Prospecto:information for the user

PLACINORAL 2 mg tablets

Lorazepam, pivalate

1.What is Placinoral and for what it is used

2.What you need to knowbeforestarting to take Placinoral

3.How to take Placinoral

4.Possible adverse effects

5.Storage of Placinoral

6.Contents of the package and additional information

Placinoral is a tranquilizer belonging to the group of short-acting benzodiazepines containing lorazepam pivalate as the active ingredient.

Placinoral is indicated for:

• the treatment of anxiety states, manifested as restlessness, fear, irritability, palpitations, sensation of suffocation, etc. In these cases, treatment usually does not need to last more than eight weeks.

• sleep rhythm disorders and all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after a premature awakening. In most cases, only a short-term treatment with Placinoral is needed (in general, it should not exceed two weeks).

Treatment should start with the lowest dose. The maximum dose should not be exceeded.

Do not take Placinoral:

-if you are allergic to the active ingredient or any of the other components of this medication

(listed in section 6).

• if you have respiratory difficultiesrelated or not to sleepfor a long time
• if you suffer from muscle problems
• if you suffer from severe liver problems.

• if you are dependent on drugs or alcohol, unless your doctor has formally indicated it. If you have any doubts, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Placinoral if:

• you have any liver or kidney disorder

• you suffer from muscle weakness

• you have other diseases

• you have allergies

Risk of dependence

The use of benzodiazepines can lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• benzodiazepines should be taken only under medical prescription (never because they have worked for other patients) and should never be recommended to others.
• do not increase the prescribed doses, or prolong the treatment longer than recommended.
• consult your doctor regularly to decide if the treatment should continue.

After stopping the administration, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to stop the medication abruptly, but to gradually reduce the dose, according to the doctor's instructions.

After taking Placinoral, it is advisable to ensure that you can sleep without being woken up for 7 hours.

Use in elderly patients

Elderly patients may be affected by Placinoral more than young patients. If you are an elderly patient, your doctor may prescribe a lower dose and check your response to the treatment. Please follow your doctor's instructions carefully.

If you have any liver or kidney disorder, or suffer from muscle weakness, your doctor will decide whether to take a lower dose of Placinoral or not to take it at all.

Children

The efficacy and safety of the medication have not been established in pediatric populations. Its use is not recommended in children.

Placinoral with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is extremely important because the simultaneous use of multiple medications can increase or decrease their effect.

Therefore, do not take other medications at the same time as Placinoral unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can reinforce the effect of Placinoral.

Strong painkillers and potent analgesics, medications for substitution therapy, and some cough medications. The use of Placinoral with opioid-type medications increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Placinoral with 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 dosage recommendation 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.

Placinoral with food and drinks

Avoid alcoholic beverages during treatment. The effect of alcohol can potentiate sedation, and this can affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

Before starting treatment, your doctor should know if you are or suspect you are pregnant, or if you want to be. The doctor will then decide whether to take Placinoral.

Benzodiazepines are excreted in breast milk, so you should consult your doctor about taking Placinoral while breastfeeding.

Driving and operating machinery

Placinoral may affect your ability to drive or operate machinery, as it can cause drowsiness, decrease attention, or decrease 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.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.Consult your doctor or pharmacist in case of doubt.

Anxiety

Take one to two tablets every 12 hours.

The dosage should be adjusted according to the symptoms being treated or the patient's age.

The treatment duration should be as short as possible. The patient should be reevaluated at regular intervals, including the need to continue treatment, especially in patients who are symptom-free. In general, the total treatment duration should not exceed 8-12 weeks, including gradual withdrawal.

In certain cases, it may be necessary to prolong treatment beyond the recommended period; this decision can only be made by the patient's doctor after weighing the patient's progress.

Insomnia

Take one to two tablets one hour before bedtime.

The treatment duration should be as short as possible. In general, the treatment duration can vary from a few days to two weeks, with a maximum duration of four weeks if gradual withdrawal is included.

Treatment should start with the lowest recommended dose. No more than two tablets should be taken per day.

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking Placinoral, and it is advisable to ensure that you can rest without being woken up for at least 7 hours. Otherwise, although this occurs in rare cases, it is possible that you may not remember what happened while you were awake.

To avoid withdrawal symptoms, do not stop taking Placinoral abruptly, especially if you have been taking it for a long time.

Elderly patients should receive lower doses.

Consider reducing the dose in patients with mild or moderate renal or hepatic insufficiency.

Tablets should be taken with a small amount of liquid.

The tablet can be divided into equal doses.

If you take more Placinoral than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Placinoral

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

If you interrupt treatment with Placinoral

Treatment with this medication, like other similar medications, may cause dependence on the medication. Dependence can be physical, leading to various symptoms when treatment is discontinued, or psychological, manifesting as addiction to the medication. This risk increases with the dose and duration of treatment and is also higher in patients with a history of drug or alcohol abuse.

If treatment is discontinued abruptly, dependence may manifest as symptoms such as headaches, muscle pain, anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms have been described: feelings of strangeness towards oneself, abnormal sharpness of hearing, tingling and cramps in the extremities, intolerance to light, sounds, and physical contact, hallucinations, or convulsions.

When treatment is discontinued, the symptoms that led to the initiation of treatment may appear - in a transient but more pronounced manner. These symptoms may be accompanied by other reactions such as mood changes, anxiety, or sleep and restlessness disorders. Since the probability of these reactions occurring is higher after abrupt treatment discontinuation, it is recommended to gradually reduce the dose until its definitive suppression.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

In addition to the beneficial effects of Placinoral, undesirable effects may occur, even when the medication is used properly. Most patients tolerate it well, but some may present the following adverse effects:

- Fatigue or drowsiness during the day, especially at the beginning of treatment.

-Anterograde Amnesia, that is, they may not remember what happened while they were awake after taking the medication, therefore they should ensure that they can rest for at least 7 hours without being disturbed.

- Sudden anxiety, hallucinations, excitement, and sleep disorders occur very rarely. If this happens, consult your doctor immediately.

If you observe any other adverse reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting Adverse Effects

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

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Placinoral

• The active ingredient isLorazepam, pivalate. Each tablet contains 2 mg of Lorazepam, pivalate.
• The other components are: mannitol (E421), hydroxypropylcellulose (E463), cornstarch, polyvinylpyrrolidone (E1201), magnesium stearate and microcrystalline cellulose (E460i).

Appearance of the product and content of the packaging

White, scored, elongated tablets, packaged in aluminum-PVC blisters.

Box containing 30 or 60 tablets.

Marketing authorization holder and manufacturer responsible

Marketing Authorization Holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer Responsible:

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet: May 2021

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