Diazepam Grindeks

Package Leaflet: Information for the Patient

Diazepam Grindeks, 5mg, Tablets

Diazepam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Diazepam Grindeks and what is it used for

Diazepam Grindeks contains diazepam, which belongs to a group of medicines called benzodiazepines, characterized by a calming, anxiolytic, anticonvulsant, muscle relaxant, and sedative effect. Diazepam Grindeks is used for the symptomatic treatment of anxiety states, tension, and other physical or mental disorders associated with anxiety. It may also be used as an adjunct in the treatment of anxiety or agitation associated with psychiatric disorders (e.g., behavioral disorders or schizophrenia) or anxiety caused by functional disorders. Diazepam Grindeks is also used as an adjunct in the treatment of reflex muscle spasms caused by local injury (inflammation, injury). It may also be used to combat excessive muscle tension in cases such as cerebral palsy and paraplegia (disorders of motor and sensory functions of the lower limbs), as well as in diseases characterized by slow and atypical movements and in the treatment of progressive stiffness syndrome. Benzodiazepines are indicated for use only when the disorder is severe, disabling, or severely impairs the patient's functioning.

2. Important information before taking Diazepam Grindeks

When not to take Diazepam Grindeks:

• if you are allergic to diazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if you have breathing difficulties or respiratory problems;
• if you have severe liver disease;
• if you have sleep apnea (pauses in breathing during sleep);
• if you have myasthenia gravis (a disease that causes muscle weakness and excessive fatigue).

Benzodiazepines are not recommended as first-line treatments for psychotic diseases. In patients with depression or anxiety associated with depression, benzodiazepines should not be used as the only treatment (monotherapy), as they may exacerbate suicidal tendencies in these patients.

Warnings and precautions

Before starting treatment with Diazepam Grindeks, discuss it with your doctor or pharmacist:

• if you have a history of alcohol abuse or drug dependence;
• if you are taking medicines that act depressively (calmingly) on the central nervous system (CNS);
• if you are elderly, frail, or have heart or lung problems. Your doctor will adjust the dose of the medicine in such cases;
• if you have depression;
• if you have kidney or liver function disorders.

Tolerance
After repeated use for a longer period, the sedative effect of benzodiazepines may weaken.
Dependence
Taking benzodiazepines and benzodiazepine-like medicines can lead to psychological and physical dependence (see Possible side effects).
The risk of dependence increases with the dose and in patients undergoing long-term therapy. It is also higher in patients with a history of alcoholism or drug dependence.
Withdrawal of treatment
If physical dependence develops, sudden withdrawal of the treatment may cause withdrawal symptoms, which may occur after a few hours, a week, or a longer period. These symptoms include: headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability. In severe cases, loss of reality, personality disorders, numbness, hypersensitivity to light, sound, and touch, hallucinations, and seizures may occur. You should inform your doctor if you experience any of these symptoms.
Insomnia and rebound anxiety
After withdrawal of the medicine, a transient state may occur in which the symptoms that necessitated benzodiazepine treatment return, even in an intensified form. These may be accompanied by mood changes, anxiety, or sleep disturbances and restlessness. The risk of such a withdrawal effect and rebound anxiety is higher after sudden withdrawal of the treatment, which is why your doctor will gradually reduce the dose of the medicine.
Amnesia (anterograde amnesia)
This medicine may cause amnesia, and the risk of its occurrence is higher when high doses are used. Memory impairment may be accompanied by behavioral disorders.
Psychological and paradoxical reactions
During treatment with this medicine, paradoxical reactions may occur, such as: restlessness, excitement, irritability, aggression, delusions, anger, nightmares, hallucinations, psychoses, inappropriate behavior, and other undesirable effects on behavior. You should inform your doctor if you experience any of these symptoms, and you should also stop the treatment. The likelihood of such symptoms is higher in children and the elderly.
Concomitant use with alcohol / medicines causing CNS depression
You should avoid concomitant use of the medicine with alcohol and/or other medicines that cause slowing of the central nervous system. Concomitant use may enhance the effect of diazepam and may lead to: severe sedation, respiratory depression, and/or circulatory depression.

Children

Diazepam Grindeks should not be given to children under 6 months of age, as it is likely not safe. The doctor may prescribe it only when other treatment methods are not available. The duration of treatment in children over 6 months should be as short as possible.

Diazepam Grindeks and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Diazepam Grindeks with other medicines may enhance the sedative effect and affect the respiratory and cardiovascular systems. These medicines include:

• antipsychotic and antidepressant medicines, e.g., fluvoxamine, fluoxetine (medicines used to treat depression and anxiety disorders);
• anxiolytic and sedative medicines (medicines used to treat anxiety);
• sleeping medicines (medicines used to treat insomnia);
• anticonvulsant medicines (medicines used to treat seizures);
• anesthetic medicines (medicines used to treat pain and other sensations);
• barbiturates (medicines used to treat seizures);
• opioid analgesics (strong painkillers);
• antihistamine medicines (medicines used to treat allergies);
• cimetidine, omeprazole (medicines used to treat ulcers);
• ketokonazole (a medicine used to treat fungal infections);
• alcohol.

Diazepam Grindeks affects the elimination of phenytoin (a medicine used to treat epilepsy) from the body.
Cisapride (used to increase motility in the upper gastrointestinal tract) may temporarily enhance the sedative effect of Diazepam Grindeks.
Concomitant use of Diazepam Grindeks and opioids (strong painkillers, medicines used for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible.
If your doctor prescribes Diazepam Grindeks with opioids, they should limit the dose and duration of concomitant treatment.
You should inform your doctor about all opioid medicines you are taking and strictly follow your doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the possibility of the above symptoms. In case of any symptoms, you should contact your doctor.

Diazepam Grindeks with alcohol

It is not recommended to take Diazepam Grindeks with alcohol, as it may enhance the sedative effect (see Concomitant use with alcohol / medicines causing CNS depression).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.
You should not take this medicine during pregnancy.
If it is necessary to take Diazepam Grindeks for medical reasons and it is taken in late pregnancy or a high dose is used during delivery, the newborn may experience symptoms such as: irregular heartbeat, weakened sucking reflex, low body temperature, weakened muscle tone, and moderate breathing difficulties.
Diazepam passes into breast milk, so you should not take this medicine during breastfeeding.

Driving and using machines

Diazepam Grindeks may cause sedation, amnesia, concentration disorders, and muscle function disorders, so you should not drive vehicles or operate machines.

Diazepam Grindeks contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Diazepam Grindeks

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will adjust the dose of Diazepam Grindeks individually for you. To facilitate swallowing, the tablet can be divided into equal doses.
The recommended dose is:
Adults
The initial dose is 5-10 mg. The usual dose is 5-20 mg, depending on the severity of the symptoms. A single oral dose should not exceed 10 mg.
Elderly patients
Your doctor will reduce the dose of the medicine. Patients will be regularly monitored in the initial treatment period to enable the administration of the smallest effective dose.
Patients with liver function disorders
Your doctor will reduce the dose of the medicine.
Patients with chronic respiratory failure
Your doctor will reduce the dose of the medicine.
Duration of treatment
Treatment should be as short as possible (see Dependence) and should not exceed 2-3 months, including the period of gradual dose reduction.
In some cases, it may be necessary to extend the treatment beyond the recommended period; in such a case, your doctor will conduct a thorough, repeated assessment of your health status.

Use in children

The dose is 0.1-0.3 mg/kg body weight per day. Treatment should be as short as possible.

