GABAGAMMA. 400 mg. 100.hard capsules
The active substance is Gabapentin.
GABAGAMMA. 400 mg. 100.hard capsules
GABAGAMMA WHAT IS AND WHAT IT IS USED
Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain ( long lasting pain caused by damage to the nerves) .
The active substance is Gabapentin .
Gabapentin is used for treating:
Different forms of epilepsy ( seizures, initially limited to certain areas of the brain such as seizures may spread to other parts of the brain or not). Your doctor will prescribe Gabapentin to help treat your epilepsy when this treatment fails to fully control your condition. You should take Gabapentin in addition to your current treatment unless prescribed otherwise. Gabapentin may be used alone in the treatment of adults and children over 12 years.
Neuropathic pain ( long lasting pain caused by nerve disorder ) . Other diseases can cause peripheral neuropathic pain (which appears first in the hands and feet) , such as diabetes or shingles . Sensation of this pain can be described as: heat, burning , throbbing , stabbing, stabbing , cramping , pain , tingling , numbness , tingling , shooting and more.
2 . WHAT YOU SHOULD KNOW BEFORE YOU TAKE Gabapentin
Do not take Gabapentin :
if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in Section 6).
Warnings and Precautions
Take special care with Gabapentin :
if you have kidney problems. Your doctor may prescribe a different dose ;
If you are on hemodialysis (removal of waste substances in renal failure) , check with your doctor if you experience muscle pain and / or weakness ;
in if you experience symptoms such as persistent abdominal pain, nausea and vomiting. Contact your doctor immediately as this can be symptoms of acute pancreatitis (inflammation of the pancreas).
Small number of people being treated with antiepileptics such as gabapentin, have had thoughts of harming or killing themselves . If you have these thoughts , immediately contact your doctor.
Important information for potential possible serious reactions
Small number of people taking Gabapentin an allergic reaction or potentially serious skin reactions, which if not treated can become a serious problem. You need to know and keep track of these symptoms while taking Gabapentin .
Read the description of the symptoms in paragraph 4 of this leaflet under " Contact your doctor immediately if you experience at any of the following symptoms after taking this medicine , as they can be serious ."
Muscle weakness , muscle pain, especially if you have additional sick or have a fever can be caused by muscle damage , which can be life threatening and can lead to kidney problems. You probably noticed the change in color of urine and abnormal results of blood tests (especially elevated creatine phosphokinase ) . Contact your doctor immediately if you experience any of these signs and symptoms.
Other drugs and Gabapentin
Tell your doctor or pharmacist if you are taking , have recently taken or taking other medicines.
Some medicines may affect the way Gabapentin acts , as well as Gabapentin may reduce the effectiveness of other medicines taken at the same time :
Medicines containing morphine
If you are taking medicines containing morphine, consult your doctor or pharmacist as morphine may increase the effects of Gabapentin .
Antacids for gastrointestinal disorders
If Gabapentin and antacid containing aluminum and magnesium are taken at the same time , the absorption ( absorption ) of Gabapentin in the stomach can be reduced ( reduced ) . It is therefore recommended to take Gabapentin at least two hours after taking antacids.
Gabapentin is not expected to interact with other antiepileptic drugs , or oral contraceptives.
Gabapentin may interfere with some laboratory parameters , if required to do urine test , tell your doctor what medications you are taking .
Gabapentin intake of food, beverages and alcohol
Gabapentin can be taken with or without food.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
Gabapentin should not be taken during pregnancy unless your doctor has advised otherwise.
Women of childbearing potential should use effective contraception.
Contact your doctor immediately if you become pregnant , if you think you may be pregnant or plan to become pregnant while taking Gabapentin .
If you find that you are pregnant, do not end suddenly taking this medicine , as this can lead to a sudden seizure, which could have serious consequences for you and your baby. No studies have been conducted specifically on the use of gabapentin in pregnant women , but the drugs used for the treatment of seizures have shown an increased risk of damage to the developing baby , and in particular , when more than one kind of drugs for treating a seizure , administered by same time . Therefore , during pregnancy , when possible , you should try to take only one type of medicine used to treat seizures and only after the advice of your doctor.
Gabapentin , the active ingredient in the composition of Gabapentin passes into breast milk.
Since it is not known what will be the effect on the baby is not recommended to breast-feed while taking Gabapentin .
Driving and using machines
Gabapentin may cause drowsiness , dizziness and fatigue.
You should not drive, operate complex machinery or engage in other potentially dangerous activities until you are sure whether this medication affects your ability to perform these activities.
Gabapentin 400 mg capsules contain lactose (a sugar ) .
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before you start using this medicine .
3 . HOW TO TAKE Gabapentin
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist before taking this medicine.
Your doctor will determine the appropriate dose for you.
If you feel that the effect of the Gabapentin is too strong or too weak, talk to your doctor or pharmacist as soon as possible .
If you are elderly (over 65 years), you should take a normal dose of Gabapentin unless you have kidney problems. Your doctor may prescribe a different dose if you have kidney problems.
Gabapentin is for oral use . Always swallow the capsules whole with plenty of water. Keep taking Gabapentin until your doctor tells you to stop taking .
The recommended dose for epilepsy :
Adults and adolescents
Take strict capsules exactly as prescribed by your doctor . Usually your doctor will increase your dose gradually. The usual initial dose is between 300 mg and 900 mg daily .
Then your doctor may increase your dose to a maximum of 3600 mg gabapentin a day. Your doctor will explain how to distribute and receive as three divided doses , for example, one morning , one at lunch and one evening .
Children 6 years and above
Your doctor will determine the dosage for your child , as it is calculated on the weight of your child . Treatment was initiated with a low dose and gradually increased over a period of about 3 days.
The usual starting dose for the control of epilepsy is 25-35 mg per kg of body weight per day . The capsules are taken every day , usually divided into 3 separate doses: one morning , one at lunch and one evening .
Gabapentin is not recommended for children under 6 years of age.
The recommended dose for peripheral neuropathic pain :
Take strict capsules exactly as prescribed by your doctor . Usually your doctor will increase your dose gradually. The usual initial dose is between 300 mg and 900 mg per day.
Then your doctor may increase your dose to a maximum of 3600 mg daily. Your doctor will explain how to distribute and receive as three divided doses , for example, one morning , one at lunch and one evening .
If you have problems with your kidneys or are on hemodialysis
If you have problems with your kidneys or are on dialysis , your doctor may prescribe a different dosing schedule .
If you take more than the amount of Gabapentin
Higher doses than recommended may lead to increased side effects, including loss of consciousness, dizziness , double vision, slurred speech , drowsiness and diarrhea.
Contact your doctor or go to the nearest hospital immediately if you take more than the required dose Gabapentin , which is prescribed by your doctor.
Take with you all the capsules have not received so far along with the package to facilitate medical professionals about what medicine you have used .
If you forget to take Gabapentin
If you miss a dose, take it as soon as you remember unless it is time for your next dose.
Do not take a double dose to make up for a forgotten capsule.
If you stop taking Gabapentin
Do not stop taking Gabapentin unless your doctor has told you to. Stopping treatment is slow for at least one week. If you stop taking Gabapentin suddenly or before your doctor advises you to do so runs the risk of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Contact your doctor immediately if you experience at any of the following symptoms after taking this medicine because they can be serious:
severe skin reactions that require immediate attention , swelling of lips and face , skin rash and redness and / or hair loss (this can be symptoms of a serious allergic reaction) ;
constant abdominal pain, nausea and vomiting , as they may be symptoms of acute pancreatitis ( inflammation of the pancreas) ;
Gabapentin may cause a serious or life-threatening allergic reaction that can affect your skin or other parts of your body such as the liver or blood cells. You may or may not have a rash with this type of reaction. You may have you hospitalized or to stop taking Gabapentin .
