DORMICUM 15 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Dormicum, 7.5 mg, coated tablets
3. Dormicum, 15 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
4. What is Dormicum and what is it used for
   1. Indications for use:
5. Important information before taking Dormicum
   1. When not to take Dormicum:
   2. Warnings and precautions
   3. Dormicum with other medicines
   4. Dormicum with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and operating machines
   7. Dormicum contains lactose
6. How to take Dormicum
   1. Taking a higher dose of Dormicum than recommended
   2. Missing a dose of Dormicum
   3. Stopping treatment with Dormicum
7. Possible side effects
   1. Reporting side effects
8. How to store Dormicum
9. Contents of the packaging and other information
   1. What Dormicum contains
   2. What Dormicum looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Dormicum, 7.5 mg, coated tablets

Dormicum, 15 mg, coated tablets

Midazolam

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dormicum and what is it used for
• 2. Important information before taking Dormicum
• 3. How to take Dormicum
• 4. Possible side effects
• 5. How to store Dormicum
• 6. Contents of the packaging and other information

1. What is Dormicum and what is it used for

Dormicum is a short-acting sleeping pill. The medicine also has a calming, anticonvulsant, and muscle relaxant effect. The active substance of the medicine is midazolam, which belongs to the benzodiazepine group.

Indications for use:

Short-term treatment of insomnia.
The use of benzodiazepines is indicated only when the symptoms are severe, disabling, or cause significant exhaustion in the patient.
Midazolam is also used in premedication before surgical or diagnostic procedures.

2. Important information before taking Dormicum

When not to take Dormicum:

• if the patient is allergic to midazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe respiratory failure;
• if the patient has severe liver failure;
• if the patient has sleep apnea syndrome;
• if the patient has myasthenia gravis;
• in children under 12 years of age, as it is not possible to obtain an appropriate dose for them using Dormicum tablets;
• if the patient is taking ketokonazole, itraconazole, voriconazole, HIV protease inhibitors, including ritonavir-boosted protease inhibitors, HCV protease inhibitors: boceprevir and telaprevir.

Warnings and precautions

Before starting to take Dormicum, discuss it with your doctor or pharmacist.

• if the patient takes the medicine repeatedly for several weeks, as the effect of the medicine may weaken;
• if the patient takes the medicine repeatedly for several weeks, as the medicine may cause dependence;
• if the patient has abused alcohol or drugs;
• if the patient is over 60 years old;
• if the patient has chronic respiratory failure;
• if the patient is taking other medicines that may enhance or weaken the effect of Dormicum;
• if the patient has liver or severe kidney function disorders, the medicine may cause subsequent amnesia. It usually occurs within a few hours of taking the medicine, so patients should make sure they can have 7-8 hours of uninterrupted sleep after taking the medicine

The patient should inform their doctor if they have psychotic disorders, depression, and anxiety disorders related to depression.
It is recommended to consult a doctor, even if the above warnings concern past situations.

Dormicum with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.
Be particularly careful when taking the following medicines with Dormicum:

• fluconazole,
• antibacterial medicines (e.g., clarithromycin, erythromycin, telithromycin, isoniazid),
• calcium channel blockers (e.g., diltiazem, verapamil),
• tyrosine kinase inhibitors (e.g., imatinib, lapatinib, idelalisib),
• nefazodone,
• aprepitant,
• netupitant,
• casopitant,
• tebimorelin,
• posaconazole,
• raloxifene.

If you are taking any of the above medicines, the dose of Dormicum should be determined individually by your doctor.
In the case of concomitant use of carbamazepine, phenytoin, and rifampicin, enzalutamide, mitotane, and St. John's Wort, the patient should receive higher doses of Dormicum to achieve the desired sedative effect.
Concomitant use of midazolam with sedative and/or hypnotic medicines is likely to increase the sedative and hypnotic effect of Dormicum, as well as increase the risk of respiratory or cardiac depression. Such substances include: alcohol, opioids (used as painkillers, antitussives, or in substitution therapy), antipsychotics, other benzodiazepines (used as sedatives or hypnotics), barbiturates, propofol, ketamine, etomidate, sedative antidepressants, antihistamines, and centrally acting antihypertensive medicines.
Administration of 250 mg of caffeine partially reverses the sedative effect of midazolam.

Dormicum with food and drink

Alcohol should be avoided during treatment with Dormicum, as concomitant use of midazolam and alcohol may enhance the sedative and hypnotic effect.

