600 mg and 800 mg film-coated tablets
gababentin
What Gabapentin Orion is and what it is used for
Gabapentin Orion 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 Orion is gabapentin.
Gabapentin Orion is used to treating:
- various forms of epilepsy (seizures that are initially limited to certain parts of the brain, with or without spreading to other parts of the brain). Your doctor may prescribe Gabapentin Orion to treat your epilepsy if your current epilepsy treatment does not work well enough. You should take Gabapentin Orion as a supplement to your current treatment, unless your doctor tells you otherwise. Gabapentin Orion can also be used as the only medicine for adults and children from 12 years.
- peripheral neuropathic pain (prolonged pain caused by nerve damage). A variety of diseases can cause peripheral neuropathic pain (mainly in the legs and / or arms), such as diabetes or shingles . The pain can be described as a hot, burning, throbbing, flashing, stinging, sharp, cramping, aching, stinging, paralyzing sensation or as ant crawls.
Gabapentin contained in Gabapentin Orion 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 take Gabapentin Orion
Do not take Gabapentin Orion
- 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 Orion
- if you have kidney problems. Your doctor may then prescribe a different dosing schedule.
- if you are undergoing hemodialysis (treatment method for renal impairment where waste products are removed). Tell your doctor if you experience muscle pain and / or muscle weakness.
- if you get symptoms such as persistent abdominal pain, nausea and vomiting. In this case, contact your doctor immediately as this may be a symptom of acute pancreatitis (inflammation of the pancreas).
- 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 who are treated with antiepileptic drugs such as gabapentin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
Important information about potentially serious reactions
A few patients taking Gabapentin Orion have a severe reaction or potentially severe 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 Orion.
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 Orion
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 medicines that contain opioids (such as morphine), tell your doctor or pharmacist, as opioids may increase the effect of Gabapentin Orion. In addition, a combination of Gabapentin Orion and opioids may cause symptoms such as drowsiness and/or decreased breathing.
Antacids for indigestion
If Gabapentin Orion is taken with antacids containing aluminum and magnesium, the absorption of Gabapentin Orion from the stomach may decrease. Gabapentin Orion should therefore be taken no earlier than two hours after taking antacids.
Gabapentin Orion
- is not expected to affect or be affected by other antiepileptic drugs or birth control pills .
- may interfere with certain laboratory tests. If you need to take a urine sample, tell your doctor or hospital staff what you are taking.
Gabapentin Orion with food, drink and alcohol
Gabapentin Orion 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 Orion should not be taken during pregnancy unless your doctor tells you otherwise. An effective contraceptive must be used by women of childbearing potential.
No studies have been performed to specifically investigate the use of gabapentin in pregnant women, but the use of other epilepsy medicines has been reported to increase the risk of birth defects, especially when more than one such medicine is taken at the same time. As far as possible, you should try not to take more than one epilepsy medication during pregnancy, and only in consultation with a doctor.
Contact your doctor immediately if you become pregnant, if you think you may be pregnant or if you are planning to become pregnant while taking Gabapentin Orion. Do not abruptly stop taking this medicine. This can lead to a breakthrough spasm and have serious consequences for you and your child.
Breast-feeding
Gabapentin, the active substance in Gabapentin Orion, passes into breast milk. As the effect on the baby is unknown, you should not breastfeed while being treated with Gabapentin Orion.
Fertility
No effect on fertility has been observed in animal studies.
Driving and using machines
Gabapentin Orion may cause dizziness, drowsiness, and fatigue. You should not drive, use advanced machines or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. Read all information in this leaflet for guidance. Ask your doctor or pharmacist if you are unsure.
How to use Gabapentin Orion
Always take this medicine exactly as your doctor or pharmacist 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 tablets prescribed by your doctor. Your doctor may increase the dose one by one. The usual starting dose is between 300 mg and 900 mg daily. Then, according to your doctor’s instructions, the dose can be increased up to a maximum of 3,600 mg daily, divided into 3 separate occasions, ie once in the morning, once in the afternoon, and once in the evening.
Children from 6 years
The doctor will decide which dose to give to your child, as it is calculated taking into account the child’s weight. The treatment begins with a low starting dose, which is then gradually increased over about 3 days. The usual dose for epilepsy treatment is 25–35 mg per kg body weight per day. The tablets are usually taken on 3 separate occasions each day, once in the morning, once in the afternoon, and once in the evening.
Gabapentin Orion is not recommended for children under 6 years of age.
Peripheral neuropathic pain, the recommended dose is
Adults
Take the number of tablets prescribed by your doctor. Your doctor may increase the dose one by one. The usual starting dose is between 300 mg and 900 mg daily. Then, according to your doctor’s instructions, the dose can be increased up to a maximum of 3,600 mg daily, divided into 3 separate occasions, ie once in the morning, once in the afternoon, and once 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 Orion, 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 effect of Gabapentin Orion is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Orion should be taken orally. Always swallow the tablets or tablet halves without chewing along with plenty of water. The tablet can be divided into two equal doses.
Keep taking Gabapentin Orion until your doctor tells you to stop.
If you take more Gabapentin Orion than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Because gabapentin tablets can make you drowsy, it is recommended that you have someone else drive you to the doctor or hospital or call for an ambulance. Symptoms of overdose include dizziness, double vision, slurred speech, unconsciousness, drowsiness, and mild diarrhea. Take the tablets you have not taken with you, together with the packaging and label, so that the staff can easily see which medicine you have taken.
If you forget to take Gabapentin Orion
If you forget to take 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 tablet.
If you stop taking Gabapentin Orion
Do not stop taking Gabapentin Orion unless your doctor tells you to. If treatment is stopped, this should be done gradually for at least 1 week. If you stop taking Gabapentin Orion suddenly or before your doctor tells you to, there is an increased risk of seizures.
If you have any further questions on the use of this product, 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 get any of the following symptoms after taking this medicine as they may be serious:
- severe skin reactions requiring immediate care, 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)
- Gabapentin Orion 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 Orion.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.
- 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)
- breathing problems, where in severe cases you may need emergency and intensive care to continue breathing normally.
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 Orion.
If you are on hemodialysis, tell your doctor if you experience muscle pain and/or muscle weakness.
Other side effects include:
Very common (may affect more than 1 user in 10)
- virus infection
- drowsiness, dizziness, uncoordinated muscle movements
- feeling tired, fever.
Common (may affect up to 1 in 10 people)
- Pneumonia , respiratory infection, urinary tract infection, ear infection or other infection s
- decreased white blood cell count
- anorexia , increased appetite
- aggression towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking clearly
- convulsions, jerky movements, speech difficulties, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensation (numbness), coordination difficulties, abnormal eye movements, increased / decreased or absence of reflexes
- blurred vision, double vision
- dizziness
- high blood pressure , redness or dilation of the blood vessels
- difficulty breathing, tracheitis , sore throat, cough, runny nose
- vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, gas
- facial swelling, bruising, rash, itching , acne
- joint pain, muscle aches, back pain, twitching
- erectile dysfunction ( impotence )
- swollen legs and arms, difficulty walking, weakness, aches, malaise, flu-like symptoms
- decreased white blood cell count , weight gain
- accidents, fractures , abrasions.
In addition, aggressive behavior and jerky movements have been reported as common side effects in clinical trials in children.
Uncommon (may affect up to 1 in 100 people)
- agitation (a state of constant restlessness and involuntary, meaningless movements)
- allergic reactions such as hives
- high blood sugar (most commonly seen in patients with diabetes )
- reduced movements, mental disorder
- palpitation
- swelling that may include face, torso and limbs
- fall accidents
- abnormal blood test results indicating liver problems
- difficulty swallowing.
Rare (may affect up to 1 in 1,000 people)
- low blood sugar (most commonly seen in patients with diabetes )
- loss of consciousness
- difficulty breathing, shallow breathing ( respiratory depression ).
Following the introduction of the drug on the market, the following side effects have been reported
- decreased platelet count (cells important for coagulation )
- hyponatremia (low sodium in the blood)
- hallucinations
- problems with abnormal movements, such as swaying or jerky movements and stiffness
- earrings
- yellowing of the skin and eyes (jaundice), inflammation of the liver
- a group of side effects that may include swollen lymph nodes (isolated, small, raised bumps under the skin), fever, rash and hepatitis occur simultaneously
- degradation of muscle fibers ( rhabdomyolysis )
- acute renal failure , incontinence
- increase in breast tissue, breast enlargement, sexual problems including inability to orgasm, late ejaculation
- side effects after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, aches, sweating), chest pain
- change in blood test results (elevated blood creatine phosphokinase).
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 Orion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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 film-coated tablet contains 600 mg or 800 mg of gabapentin.
- Other ingredients are:Tablet core: microcrystalline cellulose, copovidone, corn starch, crospovidone, magnesium stearateFilm coating: talc, hydroxypropylcellulose.
What the medicine looks like and contents of the pack
Film-coated tablet (tablet)
White, biconvex, oval, film-coated tablet with marking on one side and notch on both sides.
600 mg: marked with “D” and “24” on each side of the breaker notch. Tablet size 17.4 x 9.1 mm.
800 mg: marked with “D” and “25” on each side of the break. Tablet size 19.2 x 10.0 mm.
Pack sizes
20, 30, 50, 60, 90, 100, 200 or 500 tablets in blister packs.
20 or 500 tablets in a plastic jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland