100 mg, 300 mg and 400 mg hard capsules
gabapentin
What Gabapentin Actavis is and what it is used for
Gabapentin Actavis belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-term pain caused by nerve damage).
The active substance in Gabapentin Actavis is gabapentin.
Gabapentin Actavis is used to treat:
Epilepsy:
Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether they spread to other parts of the brain or not). Your doctor will prescribe Gabapentin Actavis to help you treat your epilepsy if your current treatment is not effective enough. You should take Gabapentin Actavis as a supplement to your current treatment unless you have been given other instructions. Gabapentin Actavis can also be used as the sole drug to treat adults and children older than 12 years.
Peripheral neuropathic pain:
Prolonged pain caused by nerve damage. A variety of diseases can cause peripheral neuropathic pain (mainly in the arms and/or legs), such as diabetes or shingles. The sensations of pain can be described as burning, stinging, throbbing, pushing, stabbing, sharp, convulsive, grinding, crawling, stinging, numbness, etc.
Gabapentin contained in Gabapentin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Gabapentin Actavis
Do not take Gabapentin Actavis:
- if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Gabapentin Actavis
- if you have kidney problems. Your doctor may then prescribe a different dosing schedule.
- if you are on hemodialysis (treatment method for renal impairment where waste products are removed), tell your doctor if you get muscle pain or develop muscle weakness.
- If you get symptoms such as persistent stomach pain, nausea and vomiting, you should contact your doctor immediately, as this may be a symptom of pancreatitis (inflammation of the pancreas).
- if you have different types of seizures, including absences.
- If you have diseases of the nervous system, respiratory diseases or if you are older than 65 years, your doctor may prescribe you a different dosage .
Cases of abuse and dependence have been reported for gabapentin since its introduction. Talk to your doctor if you have a history of substance abuse or addiction.
A small number of people treated with epilepsy drugs such as gabapentin have had thoughts of harming themselves or committing suicide. If you get these thoughts at any time, contact your doctor immediately.
Important information about potentially serious reactions
A few patients taking Gabapentin Actavis have an allergic reaction or a potentially serious skin reaction, which can develop into more serious problems if left untreated. You need to know the symptoms you need to be aware of when taking Gabapentin Actavis.
Read the description of these symptoms in section 4 of this leaflet under “Contact your doctor immediately if you get any of the following symptoms after taking this medicine as they may be serious”.
Muscle weakness, soreness, or pain, especially if you also feel unwell or have a high fever, may be due to an abnormal muscle breakdown that can be life-threatening and lead to kidney problems. You may also have discolored urine and altered blood test results (especially elevated blood creatine phosphokinase). Contact your doctor immediately if you experience any of these symptoms.
Other medicines and Gabapentin Actavis
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or mental problems.
Drugs that contain opioids such as morphine
If you are taking any medicine that contains opioids (such as morphine), tell your doctor or pharmacist as opioids may increase the effect of Gabapentin Actavis. In addition, a combination of Gabapentin Actavis and opioids may cause symptoms such as drowsiness and/or difficulty breathing.
Antacids for stomach problems
If Gabapentin Actavis is taken together with antacids for an acidic stomach and heartburn (so-called antacids) that contain aluminum and magnesium, absorption of Gabapentin Actavis from the stomach may decrease. Therefore, take Gabapentin Actavis no earlier than 2 hours after antacids.
Gabapentin Actavis is not expected to affect or be affected by other antiepileptic drugs or pills.
Gabapentin Actavis may affect certain laboratory tests. If you need to take a urine sample, tell your doctor or hospital that you are taking Gabapentin Actavis.
Gabapentin Actavis with food
Gabapentin Actavis can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Actavis should not be taken during pregnancy unless your doctor tells you to. Fertile women should use effective contraception.
There have been no studies that have specifically examined gabapentin in pregnant women, but it has been reported that other antiepileptic drugs have increased the risk of birth defects, especially when several such drugs are used at the same time. Therefore, as far as possible, you should try to take only one epilepsy medicine during pregnancy, and only in consultation with a doctor.
Do not stop using this medicine suddenly as it can lead to breakthrough seizures, which can have serious consequences for you and your child.
Breast-feeding
Gabapentin, the active ingredient in Gabapentin Actavis, passes into breast milk. As the effect on the baby is unknown, you should not breastfeed while being treated with Gabapentin Actavis.
Fertility
No effect on fertility has been observed in animal studies.
Driving and using machines
Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, use complicated machines or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform such activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Gabapentin Actavis contains lactose
The capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Gabapentin Actavis
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide which dose is right for you.
Epilepsy, the recommended dose is:
Adults and young people
Take the number of capsules that your doctor has told you to take. The doctor usually escalates the dose gradually. The starting dose is usually between 300 mg and 900 mg per day. Thereafter, the dose may be increased gradually up to a maximum of 3,600 mg daily. The doctor will instruct you to take the daily dose divided into 3 separate doses, ie. one in the morning, one in the afternoon, and one in the evening.
Children from 6 years of age
The doctor decides what dose your child should receive because it is calculated on the basis of the child’s weight. The treatment begins with a low starting dose that is gradually increased over a period of about 3 days. The usual dose to control epilepsy is 25-35 mg/kg/day. The daily dose is usually divided into 3 separate doses, usually one in the morning, one in the afternoon, and one in the evening.
Use for children under 6 years
Gabapentin Actavis is not recommended for children under 6 years of age.
Peripheral neuropathic pain, the recommended dose is:
Adults
Take the number of capsules that your doctor has told you to take. The doctor usually escalates the dose gradually. The starting dose is usually between 300 mg and 900 mg per day. Thereafter, the dose may be increased gradually up to a maximum of 3,600 mg daily. The doctor will instruct you to take the daily dose divided into 3 separate doses, ie. one in the morning, one in the afternoon, and one in the evening.
If you have kidney problems or go for hemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems or are on hemodialysis.
If you are older (over 65 years), you should take the normal dose of Gabapentin Actavis unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems.
If you have the impression that the dose is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Actavis should be swallowed. Always swallow the capsules whole with plenty of water. Do not chew the capsules.
Continue to take Gabapentin Actavis until your doctor tells you to stop.
If you take more Gabapentin Actavis than you should
If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or the Poison Information Center for risk assessment and advice, or go to the nearest hospital immediately. Because Gabapentin Actavis may make you drowsy, it is recommended that you have someone else drive you to the doctor or hospital, or to call an ambulance. Symptoms of overdose include dizziness, double vision, slurred speech, unconsciousness, drowsiness and mild diarrhea.
Take any remaining capsules, package and package leaflet with you so that the hospital can easily see which medicine you have taken.
If you forget to take Gabapentin Actavis
If you forget to take a dose , take it as soon as you remember, unless it is time to take the next dose . Do not take a double dose to make up for a forgotten dose .
If you stop taking Gabapentin Actavis
Do not stop taking Gabapentin Actavis unless your doctor tells you to. If treatment is to be discontinued, dose one should be reduced over at least 1 week. If you suddenly stop taking Gabapentin Actavis or before your doctor tells you to do so, the risk of seizures increases.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Gabapentin Actavis can cause side effects, although not everybody gets them.
Contact your doctor immediately if you get any of the following symptoms after taking this medicine as they may be serious:
- severe skin reactions that require immediate care, such as swollen lips and face, skin rash and redness and / or hair loss (this may be a symptom of a severe allergic reaction )
- persistent abdominal pain, nausea and vomiting as this may be a symptom of acute pancreatitis (inflammation of the pancreas)
- breathing problems, where in severe cases you may need emergency and intensive care to continue breathing normally
- Gabapentin Actavis can cause a serious or life-threatening allergic reaction that can affect your skin or other parts of your body such as your liver or blood cells. When you get such a reaction, you can either get a rash or not. You may need to be hospitalized or stop taking Gabapentin Actavis.
Contact your doctor immediately if you have any of the following symptoms:
- rash
- hives
- fever
- swollen glands that do not disappear
- swelling of the lip or tongue
- yellow skin or whites of the eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- unexpected muscle pain
- frequent infection is
These symptoms may be the first signs of a severe reaction. A doctor will examine you to decide if you should continue to take Gabapentin Actavis.
If you go for hemodialysis and develop muscle aches or muscle weakness, tell your doctor immediately.
Other side effects include:
Very common (may affect more than 1 user in 10):
- virus infection
- drowsiness, dizziness, lack of coordination
- fatigue, fever
Common ( may affect up to 1 in 10 people):
- Pneumonia , respiratory infection, urinary tract infection, infection , ear infection or other infection s
- low white blood cell count
- general malaise, increased susceptibility to infection (low white blood cell count )
- anorexia , increased appetite
- anger at others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
- convulsions, jerky movements, speech disorders, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness (numbness), impaired coordination, abnormal eye movements, stronger, weaker or absent reflexes
- blurred vision, double vision
- dizziness
- high blood pressure , hot flashes or dilation of blood vessels
- difficulty breathing, bronchitis , sore throat, cough, dry nose
- vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or dry throat, flatulence
- facial swelling, bruising, rash, itching , acne
- pain in joints, muscles and back, cramps
- erection problem ( impotence )
- swelling of the arms and legs, difficulty walking, weakness, pain, general malaise, flu-like symptoms
- decreased white blood cell count (determined in laboratory tests), weight gain
- accident, fracture , abrasions
In addition to the above side effects , aggressive behavior and jerky movements were reported as common side effects in clinical trials in children.
Uncommon (may affect up to 1 in 100 people):
- allergic reactions such as hives
- reduced movements
- palpitation
- swelling that may include face, torso and limbs
- abnormal blood test results indicating liver problems
- psychological disorder
- fall accidents
- high blood sugar (most commonly seen in patients with diabetes )
- agitation (a state of constant restlessness and involuntary, meaningless movements)
- difficulty swallowing
Rare (may affect up to 1 in 1,000 people):
- low blood sugar (most commonly seen in patients with diabetes )
- unconsciousness
- difficulty breathing, shallow breathing ( respiratory depression )
Other side effects that have been observed after marketing authorization and for which the frequency can not be calculated from the available data:
- bleeding from skin and mucous membranes and bruising due to decreased platelet count ( blood cells responsible for coagulation )
- hallucinations
- problems with abnormal movements such as distortion, jerky movements and stiffness
- ringing in the ears ( tinnitus )
- a group of side effects that may include swollen lymph nodes (isolated, small raised bumps under the skin), fever, rash and hepatitis occur simultaneously
- yellowing of the skin and eyes (jaundice), inflammation of the liver
- acute renal failure , incontinence
- increase in breast tissue, breast enlargement or breast growth in men
- side effects after abrupt treatment discontinuation (anxiety, difficulty sleeping, nausea, pain, sweating, chest pain)
- degradation of muscle tissue ( rhabdomyolysis )
- change in blood test results (elevated blood creatine phosphokinase)
- sexual problems including inability to orgasm, delayed ejaculation
- low sodium level in the blood
- anaphylactic reaction (severe allergic reaction that can be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat and tongue and low blood pressure that requires emergency treatment)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Gabapentin Actavis
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store the capsules in the original package. Keep the jar tightly closed. Moisture sensitive.
Gabapentin Actavis capsules should be used within 12 weeks of opening the package.
Do not use this medicine after the expiry date which is stated on the carton / label after EXP. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
Content declaration
- The active substance is gabapentin. Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
- Other ingredients are:
Gabapentin Actavis 100 mg hard capsules:
Capsule content: anhydrous lactose , corn starch, talc
Capsule shell: titanium dioxide (E171), gelatin
Gabapentin Actavis 300 mg hard capsules:
Capsule content: anhydrous lactose , corn starch, talc
Capsule shell: titanium dioxide (E171), E172), gelatin
Gabapentin Actavis 400 mg hard capsules:
Capsule content: anhydrous lactose , maize starch, talc
Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), gelatin
What the medicine looks like and contents of the pack
Gabapentin Actavis 100 mg hard capsules are white, opaque, two-part capsules containing white powder.
Gabapentin Actavis 300 mg hard capsules are yellow, opaque, two-part capsules containing white powder.
Gabapentin Actavis 400 mg hard capsules are orange, opaque, two-part capsules containing white powder.
Gabapentin Actavis 100 mg, 300 mg or 400 mg hard capsules are packaged in:
Plastic jars: 50, 100 or 250 capsules.
Blister packs: 10, 20, 30, 50, 90, 100, 200 (2×100), 250 capsules.
Hospital packaging: 500 (5×100), 1000 (10×100) capsules.
Dosage packs: 20×1, 60×1, 100×1 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Agent
Teva AB
Box 1070
251 10 Helsingborg