DORMICUM 7.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Dormicum7.5 mgfilm-coated tablets

Midazolam

Read the entire package leaflet carefully beforestarting to takethis medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dormicum and what is it used for
2. What you need to know before taking Dormicum
3. How to take Dormicum
4. Possible side effects
5. Storage of Dormicum
6. Package contents and additional information

1. What is Dormicum and what is it used for

Dormicum contains midazolam as the active ingredient. It belongs to a group of medications called benzodiazepines.

Midazolam is a potent sleep inducer with rapid action. It also relieves anxiety, as well as muscle tension and spasms.

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

2. What you need to know before taking Dormicum

Do not take Dormicum

• if you are allergic to the active ingredient midazolam, to other medications in the benzodiazepine group, or to any of the other components of this medication (listed in section 6)
• if you have respiratory difficulties related or unrelated to sleep for a long time
• if you have severe muscle problems (myasthenia gravis)
• if you have severe liver problems
• if you have or have had drug or alcohol dependence problems, unless your doctor formally indicates it
• if you are taking medications to treat fungal infections
• if you are taking a type of medication used to treat HIV (AIDS) (HIV protease inhibitors, including ritonavir-boosted protease inhibitor formulations)
• Dormicum should not be administered to children under 12 years of age

Warnings and precautions

• if you have liver or kidney disease,
• if you suffer from muscle weakness,
• if you have other diseases,
• if you have allergies,
• if you are taking other medications.

Your doctor will decide whether it is convenient for you to take a lower dose of Dormicum or not to take it at all.

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

Children and adolescents

Neither children nor adolescents should take this medication.

Taking Dormicum with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication. This is very important, as taking several medications at the same time can increase or decrease their effect.

For example, tranquilizers, sleep-inducing medications, medications that act on the central nervous system, and medications to treat fungal infections can increase the effect of Dormicum.

Therefore, you should not take Dormicum with other medications without consulting your doctor. When your doctor authorizes it, you can start taking it.

Taking Dormicum with food, drinks, and alcohol

During treatment with Dormicum, avoid alcoholic beverages. Alcoholic beverages increase the effect of this medication and can cause decreased reflexes, coordination problems, drowsiness, and cardio-respiratory depression (slow and shallow breathing and the heart beats very slowly). If you need additional information, consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Your doctor will then decide if you should be treated with Dormicum.

You must inform your doctor if you are breastfeeding. In this case, your doctor will decide if you should be treated with Dormicum (since benzodiazepines are excreted in breast milk).

Driving and using machines

Dormicum is a sleep-inducing medication. Do not drive or operate heavy machinery until you have fully recovered. Your doctor should decide when you can resume these activities.

Dormicum contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Dormicum

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, your response to the medication, your age, and your weight, your doctor will prescribe the appropriate dose. Treatment should begin with the lowest dose. Do not exceed the maximum dose (15 mg per day, i.e., two tablets per day).

The recommended doses are as follows:

Adults:1-2 tablets per day (7.5-15 mg of midazolam per day).

Elderly patients:1 tablet per day (7.5 mg of midazolam per day)

In elderly patients with liver, kidney, or muscle weakness problems, the doctor will prescribe a lower dose.

Dormicum may affect elderly patients more than younger patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

Do not increase the indicated limits and the total daily dose prescribed by your doctor unless your doctor prescribes a higher dose.

Patients with renal or hepatic problems

If you have mild or moderate renal or hepatic insufficiency, your doctor will prescribe a lower dose. If you have severe hepatic insufficiency, you should not be treated with Dormicum.

Guidelines for correct administration

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

Under normal conditions, you should not take more than 20 minutes to fall asleep after taking Dormicum, and it is advisable to ensure that you can rest without being awakened for at least 7 hours. If this is not the case, it is possible that you will not remember what happened while you were awake, although this happens rarely.

The score line is only for breaking the tablet if you find it difficult to swallow whole.

Never change the dose prescribed by your doctor yourself.

To avoid withdrawal symptoms, do not stop taking Dormicum abruptly, especially if you have been taking it for a long time (see section 4 of the package leaflet).

If you think the effect of Dormicum is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

Your doctor will indicate the duration of your treatment with Dormicum. In most cases, only short-term treatment with this medication is needed (generally not exceeding two weeks). Consult your doctor regularly to decide if treatment should be continued. Do not prolong treatment longer than recommended by your doctor.

If you take more Dormicum than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dormicum

Do not take a double dose to make up for forgotten doses. Instead, continue with the normal dose.

If you interrupt treatment with Dormicum

When stopping treatment, restlessness, anxiety, insomnia, lack of concentration, headache, muscle pain, confusion, irritability, 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. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

The side effects that may occur during treatment with this medication, and that have been observed with an unknown frequency (cannot be estimated from the available data), are:

Immune system disorders: Hypersensitivity reactions and angioedema (swelling in the face) may occur in prone individuals.

Chest pain has been observed as a sign of a severe allergic reaction called Kounis syndrome.

Psychiatric disorders: Confusion, disorientation, emotional and mood changes, libido disorders (alteration of sexual desire), depression (the use of this medication may cause a pre-existing depression to appear), restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressive behavior, outbursts of anger, nightmares, abnormal dreams, hallucinations, inappropriate behavior, physical dependence, withdrawal syndrome, and abuse.

Nervous system disorders: Drowsiness (sleep), headache, dizziness (alteration of balance), decreased alertness (slowness in reflexes), ataxia (lack of coordination of voluntary movements), sedation (after an operation), and anterograde amnesia (situation that occurs when you do not remember what happened while you were awake after taking the medication).

Ocular disorders: Diplopia (double vision).

Cardiac disorders: Heart failure (the heart does not pump well) and cardiac arrest (heart attack).

Musculoskeletal and connective tissue disorders: Muscle weakness.

Respiratory disorders: Respiratory depression (slow and shallow breathing).

Gastrointestinal disorders: Gastrointestinal changes.

Skin and subcutaneous tissue disorders: Skin changes.

General disorders and administration site conditions: Fatigue.

Traumatic injuries, poisonings, and complications of therapeutic procedures: Increased risk of falls and fractures in elderly patients and patients taking other sedatives (including alcoholic beverages) at the same time.

Risk of dependence

The use of benzodiazepines can lead to dependence. This occurs mainly after uninterrupted use of the medication 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 been effective in other patients) and will never be recommended to other people.
  • Do not increase the doses prescribed by the doctor, nor prolong the treatment longer than recommended.

• Consult your doctor regularly to decide if treatment should be continued.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Withdrawal

To minimize the appearance of the withdrawal syndrome/rebound insomnia (difficulty sleeping more intensely than at the start of treatment), do not stop the medication abruptly, but rather gradually reduce the dose, always according to the doctor's instructions.

When stopping the administration, insomnia, anxiety, headache, diarrhea, confusion, muscle pain, mood changes, and restlessness may appear.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dormicum

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

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Dormicum

• The active ingredient is midazolam. Each tablet contains 7.5 mg of midazolam.
• The other components are anhydrous lactose, microcrystalline cellulose, pregelatinized cornstarch, magnesium stearate, hydroxypropyl methylcellulose, talc, and titanium dioxide.

Appearance of the product and package contents

Dormicum 7.5 mg film-coated tablets:

Film-coated tablets, oval in shape, white in color, and with the inscription 7.5 on one face of the tablet.

Available in packages of 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative:

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer:

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

Leganés

28914 Madrid

Spain

Date of the last revision of this package leaflet:August 2023.

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