Label: information for theuser

Dormicum7,5 mgfilm-coated tablets

Midazolam

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

• Keep this label, as you may need to read it again.
• If youhave any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone,and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

1. What is Dormicumand for what it is used

2.What you need to know before starting to take Dormicum

3. How to take Dormicum

4.Possible adverse effects

5. Storage of Dormicum

6.Contents of the package and additional information

Dormicumcontainsmidazolamasitsactiveingredient. Itbelongs to a group of medicationsknownas benzodiazepines.

Midazolam is a strong rapid-acting sleep inducer. It also relieves anxiety, as well as muscle tension and spasms.

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

Do not take Dormicum

-if you are allergic to the active ingredient midazolam, to other medications in the benzodiazepine group in general, or to any of the other components of this medication (listed in section 6)

-if you have breathing 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 a history of drug or alcohol dependence, unless your doctor has formally indicated otherwise

-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-potentiated formulations)

-Dormicum should not be administered to children under 12 years old

Warnings and precautions

-if you have any 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 you should take a lower dose of Dormicum or not take it at all.

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

Children and adolescents

Neither children nor adolescents should take this medication.

Taking Dormicum with other medications

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

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

Therefore, do 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 may cause decreased reflexes, coordination problems, drowsiness, and cardio-respiratory depression (slow breathing and low intensity, and the heart pumps blood 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 whether you should be treated with Dormicum.

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

Driving and operating machinery

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

Dormicum contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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, that is, two tablets per day).

The recommended doses are as follows:

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

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

In senior patients with any liver, kidney, or muscle weakness problem, the doctor will prescribe a lower dose.

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

Do not increase, at all, 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 renal insufficiency or mild to moderate 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 Dormicumjust before going to bedand swallow the tablet without crushing it, with water or another non-alcoholic beverage.

Under normal conditions, you will 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 not, it is possible that you may not remember what happened while you were awake, although this occurs in rare cases.

The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

Never change the dose prescribed by your doctor yourself.

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

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

Treatment duration

Your doctor will indicate the duration of your treatment with Dormicum. In most cases, only a short-term treatment with this medication is needed (usually not exceeding two weeks). Consult your doctor regularly to decide if treatment should be continued. Do not prolong treatment beyond the recommended time 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dormicum

Do not take a double dose to compensate for the missed doses. Instead, continue with the normal dose.

If you interrupt treatment with Dormicum

When stopping treatment, anxiety, insomnia, lack of concentration, headache, muscle pain, confusion, irritability, and hot flashes may appear. It is generally not recommended to stop treatment 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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Most patients tolerate this medicine 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 medicine, and which have been observed with an unknown frequency (cannot be estimated from the available data) are:

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

A chest pain sign of a severe allergic reaction called Kounis syndrome has been observed.

Mental health disorders: confusion, disorientation, emotional and mood alterations, libido disorders (alteration of sexual desire), depression (the use of this medicine may reveal existing depression), restlessness, agitation, hyperactivity, nervousness, anxiety, irritability, aggressive behavior, anger attacks, nightmares, abnormal dreams, hallucinations, inappropriate behavior, physical dependence, withdrawal syndrome, and abuse.

Nervous system disorders: drowsiness (sleep), headache, dizziness (alteration of balance sense), decreased alertness (slowness of reflexes), ataxia (discoordination of voluntary movements), sedation (after surgery), and anterograde amnesia (situation where you do not remember what happened while awake after taking the medicine).

Eye disorders: diplopia (double vision of objects).

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

Musculoskeletal and connective tissue disorders: muscle weakness.

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

Gastrointestinal disorders: gastrointestinal disturbances.

Skin and subcutaneous tissue disorders: skin alterations (skin changes).

General disorders and administration site conditions: fatigue.

Accidental injuries, intoxications, 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 may lead to dependence. This occurs mainly after taking the medicine continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

-The taking of benzodiazepines will be done only under medical prescription (never because they have worked in other patients) and never recommended to others.

• Do not increase the prescribed doses at all, or prolong the treatment longer than recommended.

• Consult the doctor regularly to decide if the treatment should continue.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Abstinence

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

Upon cessation of administration, insomnia, anxiety, headache, diarrhea, confusion, muscle pain, mood changes, and restlessness may appear.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE point of your pharmacy.Askyour pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

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, hydroxypropylmethylcellulose, talc, and titanium dioxide.

Appearance of the product and contents of the packaging

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 packs of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Responsible for manufacturing:

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

Leganés

28914 Madrid

Spain

Last review date of this leaflet:August 2023.

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