TRANXENE 5 mg. 30 capsules
Excipients: Potassium carbonate, talc; Capsule body: erythrosine titaiov dioxide, gelatin.
c) PHARMACEUTICAL FORM
30 pink - white capsules.
d) THERAPEUTIC CLASS
2. WHAT TRANXENE of 5 mg IS USED? (Showing)
This medicine is used to treat severe anxiety accompanied with disorder of daily activities or for the prevention and / or treatment of withdrawal conditions in alcoholism.
3. Before using the 5 mg TRANXENE
a) WHEN SHOULD NOT BE USED TRANXENE? (CONTRAINDICATIONS)
TRANXENE 5mg should not be accepted in the following cases:
• known hypersensitivity to benzodiazepines or to other ingredients of the medicinal product.
• severe respiratory insufficiency,
• "sleep apnea" syndrome (pauses in breathing during sleep), • severe hepatic insufficiency
• myasthenia (muscle weakness)
IF YOU HAVE ANY DOUBTS, ASK for advice your doctor or pharmacist.
b) SPECIAL WARNING
If treatment is insufficient effectively double dose.
The risk of dependence: during treatment with this medicine may develop physical or psychological dependence. There are several factors that contribute to the development of dependence:
- Duration of treatment
- Cases of addiction to other substances (drugs or not) and alcohol.
Dependence can occur in patients in whom these factors are not present.
For more information, consult your doctor or pharmacist.
Discontinuation of treatment can suddenly cause
Withdrawal syndrome. It appears after a few hours or a few days and is characterized by the following features: marked anxiety, insomnia, muscle pain, anxiety, irritation, headache, numbness and sensitivity of the fingers and toes, hypersensitivity to noise, light and touch, and etc.
Interruption of treatment should first be discussed with your doctor.
The gradual reduction of the dose and increase the interval between doses is the most appropriate way to prevent withdrawal syndrome. The longer he was taking the medicinal product, the longer should be the period.
Notwithstanding the gradual reduction of the dose may occur the so-called "REBOUND" phenomenon, which is characterized by transient recurrence of symptoms (anxiety), which in turn again requires treatment.
Several hours after administration can be monitored memory disorders and psychomotor function.
In some patients, this product may cause effects opposite of the desired: insomnia, nightmares, agitation, nervousness, euphoria or irritability, tension, impaired consciousness, even potentially dangerous behavior (aggression towards yourself and others, behavioral disorders behavioral automatism ).
If you notice any of these effects, contact your doctor.
Benzodiazepines and similar substances must be used with caution in elderly patients due to the risk of drowsiness and / or weakening the muscles, causing serious injuries.
c) PRECAUTIONS FOR USE TRANXENE of 5 mg
This treatment administered alone can not solve the states of anxiety. Seek advice to your doctor who will help you deal with your problem.
The use of this medicine requires regular medical supervision, especially in the case of renal dysfunction, chronic liver disease, alcoholism or respiratory failure.
This medicine does not cure depression. Should not be used alone in patients with depression as it helps the emergence of suicidal ideation (suicidal)
Do not use alcohol during treatment.
If in doubt, consult the advice of your doctor or pharmacist
d) DRUG AND OTHER INTERACTIONS
To avoid possible drug interactions, you should tell your doctor or pharmacist about other medicines taken.
e) Pregnancy and lactation
Not recommended intake of the medicinal product during the first three months of pregnancy.
If the drug was administered before birth is compelling medical monitoring of the newborn.
Since it is possible the passage of TRANXENE of 5 mg in breast milk is not recommended for use during breastfeeding.
The basic rule is to always consult a doctor or pharmacist before using a medicinal product during pregnancy and lactation.
f) EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
The ability to drive and use machines may be impaired due to drowsiness and impaired alertness.
Any combination with other sedative or hypnotic drugs and alcohol should be avoided when driving or operating machinery. The risk of impaired vigilance increases and lack of sleep.
4. HOW TO USE
For adults and children over 6 years.
The dose is strictly individual, there is no standard dose.
In all cases, must strictly observe the dose prescribed by your doctor.
b) OF ADMINISTRATION
Medicinal product taken orally; the capsule is swallowed with a glass of water.
c) duration of treatment
Treatment duration should be as short as possible, should not exceed 8-12 weeks.
In overdose you should tell your doctor or pharmacist.
e) FOR RELEASE OF A RECEPTION
When skipping a dose, take the next as usual. Do not take a double dose at the expense of missed.
f) the withdrawal syndrome
Withdrawal symptoms and "rebound" phenomenon (see paragraph. 36)
5. SIDE EFFECTS
Like all medicines this medicine can cause adverse drug reactions.
They depend on the dose received and the sensitivity of the patient.
Adverse neuropsychiatric effects (see 3 b, SPECIAL WARNING)
• memory disorders (inattention) can be obtained at the therapeutic dose, the risk increases in a dose dependent manner,
• behavioral disorders, impaired consciousness, irritability, aggression, nervousness,
• physical and psychological dependence even at therapeutic doses associated with withdrawal syndrome or 'rebound "phenomenon upon discontinuation of treatment,
• dizziness, headache, difficulty in coordination of certain movements
• confusion, decreased alertness, even drowsiness (especially in elderly patients), insomnia, nightmares, tension,
• changes in libido
- Skin rash (with or without itching)
- Muscle weakness, fatigue
- Double vision
- Disorders of the gastrointestinal tract
Tell your doctor or pharmacist about the occurrence of any adverse reaction not mentioned in the leaflet.
Do not use after the expiry date stated on the packaging.
No special storage conditions.
Keep out of reach of children.