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

Diazepam is a medicine used to treat anxiety and tension in the benzodiazepine group.

Diazepam ratiopharm® 5 mg is used

    for the symptomatic treatment of acute and chronic tension, agitation and anxiety. The use of Diazepam in sleep disorders requiring treatment, which are caused by anxiety, tension and arousal, is only justified if at the same time the diazepam effects are desired during the daytime. Note: Not all states of tension, excitation and anxiety require drug therapy. Often they are expressions of physical or mental illness and can be influenced by other measures or by a therapy of the underlying disease.
    for reassurance and preparation (premedication) before surgical and diagnostic interventions or afterwards (postoperative medication).
    for the treatment of conditions with increased muscle tension (increased muscle tone).

2. What do you need to know before you take Diazepam?

Diazepam should not be taken

    if you are allergic (hypersensitive) to diazepam or other benzodiazepines or any of the other ingredients of Diazepam ratiopharm 5 mg
    Dependent disease in history (alcohol, drugs, drugs)
    in certain forms of severe, pathological muscle weakness (myasthenia gravis)

Take special care with Diazepam

    acute poisoning with alcohol, sleeping and painkillers as well as preparations for the treatment of mental and emotional disorders (neuroleptics, antidepressants and lithium)
    Disorders of the ordered interaction of muscle groups (spinal and cerebellar ataxias)
    acute increase in intraocular pressure (narrow-angle glaucoma, cataract)
    severe liver damage, eg. B. Jaundice with biliary congestion (cholestatic jaundice)
    Respiratory dysfunction in sleep (sleep apnea syndromes)
    Patients with organic brain changes
    Circulatory and respiratory weakness (chronic obstructive respiratory insufficiency)

Prolonged intake is recommended for blood and liver function.

This medicine contains a "benzodiazepine". Benzodiazepines are medicines used to treat certain conditions associated with restlessness, anxiety, inner tension or insomnia. When using benzodiazepines there is a danger of training or promoting dependency. Even with daily intake over a few weeks, the danger of a dependency development is given. This applies not only to the misuse of particularly high doses, but also to the therapeutic dose range. To minimize this risk, you are advised to pay close attention to the following:

    Benzodiazepines have been created solely for the treatment of morbid conditions and may only be taken on medical advice.
    At the latest after 4 weeks of taking the doctor should decide whether a treatment must be continued. Continuous, longer-term intake should be avoided as it can lead to dependency. Taking it without a doctor's prescription reduces your chances of helping you with these medicines.
    Never increase the dose prescribed by the doctor, even if the effect wears off. By unauthorized dose increase, the targeted treatment is difficult.
    When discontinued after prolonged use, restlessness, anxiety and insomnia can occur, often with a few days delay. These settling symptoms generally disappear after 2-3 weeks.
    If you are or have ever been addicted to alcohol, medicines or drugs, you should not take benzodiazepines; rare, only situations to be judged by the doctor. Tell your doctor about this.
    Never take medicines containing benzodiazepines because they have "helped others so well" and never give them to others.

Taking Diazepam with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Concomitant use of other drugs acting on the nervous system may increase the effects of each other. These medicines include, for. B. preparations for the treatment of mental disorders (psychotropic drugs), sleeping pills, some painkillers, anesthetics or certain drugs for the treatment of allergies or colds (antihistamines).

The effect of medicines that lower muscle tension (muscle relaxants) can be strengthened.

If you are taking cimetidine or omeprazole (medicines used to treat stomach ulcers, for example) or disulfiram (medicines used to treat alcohol withdrawal), the effects of Diazepam may be increased and prolonged.

In smokers, the excretion of diazepam can be accelerated.

Theophylline (medicines used to treat, for example, asthma) in low doses relaxes Diazepam sedation.

Diazepam may inhibit the effects of levodopa (Parkinson's disease medicines).

In rare cases, Diazepam can inhibit the metabolism of phenytoin (an epilepsy drug) and increase its effectiveness. Phenobarbital and phenytoin (medicines used to treat epileptic seizures) can accelerate the metabolism of Diazepam.

In patients undergoing long-term treatment with other medicinal products, such as For example, certain medicines for high blood pressure (centrally effective antihypertensive agents, beta-adrenoceptor blockers), anticoagulants and cardiovascular agents (cardioactive glycosides) are unpredictable in their nature and extent. Therefore, special care should be taken when taking the product at the same time, especially at the beginning of treatment. Tell your doctor if you are receiving such long-term treatment.

