TRAMADOL table. 50 mg. 30 tab
STADA tramadol 50 mg hard capsules are used in medium strong to severe pain.
TRAMADOL table. 50 mg. 30 tab
What is Tramadol STADA 50 mg hard capsules and what it is used?
STADA Tramadol 50 mg capsules was analgesic drug acting on the central nervous system , belonging to the class of opioids .
STADA tramadol 50 mg hard capsules are used in medium strong to severe pain .
2 . Before taking Tramadol STADA 50 mg hard capsules
Do not use STADA Tramadol 50 mg:
If you are allergic (hypersensitive) to tramadol or any of the other ingredients of the product;
In severe intoxication with alcohol, hypnotics , analgesics , opioids or other psychoactive drugs ( drugs that affect mood , mental state and emotions ) ;
If you are taking MAO inhibitors (antidepressants ) or have used these last two weeks before starting treatment with Tramadol STADA 50 mg hard capsules ( see: Taking other medicines ) ;
As a substitute in a scheme to quit opiates ;
If you suffer from severe liver disease ;
If you suffer from severe renal insufficiency (creatinine clearance <10 ml / min)
When should I take special care with STADA Tramadol 50 mg capsules ?
At therapeutic doses reported symptoms characteristic of the period of withdrawal from a drug at a frequency of 1 per 8,000 patients treated . Tramadol may induce psychic and physical dependence ( see: What are the possible side effects) . There are frequent reports of dependence and abuse , so the clinical need for continued treatment with analgesics should be regularly reviewed .
In patients with drug addiction and a tendency to abuse drugs , treatment should be brief and be under close medical supervision.
Tramadol is not suitable as a substitute in schemes to quit opiates. Although it is an opioid agonist , tramadol can not suppress symptoms typical of the period of withdrawal from morphine.
Convulsions have been reported at therapeutic doses, the risk may be increased at doses higher than those in the highest dose (400 mg of tramadol ) . Patients with epilepsy or predisposed to seizures should only be treated with tramadol only in exceptional cases. The risk of seizures may be increased in patients receiving concomitant Tramadol and drugs that can cause seizures or lower their threshold ( see: Taking other medicines).
STADA tramadol 50 mg capsules should be used with caution in patients with head injury with increased intracranial pressure , such predisposed to seizures or shock.
Must be addressed in the treatment of patients with respiratory depression or receiving CNS depressants , as in this case can not be excluded from respiratory depression . At therapeutic doses rarely reported respiratory depression .
STADA tramadol 50 mg capsules are not suitable for children under 12 years ( see: How to take Tramadol STADA 50 mg capsules ) .
In elderly patients may require dosing interval to be increased (see : How to take Toamadol STADA 50 mg capsules ) .
Patients with impaired hepatic and renal function
In patients with impaired hepatic or renal function (creatinine clearance <30 ml / min) should be considered an extension of the interval between doses ( see: How to take Tramadol STADA 50 mg capsules ) .
You should inform your doctor if any of these problems occur during treatment with Tramadol STADA 50 mg capsules or if to you there are some of these problems.
Taking other medicines
Before you start taking Tramadol STADA 50 mg, tell your doctor if you are taking or have recently taken any other medicines , including medicines obtained without a prescription.
Tramadol should not be combined with MAO inhibitors ( see: Do not use STADA Tramadol 50 mg capsules ) .
Concomitant use of tramadol with alcohol or other medicines that suppress the function of the brain, may increase CNS effects (see : What are the possible side effects) .
Concomitant with carbamazepine ( enzyme- inducing antiepileptic effect) significantly reduced serum concentrations of tramadol anesthetic reduces its activity and its duration of action.
Concomitant use of cimetidine ( an anti- drug) was associated with a small delay in the elimination of Tramadol , this does not affect its effectiveness.
Combining agonists / antagonists ( other painkillers such as buprenorphine , nalbuphine , pentazocine ) and Tramadol is not recommended as the analgesic effect of a pure antagonist could theoretically be reduced in these circumstances.
Concomitant use of tramadol with selective inhibitors of serotonin reuptake ( fluoxetine, fluvoxamine ) , tricyclic antidepressants, antipsychotics ( medications to treat mental disorders) and drugs that can cause seizures or lower the threshold can result in seizures and increase risk of its occurrence ( see: Take special care with STADA Tramadol 50 mg capsules ) .
Should be addressed during concomitant treatment with tramadol and drugs that reduce the ability of blood to clot ( coumarin derivatives , eg . Warfarin ) due to reports of increased bleeding tendency in some patients.
