diazepam ratiopharm 5 tablets
drug: diazepam 5 mg
composition
Active ingredient: 1 tablet contains 5 mg diazepam.
Other ingredients: lactose, corn starch, cellulose powder, copolyvidone, talc, silica, magnesium stearate.
dosage form and content pack of 10 tablets (N1)
Pack 20 tablets (N2)
box of 50 tablets (N3)
Pharmacotherapeutic group antidote to fear and tension from the group of benzodiazepines.
Authorisation Holder and Manufacturer Pharmaceutical company: ratiopharm GmbH Graf-Arco-Str. 3, 89079 Ulm
Phone: (07 31) 4 02 02, Fax: (07 31) 4 02 73 30
Manufacturer: Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren
Phone: (0 73 44) 1 40, fax: (0 73 44) 14 16 20
applications - -Symptomatic treatment of acute and chronic Stress, arousal and anxiety.
The use of diazepam ratiopharm 5 in need of treatment sleep disorders that are caused by anxiety, tension and excitement is justified only if at the same day the diazepam-effects are desired.
Note: Not all stress, arousal and anxiety states require drug therapy. Often they are an expression of physical or mental illness and may be influenced by other means or by treatment of the underlying disease.
- to calm and preparation (pre-medication) to surgical and diagnostic procedures or after (post-operative medication)
- to treat conditions with increased muscle tone (increased muscle tone)
Contraindications When you should not take Diazepam-ratiopharm 5? You may Diazepam-ratiopharm 5 does not apply in
- known hypersensitivity to diazepam or other benzodiazepines or any of the other ingredients
- dependence disorder in the history (alcohol, drugs, drugs)
- certain forms of serious, abnormal muscle weakness (myasthenia gravis)
When should Diazepam-ratiopharm 5 take place after consultation with your doctor? The following describes when you may Diazepam-ratiopharm only under certain conditions and with caution. Consult your doctor for this. This is true even if the information is accurate when you used to be. You may Diazepam-ratiopharm 5 apply only with caution in
- acute intoxication with alcohol, sleeping and pain medications and medications to treat mental and emotional disorders (antipsychotics, antidepressants and lithium)
- disorders of the parent interaction between muscle groups (spinal cerebellar ataxia and)
- acute increase in intraocular pressure (narrow-angle glaucoma, glaucoma)
- in severe liver damage such as jaundice with biliary obstruction (cholestatic jaundice)
- with breathing disorders during sleep (sleep apnea syndromes)
you take during pregnancy? You should not use during pregnancy diazepam-ratiopharm 5th Please apply to your doctor about the occurrence of a pregnancy so that he can decide on the termination or continuation of the therapy.
A longer-term use of diazepam ratiopharm 5 in the pregnancy through habituation and dependence withdrawal symptoms neonatal lead.
doses greater doses before or during birth can cause a lowered body temperature in infants, low blood pressure, depressed respiration and poor feeding (so-called "floppy infant syndrome").
What have you observed in breast-feeding? While breastfeeding you should not take Diazepam-ratiopharm 5, proceed as diazepam ratiopharm 5 and its metabolites in breast milk. If treatment is unavoidable, should be discontinued.
What has to be considered in children and older people? newborns and infants up to age of 6 months of treatment with diazepam ratiopharm 5 excluded. Exceptions are possible for treatment for urgent reason for ingestion under hospital conditions.
Treatment of children and young people under 14 with diazepam ratiopharm 5 should only be made when strictly indicated.
in elderly or debilitated patients and patients with organic brain changes, circulatory and respiratory failure (chronic obstructive respiratory insufficiency), and renal or hepatic impairment caution (dosage instructions!).
precautions for use and warnings What precautions should be taken? diazepam ratiopharm 5 has an addictive property (primary dependence potential). Already a few weeks of daily dosing on the risk of developing dependence is given. This applies not only to the most abusive use of high doses, but also for the therapeutic dose range.
Prolonged intake controls the blood count and liver function are recommended.
What do you need on the road and at work when working with machinery and unsafe conditions? This medicine can also be intended Use the reactivity change to the extent that the ability is impaired to participate actively drive or operate machinery. This applies even more in combination with alcohol.
