Dormodor 30 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

DORMODOR 30 mg hard capsules

Flurazepam hydrochloride

Read this entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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.

Contents of the leaflet

1. What Dormodor is and what it is used for.
2. What you need to know before taking Dormodor.
3. How to take Dormodor.
4. Possible side effects.
5. How to store Dormodor.

Pack contents and additional information

1. What Dormodor is and what it is used for

The active substance is flurazepam hydrochloride, which is a benzodiazepine with hypnotic properties.

Dormodor is used for sleep rhythm disorders and for all forms of insomnia, especially when there are difficulties in falling asleep, either initially or after an early awakening.

In most cases, only short-term treatment with Dormodor 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 taking Dormodor

Do not take Dormodor

• If you are allergic to flurazepam or to any of the other components of this medicine (listed in section 6).
• If you are allergic to any medicine belonging to the benzodiazepine group.
• If you have long-standing respiratory or pulmonary difficulties, whether or not related to sleep.

-If you have phobias (fear of something) or obsessions.

-If you suffer from a chronic mental disorder.

• You have severe muscular or hepatic problems.
• If you are dependent on drugs or alcohol. You should not take Dormodor unless your doctor specifically instructs you to do so. If you have any doubts about this, consult your doctor.
• Dormodor must not be given to children.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dormodor.

Before starting treatment, make sure your doctor knows if you:

• have any liver or kidney disorders

• suffer from muscle weakness

• have other illnesses

• have allergies

Risk of dependence

The use of benzodiazepines may lead to dependence.

This occurs mainly after prolonged, uninterrupted use of the medicine. 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 for other patients), and should never be recommended to other people.
• do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
• consult your doctor regularly so they can decide whether the treatment should continue.

A transient syndrome has been described, characterized by the return of the symptoms that led to starting the treatment, although more pronounced. It may be accompanied by other reactions such as depression, nervousness, mood changes, anxiety or sleep disturbances, restlessness, sweating, and diarrhea. Since the likelihood of a rebound phenomenon is higher when treatment is stopped abruptly, it is recommended to gradually reduce the dose until complete discontinuation, in accordance with your doctor's instructions.

After taking Dormodor, you should ensure that you will be able to rest undisturbed for 7 hours.

Due to its muscle-relaxing effect, there is a risk of falls and, consequently, of fractures in elderly individuals.

Children

Children must not take this medicine.

Other medicines and Dormodor

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

The simultaneous use of Dormodor with opioids (analgesics, medications for substitution therapy, and some antitussives) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, combined administration should only be considered when no other alternative treatments are possible.

However, if your doctor prescribes Dormodor together with opioids, the dosage and duration of simultaneous treatment should be limited by your doctor.

Please inform your doctor about all opioids you are taking, and carefully follow the dosage recommendations provided by your doctor. 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 such symptoms.

Taking more than one medicine at the same time may increase or decrease its effect. Therefore, you should not take other medicines simultaneously with Dormodor unless your doctor is informed and has approved it beforehand. For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of Dormodor. The administration of theophylline or aminophylline (medicines for asthma) may reduce the sedative effects of benzodiazepines.

Taking Dormodor with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol may enhance sedation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Dormodor should not be used during pregnancy, especially during the first and last trimester, unless your doctor considers it necessary.

As with all benzodiazepines, passage into breast milk may be expected. Therefore, if possible, the use of Dormodor should be avoided in breastfeeding mothers.

Driving and using machines

Dormodor is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if you notice that your attention and reaction ability are reduced. Pay special attention at the beginning of treatment or when the dose is increased.

3. How to take Dormodor

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

The recommended dose for adults is one capsule (30 mg of flurazepam hydrochloride) of Dormodor daily, taken before going to bed.

Each individual dose must not exceed the stated limits, nor must the total daily dose, unless your doctor prescribes a higher dose.

Take Dormodor just before going to bed, swallowing the capsule whole, without chewing, with water or another non-alcoholic drink.