Pregnancy and breastfeeding

In pregnancy and breastfeeding, or if pregnancy is suspected, or if pregnancy is planned, consult a doctor or pharmacist before taking this medicine.
There is insufficient data to assess the safety of midazolam during pregnancy. Benzodiazepines should not be used in pregnant women unless absolutely necessary. There is an increased risk of congenital malformations associated with benzodiazepine use during the first trimester of pregnancy.
If, in exceptional cases, the doctor considers administering the medicine during the last trimester of pregnancy or during the postpartum period, they should consider the possibility of hypothermia (lowered body temperature), hypotonia (muscle weakness), sucking disorders, or moderate respiratory depression in the newborn. In children of mothers who have taken benzodiazepines for a long time during the last period of pregnancy, physical dependence on the medicine may develop, and there is a risk of withdrawal symptoms in the postnatal period.
Women who are breastfeeding should not take Dormicum, as midazolam passes into breast milk.

Driving and operating machines

Do not drive vehicles or operate machines.

Dormicum contains lactose

Therefore, it should not be taken by patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.

3. How to take Dormicum

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Treatment should be as short as possible, usually from a few days to a maximum of two weeks. The method of reducing the dose during withdrawal of the medicine will be determined individually by the doctor for each patient.
Treatment should not be stopped abruptly. Sometimes it may be necessary to extend treatment beyond the recommended maximum treatment period. The doctor will make this decision after re-evaluating the patient's condition.
Due to the rapid action of the medicine, Dormicum tablets should be taken before rest. Dormicum tablets can be taken at any time of the day, provided that the patient goes to rest after taking the medicine and has at least 7-8 hours of uninterrupted sleep. The tablets should be taken whole, without chewing, with a drink. The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, not to divide it into equal doses.
Usual dosage
Adults: from 7.5 mg to 15 mg.
Treatment should be started with the lowest recommended dose. Do not exceed the maximum dose due to the increased risk of side effects from the central nervous system, including clinically significant respiratory depression (slowing or shallowing of breathing) and cardiovascular depression (slowing of heart rate).
Do not take the medicine for longer than your doctor has prescribed.
Dosing instructions for special patient groups
Elderly and/or debilitated patients:
Dormicum acts more strongly in elderly and/or debilitated patients. Therefore, the risk of significant respiratory and/or cardiovascular depression is higher in this group of patients. In elderly and/or debilitated patients, the recommended dose is 7.5 mg.
Patients with liver function disorders:
Dormicum should not be used in patients with severe liver failure. In patients with mild to moderate liver function disorders, the smallest dose should be used, not exceeding 7.5 mg.
Patients with kidney function disorders:
In patients with severe kidney damage, more pronounced and prolonged sedation and respiratory and/or cardiovascular disorders may occur. The smallest dose should be used, not exceeding 7.5 mg.
Premedication
In premedication (pharmacological preparation for a procedure), Dormicum should be administered 30 to 60 minutes before the procedure.
If you feel that the effect of Dormicum is too strong or too weak, consult your doctor.
This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor. If you are not sure, consult your doctor or pharmacist.

Taking a higher dose of Dormicum than recommended

Symptoms
Midazolam, like other benzodiazepines, often causes drowsiness, confusion, speech disorders, nystagmus. Overdose of Dormicum rarely threatens life if not taken with other medicines, but may lead to loss of reflexes (i.e., loss of automatic body reactions to stimuli), apnea, decreased muscle tone, hypotension, respiratory and/or cardiovascular disorders, and in rare cases, coma. Coma, if it occurs, usually lasts a few hours but may be severe and recurrent, especially in elderly patients. Respiratory disorders are more severe after benzodiazepine use in patients with respiratory diseases.
Benzodiazepines enhance the effect of other substances acting on the central nervous system, including alcohol.
Treatment
The doctor will monitor the patient's vital signs and implement additional monitoring, diagnostic, and therapeutic procedures as needed. Symptomatic treatment of cardiovascular and/or central nervous system disorders may be necessary.
After an overdose within 1-2 hours of oral administration of the medicine, activated charcoal should be used to reduce the absorption of the medicine. If the patient is drowsy but it has been decided to administer activated charcoal, protection of the airways should be ensured. In case of mixed poisoning, gastric lavage may be considered, but this is not a routine procedure.
In case of central nervous system disorders, the doctor will consider administering medicines that act against benzodiazepines, such as flumazenil. However, it should be remembered that the patient absolutely requires monitoring of their clinical condition. Flumazenil should be used with particular caution when there has been concomitant poisoning with medicines that lower the seizure threshold (e.g., tricyclic antidepressants).
In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