Therefore, you should drive vehicles that use machines, or other dangerous activities entirely omitted or at least during the first days of treatment. The decision in each case, the attending physician shall, having regard to the individual reaction and the respective dosage.
Things to watch out for? An uninterrupted for more than 4-week intake should be avoided because it can lead to addiction. With an intake without medical advice reduces the chance to help you with this medicine. Later than four weeks of taking to the doctor decide whether treatment should be continued.
Increase in no case by the physician prescribed dose, not even then, when the effect wears off. Unauthorized dose increase the targeted treatment is difficult.
At weaning after prolonged use can occur, often with delays of several days, restlessness, anxiety and insomnia. The withdrawal symptoms usually disappear after 2-3 weeks.
If you are currently or used to be dependent on alcohol, drugs or drugs or have been, you should not take benzodiazepines, except for rare, only by a doctor to be assessed situations. Make your doctor aware of this fact.
Take benzodiazepine drugs containing a never because they have helped others as well.
interactions with other agents What other drugs affect the action of diazepam ratiopharm 5 and what to consider when you are taking other medicines?
Please note that this information also apply to recently administered drugs can! when co-administered to the nervous system acting drugs (eg, psychotropic drugs [drugs to treat mental and emotional disorders], sleeping pills, partly analgesics, anesthetics or antihistamines [medicines such as to treat allergies or colds ]) it can lead to mutually reinforcing effects.
The effect of drugs that reduce the muscle tension (muscle relaxants) may be enhanced.
Concomitant administration of cimetidine or omeprazole (medicines to treat stomach ulcers, for example) or disulfiram (drug treatment for alcohol withdrawal), the effect of diazepam ratiopharm 5 are reinforced and extended.
In smokers, the elimination of diazepam-ratiopharm 5 are accelerated.
theophylline (a medicine used to treat asthma, for example) does low-dose diazepam on by-ratiopharm 5 causes sedation.
diazepam ratiopharm 5, the effect of levodopa (used for treatment of paralysis agitans [Parkinson disease]) inhibit.
In rare cases, by diazepam ratiopharm 5 of the metabolic breakdown (metabolism) of phenytoin (a medicine used to treat epilepsy) and inhibited the effect will be reinforced. Phenobarbital and phenytoin (used to treat seizure disorders) may accelerate the metabolic elimination of diazepam ratiopharm 5th
In patients who are chronically treated with other drugs, such as centrally acting antihypertensive agents (on the nervous system acting agents for high blood pressure), beta-blockers (on the heart-acting remedy for high blood pressure), anticoagulants ( anticoagulant agent) and cardiac glycosides (means of reinforcing the strength of the heart are) the nature and extent of interactions can not predict. Therefore, while taking the drug, especially at the beginning of treatment, particular care. The clinician should therefore prior to administration clarify of diazepam-ratiopharm 5 whether there are corresponding continuous treatment.
Because slower elimination of diazepam in the body (elimination) you also need to stop treatment with diazepam ratiopharm 5 still face possible interactions.
What beverage, food and beverages you should avoid? during treatment with diazepam ratiopharm 5, you should avoid alcohol, because alcohol is changed, the effect of diazepam ratiopharm 5 in unpredictable ways and reinforced.
Dosage and duration of application The following information applies, where you did your doctor not diazepam ratiopharm 5 otherwise. Please follow the instructions since diazepam ratiopharm 5 can not act properly. The dosage depends on the individual response location, age and weight of the patient and the nature and severity of the disease. Here the principle applies, the dose so low and keep the treatment time as short as possible. As much as
of diazepam-ratiopharm 5 and often should you apply diazepam ratiopharm 5? - - requiring treatment tension, excitement and anxiety
treatment outside the hospital: adults and young people take more than 14 years at the start of treatment 1 by 1 tablet or 2 x ½ tablet diazepam ratiopharm 5 (equivalent to 5 mg diazepam) per day. If at this dose, the desired effects can not be achieved, the dose from the doctor 2 times 1 times 1 tablet or 2 tablets of Diazepam-ratiopharm 5 (corresponding to 10 mg diazepam) to increase per day. Higher doses are necessary only in rare cases (such as psychiatric and neurological disorders) and generally occur only in the hospital.