Under normal conditions, you should fall asleep within 20 minutes after taking Dormodor. It is advisable to ensure that you will be able to rest undisturbed for at least 7 hours. Otherwise, although this occurs rarely, you may not remember what happened during the time you were awake.

Never change your prescribed dose on your own. If you feel that the effect of Dormodor is too strong or too weak, inform your doctor or pharmacist.

You must always take Dormodor exactly as directed by your doctor. Depending on the nature of your condition, your age and weight, your doctor will prescribe the appropriate dose.

Your doctor is best qualified to determine when you should stop treatment with Dormodor. However, remember that treatment with Dormodor is of limited duration.

Remember to take your medicine.

Use in elderly patients

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

If you have any liver or kidney disorder, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose or should not take the medicine at all.

If you take more Dormodor than you should

If you or someone else has taken an overdose of Dormodor, contact your doctor, pharmacist, or the nearest hospital immediately.

Overdose with benzodiazepines generally manifests as varying degrees of central nervous system depression. In moderate cases, symptoms include drowsiness, confusion, and lethargy (continuous deep sleep); vomiting should be induced within a maximum of 1 hour after massive ingestion of Dormodor. In more serious cases, immediate hospitalization is required.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone (91) 562.04.20, indicating the medicine and the amount ingested.

If you forget to take Dormodor

Do not take a double dose to make up for a missed dose. Continue with your normal dose.

If you stop treatment with Dormodor

If you wish to discontinue treatment, consult your doctor first, as abrupt discontinuation may cause symptoms of dependence. To avoid this, do not stop treatment with Dormodor suddenly, especially if you have been taking it for a long time.

Upon stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Generally, abrupt discontinuation of the medication is not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.

Your doctor is best qualified to determine when treatment should end. Remember that treatment with Dormodor is of limited duration.

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

4. Possible adverse effects

Like all medicines, Dormodor may cause adverse effects, although not everyone experiences them.

Most patients tolerate Dormodor well, but some, especially at the beginning of treatment, may feel somewhat tired or drowsy during the day.

You may develop anterograde amnesia, meaning you do not remember events that occurred while you were awake after taking the medicine; therefore, you must ensure you can rest for at least 7 hours without interruption.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Frequent adverse effects (may affect up to 1 in 10 people):

Somnolence, reduced alertness, lack of motor coordination, dizziness, headache, altered sense of taste, amnesia, emotional blunting, fatigue, muscle weakness.

Rare adverse effects (may affect fewer than 1 in 1,000 people):

Hypersensitivity, visual disturbances (double vision), vertigo, low blood pressure, respiratory depression (particularly at night), gastrointestinal disturbances, nausea, urinary retention, changes in libido.

If you experience allergic reactions accompanied by swelling of the face, lips, throat, or tongue, and difficulty breathing or swallowing (angioedema), contact your doctor immediately or go to the nearest hospital emergency department.

Very rare adverse effects (may affect fewer than 1 in 10,000 people):

Jaundice, increased liver enzymes.

Frequency not known (cannot be estimated from available data):

Abnormal blood test results, confusion, hallucinations, symptoms of dependence, depression, anxiety, sleep disorders, nightmares, restlessness, aggressiveness, agitation, irritability, inappropriate behavior, emotional disturbances, suicidal thoughts.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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 Dormodor.

Store below 30 °C.

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

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, 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 Dormodor

• The active substance is Flurazepam hydrochloride. Each capsule contains 30 mg of flurazepam hydrochloride.
• The other components are: mannitol, talc, magnesium stearate, hard gelatin, erythrosine (E127); indigo carmine (E132); quinoline yellow (E104); black iron oxide (E172); and titanium dioxide (E171).

Appearance of the product and contents of the pack

Each pack contains 30 capsules. Each capsule contains 30 mg of flurazepam hydrochloride.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Labiana Pharmaceuticals S.L.U.
Casanova, 27 31
08757 Corbera de Llobregat (Barcelona) Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: July 2022

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