Missing a dose of Dormicum

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

Stopping treatment with Dormicum

Treatment should not be stopped abruptly.
After stopping treatment with Dormicum, the following may occur:

• rebound insomnia. This is a transient state characterized by the recurrence of symptoms that led to the administration of Dormicum. After stopping treatment with Dormicum, insomnia may recur, even more severe than before treatment. Additionally, mood changes, anxiety, restlessness, especially motor restlessness, may occur;
• withdrawal symptoms. In case of physical and psychological dependence after sudden cessation of treatment, withdrawal symptoms may occur. These may include: headaches, muscle pain, severe anxiety, tension, restlessness, especially motor restlessness, irritability, and aggression. In severe cases, the following may occur: depersonalization (feeling of loss of one's own identity), derealization (feeling of strangeness of the world), hypersensitivity to sounds, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures. Due to the increased risk of withdrawal symptoms or rebound insomnia, it is recommended to gradually reduce the dose.

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Dormicum tablets:
All the side effects listed below have been reported with an unknown frequency (frequency cannot be estimated from the available data) after oral administration of midazolam:

• in sensitive individuals - hypersensitivity reactions and angioedema (swelling of the lips, tongue, mouth, difficulty swallowing). Chest pain has been observed, which is a symptom of a serious allergic reaction called Kounis syndrome,
• confusion, disorientation, emotional disorders, and mood disorders (mainly at the beginning of treatment, transient),
• libido disorders,
• depression may be revealed during treatment with Dormicum
• restlessness, especially motor restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggression, anger, nightmares, unusual dreams, hallucinations, and other undesirable behavioral disorders, more frequently in elderly patients. If such symptoms occur, the use of the medicine should be discontinued,
• drowsiness during the day, headache, dizziness, decreased alertness, clumsiness (mainly at the beginning of treatment, transient). The medicine used in premedication (pharmacological preparation for a procedure) may cause postoperative sedation. After therapeutic doses of the medicine, memory lapses may occur, more frequently after higher doses of the medicine. Memory lapses may be associated with inappropriate behavior,
• double vision, mainly at the beginning of treatment, usually resolves after subsequent administrations of the medicine,
• heart failure, including cardiac arrest,
• respiratory depression (suppression of breathing),
• gastrointestinal disorders,
• skin reactions,
• muscle weakness, mainly at the beginning of treatment; usually resolves after subsequent administrations of the medicine,
• fatigue, mainly at the beginning of treatment; usually resolves after subsequent administrations of the medicine,
• falls and bone fractures - the risk of these events is higher in elderly patients and those taking sedatives and alcohol concomitantly.

Dependence:taking Dormicum (even in therapeutic doses) may lead to physical dependence (especially in individuals dependent on other medicines). Sudden cessation of treatment may cause withdrawal symptoms or rebound symptoms (i.e., symptoms opposite to the effect of the medicine), including rebound insomnia, mood changes, anxiety, restlessness. Psychological dependence may also develop.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dormicum

Keep this medicine out of the sight and reach of children.
Dormicum 7.5 mg coated tablets: Store in a temperature below 30°C.
Dormicum 15 mg coated tablets: Store in a temperature below 30°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dormicum contains

• The active substance of the medicine is midazolam in the form of maleate. Each coated tablet contains 7.5 mg or 15 mg of midazolam
• Other ingredients are: Dormicum 7.5 mg coated tablets:

tablet core: lactose, microcrystalline cellulose, modified starch, magnesium stearate;
tablet coating: hypromellose, talc, titanium dioxide (E171).
Dormicum 15 mg coated tablets:
tablet core: lactose, microcrystalline cellulose, corn starch, magnesium stearate;
tablet coating: hypromellose, Eudragit E 30 D, polyethylene glycol 6000, polyethylene glycol 400, talc, titanium dioxide (E 171), sodium carboxymethylcellulose, indigo carmine.

What Dormicum looks like and contents of the packaging

Dormicum is packaged in blisters placed in a cardboard box.
Dormicum 7.5 mg coated tablets are white, round, convex coated tablets with a dividing line on one side and the inscription "7.5" on the other side.
Dormicum 15 mg coated tablets are gray-blue, round, convex coated tablets with a dividing line on one side and the inscription "15" on the other side.
Dormicum 7.5 mg is available in packaging containing 10 coated tablets.
Dormicum 15 mg is available in packaging containing 100 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Recipharm Leganés S.L.U.
Calle Severo Ochoa, 13
Leganés
28914 Madrid
Spain
To obtain more detailed information, please contact:
Komtur Polska Sp. z o.o.
[email protected]

Date of last revision of the leaflet: