GALANTAMINE 16 mg. 30 capsules
GALANTAMINE contains a drug which increases the amount of acetylcholine in the brain. GALANTAMINE is used to treat the symptoms of mild to moderately severe dementia of the Alzheimer's type - a disease that alters brain function.
2. BEFORE YOU TAKE GALANTAMINE
Do not take GALANTAMINE
if you are allergic to galantamine or any of the other ingredients of this medicine (listed in section 6);
if you have severe liver and / or renal disease.
Take special care with GALANTAMINE
If this drug is prescribed for you, you will need the advice of an experienced doctor before you start taking this medicine, and this doctor will review regularly therapeutic benefit, tolerability and dose GALANTAMINE prolonged-release capsules.
The benefit of GALANTAMINE not been established in patients with other types of dementia or other memory disorders. Therefore GALANTAMINE should be used in Alzheimer's disease, but not in other forms of memory loss or confusion.
Your doctor will monitor your weight while taking this medicine. Your guardian must be sure that you are taking your medicine regularly.
Requires particularly careful approach, if you have any of the following diseases or conditions:
certain heart conditions (sick sinus syndrome or other node conduction, starting from the upper part of the heart);
if you are taking medicines that slow the heart rate such as digoxin or beta-blockers (see also "Taking other medicines");
if you have uncorrected electrolyte imbalance in the blood (such as high / low potassium levels);
cardiovascular disease, as many recent heart attack, recent onset atrial fibrillation, AV block, unstable angina, heart failure;
increased risk of developing gastric ulcer or duodenal ulcer, for example due to a genetic predisposition or a history of certain diseases; This includes patients who at the same time take some painkillers (NSAIDs);
seizures or seizures (epilepsy);
Symptoms of Parkinson's disease;
conditions which lead to a deterioration in blood flow to the brain;
certain past or present condition of the lung (severe asthma, obstructive lung disease, or pneumonia).
This drug is not recommended if you have the following conditions:
acute abdominal pain from obstruction of the stomach or intestines (gastrointestinal obstruction);
if you are recovering from gastrointestinal surgery;
if you have difficulty in urinating, obstruction of the lower urinary tract or if you are recovering from surgery on the bladder.
If any of the above warnings apply to you, report it to your doctor. You may need particularly careful monitoring of your treatment or dose adjustment.
If you need to make your surgery while taking GALANTAMINE, you should tell your anesthetist that you are taking this medicine as GALANTAMINE may increase the effects of succinylcholine some muscle relaxants during anesthesia, especially in people with pseudocholinesterase deficiency (hereditary anomaly enzyme activity in blood plasma).
Tell your doctor about any liver or kidney problems, if you have any. Depending on the severity of the disease. Your doctor will decide whether treatment with GALANTAMINE is suitable for you and if your dose should be adjusted (see "How to take GALANTAMINE").
Children and adolescents
Galantamine is not recommended for use in children (see "How to take GALANTAMINE").
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
GALANTAMINE should not be taken with drugs that have a similar mode of action and should be used with:
ambenonium, neostigmine or pyridostigmine (for severe muscular weakness);
rivastigmine or donepezil (used for the treatment of dementia due to Alzheimer's disease or Parkinson's);
pilocarpine (for dry mouth or dry eyes) if taken by mouth;
If at the same time taking certain medications (anticholinergic drugs) against diarrhea, Parkinson's disease or bronchospastic conditions (such as asthma), please consult with your doctor about whether they can influence treatment GALANTAMINE.
GALANTAMINE may be reacted with:
drugs for certain heart conditions or high blood pressure (eg. digoxin, beta-blockers, calcium antagonists and some amiodarone). Drugs that may induce torsades de pointes should be used with caution. In such cases, you do ECG;
nonsteroidal anti-inflammatory drugs (eg., ibuprofen), which can increase the risk of ulceration;
succinylcholine muscle relaxants during anesthesia (especially in people with pseudocholinesterase deficiency). GALANTAMINE may increase the effects of these drugs.
Coadministration of some drugs that inhibit the metabolism of GALANTAMINE incidence of adverse effects, especially nausea and vomiting may be increased. It may be necessary to reduce the dose.
paroxetine or fluoxetine (a medicine for depressive disorders);
quinidine (a medicine for heart rhythm disturbances):
ketoconazole (a drug for the treatment of fungal diseases);
erythromycin (a medicine for bacterial infections);
ritonavir (medicine for the treatment of AIDS).
Pregnancy and lactation
If you are pregnant, think you may be pregnant or planning to become pregnant, talk to your doctor before taking GALANTAMINE.
You should not breast-feed while taking GALANTAMINE.
Driving and using machines
GALANTAMINE can make you feel dizzy or sleepy, especially during the first few weeks of treatment.
This can affect your ability to drive or operate machinery. Therefore, if you experience these symptoms, do not drive or operate machinery.
Your doctor will periodically assess your ability to drive or operate machinery.
3. HOW TO TAKE GALANTAMINE
Diagnosis of "dementia Alzheimer's type" must be carried out in accordance with current guidelines prior to initiating therapy.
Always take this medicine exactly as prescribed by your doctor. You should consult with your doctor or pharmacist if you are unsure.
GALANTAMINE treatment should start with a low dose, which should then be gradually increased to a dose that is best for you.
Your doctor will tell you exactly how to increase your dose.
Unless otherwise prescribed by your doctor, the usual starting dose is 8 g of galantamine once daily for four weeks.
The initial maintenance dose is 16 mg once a day galantamine. This dose should be maintained for at least 4 weeks.
Then your doctor may consider further increasing the maintenance dose to 24 mg, and make an individual assessment.
Use in patients with impaired hepatic or renal function:
In patients with moderately impaired hepatic function, it is recommended to begin treatment with galantamine 8 mg daily, preferably in the morning for one week.
Then patients should continue treatment with 8 mg galantamine once daily for 4 weeks. In these patients should not exceed a daily dose of 16 mg of galanthamine.
GALANTAMINE should not be used in patients with severely impaired hepatic function (see "Do not take GALANTAMINE"). Does not require dosage adjustment in patients with mildly impaired liver function.
Does not require dosage adjustment in patients with mild to moderate renal impairment (creatinine clearance of> 9 ml / min). GALANTAMINE should not be used in patients with severe renal impairment (creatinine clearance <9 ml / min) (see "Do not take GALANTAMINE").
Use in children
GALANTAMINE not recommended for use in children due to lack of data on safety and efficacy.
Method of administration
GALANTAMINE is for oral administration.
GALANTAMINE should be taken once daily in the morning, preferably with breakfast.
The capsules should be swallowed whole with sufficient fluid. The capsules should not be chewed or crushed.
Ensuring adequate fluid intake during treatment with GALANTAMINE (see "Possible side effects"). Weekdays are marked on the blisters to provide easy checking whether the capsules are taken regularly.
Duration of treatment
The duration of treatment and the dose will be determined individually by your doctor. For this purpose, your doctor will evaluate at regular intervals. Treatment may last as long as necessary to obtain a therapeutic effect and tolerance to treatment.
Please talk to your doctor or pharmacist if you feel that the effect of GALANTAMINE is too strong or too weak.
How to switch from galantamine tablets, coated tablets or oral solution to GALANTAMINE hard prolonged-release capsules
If you are currently taking active substance galantamine tablets, film-coated tablets or oral solution, your doctor has decided to go to GALANTAMINE hard prolonged-release capsules:
Take the last dose of galantamine tablets, coated tablets or oral solution in the evening;
Take the first dose of GALANTAMINE hard prolonged-release capsules in the morning.
Do NOT take more than one prolonged-release capsule daily. Do NOT take galantamine tablets, coated tablets or oral solution, if you are already taking GALANTAMINE hard prolonged-release capsules.
If you take more dose GALANTAMINE
GALANTAMINE overdose may cause the following symptoms:
muscle weakness and involuntary muscle contractions;
severe nausea, vomiting;
urination, bowel evacuation;
increasing the flow of saliva, dry mouth;
lacrimation (production, secretion and shedding of tears);
changes in heart rhythm (torsades de pointes, QT prolongation, ventricular tachycardia [rapid heartbeat], bradycardia [slow heartbeat |);
drop in blood pressure;
collapse and fainting;
Increasing muscle weakness associated with excessive accumulation of mucus in the trachea and bronchospasm may lead to life-threatening airway obstruction.
If any of the above, contact your doctor because you may need medical treatment.
If you forget to take GALANTAMINE
If you miss a dose of GALANTAMINE wait until it is time for the next dose and continue the treatment regimen prescribed by your doctor. Do not take a double dose to make up the missed dose.
If you miss more than one dose, please tell your doctor.
If you stop taking GALANTAMINE
If you want to stop, please first consult your doctor. Do not stop taking this medicine at its discretion, because it can endanger the success of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
As with all medications GALANTAMINE can cause side effects, although they do not occur in every patient.
Stop taking the medicine and see a doctor immediately if you experience:
heart problems, including changes in heart beat (slow or irregular);
palpitations (heart palpitations);
conditions that can be described as "dim sight."
Side effects include:
Very common side effects (may affect more than 1 in 10 people):
Nausea and / or vomiting.
If these side effects occur, they are mostly at the beginning of treatment or when increasing the dose. As your body gets used to the treatment, these effects disappear gradually and usually does not last more than a few days. If you have these effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medicine to improve your condition.
Common side effects (may affect up to 1 in 10 people) include:
loss of appetite;
stomach pain or discomfort;
high blood pressure;
a feeling of weakness;
general feeling of discomfort;
see, feel or hear things that are not real (hallucinations);
feelings of sadness (depression).
Uncommon side effects (may affect up to 1 in 100 people):
elevated liver enzymes in the blood (based on laboratory test results that show how well your liver is working);
as "jumping" of the heart;
interference in the mechanisms of conducting impulses in the heart;
feeling of irregular heartbeat (palpitations);
tingling, pricking or tingling of the skin;
change in sense of taste;
highly ringing or buzzing in the ears (tinnitus);
feeling the need to vomit;
excessive loss of body water;
Rare side effects (may affect up to 1 in 1,000 people):
inflammation of the liver (hepatitis).
Some of these symptoms may be caused by the underlying disease. However, be sure to tell your doctor because you may need medical attention.
If during treatment with GALANTAMINE any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE GALANTAMINE
Keep out of reach of children!
GALANTAMINE not use after the expiry date stated on the carton!
The expiry date refers to the last day of that month.
If your doctor tells you to stop taking your medicine, you must return to your pharmacist any tablets that you have not used.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is galantamine.
Each capsule contains 16 mg galantamine (as hydrobromide).
Other ingredients are:
microcrystalline cellulose, povidone K 30, glyceryl behenate, magnesium stearate, hypromellose, macrogol 400, macrogol 8000, talc, gelatin, titanium dioxide (E 171), iron oxide red (172).
Looks GALANTAMINE 16 mg prolonged-release hard
Pink, opaque, size 2, prolonged-release capsules, hard, containing 4 white to off-white mini-tablets.
Packs of 28, 30, 56, 84 or 112 hard prolonged-release capsules.
Not all pack sizes may be marketed.