Placinoral 2 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PLACINORAL 2 mg tablets

Lorazepam, pivalate

Package leaflet contents

1. What Placinoral is and what it is used for
2. What you need to know before taking Placinoral
3. How to take Placinoral
4. Possible side effects
5. Storage of Placinoral
6. Contents of the pack and other information

1. What Placinoral is and what it is used for

Placinoral is a short-acting anxiolytic belonging to the benzodiazepine group and contains the active substance lorazepam pivalate.

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 longer than eight weeks.

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

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

2. What you need to know before starting Placinoral

Do not take Placinoral:

• if you are allergic to the active substance or to any of the other components of this medicine
  (listed in section 6).

• if you have long-term breathing difficulties with or without sleep-related symptoms

• if you suffer from muscle disorders

• if you have severe liver problems

• if you have drug or alcohol dependence, unless formally instructed by your doctor. If you have any doubts about this, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting Placinoral if:

• you have any liver or kidney disorder
• you suffer from muscle weakness
• you have other medical conditions
• you have allergies

Risk of dependence

The use of benzodiazepines may 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 observed:

• Benzodiazepines should only be taken under medical prescription (never because they have worked in other patients), and should never be recommended to other people.
• Do not increase the prescribed dose in any way, nor extend treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether treatment should continue.

When stopping administration, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flashes may occur. Generally, it is not recommended to abruptly stop the medication; instead, the dose should be gradually reduced according to your doctor's instructions.

After taking Placinoral, it is advisable to ensure you will be able to rest undisturbed for 7 hours.

Use in elderly patients

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

If you have any liver or kidney disorders, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of Placinoral or avoid it altogether.

Children

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

Taking Placinoral with other medicines

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

This is extremely important because taking more than one medicine simultaneously may increase or decrease their effects.

Therefore, you should not take other medications at the same time as Placinoral unless your doctor is aware and has approved it beforehand. For example, tranquilizers, sleep-inducing agents, and similar medicines act on the brain and nerves and may enhance the effect of Placinoral.

Medicines used to relieve severe pain and strong analgesics, medications for substitution therapy, and some cough medicines. The use of Placinoral together with opioid-type medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Placinoral 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 dosage 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.

Taking Placinoral with food and drinks

During treatment, avoid alcoholic beverages. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further information on this point, consult your doctor.

Pregnancy, breastfeeding, and fertility

Before starting treatment, your doctor must know whether you are pregnant or suspect you are pregnant, or if you intend to become pregnant. Your doctor will then decide whether it is appropriate for you to take Placinoral.

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

Driving and using machines

Placinoral may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or decreased 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.

3. How to take Placinoral

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

Anxiety

Half or one tablet every 12 hours.

At the physician's discretion, the dosage should be adjusted according to the symptoms being treated or 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 patients who are symptom-free. In general, the total duration of treatment should not exceed 8–12 weeks, including gradual withdrawal of the medication.

In certain cases, it may be necessary to extend treatment beyond the recommended period; such a decision may only be made by the physician in charge of the patient after careful evaluation of the patient's condition.

Insomnia

Half or one tablet one hour before bedtime.

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

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

Under normal conditions, you should fall asleep within 20 minutes after taking Placinoral, and it is advisable to ensure that you can rest undisturbed for at least 7 hours. Otherwise, although this occurs rarely, you may not remember events that occurred 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.

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

The tablets should be taken with some liquid.

The tablet may be divided into equal doses.

If you take more Placinoral than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Placinoral

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

If you stop taking Placinoral

Treatment with this medicine, as with other similar medicines, may lead to dependence. Dependence may be physical—resulting in the appearance of various symptoms upon discontinuation—or psychological, manifesting as addiction to the medication. This risk increases with higher doses and longer duration of treatment, and is also greater in patients with a history of drug or alcohol abuse.

If treatment is stopped abruptly, dependence may manifest as symptoms such as headache, muscle pain, marked anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following symptoms have been reported: feelings of detachment from oneself, abnormally heightened auditory acuity, tingling and cramps in the limbs, intolerance to light, sounds, and physical contact, hallucinations, or seizures.

When discontinuing treatment, the symptoms that led to initiating therapy may reappear—transiently but more intensely. These symptoms may be accompanied by other reactions such as mood changes, anxiety, sleep disturbances, and restlessness. Since the likelihood of such reactions is higher after abrupt discontinuation, it is recommended to gradually reduce the dose until treatment is completely stopped.

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 may cause adverse effects, although not everyone experiences them.

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

• Tiredness or daytime drowsiness, especially at the beginning of treatment.

• Anterograde amnesia, meaning that you do not remember events that occurred while awake after taking the medicine; therefore, you must ensure you can rest for at least 7 hours without being disturbed.

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

If you notice any other adverse reactions not described in this leaflet, consult 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Placinoral

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

Appearance of the product and contents of the pack

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

Carton packs 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 most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es.