Due to slow excretion of diazepam from the body, you should still expect possible interactions after stopping treatment with Diazepam.

Taking Diazepam with food and drink

Avoid alcohol during treatment with Diazepam, as alcohol will alter and enhance the effects of Diazepam unpredictably.

pregnancy and breast feeding period

In pregnancy, you should only use Diazepam in exceptional cases for compelling reasons. If you become pregnant or suspect you are pregnant while receiving Diazepam-ratiopharm®, tell your doctor immediately. Long-term use of Diazepam during pregnancy may lead to withdrawal symptoms in the newborn. The administration of larger doses before or during childbirth can cause a lowered body temperature, depressed respiration, reduced muscle tension and dehydration (so-called "floppy-infant syndrome") in the infant.

During breast-feeding, you should not use Diazepam as diazepam, the active substance in Diazepam, and its breakdown products are excreted in breast milk. If treatment is inevitable, it should be weaned.

Driving and using machines

This medicinal product, even when used properly, may alter the ability to react so far as to affect the ability to drive or operate machinery. This applies even more in combination with alcohol.

Therefore, you should refrain from driving, operating machinery or any other dangerous activity altogether, or at least during the first few days of treatment. The decision in each individual case is made by the treating physician, taking into account the individual reaction and the respective dosage.

Important information about some of the ingredients of Diazepam

This medicine contains lactose. Therefore, you should only take Diazepam after consulting your doctor, if you are aware that you have an intolerance to certain sugars.

3. How to take Diazepam?

Always take Diazepam exactly as your doctor has told you. Please check with your doctor or pharmacist if you are not sure.

The dosage depends on the individual reaction situation, age and weight of the patient as well as the type and severity of the clinical picture. The principle is to keep the dose as low and the duration of treatment as short as possible.

Unless otherwise prescribed by the doctor, the usual dose is

Treatment-requiring tension, excitement and anxiety

Out-of-hospital treatment Adults and adolescents over the age of 14 take 1 tablet once daily or ½ tablet twice daily (equivalent to 5 mg diazepam per day) at the beginning of treatment. If at this dose the desired effects can not be achieved, the dose may be increased by the doctor twice daily 1 tablet or once daily 2 tablets (equivalent to 10 mg diazepam per day). Higher doses are only necessary in rare cases (eg psychiatric and neurological diseases) and are usually only in the hospital.

Inpatient treatment In severe tension, agitation, anxiety and restlessness, the dose may be gradually increased to 3 to 6 times daily 2 tablets (equivalent to 30-60 mg diazepam per day). Dosage strengths of 10 mg are also suitable for this purpose.

Treatment of conditions with increased muscle tension

At the beginning of the treatment, take 1 tablet (equivalent to 10-20 mg diazepam per day) 2 to 4 times a day. To continue treatment, 1 tablet (equivalent to 5-10 mg diazepam per day) is sufficient once or twice daily.

For reassurance and surgical preparation in anaesthesiology and surgery or afterwards (premedication / postoperative medication)

On the eve of surgery adults receive 2-4 tablets (equivalent to 10-20 mg diazepam). After the operation Adults receive 1-2 tablets (equivalent to 5-10 mg diazepam), if necessary a repetition is possible.

Special dosage instructions

Elderly or weakened patients as well as patients with organic brain changes, circulatory and respiratory dysfunction as well as impaired liver or kidney function as well as children over the age of 3 and adolescents up to the age of 14 generally receive half of the daily dosage indicated above; H. initially ½ tablet per day (equivalent to 2.5 mg diazepam) to a maximum of 1 tablet (5 mg diazepam).

type of application

Take Diazepam whole with plenty of fluid. The tablets are divisible. For outpatient treatment of tension, agitation and anxiety, you should take Diazepam mainly in the evening.

In the evening you should take Diazepam about half an hour before going to bed and not on a full stomach, otherwise with delayed onset of action and - depending on the sleep duration - with increased after effects (eg, tiredness, difficulty concentrating) next Morning must be expected.

For inpatient treatment of tension, excitement and anxiety, as well as for the treatment of conditions of increased muscle tension, you should take Diazepam throughout the day regardless of the meals.

Duration of application

Depending on the type and severity of the disease, the doctor will decide on the duration of the dose.

In acute tension, agitation and anxiety, you should limit the use of Diazepam to single doses or a few days.

