Label:patient information

DORMODOR 30 mg hard capsules

Flurazepam hydrochloride

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label.

Contents of the package and additional information

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

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

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

- If you are allergic to flurazepam or any of the other components of this medication (listed in section 6).

- If you are allergic to any medication in the benzodiazepine group.

- If you have respiratory or pulmonary difficulties, related or unrelated to sleep, for a long time.

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

- If you have a chronic mental disorder.

- If you have severe muscle or liver problems.

- If you suffer from drug or alcohol dependence. Do not take Dormodor unless your doctor instructs you to do so. If you have any doubts, consult your doctor.

- Dormodor should not be administered 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 disorders

• suffer from muscle weakness
• have other diseases
• have allergies

Risk of dependence

The use of benzodiazepines can produce 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 only be taken 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 treatment should continue.

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

After taking Dormodor, make sure you can sleep without being woken up for 7 hours.

Due to the muscle relaxation effect, there is a risk of falls and, consequently, fractures in older adults.

Children

Children should not take this medication.

Other medications and Dormodor

Inform your doctor or pharmacist that you aretaking, havetakenrecentlyor may need to take any other medication.

The simultaneous use of Dormodor with opioids (analgesics, substitution therapy medications, and some antitussives) increases the risk of drowsiness, respiratory difficulty (respiratory depression), coma, and can be life-threatening. Therefore, concurrent administration should only be considered when alternative treatments are not possible.

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

Please inform your doctor of all opioids you are taking, and follow carefully the dosage recommendations provided by your doctor. It may be helpful to inform friends or family members of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

The simultaneous use of multiple medications can increase or decrease their effect. Therefore, do not take other medications at the same time as Dormodor 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 enhance the effect of Dormodor. The administration of theophylline or aminophylline (asthma medications) may reduce the sedative effects of benzodiazepines.

Taking Dormodor with food, drinks, and alcohol

Avoid drinking alcoholic beverages during treatment. The effect of alcohol can potentiate sedation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Like all benzodiazepines, it is expected that Dormodor can pass into breast milk. Therefore, if possible, it should be avoided in mothers during the breastfeeding period.

Driving and operating machinery

Dormodor is a sleep medication. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Follow exactly the administration instructions of this medication as indicated 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 before bedtime.

No individual dose should 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 whole, with water or another non-alcoholic beverage.

Under normal conditions, you should not take more than 20 minutes to fall asleep after taking Dormodor, 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, you may not remember what happened while you were awake.

Never change the dose prescribed for you. If you estimate that the action of Dormodor is too strong or too weak, inform your doctor or pharmacist.

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

Your doctor is the one who best knows when you should stop taking Dormodor. But remember that the treatment with Dormodor has a limited duration.

Remember to take your medication.

Use in elderly people

Elderly people may be affected by Dormodor more than young 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 muscle weakness, your doctor will decide whether you should take a lower dose or not take it at all.

If you take more Dormodor than you should

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

Benzodiazepine overdose typically manifests by different degrees of central nervous system depression. In moderate cases, symptoms include drowsiness, confusion, and lethargy (continuous and deep sleep), and induced vomiting should be performed within 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 Toxicological Information Service, phone (91) 562.04.20, indicating the medication and the amount ingested.

If you forgot to take Dormodor

Do not take a double dose to compensate for the missed dose. You should continue with the normal dose.

If you interrupt the treatment with Dormodor

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

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

Your doctor is the one who best knows when to stop treatment. Remember that the treatment with Dormodor has a limited duration.

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

Like all medications, Dormodor can produce adverse effects, although not all people will experience 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, meaning you will not remember what happened while you were awake after taking the medication, so you should ensure that you can rest

for at least 7 hours without being disturbed.

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

Frequent Adverse Effects(may affect up to 1 in 10 people):

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

Rare Adverse Effects(may affect fewer than 1 in 1,000 people):

Hyper-sensitivity, visual disturbances (double vision), vertigo, low blood pressure. Respiratory depression (particularly at night). Gastrointestinal alterations, 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 room.

Very rare Adverse Effects (may affect fewer than 1 in 10,000 people):

Jaundice, elevation of liver enzymes.

Unknown frequency (cannot be calculated from available data):

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

This product does not require special conservation conditions.

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

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

Do not use this medication if you observe visible signs of deterioration.

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

Composition of Dormodor

- The active ingredient is Flurazepam hydrochloride. Each capsule contains 30 mg of Flurazepam hydrochloride.

- The other components are: mannitol, talc, magnesium stearate, hard gelatin, erythrosine (E127); indigotin (E132); quinoline yellow (E104); iron oxide black (E172) and titanium dioxide (E171).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder

Meda Pharma SL

C/General Aranaz, 86

28027 Madrid

Spain.

Responsible for manufacturing

Labiana Pharmaceuticals S.L.

Casanova, 27 31

08757 Corbera de Llobregat (Barcelona)Spain

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:July 2022

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/