PLACINORAL 2 mg TABLETS

1. What Placinoral is and what it is used for

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

Placinoral is indicated:

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

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

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

2. What you need to know before taking Placinoral

Do not take Placinoral:

• if you are allergic to the active ingredient or to any of the other components of this medicine

(including those listed in section 6).

• if you have long-standing breathing difficulties related or not to sleep
• if you have muscle problems
• if you have severe liver problems.

• if you have drug or alcohol dependencies, unless your doctor formally indicates 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 have muscle weakness

• you have other illnesses

• you have allergies

Risk of dependence

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

• the use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients) and will never be recommended to other people.
• do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• consult your doctor regularly so that he can decide whether to continue treatment.

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

After taking Placinoral, it is advisable to ensure that you can rest without being awakened for 7 hours.

Use in elderly patients

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

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

Children

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

Taking Placinoral with other medicines

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

This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

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

Drugs used to relieve strong pain and potent analgesics, drugs for substitution therapy, and some cough medicines. The use of Placinoral together with opioid-type medications increases the risk of drowsiness, breathing difficulties (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 Placinoral together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all the opioid medications you are taking and closely follow your doctor's dose recommendation. It may be helpful to inform friends or family members so that they are aware of the signs and symptoms indicated above. Contact your doctor if you experience any of these symptoms.

Taking Placinoral with food and drinks

During treatment, avoid alcoholic beverages. The effect of alcohol can potentiate sedation, and this can affect the 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 become pregnant. The doctor will then decide whether it is convenient for you to take Placinoral.

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

Driving and using machines

Placinoral may alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease 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 operate machinery if you experience any of these effects.

3. How to take Placinoral

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

Anxiety

Half or one tablet every 12 hours.

At the doctor's discretion, the dosage should be adapted to the symptoms being treated or to the patient's age.

The duration of treatment should be as short as possible. The patient should be reassessed at regular intervals, including the need to continue treatment, especially in those patients who are symptom-free. In general, the total duration of treatment 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 doctor in charge of the patient after weighing the patient's evolution.

Insomnia

Half or one tablet one hour before bedtime.

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

Treatment should be started 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 awakened for at least 7 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

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

Elderly patients should receive lower doses.

A dose reduction should be considered in patients with mild or moderate renal or hepatic insufficiency.

The tablets should be taken with some liquid.

The tablet can be divided into equal doses.

If you take morePlacinoralthan you should

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

If you forget to takePlacinoral

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

If you interrupt treatment withPlacinoral

Treatment with this medicine, like that of similar medicines, can cause dependence on it. Dependence can be physical - which involves the appearance of various symptoms when treatment is withdrawn - or psychological, manifesting as addiction to the medication. This risk increases with the dose and duration of treatment and is also greater in patients with a history of drug or alcohol abuse.

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

When withdrawing treatment, the symptoms that led to its initiation may reappear - in a transitory but more pronounced way. These symptoms can be accompanied by other reactions such as mood changes, anxiety, or sleep disorders and restlessness. Since the probability of these reactions is higher after abruptly stopping treatment, it is recommended to gradually reduce the dose until its definitive suppression.

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

4. Possible side effects

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

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

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

• Anterograde amnesia, i.e., not remembering what happened while awake after taking the medicine, so you should ensure that you can rest for at least 7 hours without being disturbed.

• Very rarely, sudden anxiety, hallucinations, excitement, and sleep disorders. If this happens, consult your doctor immediately.

If you observe any other adverse reaction not described in this leaflet, consult 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 that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Placinoral

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Placinoral

• The active ingredient is Lorazepam, 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 package contents

White, elongated tablets with a score line, packaged in aluminum-PVC blisters.

Box containing 30 or 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Manufacturer:

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Date of the last revision of this leaflet: May 2021

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