In chronic tension, agitation and anxiety, the duration of ingestion depends on the course. After 2 weeks of daily use, the doctor should determine by a gradual dose reduction if further treatment with Diazepam is indicated. However, you should not use Diazepam for more than 4 weeks in chronic tension, agitation and anxiety.

For prolonged periods of use (longer than 1 week), the dose should be gradually reduced when discontinuing Diazepam. You must be aware of possible withdrawal symptoms (see "If you stop taking Diazepam ratiopharm® 5 mg").

For the preparation of surgical or diagnostic procedures, as well as for the treatment of conditions with increased muscle tension, the drug is generally used at short notice.

If you have the impression that the effect of Diazepam is too strong or too weak, talk to your doctor or pharmacist.

If you take more Diazepam ratiopharm 5 mg than you should

In case of overdose, the doctor should ask for advice. Regardless, you can try to empty the stomach contents by forced vomiting. Each time a poisoning is assessed, consideration should be given to multiple poisoning by possible ingestion / use of multiple drugs. The symptoms of overdose are more pronounced under the influence of alcohol and other brain depressants.

Symptoms of overdose and necessary action

Symptoms of mild overdose can be Confusion, drowsiness, gait and movement disorders, slurred speech, drop in blood pressure, muscle weakness. If such signs of disease appear, a doctor should be informed immediately, who decides on the severity and any further measures that may be required.

In cases of severe poisoning, central reduction of cardiovascular and respiratory functions may occur with blue-red staining of the skin and mucosa, unconsciousness or even respiratory arrest or cardiac arrest. In such cases intensive monitoring is necessary!

High levels of arousal may occur during the decay phase.

If you forget to take Diazepam

Take the prescribed dose at the next scheduled time, but never twice the dose.

If you stop taking Diazepam

If you want to stop treatment, talk to your doctor first. Do not terminate the medical treatment without your doctor's advice. You can endanger the success of therapy.

By sudden discontinuation of the drug after prolonged daily use may occur after about 2-4 days insomnia and increased dreams. Anxiety, states of tension as well as arousal and inner restlessness can get more intensified. The appearance can manifest itself in tremors and sweating and may increase to threatening physical (eg, convulsions) and mental reactions such as symptomatic psychosis (eg withdrawal delirium).

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. Side effects of diazepam

Frequently

Unwanted strong calm during the day as well as fatigue (drowsiness, fatigue, drowsiness, prolonged reaction time), dizziness, gait and movement disorders, headache, confusion; In addition, temporary memory lapses may occur after taking diazepam.

Concentration disorders and residual fatigue may affect responsiveness in the morning after evening administration.

Due to the pronounced muscle-relaxing effect of Diazepam, caution (risk of falling!) Is required especially in the elderly.
Rare

gastrointestinal upset (nausea, vomiting, abdominal discomfort, constipation, diarrhea), jaundice, urinary retention, fits of cramps, chest pain, drop in blood pressure, slowing of heartbeat, depression, decreased sexual desire, and in menstruation disorders , Appetite increase, dry mouth, allergic skin changes (such as itching, redness, rash) as well as respiratory damping.

The atraumatic effect may be more pronounced in the case of existing respiratory distress due to narrowed airways and in patients with brain damage. This is especially important when used with other medicines that affect the brain.

Excessive doses of the drug for several days may cause colicky abdominal pain and diarrhea.

High doses and prolonged use of Diazepam may cause temporary disturbances such as slow or slurred speech, visual disturbances (double vision, blurred vision, eye shaking), movement and gait insecurity.

Prolonged or repeated use of Diazepam may lead to a decrease in the effect (so-called tolerance development).

In patients with pre-existing depressive illness depressive moods can be exacerbated. There is also the possibility that sensory disorders (hallucinations) occur or an inversion of activity ("paradoxical reactions"), such. As acute arousal states, anxiety, suicidality (suicidal tendencies), sleep disorders, tantrums or increased muscle spasms occurs.

Weaning phenomena: See 3. under "If you stop taking Diazepam ratiopharm® 5 mg".

countermeasures

If you experience one or more of the above side effects, tell your doctor so that he or she can decide on the severity and any other necessary measures. Side effects generally recur after dose reduction and can usually be avoided by careful and individual adjustment of daily doses.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Diazepam?

Store drug out of reach of children.

Do not use after the expiry date which is stated on the carton and blister packs. The expiration date refers to the last day of the month.

This medicinal product does not require special storage conditions.