Hospitalization In the case
severe stress, excitement, anxiety and agitation, the dose gradually increased to 2 tablets 3-6 times diazepam ratiopharm 5 (corresponding to 30-60 mg diazepam) per day. (This is also the Darreichungsstärke to 10 mg.)
- treatment of conditions with increased muscle tension
Take one at the beginning of the treatment 2-4 times a tablet diazepam ratiopharm 5 (corresponding to 10-20 mg diazepam) per day.
enough to continue treatment 1-2 times a tablet diazepam ratiopharm 5 (corresponding to 5-10 mg diazepam) per day. - To calm in preparation for surgery and anesthesiology and surgery or after (pre-medication / postoperative medication):
On the eve of Operation: 2-4 adults receive
Tablets diazepam ratiopharm 5 (corresponding to 10-20 mg diazepam).
After surgery:
adults receive 1-2 tablets diazepam ratiopharm 5 (corresponding to 5-10 mg diazepam), and if necessary repeat operation.
Special dosage instructions
elderly or debilitated patients and patients with organic brain changes, cardiovascular and respiratory weakness, and impaired liver or kidney function, and children over 3 years and adolescents up to 14 years are generally half the above-mentioned daily dose, ie first ½ tablet per day diazepam ratiopharm 5 (corresponding to 2.5 mg diazepam) to a maximum of 1 tablet (5 mg diazepam).
How and when should you take Diazepam-ratiopharm 5? Take Diazepam-ratiopharm 5 whole with sufficient fluid. (The tablets are divisible.)
should the case of outpatient treatment of stress, excitement and anxiety you are taking Diazepam-ratiopharm 5 mainly in the evening.
In-patient treatment of stress, arousal and anxiety and in the treatment of conditions with increased muscle tone should you take distributed diazepam ratiopharm 5 on the day without food.
evening, you should Diazepam-ratiopharm 5 about ½ hour before bedtime and not take on a full stomach, otherwise must be expected with increased after-effects (eg fatigue, concentration problems) the next morning - with a delayed onset and - depending on the duration of sleep.
How long should you use diazepam ratiopharm 5? The duration of application, the doctor will decide the type and severity of the disease.
In acute stress, arousal and anxiety, you should limit the use of diazepam ratiopharm 5 on individual gifts or a few days.
In chronic stress, arousal and anxiety, the duration of the application depends on the course. After 2 week daily dosing should be clarified by the doctor by a progressive reduction of the dose, if further treatment is indicated with diazepam ratiopharm 5th However, you should not even in chronic tension, excitement and anxiety diazepam ratiopharm 5 more apply than 4 weeks.
With prolonged use (longer than 1 week) should be used when issuing diazepam ratiopharm 5, the dose should be gradually reduced. Here, you have to expect the occurrence of withdrawal reactions (see "Side Effects").
In preparation for surgical or diagnostic procedures and for the treatment of conditions with increased muscle tension, the drug is generally used short-term.
overdose and other application errors What to do when diazepam was used-ratiopharm 5 in excessive quantities (intentional or accidental overdose)? In case of overdose, the doctor is to ask for advice. Regardless, you can try to empty through a forced vomiting stomach contents. In any assessment of poisoning should be considered in the presence of multiple possible poisoning by ingestion / use of multiple drugs.
Symptoms of overdose are increased under the influence of alcohol and other dampening effect on the brain agents acting on.
symptoms of overdose and action required symptoms can easily overdose such as confusion, sleepiness (somnolence), his gait and movement disorders (ataxia), slurred speech (dysarthria), hypotension, muscular weakness. If such symptoms appear, is a doctor immediately to inform the decision on the severity and any necessary further action.
In cases of severe poisoning are central to a reduction in cardiovascular and respiratory functions (blue-red color of skin and mucous membrane [cyanosis], loss of consciousness lead to respiratory arrest, cardiac arrest occur). In such cases, an intensive monitoring is necessary!
for the abolition of the central depressant effects of benzodiazepines flumazenil is indicated. It is used for example in the following indication: ". Repeal of sedation induced by benzodiazepines in therapeutic interventions in hospitalized patients"
The decay can occur severe agitation.
What should have in mind when you have too little diazepam ratiopharm taken five or forget a dose? Take the next scheduled time, the prescribed dose one, but not twice as much.
What you need, when you stop the treatment or prematurely? If you want to interrupt the treatment, discuss this with your doctor. Quit acting independently of the drug treatment without medical advice. You can thus jeopardize the success of treatment.
side effects What side effects can occur when taking Diazepam-ratiopharm 5? must reckon with the following side effects common:
undesirable heavy sedation during the day and sleepiness (somnolence, Fatigue, dizziness, prolonged reaction time), dizziness, gait and movement disorders (ataxia), headache, confusion, temporary memory loss can also after administration of diazepam (anterograde amnesia) may occur.
can the morning after the evening administration affect over effects in the form of fatigue, impaired concentration, and residual reaction time.
Because of the marked muscle relaxation effect of diazepam ratiopharm 5, especially in the elderly care (fall hazard) offered.
rarely causes gastrointestinal disturbances (nausea, vomiting, abdominal pain, Constipation, diarrhea), jaundice, urinary retention, laryngospasm (Glottisspasmen), chest pain, blood pressure, slowed heart rate (bradycardia), depression (depression), decrease of sexual need and for women to disturbances of menstruation, increased appetite, dry mouth, allergic skin disorders (such as such as itching, skin redness, rash) and respiratory loss.
The respiratory depressant effect may, based on breathing through narrowed airways (airway obstruction) and are increased in patients with brain damage in appearance. This is especially when co-administered with other drugs acting on the brain be observed.
In high doses and prolonged use of diazepam ratiopharm 5, temporary disturbances such as slowed or slurred speech (articulation disorder), visual disturbances (double vision, blurred vision, nystagmus) may occur, movement and gait instability.
for prolonged or repeated oral doses of diazepam ratiopharm 5, it can lead to loss of effect (tolerance) can occur.
in patients with underlying depressive illness depression can be enhanced.
There is also the possibility that there are sensory disturbances (hallucinations) or an effect of reversal (paradoxical reactions), such as acute agitation, anxiety, suicidality (suicidal tendencies), sleep disturbances, temper tantrums or increased muscle spasms occur.
Sudden discontinuation of the drug after prolonged daily dosing may occur after 2-4 days of insomnia and increased dreaming. Anxiety, tension and excitement and agitation can be adjusted to become once again. The appearance can manifest itself in trembling and sweating and increase up to threatening physical (eg, seizures) and emotional reactions such as symptomatic psychoses (eg Entzugsdelir) (see also counter-measures for side effects).
If you notice any side effects that are not listed in this leaflet, please inform your doctor or pharmacist. What counter measures are taken if side effects? If you observe one or more of the above side effects with them, tell your doctor so that he can decide on the severity and any necessary further action. Side effects are usually explained by reduction in the dose and can usually avoid by careful and individual adjustment of doses.
Notes and data concerning the stability of the drug The expiry date of this medicine is printed on the carton and blister packs. Use this medicine after this date!
Note contains the patient This drug is a "benzodiazepine".
Benzodiazepines are drugs used to treat certain disease states associated with restlessness and anxiety, internal tension and insomnia. With the use of benzodiazepines is the risk of training or promotion of a dependency. To minimize this risk as small as possible, you are advised to The following instructions should be observed:
- benzodiazepines have been created solely for the treatment of pathological conditions and may be taken only on medical advice. At the latest after 4 weeks of taking
- to the doctor decide whether treatment should be continued. A continuous, long-term use should be avoided because it can lead to addiction. With an intake without medical advice reduces the chance to help you with these drugs.
- Increase in no case by the physician prescribed dose, not even then, when the effect wears off. Unauthorized dose increase is the specific treatment difficult.
- discontinuation after prolonged use can - occur restlessness, anxiety and insomnia - often with delays of several days. These withdrawal symptoms usually disappear after 2-3 weeks.
- If you are currently or used to be dependent on alcohol, drugs or drugs or have been, you should not take benzodiazepines, rare, only to be assessed by a doctor other than situations. Make your doctor aware of this fact.
- Take Benzodiazepine drugs containing a never because they "have helped other so well and never give these medicines to others.
prior information
January 1999
Always make sure, Diazepam-ratiopharm ® 5 mg tablets be retained, that this medicine for children is not to achieve!
version code Z01
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