Contact your doctor immediately if you experience any of the following symptoms:
skin rash ;
swollen lymph nodes that do not disappear ;
swelling of the lips and tongue ;
yellowing of the skin or whites of the eyes ;
unusual bruising or bleeding ;
severe tiredness or weakness ;
unexpected muscle pain ;
frequent infections .
These symptoms may be early signs of a serious reaction. You must be examined by a doctor to determine whether you need to continue taking Gabapentin
Consult your doctor if you are on dialysis , or develop muscle pain and / or weakness.
Other side effects:
Very common: may affect more than 1 in 10 patients ;
Common: may affect up to 1 in 10 patients ;
Uncommon: may affect up to 1 in 100 patients ;
Rare: may affect up to 1 in 1,000 ;
Very rare: may affect up to 10 users in 10,000 ;
Not known: frequency can not be estimated from the available data.
lack of coordination ;
viral infection ;
jerky movements ;
difficulty in speaking ;
memory loss ;
difficulty sleeping ;
sensitive skin ;
decreased sensation ( numbness )
difficulty with coordination ;
abnormal movements of the eyes ;
increased , decreased or absent reflexes ;
pneumonia , respiratory infections , urinary tract infections , ear infections or other infections ;
low level of white blood cells;
increased appetite ;
anger toward others;
mood changes ;
difficulty in thinking;
blurred vision , double vision ;
high blood pressure ;
dilation of blood vessels ;
breathing difficulties , bronchitis, sore throat, cough;
dry nose ;
vomiting , nausea ;
problems with teeth, inflamed gums ;
stomach pain ;
gastrointestinal disorder ;
dry mouth or throat ;
bloated stomach gas ;
swelling of the face ;
joint pain, muscle pain , back pain ;
difficulty achieving erection ( impotence )
swelling of the hands and feet ;
difficulty in walking ;
flu-like symptoms ;
reduced number of white blood cells;
increased weight ;
accidental injury , fracture, abrasion .
In addition, in clinical trials in children have been reported aggressive behavior and sudden movements.
Allergic reactions such as hives ;
Decreased movement ;
Increased heart rate ;
Swelling of the face, body and limbs;
Abnormal blood test results suggestive of liver problems .
After the introduction on the market the following adverse reactions :
Acute renal failure, urinary retention ;
Yellowing of the skin and eyes ( jaundice) , inflammation of the liver;
Abnormal movements, sudden movements and stiffness ;
Adverse effects on sudden discontinuation of gabapentin ( anxiety , difficulty sleeping, nausea , pain , sweating ) , chest pain;
Increase in breast tissue , breast enlargement ;
Reduced number of platelets ( clotting cells ) ;
Ringing in the ears ;
A group of side-effects, which can include swelling of the lymph nodes ( isolated small raised lumps under the skin ), fever , rash, and liver inflammation occur together ;
Fluctuations in blood sugar levels in diabetic patients ;
Tearing of muscle fibers (rhabdomyolysis ) ;
Abnormal results of blood tests ( elevated creatine phosphokinase ) .
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet . You can also report side effects dir
As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . HOW TO STORE Gabapentin
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after " EXP" . The expiry date refers to the last day of that month.
Do not store above 25 ° C.
PVC / Alu blister : Store in original container.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . PACKAGE CONTENTS AND ADDITIONAL INFORMATION
What does Gabapentin 400 mg hard capsules
The active agent is gabapentin . Each capsule contains 400 mg of gabapentin .
The other ingredients of Gabapentin 400 mg capsules are lactose anhydrous, maize starch, talc , gelatin, and titanium dioxide ( E171 ) .
Iron oxide yellow (E172) .
Red iron oxide (E172) .
Looks like Gabapentin 400 mg capsules and contents of the pack
hard gelatin capsule with orange opaque cap and body .
Package Contents :
PVC / Alu blisters: x 10 capsules.
Gabapentin 400 mg capsules : 50, 100 capsules .
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: