Инсомин таблетки турция инструкция по применению

Insomin tablets should not be used alone to treat depression or anxiety with depression, since suicide may be precipitated in such patients.

In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced. Benzodiazepines are contraindicated in patients with severe hepatic insufficiency.

Benzodiazepines are not recommended for the primary treatment of psychotic illness. If the patient is awoken during the period of maximum drug activity, recall may be impaired.

In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

Insomnia

An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.

Tolerance

Some loss of efficacy, due to the hypnotic effects of benzodiazepines, may develop after repeated use for a few weeks.

Dependence (including use with alcohol) and withdrawal

Use of benzodiazepines may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential; routine repeat prescriptions should be avoided and treatment should be withdrawn gradually. Symptoms such as depression, headaches, muscle weakness, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, rebound insomnia, irritability, sweating, and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time.

When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact and hallucinations or epileptic seizures. In rare instances, withdrawal following excessive dosages may produce confusional states and psychotic manifestations and convulsions. Abuse of the benzodiazepines has been reported.

Rebound insomnia and anxiety

This is a transient syndrome that may occur on withdrawal of treatment whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.

Duration of treatment

The duration of treatment should be as short as possible (see 4.2 Posology and method of administration) depending on the indication, but should not exceed 4 weeks for insomnia, including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation. Routine prescriptions should therefore be avoided.

It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.

There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.

When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop.

Amnesia

Benzodiazepines may induce anterograde amnesia. The condition occurs most often one to two hours after taking the product and may last several hours, therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours.

Psychiatric and paradoxical reactions

Extreme caution should be used in prescribing Insomin to patients with personality disorders.

Reactions like restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects (such as the uncovering of depression with suicidal tendencies) are known to occur when using benzodiazepines. These reactions may be quite severe and are more likely to occur in the elderly and children. Should this occur, use of the medicinal product should be discontinued.

Specific patient groups

Due to the myorelaxant effect there is a risk of falls and consequently of hip fractures particularly for elderly patients when they get up at night.

Hypoalbuminaemia (may predispose patient to higher incidence of sedative side effects).

Care should be exercised in patients with epilepsy since there have been reports of rare paradoxical exacerbation of seizures in these patients.

Care should be taken in patients with chronic renal or hepatic disease as the elimination half-life of Insomin may be prolonged.

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                                1 
 
KULLANMA TALİMATI 
 
İ
NSOMİN DRAJE 50 MG  
AĞIZDAN ALINIR. 
 
_ETKIN MADDE_: Bir draje 50 mg opipramol dihidroklorür içerir. 
 
_YARDIMCI  MADDELER  :  _Laktoz  monohidrat,  Avicel,  PVP  K30,  Kurutulmuş  nişasta,  Magnezyum 
stearat,  
Kaplama maddeleri : Sodyum karboksimetilselüloz, titanyum dioksit, etil selüloz, gliserol oleat, 
polisorbat 80, PVP K30, şeker, aerosil 200, talk, sunset yellow S lake, brilliant scarlet 4 R lake, 
PEG 6000 NF. 
 
 
BU  ILACI  KULLANMAYA  BAŞLAMADAN  ÖNCE  BU  KULLANMA  TALİMATINI  DIKKATLICE 
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR. 
 
•  _Bu  kullanma  talimatını  saklayınız.  Daha  sonra  tekrar  okumaya  ihtiyaç _
_duyabilirsiniz. _
•  _Eğer ilave sorularınız olursa, lütfen doktorunuza veya eczacınıza danışınız. _
•  _Bu ilaç kişisel olarak sizin için reçete edilmiştir, başkalarına vermeyiniz. _
•  _Bu  ilacın  kullanımı  sırasında,  doktora  veya  hastaneye  gittiğinizde  doktorunuza  bu _
_ilacı kullandığınızı söyleyiniz. _
•  _Bu  talimatta  yazılanlara  aynen  uyunuz.  İlaç  hakkında  size  önerilen  dozun  dışında _
_YÜKSEK VEYA DÜŞÜK doz kullanmayınız.  _
 
 
 
BU KULLANMA TALIMATINDA: 
 
_1. _
_İ_
_NSOMİN  NEDIR VE NE IÇIN KULLANILIR? _
_2. _
_İ_
_NSOMİN'I KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER _
_3. _
_İ_
_NSOMİN  NASIL KULLANILIR? _
_4. _
_OLASI YAN ETKILER NELERDIR? _
_5. _
_İ_
_NSOMİN ' IN SAKLANMASI _
_ _
BAŞLIKLARI YER ALMAKTADIR. 
1.
  İNSOMİN NEDIR VE NE IÇIN KULLANILIR? 
 
İ
NSOMİN sakinleştirici özelliklere sahip trisiklik antidepresanlar olarak bilinen bir ilaç grubuna 
dahildir. Bu ilaç beyninizdeki bazı kimyasal maddelerin etkisini değiştirerek etkili olur. 
Her
                                
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Характеристики продукта

                                1 
 
KISA ÜRÜN BİLGİLERİ 
 
1. BEŞERİ TIBBİ ÜRÜNÜN ADI 
 
İ
NSOMİN draje 50 mg 
                                                                                                                                                                       
2. KALİTATİF VE KANTİTATİF BİLEŞİM 
 
ETKIN MADDE :  
Opipramol dihidroklorür 50 mg  
 
YARDIMCI MADDELER :   
Laktoz Monohidrat 
 
37.0 mg 
Ş
eker 
 
47.913 mg 
Sunset Yellow S Lake (E110)   
0.080 mg 
Brilliant scarlet 4R Lake (E124) 
0.059 mg 
 
Yardımcı maddeler için 6.1'e bakınız. 
 
3. FARMASÖTİK FORM   
 
Draje 
İ
NSOMİN drajeler uçuk pembe renkli, yuvarlak şeklindedir. 
 
4. KLİNİK ÖZELLİKLER 
 
4.1. TERAPÖTIK ENDIKASYONLAR 
 
YETIŞKINLER: 
Depresif  durumun  eşlik  ettiği  ruhsal  hastalıklar,  anksiyete  ve  somatoform  bozukluklar  ve 
psikosomatik hastalıklara bağlı sekonder ruhsal belirtilerin tedavisinde kullanılabilir. 
 
ÇOCUKLAR VE ERGENLER: 
Çocuklar  ve  ergenlerdeki  güvenilirlik  ve  etkinliği  henüz  saptanamamış  olup,  çocuk  ve 
ergenlerde (0-17 yaş) kullanılması önerilmez. 
 
4.2. POZOLOJI VE UYGULAMA ŞEKLI 
 
POZOLOJI / UYGULAMA SIKLIĞI VE SÜRESI:  
YETIŞKINLER 
Hafif  vakalarda  tercihen  akşamları  olmak  üzere  günde  1-2  draje,  orta  derecede  ciddi 
vakalarda 1 draje sabah, 2 draje akşam veya günde 3 defa 1 er draje yemek ile beraber veya 
yemekten sonra; şiddetli vakalarda günde 3 defa 2 şer draje alınabilir. 
İ
NSOMİN'in  etkisi  derhal  başlamadığından  ve  yeniden  düzenleme  etkisi  yavaş  yavaş 
meydana geldiğinden, ilaç en azından iki hafta s�
                                
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