DORMICUM 7.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Dormicum, 7.5 mg, Film-Coated Tablets
3. Dormicum, 15 mg, Film-Coated Tablets
   1. Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.
   2. Contents of the Pack and Other Information
4. What is Dormicum and What is it Used For
   1. Indications for Use:
5. Before You Take 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 Using Machines
   7. Dormicum Contains Lactose
6. How to Take Dormicum
   1. Overdose of Dormicum
   2. Missed Dose of Dormicum
   3. Stopping Treatment with Dormicum
7. Possible Side Effects
   1. Reporting of Side Effects
8. How to Store Dormicum
9. Contents of the Pack and Other Information
   1. What Dormicum Contains
   2. What Dormicum Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Manufacturer
   6. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the User

Dormicum, 7.5 mg, Film-Coated Tablets

Dormicum, 15 mg, Film-Coated Tablets

Midazolam

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

Important Information for Patients.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What is Dormicum and What is it Used For
• 2. Before You Take Dormicum
• 3. How to Take Dormicum
• 4. Possible Side Effects
• 5. How to Store Dormicum
• 6. Contents of the Pack and Other Information

1. What is Dormicum and What is it Used For

Dormicum is a short-acting sleeping pill. The drug also has a calming, anticonvulsant, and muscle relaxant effect. The active substance of the drug 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 causing significant distress to the patient.
Midazolam is also used in premedication before surgical or diagnostic procedures.

2. Before You Take Dormicum

When Not to Take Dormicum:

• if you are allergic to midazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe respiratory failure;
• if you have severe liver failure;
• if you have sleep apnea syndrome;
• if you have 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 you are taking concomitantly ketokonazole, itraconazole, voriconazole, HIV protease inhibitors, including ritonavir-boosted protease inhibitors, HCV protease inhibitors: boceprevir and telaprevir.

Warnings and Precautions

Before taking Dormicum, discuss it with your doctor or pharmacist.

• if you take the drug repeatedly for several weeks, as the drug's effect may weaken;
• if you take the drug repeatedly for several weeks, as the drug may cause dependence;
• if you have abused alcohol or drugs;
• if you are over 60 years old;
• if you have chronic respiratory failure;
• if you are taking other medicines that may enhance or weaken the effect of Dormicum;
• if you have liver or severe kidney function disorders, the drug may cause subsequent memory loss. This usually occurs within a few hours of taking the drug, so patients should make sure they can have 7-8 hours of uninterrupted sleep after taking the drug

The patient should inform the 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 the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Particular caution is advised when taking Dormicum concomitantly with:

• fluconazole,
• antibacterial agents (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 concomitantly, 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 agents 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 agents.
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 you think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no sufficient data to assess the safety of midazolam during pregnancy. Benzodiazepines should not be used during pregnancy unless absolutely necessary. There is an increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy.
If, in exceptional cases, the doctor considers administering the drug during the last trimester of pregnancy or during the postpartum period, it should be taken into account that the newborn may experience hypothermia (lowered body temperature), hypotonia (muscle weakness), sucking disorders, or moderate respiratory depression, related to the effect of midazolam. In children of mothers who have taken benzodiazepines for a long time during the last period of pregnancy, physical dependence on the drug 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 Using Machines

Do not drive or operate machinery.

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

This medicine should always be taken exactly as directed by your doctor. 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 drug will be determined individually by the doctor for each patient.
Treatment should not be stopped abruptly. Sometimes it may be necessary to extend the 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 drug, 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 drug and has at least 7-8 hours of uninterrupted sleep. The tablets should be taken whole, without chewing, washed down with liquid. The dividing line on the tablet makes it easier to break, but not to divide into equal doses.
Usual Dosage
Adults: from 7.5 mg to 15 mg.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded due to the increased risk of adverse reactions 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 drug for longer than your doctor has told you.
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 lowest dose should be used, not exceeding 7.5 mg.
Patients with Renal Function Disorders:
In patients with severe kidney damage, more pronounced and prolonged sedation, as well as respiratory and/or cardiovascular disorders, may occur. The lowest 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, you should 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, ask your doctor or pharmacist.

Overdose of Dormicum

Symptoms
Midazolam, like other benzodiazepines, often causes drowsiness, confusion, speech disorders, nystagmus. Overdose of Dormicum rarely threatens life if it is not taken concomitantly 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 the use of benzodiazepines by 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.
Activated charcoal may be administered within 1-2 hours after oral administration of the drug to reduce drug absorption. If the patient is drowsy but it has been decided to administer activated charcoal, airway protection should be ensured. In the case of mixed poisoning, gastric lavage may be considered, but it is not a routine procedure.
In the case of central nervous system disorders, the doctor may consider administering drugs that act oppositely to benzodiazepines, such as flumazenil. However, it should be remembered that the patient absolutely requires clinical monitoring. Flumazenil should be used with particular caution when there has been concomitant poisoning with drugs that lower the seizure threshold (e.g., tricyclic antidepressants).
In case of an overdose, seek medical attention immediately.

Missed Dose of Dormicum

Do not take a double dose to make up for a forgotten 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 condition 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 the case of physical and psychological dependence developed after stopping 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), increased sensitivity to sounds, numbness and tingling of limbs, increased sensitivity 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 questions about the use of this medicine, ask 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 following side effects 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 disturbances, and mood changes (mainly at the beginning of treatment, transient),
• disturbances of sexual desire,
• depression may be unmasked during treatment with Dormicum
• restlessness, especially motor restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggression, anger, nightmares, unusual dreams, hallucinations, inappropriate behavior, and other undesirable behavioral disorders, more frequently in elderly patients. If such symptoms occur, the use of the drug should be discontinued,
• drowsiness during the day, headache, dizziness, decreased alertness, clumsiness (mainly at the beginning of treatment, transient). The drug used in premedication (pharmacological preparation for a procedure) may cause postoperative sedation. After therapeutic doses of the drug, memory lapses may occur, more frequently after higher doses of the drug. Inappropriate behavior may be associated with amnesia,
• double vision, mainly at the beginning of treatment, usually resolves after subsequent administrations of the drug,
• 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 drug,
• fatigue, mainly at the beginning of treatment; usually resolves after subsequent administrations of the drug,
• falls and fractures - the risk of these events is higher in elderly patients and those taking sedatives and alcohol concomitantly.

Dependence:the use of Dormicum (even in therapeutic doses) may lead to the development of physical dependence (especially in individuals dependent on other drugs). Abrupt discontinuation of treatment may cause withdrawal symptoms or rebound phenomena (i.e., symptoms opposite to the effect of the drug), including rebound insomnia, mood changes, anxiety, restlessness. Psychological dependence may also develop.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.

5. How to Store Dormicum

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

6. Contents of the Pack and Other Information

What Dormicum Contains

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

tablet core: lactose, microcrystalline cellulose, modified starch, magnesium stearate;
tablet coating: hypromellose, talc, titanium dioxide (E171).
Dormicum 15 mg film-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 Pack

Dormicum is packaged in blisters placed in a cardboard box.
Dormicum 7.5 mg film-coated tablets are white, round, convex film-coated tablets with a dividing line on one side and the inscription "7.5" on the other side.
Dormicum 15 mg film-coated tablets are gray-blue, round, convex film-coated tablets with a dividing line on one side and the inscription "15" on the other side.
Dormicum 7.5 mg is available in a pack containing 10 film-coated tablets.
Dormicum 15 mg is available in a pack containing 100 film-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
For more detailed information, please contact:
Komtur Polska Sp. z o.o.
[email protected]

Date of Last Revision of the Leaflet: