Grandaxin 50 mg. 20 tablets
Grandaxin is a medicine on the central nervous system, belonging to the group
benzodiazepines. It is used to treat psychiatric (neuritic) and body diseases,
characterized by tension, anxiety, disorders of the autonomic nervous system, lack
motivation and energy, apathy, fatigue, depressed mood, and relief
autonomous excitatory signs on cessation of alcohol abuse.
Because Grandaxin lacks muscle relaxing effect, this product can
be prescribed in cases where it is undesirable or contraindicated (eg
diseases myasthenia gravis, myopathy and neurogenic muscular atrophy).
2. BEFORE YOU TAKE Grandaxin
Do not take Grandaxin
• if you are allergic to tofisopam or any of the other ingredients of Grandaxin (see section. 6), or to other benzodiazepines;
• If you suffer from respiratory failure and you currently have events;
• if you have experienced in the past suddenly stop breathing during the night;
• If you are in a coma;
• if you are pregnant (especially during the first three months of pregnancy. This medicine should not be taken during pregnancy, except in exceptional cases and only under careful discretion of the physician);
• if you are breastfeeding.
Take special care with Grandaxin
Any comorbidities may benefit from taking this medicine so please tell your doctor:
• if you suffer from liver and / or kidney disease, since the release of the drug from the body may be delayed in such cases and to enhance its effects;
• If you suffer from chronic respiratory failure or have spent acute respiratory failure because in this case drug administration requires special attention;
• If you suffer from epilepsy because Grandaxin can provoke a seizure;
• if you have narrow-angle glaucoma because then need special attention;
• if you suffer from a mental illness (depression, psychosis, personality disorder, anxiety or obsessive experiences states) because the adoption of Grandaxin can affect these diseases.
Taking other medicines
Please note that the potential for drug interaction may also cover
and drugs used in the past or that will be used in the future. Please
tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. If you start taking medications (especially acting on the central nervous system) during therapy with Grandaxin or 1 month after stopping treatment with it, please tell your doctor about adopting Grandaxin.
Caution (medical examinations) when co-administering Grandaxin following medicines:
It is extremely important to tell your doctor if you are taking or have recently taken
drug acting on the central nervous system (such as sedatives, depression, epilepsy, allergy, for mental illnesses, anesthetic, hypnotics), anticoagulants, antifungal, drugs for arrhythmia, cardiac glycosides (eg, digoxin), high blood pressure, stomach acids and contraceptives. Also tell him if you regularly drink alcohol.
In the following cases, monitoring is required, and sometimes a change in dose.
Taking Grandaxin with food and drink
Must not consume alcohol during treatment with Grandaxin.
Pregnancy and lactation
Although studies have not shown that the active substance damaging the unborn child, it is known
it crosses the placenta. Dosing in the first three months of pregnancy is contraindicated, and in its later periods can be applied, but only after careful consideration by the doctor.
Drug is excreted into breast milk so Grandaxin is contraindicated during lactation.
Ask your doctor or pharmacist before taking any medicine if you are
pregnant or breastfeeding.
Driving and using machines
Although Grandaxin will make you sleepy and too calm, do not drive or operate machinery at the beginning of treatment. Later extent and duration of this restriction will be considered individually by your doctor.
Important information about some of the ingredients of Grandaxin
Each tablet contains 92 mg lactose. If you are informed that you have an intolerance to some sugars, talk to your doctor before you start taking this medicine.
3. HOW TO TAKE Grandaxin
Always take Grandaxin exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
The dose of Grandaxin depends on the type of disease, condition and you should be initiated individually.
If not prescribed otherwise, the usual adult doses are 1-2 tablets 1-3 times a day (50-300 mg per day).
When given in the specific case, the dose may be 1-2 tablets.
Due to the good tolerability of Grandaxin tablets and lack of response to Bodmin state will need to gradually increase the dose, so that you can begin to accept
the required dose from the outset of treatment.
You should not stop treatment without authorization.
If you take more dose Grandaxin
Signs: vomiting, confusion, coma, respiratory depression and epileptic seizures.
In case of overdose or if you suspect such contact emergency unit.
Not opigvayte vomit if you notice signs above as there is a risk
Aspiration of gastric contents.
To reduce the absorption of the drug can not be accepted or purgative charcoal medicine.
If you forget to take Grandaxin
If you forget to take Grandaxin at the usual time, take the missed dose as
possible soon. If it's time for your next dose do not take a double dose to make up for missed. This will not happen, and the risk of overdose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Grondaksin can cause side effects. Although they are rare and usually mild and most often occur when using higher doses, ask your doctor for advice if you notice any of them.
Adverse reactions are divided into the following categories according to frequency of occurrence:
• very common (≥ 1/10),
• Common (≥ 1/100, <1/10)
• uncommon (≥ 1/1000, <1/100)
• Rare (≥ 1/10 000 to <1/1000)
• very rare (<1/10 000)
• not known (can not be estimated from the available data).
Nervous system disorders
• Common: insomnia;
• Very rare: provoked seizures in patients with epilepsy.
Respiratory, thoracic and mediastinal disorders
• Rare: respiratory depression.
• Common: vomiting, nausea, constipation, flatulence, dry mouth.
Skin and subcutaneous tissue disorders
• Rare: skin rash and one similar to scarlet fever.
Disorders of the musculoskeletal system and connective tissue
• Rare: muscle tension, muscle pain.
General disorders and administration site conditions
• Common: headache, itching.
• Very rare: jaundice.
• Common: irritability, tension;
• Rare: agitation;
• Very rare: confusion.
These side effects do not occur in everyone.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Grandaxin
Do not store above 25 ° C. Do not use Grandaxin tablets after the expiry date stated on the packaging. The expiry date refers to the last day of that month. Keep out of reach of children.
6. ADDITIONAL INFORMATION
• Active substance: Each tablet contains 50 mg of tofisopam.
• Excipients: lactose monohydrate (92 mg), gelatin, stearic acid, potato starch, talcum, magnesium stearate, microcrystalline cellulose.
Grandaxin looks like and contents of the pack
Description of tablets: white or greyish white, disc-shaped, flat tablets with bevelled edges,
scored strip on one side and marked with "Grandax" the other side.
20 tablets were placed in amber glass bottle or blister strips placed in a cardboard box together with the package leaflet.