Diazepam grindeks

Package leaflet: Information for the patient

Diazepam Grindeks, 5 mg, tablets
Diazepamum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, 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, which have a calming, anti-anxiety, anticonvulsant, muscle relaxant effect on skeletal muscles, and also a hypnotic effect.
Diazepam Grindeks is used for symptomatic treatment of anxiety states, tension, and other physical or psychological disorders associated with anxiety. It may also be used as an adjunct in the treatment of anxiety or agitation associated with mental disorders (e.g. behavioural 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 (inflammatory condition, trauma). It may also be used to relieve excessive muscle tension in conditions such as cerebral palsy and paraplegia (impairment of motor and sensory functions of the lower limbs), as well as in diseases characterized by slow and unusual movements, and in the treatment of progressive stiffness syndrome.
Benzodiazepines are indicated only when the disorder is severe, disabling, or causes extreme difficulty in the patient's functioning.

2. Important information before using Diazepam Grindeks

When not to use Diazepam Grindeks:

• if the patient is allergic to diazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has difficulty catching breath or breathing problems;
• if the patient has severe liver disease;
• if the patient has sleep apnoea (pauses in breathing during sleep);
• if the patient suffers from myasthenia gravis (a disease causing muscle weakness and excessive fatigue).

Benzodiazepines are not recommended as first-choice drugs for the treatment of psychotic disorders.
In patients with depression or anxiety associated with depression, benzodiazepines should not be used as the sole treatment (monotherapy), because suicidal tendencies may worsen in these patients.

Warnings and precautions
Before starting treatment with Diazepam Grindeks, discuss the following with your doctor or pharmacist:

• if the patient has previously abused alcohol or been dependent on drugs;
• if the patient is taking medicines that depress (calm) the central nervous system (CNS);
• if the patient is elderly, debilitated, or has heart or lung disease. In such cases, the doctor will adjust the dose;
• if the patient has depression;
• if the patient has impaired kidney or liver function.

Tolerance
After prolonged and repeated use, the sleep-inducing effect of benzodiazepines may diminish.

Dependence
The use of benzodiazepines and drugs similar to benzodiazepines may lead to psychological and physical dependence (see Possible side effects).
The risk of dependence increases with dose and duration of treatment. It is also higher in patients with a history of alcoholism or drug dependence.

Discontinuation of treatment
If physical dependence develops, abruptly stopping treatment may cause withdrawal symptoms, which may appear within hours, a week, or longer. These symptoms include: headache, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability. In severe cases, loss of reality perception, personality changes, limb numbness, hypersensitivity to light, sound, and touch, hallucinations, and epileptic seizures may occur. Inform your doctor if any of these symptoms occur.

Rebound insomnia and anxiety
After stopping the medicine, a temporary condition may occur in which the symptoms that led to benzodiazepine treatment return, sometimes in a more severe form. This may be accompanied by mood changes, anxiety, sleep disturbances, and restlessness. The risk of such rebound effects and anxiety is greater after abrupt discontinuation; therefore, your doctor will gradually reduce the dose.

Amnesia (anterograde amnesia)
This medicine may cause amnesia, and the risk increases with higher doses. Behavioural disturbances may accompany this amnesic effect.

Psychological and paradoxical reactions
While taking this medicine, paradoxical reactions such as restlessness, agitation, irritability, aggression, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour, and other adverse behavioural effects may occur. Inform your doctor if any of these symptoms occur, and discontinue treatment.

The likelihood of such reactions is higher in children and elderly patients.

Concomitant use with alcohol / medicines causing central nervous system (CNS) depression
Avoid concomitant use of Diazepam Grindeks with alcohol and (or) other medicines causing CNS depression. Concurrent use may enhance the effect of diazepam and may lead to: strong 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. A doctor may prescribe it only if other treatment methods are unavailable. 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 currently taking, have recently taken, or plan to take.

Concomitant use of Diazepam Grindeks with other medicines may enhance sedative effects and affect the respiratory and cardiovascular systems. These include:

• antipsychotics and antidepressants, e.g. fluvoxamine, fluoxetine (medicines used to treat depression and anxiety disorders);
• anxiolytics and sedatives (medicines used to treat anxiety);
• hypnotics (medicines used to treat insomnia);
• anticonvulsants (medicines used to treat epileptic seizures);
• anaesthetics (medicines used to treat pain and other sensations);
• barbiturates (medicines used to treat epileptic seizures);
• opioid analgesics (strong painkillers);
• antihistamines (medicines used to treat allergies);
• cimetidine, omeprazole (medicines used to treat ulcers);
• ketoconazole (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 in substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and even death. Therefore, concomitant use should only be considered when no other treatment options are available.
If your doctor prescribes Diazepam Grindeks together with opioids, the dose and duration of combination therapy should be limited.
Inform your doctor about all opioid medicines you are taking and strictly follow the doctor’s dosing instructions. It may be helpful to inform friends or family members about the possibility of the above-mentioned symptoms. Contact your doctor if any symptoms occur.

Diazepam Grindeks and alcohol
The use of Diazepam Grindeks with alcohol is not recommended, as it may intensify the sedative effect (see Concomitant use with alcohol / medicines causing CNS depression).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
This medicine should not be used during pregnancy.
If Diazepam Grindeks must be used for medical reasons late in pregnancy or a high dose is administered during delivery, the newborn may experience symptoms such as: irregular heartbeat, weakened sucking reflex, low body temperature, reduced muscle tone, and moderate breathing disturbances.

Diazepam passes into human milk; therefore, this medicine should not be used during breastfeeding.

Driving and operating machinery
Diazepam Grindeks may cause sedation, amnesia, concentration difficulties, and impaired muscle function; therefore, patients should not drive or operate machinery.

Diazepam Grindeks contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Diazepam Grindeks

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
The doctor will individually adjust the dose of Diazepam Grindeks for each patient. To facilitate
swallowing, the tablet may be divided into equal doses.

Recommended dose:
Adults
The initial dose is 5–10 mg. The usual dose is 5–20 mg, depending on the severity of symptoms.
The single oral dose must not exceed 10 mg.

Elderly patients
The doctor will reduce the dose of the medicine. Patients will be regularly monitored during the
initial treatment period to allow administration of the lowest effective dose.

Patients with impaired liver function
The doctor will reduce the dose of the medicine.

Patients with chronic respiratory insufficiency
The doctor will reduce the dose of the medicine.

Duration of treatment
Treatment should be as short as possible (see section Dependence) and should not exceed 2–3 months,
including the period of gradual dose reduction.
In certain cases, treatment may need to be extended beyond this period; in such a situation, the doctor
will perform a thorough reassessment of the patient's 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.

Taking more Diazepam Grindeks than prescribed
If more Diazepam Grindeks has been taken than prescribed, contact a doctor immediately.
Overdose of Diazepam Grindeks may cause depression of the central nervous system, including
drowsiness, clumsiness, lack of coordination, slurred speech, and uncontrolled eye movements.
Severe overdose may lead to coma, depressed reflexes, and breathing difficulties. The respiratory
depressant effect of benzodiazepines is more pronounced in patients with respiratory disorders.
Overdose symptoms are more severe if the patient has also taken alcohol or other medicines affecting
the central nervous system, which may be life-threatening.

In case of overdose, the doctor will monitor the patient's vital signs and initiate appropriate treatment
according to the patient's clinical condition. Some patients may require treatment for heart, circulatory,
respiratory, or central nervous system function.
To prevent further absorption of the medicine, activated charcoal should be administered within 1–2 hours
after overdose. In special circumstances, if overdose involves multiple drugs, gastric lavage may be considered.
In cases of severe central nervous system depression, administration of a medicine called flumazenil
(an antidote that reverses the effects of diazepam) should be considered; in such cases, close monitoring of
the patient's clinical condition is essential.

Missed dose of Diazepam Grindeks
If a dose is missed, take the medicine 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.

Stopping treatment with Diazepam Grindeks
Do not stop taking the medicine suddenly without first consulting your doctor. The doctor may recommend
gradually reducing the number of tablets taken until treatment is completely discontinued.

If treatment with Diazepam Grindeks is stopped abruptly, symptoms such as headache, muscle pain,
severe anxiety, tension, motor restlessness, confusion, and irritability may occur. In severe cases,
loss of reality perception (derealization), feeling of "leaving one's body" (depersonalization),
numbness and tingling of limbs, hypersensitivity to light, sound, and touch, hallucinations, and
epileptic seizures may occur.

Diazepam Grindeks should be discontinued gradually; otherwise, symptoms of the illness may return
with increased intensity (rebound insomnia and anxiety). The risk of these symptoms is greater if the
medicine is stopped suddenly. Mood changes, anxiety, nervousness, and changes in sleep rhythm may
also occur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly reported adverse effects are: fatigue, drowsiness, and muscle weakness.
These effects are usually dose-dependent. They typically occur at the beginning of treatment and usually subside after subsequent doses are administered.
Dependence
Prolonged use of the medicine (even at therapeutic doses) may lead to the development of physical and psychological dependence. Discontinuation of treatment may result in withdrawal symptoms or rebound effects.
Psychiatric disorders / paradoxical reactions
Paradoxical reactions such as irritability, restlessness, excitement, agitation, hallucinations, aggression, nightmares, delusions, psychoses, inappropriate behaviour, and other behavioural disturbances associated with benzodiazepine administration have been reported.
If any of the above symptoms occur, treatment should be discontinued.
These reactions occur more frequently in children and elderly patients.
Possible adverse effects:

• jaundice;
• increased liver enzyme activity in blood tests;
• confusion, emotional blunting, reduced alertness, depression, increased or decreased libido;
• uncoordinated movements, speech disorders, slurred speech, headache, tremor, dizziness, anterograde amnesia (impaired ability to form new memories, leading to partial or complete inability to recall recent events);
• double vision, blurred vision;
• dizziness;
• heart failure, including cardiac arrest;
• low blood pressure, circulatory depression (marked slowing of heart rate);
• respiratory depression (severe breathing difficulties), including respiratory failure;
• nausea, dry mouth or excessive salivation, constipation, and other gastrointestinal disturbances;
• skin reactions;
• urinary incontinence, urinary retention;
• irregular heartbeat;
• falls and fractures.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diazepam Grindeks

Do not store above 25°C.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
(Exp). The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Diazepam Grindeks contains

• The active substance is diazepam (Diazepamum). 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
White, round, flat tablets with bevelled edges and a division line on one side.
Tablet dimensions: diameter 6.6–7.4 mm, thickness 2.5–2.7 mm.
10 tablets in a blister pack.
1, 2 or 3 blisters (10, 20 or 30 tablets) in a cardboard box.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

For further information on this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Diazepam Grindeks
Portugal: Diazepam Grindeks 5 mg comprimidos