It has been reported for isolated cases of serotonin syndrome associated with the therapeutic use of tramadol in combination with other serotonergic medications as selective inhibitors of serotonin reuptake (SSRIs). Serotonin syndrome is manifested by symptoms such as confusion , restlessness , fever , sweating, problems with movement coordination ( ataxia ) , exaggerated reflexes ( hyperreflexia ) , involuntary layoffs muscles ( myoclonus ) , and diarrhea. Termination of use of serotonergic agent produces rapid improvement.
The analgesic effect of tramadol is partly due to the reuptake of norepinephrine and an increase of the release of serotonin ( 5-HT) . In studies of pre-or post-operative use of an anti-emetic 5 NTG antagonist ondansetron is an increase of the requirement of tramadol in patients with postoperative pain.
Taking Tramadol STADA 50 mg hard capsules with food and drink
You should not drink alcohol during treatment with Tramadol STADA 50 mg, capsules because its effect can be enhanced .
Pregnancy and lactation
If you are pregnant , your doctor will prescribe Tramadol STADA 50 mg capsules only if absolutely necessary. Usually, the use of Tramadol STADA 50 mg hard capsules during pregnancy is not recommended , as safety has not been studied. The systemic use of STADA Tramadol 50 mg capsules in the entire period of pregnancy can lead to the development of withdrawal symptoms in the newborn as a result of habituation to the active ingredient of this drug .
Use of Tramadol STADA 50 mg capsules before or at the time of birth do not affect contractions of the uterus , which is important for a natural birth .
Consult your doctor or pharmacist before taking any of the drugs .
Small amount of tramadol is excreted in human milk. Therefore STADA Tramadol 50 mg capsules should not be used during lactation . In a single application , however , usually do not require discontinuation of breastfeeding.
Driving and using machines
Tramadol may cause drowsiness, which can be enhanced with the use of alcohol or other CNS depressants . If you experience such changes do not drive and suspend work requiring the use of power tools or machines.
3 . How to take Tramadol STADA 50 mg hard capsules
STADA always take Tramadol 50 mg hard capsules exactly as instructed by your doctor . If you have any doubts or questions , contact your doctor or pharmacist .
Dosage should be adjusted to the severity of pain and the patient's individual sensitivity to pain . The average duration of action of 4 to 8 hours , depending on the severity of pain .
Treatment with tramadol should be short and a period as possible to occur depending . Should be evaluated benefits and risks of a prolonged treatment with this drug ( see: Take special care with STADA Tramadol 50 mg hard capsules and What are the possible side effects ) .
Daily dose of 400 mg should not be exceeded.
The usual dose is :
Adults and children over 12 years
The usual single dose is 1-2 capsules STADA Tramadol 50 mg capsules (equivalent to 50-100 mg of tramadol hydrochloride) 3-4 times a day. If pain is not relieved , the dosage should be increased.
Children under 12 years
STADA tramadol 50 mg capsules are not suitable for children under 12 years , as it can be dosed individually. There are molds for children with a smaller amount of the drug substance .
Elderly patients less than 75 years without clinical hepatic or
renal failure usually do not require dose adjustment . In patients over 75 years , the elimination of tramadol may be delayed , so you may need the interval between doses can be increased individually.
Patients with hepatic or renal insufficiency
The elimination of tramadol may be prolonged in such patients. When a single dose for relief of acute pain is not necessary to adjust the dose . Tramadol is contraindicated in patients with severe hepatic or renal insufficiency (creatinine clearance <10 ml / min). Should be considered an extension of the interval between doses in patients with creatinine clearance <30 ml / min. Any increase in dose should be done under medical supervision.
Since Tramadol is eliminated very slowly by hemodialysis or haemofiltration , it is usually necessary to maintain postdializno administration of analgesia .
STADA tramadol 50 mg capsules can be used continuously only if absolutely necessary and therapeutically justified. Need for chronic therapy should be reassessed regularly ( see: Take special care with STADA Tramadol 50 mg capsules ) .
If you have the impression that the effect of STADA Tramadol 50 mg hard capsules is too strong or too weak, please talk with your doctor or pharmacist.
Method of administration :
The capsules should be swallowed whole , without breaking , a sufficient amount of liquid without food.
If you take an overdose of Tramadol STADA 50 mg hard capsules
Implementation of the quantities of the drug , significantly above the therapeutic doses causes constriction of the pupils ( miosis ) , vomiting , circulatory collapse , clouding of consciousness to coma ( a deep state of unconsciousness ) , epileptic seizures, and respiratory depression .
If you experience any of these symptoms, immediately contact your nearest doctor. He / she will take the necessary measures.
Note to physician:
Follow the general rules for emergency measures for maintaining a patent airway ( aspiratsiya! ) and support of respiratory function and circulation depending on the symptoms . Naloxone has been successfully used as an antidote for respiratory depression. For controlling seizures apply diazepam .
Tramadol is poorly dialysable . Therefore treatment of acute intoxication with tramadol only by hemodialysis or hemofiltration is insufficient detoxification . You have to make emptying of the stomach by emesis (in patients who are conscious) or lavage . Gastric emptying , it is necessary to discard the unabsorbed drug , especially when it is a modified release .
If you forget to take Tramadol STADA 50 mg capsules ?
Provided that the dosage of Tramadol STADA 50 mg hard capsules meets your needs, even skipping a dose can cause a recurrence of pain. If you miss a dose , however , do not take a double dose of the next dose and continue your treatment as you stated.
If you stop taking Tramadol STADA 50 mg?
Premature interruption or discontinuation of STADA Tramadol 50 mg capsules will cause recurrence of pain. If you wish to stop treatment because of the occurrence of side effects , talk with your doctor .
4 . What are the possible side effects?
Like all medicines, STADA Tramadol 50 mg capsules can cause side effects, although not everybody gets treated with this medicine patient gets them.
To determine the frequency of occurrence of adverse events using the following convention :
Very common: More than 1 in 10 patients treated ;
Common: In less than 1 and 10 in more than 1 in 100 patients ;
Uncommon in less than 1 in 100 and more than 1 to 1, 000 patients treated ;
Rare : If less than 1 part in 1000 and more than 1 in 10 000 patients treated ;
Very rare in less than 1 in 10 000 patients treated .
The most frequently reported side effects such as nausea and dizziness that occurs in more than 10 out of 100 treated with this medicine patients.
Rare: after administration of tramadol may occur various psychiatric disorders , which differ in strength and appearance , depending on the individual characteristics and the duration of administration. These side effects include mood changes (often elated but sometimes dysphoria ( morbid melancholy mood - sadness, anger , resentment ) , reduced or , in rare cases, increased activity and changes in cognitive and sensory functions (distortions in perception , difficulty in making decisions ) , hallucinations , confusion, sleep disturbances and nightmares.
Very common: dizziness ;
Common: headache and dizziness ;
Rare: respiratory depression . It can occur if the prescribed dose is significantly exceeded , and if taken during treatment other centrally acting depressants . Seizures occur mainly after the use of high doses of tramadol or concomitant use of drugs that cause seizures or lower the seizure threshold ( see: Taking other medicines). Paraesthesia , tremor, change in appetite.
Rare: blurred vision.
Uncommon: disturbances in the regulation of blood circulation ( heart palpitations, rapid heart beat, sudden feeling of weakness for hard standing ( postural hypotension ) or cardiovascular collapse ) . These side effects may occur in particular for intravenous administration in patients subjected to severe physical stresses and strains;
Rare in heart rate (bradycardia ), a rise in blood pressure.
Respiratory, thoracic and mediastinal disorders
Was reported worsening of asthma, although a causal relationship has not been established.
Very common: nausea ;
Common: vomiting , constipation, dry mouth ;
Uncommon: nausea, gastrointestinal disturbances (feeling of tightness , swelling ) ;
Rare : changes in appetite.
In a few isolated cases have been reported transient increases in liver enzymes in relation to treatment with tramadol .
Skin and subcutaneous tissue
Common: sweating ;
Uncommon: skin reactions ( eg, itching , rash, hives) .
Disorders of the musculoskeletal system and connective tissue
Rare: motor weakness .
Renal and urinary disorders
Rare: dysuria and urinary retention .
General disorders and administration site conditions
Rare: allergic reactions ( eg, dyspnea , bronchospasm , wheezing, painful swelling of the skin and mucous membranes ) and anaphylactic shock.
If any of those listed in this leaflet is serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
You can seek help from the nearest doctor if you experience any of the above side effects . If you receive another adverse reaction please contact your doctor .
5 . How to Store STADA Tramadol 50 mg capsules ?
Do not store above 25 ° C.
Keep out of reach of children .
Do not use STADA Tramadol 50 mg capsules after the expiry date which is stated on the package.
6 . Additional information
What does Tramadol STADA 50 mg capsules , hard.
The active ingredient is tramadol hydrochloride .
Each capsule contains 50 mg of tramadol hydrochloride .
Excipients include: calcium hydrogen phosphate dihydrate, gelatin, magnesium stearate, colloidal anhydrous silica dioxide , titanium dioxide (E 171).
STADA looks like Tramadol 50 mg hard capsules and contents of the packaging ? STADA Tramadol 50 mg capsules are packed in blisters 10, 30 or 50 white opaque , hard gelatin capsules.