Overdose of Diazepam Grindeks

If you have taken more than the recommended dose of Diazepam Grindeks, contact your doctor immediately.
Overdose of Diazepam Grindeks may cause slowing of the central nervous system, including drowsiness, clumsiness, lack of coordination, speech disorders, and uncontrolled eye movements. Severe overdose may cause coma, problems with reflexes, and breathing difficulties. The depressant effect of benzodiazepines on the respiratory system is more pronounced in people with respiratory diseases.
Symptoms of overdose are more pronounced if you have also taken alcohol or other medicines that affect the central nervous system, which can be life-threatening.
In case of overdose, your doctor will monitor your vital signs and initiate appropriate treatment according to your clinical condition. In some patients, treatment of heart, circulatory, respiratory, or central nervous system function may be necessary.
To prevent further absorption of the medicine, activated charcoal should be given within 1-2 hours after the overdose. In special situations, if there has been concomitant overdose of different medicines, gastric lavage may be used.
In case of severe central nervous system depression, the administration of a medicine called flumazenil (which reverses the effects of diazepam) should be considered, and the patient's clinical condition should be monitored.

Missed dose of Diazepam Grindeks

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Withdrawal of Diazepam Grindeks

Do not stop taking the medicine suddenly without consulting your doctor. Your doctor may advise gradual reduction of the number of tablets taken until you stop treatment completely.
If you stop taking Diazepam Grindeks suddenly, you may experience symptoms such as: headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, loss of reality (derealization), feeling of "being outside one's body" (depersonalization), numbness, hypersensitivity to light, sound, and touch, hallucinations, and seizures may occur.
Diazepam Grindeks should be withdrawn gradually; otherwise, the symptoms of the disease may return with increased intensity (rebound insomnia and anxiety). The risk of these symptoms is higher in case of sudden withdrawal of the medicine. They may be accompanied by mood changes, anxiety, nervousness, and changes in sleep rhythm.
If you have any doubts about the use of the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diazepam Grindeks can cause side effects, although not everybody gets them.
The most commonly reported side effects are: fatigue, drowsiness, and muscle weakness. These effects are usually dose-dependent. They usually occur at the beginning of treatment and usually disappear after subsequent doses.
Dependence
Long-term use of the medicine (even in therapeutic doses) may lead to the development of physical and psychological dependence, and cessation of treatment may cause withdrawal symptoms or rebound effect.
Psychological disorders / paradoxical reactions
Paradoxical reactions have been reported, such as anxiety, excitement, irritability, agitation, delirium, aggression, nightmares, hallucinations, psychoses, inappropriate behavior, and other behavioral disorders associated with benzodiazepine use.
If you experience any of these symptoms, you should stop the treatment. These reactions occur more frequently in children and elderly patients.
Possible side effects:

• jaundice;
• increased liver enzyme activity in blood tests;
• confusion, emotional indifference, decreased alertness, depression, increased or decreased libido;
• uncoordinated movements, speech disorders, changed speech (slurred speech), headaches, tremors, dizziness, anterograde amnesia (loss of ability to remember, leading to partial or complete inability to recall recent past);
• double vision, blurred vision;
• dizziness;
• heart failure, including cardiac arrest;
• low blood pressure, circulatory depression (significant slowing of heart rate);
• respiratory depression (severe breathing difficulties), including respiratory failure;
• nausea, dry mouth or excessive salivation, constipation, and other gastrointestinal disorders;
• skin reactions;
• urinary incontinence, urinary retention;
• irregular heartbeat;
• falls and fractures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 the medicine.

5. How to store Diazepam Grindeks

Do not store above 25°C.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the package after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diazepam Grindeks contains

• The active substance of the medicine is diazepam ( Diazepam). Each tablet contains 5 mg of diazepam.
• The other ingredients are: lactose monohydrate, hydroxypropyl starch, microcrystalline cellulose, silicon dioxide, talc, magnesium stearate.

What Diazepam Grindeks looks like and contents of the pack

Tablet
The tablets are white, round, flat, with beveled edges, and have a dividing line on one side of the tablet.
Tablet dimensions: diameter 6.6-7.4 mm, thickness 2.5-2.7 mm.
10 tablets in a blister pack.
1, 2, or 3 blister packs (10, 20, or 30 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
Email: grindeks@grindeks.lv
To obtain more detailed information about this medicine, you should contact the marketing authorization holder.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Diazepam Grindeks
Portugal:
Diazepam Grindeks 5 mg comprimidos

Date of last revision of the leaflet: