DORMODOR 30 mg HARD CAPSULES

2. What you need to know before taking Dormodor

Do not take Dormodor

• If you are allergic to flurazepam or any of the other components of this medicine (listed in section 6).
• If you are allergic to any benzodiazepine medicine.
• If you have breathing or lung problems, related or not to sleep, for a long time.

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

-If you have a chronic mental disorder.

• You have severe muscle or liver problems.
• If you are dependent on drugs or alcohol. You should not take Dormodor unless your doctor formally indicates it. If you have any doubts, consult your doctor.
• Dormodor should not be given to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormodor.

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

• have any liver or kidney disorder

• have muscle weakness
• have other illnesses
• 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:

• the use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• do not increase the prescribed doses in any way, nor prolong treatment longer than recommended.
• consult your doctor regularly to decide if treatment should be continued.

A transient syndrome has been described, characterized by the reappearance of symptoms, although more pronounced, that led to the initiation of treatment. It can be accompanied by other reactions such as depression, nervousness, mood changes, anxiety, or sleep disorders, restlessness, sweating, and diarrhea. Since the probability of a rebound phenomenon is higher after abruptly stopping treatment, it is recommended to gradually decrease the dose until its definitive suppression, according to the doctor's instructions.

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

Due to the muscle relaxant effect, there is a risk of falls and, consequently, fractures in elderly people.

Children

Children should not take this medicine.

Other medicines and Dormodor

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

The simultaneous use of Dormodor with opioids (analgesics, substitution therapy medications, and some cough medicines) increases the risk of drowsiness, respiratory difficulty (respiratory depression), coma, and can be life-threatening. Due to this, concomitant administration should only be considered when no alternative treatments are possible.

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

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

The simultaneous use of more than one medicine can increase or decrease its effect. Therefore, you should not take other medicines at the same time as Dormodor unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can 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 can potentiate 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 the doctor considers it necessary.

As with all benzodiazepines, it can be expected to pass into breast milk. Therefore, if possible, the use of Dormodor should be avoided in breastfeeding mothers.

Driving and using machines

Dormodor is a sleep-inducing medicine. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced. Pay special attention at the start of treatment or if the dose is increased.

3. How to take Dormodor

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

The recommended dose for adults is one capsule (30 mg of flurazepam hydrochloride) of Dormodor daily before bedtime.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

Take Dormodor just before bedtime and swallow the capsule without chewing, with water or another non-alcoholic beverage.

Under normal conditions, you should not take longer than 20 minutes to fall asleep after taking Dormodor, and it is advisable to ensure that you can rest without being awakened for at least 7 hours. Otherwise, although this happens rarely, you may not remember what happened while you were awake.

Never change the dose prescribed by your doctor yourself. If you think the effect of Dormodor is too strong or too weak, inform your doctor or pharmacist.

You should always take Dormodor as indicated by your doctor. Depending on the nature of your illness, age, and weight, your doctor will prescribe the appropriate dose.

Your doctor is the best person to decide when you should stop treatment with Dormodor. Remember that treatment with Dormodor has a limited duration.

Remember to take your medicine.

Use in elderly people

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

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

If you take more Dormodor than you should

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

Overdose with benzodiazepines is generally characterized by different degrees of central nervous system depression. In moderate cases, symptoms include drowsiness, confusion, and lethargy (continuous and deep sleep), so vomiting should be induced within a maximum of 1 hour after massive ingestion of Dormodor. In more serious cases, you should go to a hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 562.04.20, indicating the medicine and the amount taken.

If you forget to take Dormodor

Do not take a double dose to make up for the forgotten dose. You should continue with the normal dose.

If you stop treatment with Dormodor

If you want to stop treatment, consult your doctor beforehand, as sudden interruption can cause dependence symptoms. To avoid this, do not stop treatment with Dormodor abruptly, especially if you have been taking it for a long time.

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

Your doctor is the best person to decide when to stop treatment. Remember that treatment with Dormodor has a limited duration.

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

4. Possible side effects

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

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

You may develop anterograde amnesia, i.e., you do not remember what happened while you were awake after taking the medicine. Therefore, you should ensure that you can rest for at least 7 hours without being disturbed.

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

Common side effects (may affect up to 1 in 10 people):

Drowsiness, reduced alertness, lack of coordination, dizziness, headache, alteration of taste, amnesia, emotional numbness, fatigue, muscle weakness.

Rare side effects (may affect less than 1 in 1,000 people):

Hypersensitivity, visual disturbances (double vision), vertigo, low blood pressure. Respiratory depression (especially at night). Gastrointestinal disorders, 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 or go to the emergency department of the nearest hospital immediately.

Very rare side effects (may affect less than 1 in 10,000 people):

Jaundice, elevated liver enzymes.

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

Blood test changes. Confusion, hallucinations, dependence symptoms, depression, anxiety, sleep disorders, nightmares, restlessness, aggression, agitation, irritability, inappropriate behavior, emotional changes, suicidal thoughts.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's online system: https://www.notificaram.es. By reporting side 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 visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Dormodor

• The active ingredient is Flurazepam hydrochloride. Each capsule contains 30 mg of Flurazepam hydrochloride.
• The other ingredients 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.

Casanova, 27 31

08757 Corbera de Llobregat (Barcelona) Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:July 2022

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