache, sweating, depression, rebound phenomena, derealization (unreal or unfamiliar perception of your immediate environment), dizziness, depersonalization (detachment from reality), involuntary movements, nausea, vomiting, diarrhea, loss of appetite, tremor, abdominal cramps, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia (excessive stimulation), short-term memory loss, and hyperthermia (increased internal body temperature), which is why your doctor will give you precise instructions on how to gradually reduce the dose.

If you have any further 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 everyone will experience them.

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

Very common: Affects at least 1 in 10 patients
Common: Affects at least 1 in 100 patients
Uncommon: Affects at least 1 in 1,000 patients
Rare: Affects at least 1 in 10,000 patients
Very rare: Affects less than 1 in 10,000 patients
Frequency not known: Cannot be estimated from the available data

Blood and lymphatic system disorders

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

Immune system disorders

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

Endocrine disorders

Frequency not known: Syndrome of inappropriate antidiuretic hormone secretion.

Metabolism and nutrition disorders

Frequency not known: Hyponatremia (sodium deficiency).

Psychiatric disorders

Frequent: Confusion, depression, unmasking of depression.

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

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

Nervous system disorders

Very frequent: Sensation of breathlessness.

Frequent: Ataxia (motor incoordination and speech difficulties), dizziness.

Frequency not known: Extrapyramidal symptoms: tremor, dysarthria (difficulty articulating words), headache, seizures, 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: 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 (yellowish discoloration 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 may cause airway obstruction which can be fatal), skin allergic reactions, alopecia (hair loss).

Musculoskeletal and connective tissue disorders

Frequent: Muscle weakness.

Reproductive system and breast disorders

Uncommon: Impotence.

General disorders and administration site conditions

Very frequent: Sensation of breathlessness.

Frequent: 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 indicated above, discontinuation of the product may lead to the recurrence of certain symptoms due to dependence development.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide 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 expiry date stated on the container, after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orfidal

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

Appearance of the product and contents of the pack

Orfidal is available in packs 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 most recent review of this leaflet: March 2023

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