600 mg and 800 mg film-coated tablets
gabapentin
1. WHAT GABAPENTIN ACCORD IS AND WHAT IT IS USED FOR
Gabapentin Accord is part of a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-term pain caused by nerve damage).
The active substance in Gabapentin Accord is gabapentin.
Gabapentin Accord is used to treat:
- Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, with or without spread to other parts of the brain). The doctor treating you or your child 6 years of age or older may prescribe Gabapentin Accord to treat epilepsy if the current treatment does not provide sufficient effect. You or your child 6 years of age or older should take Gabapentin Accord in addition to the current treatment, unless your doctor tells you otherwise. Gabapentin Accord can also be used as the only medicine for adults and children over 12 years of age.
- 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 the Gabapentin Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. BEFORE YOU USE GABAPENTIN ACCORD
Do not use Gabapentin Accord
- If you are allergic to gabapentin or any of the other ingredients of Gabapentin Accord.
Take special care with Gabapentin Accord
Talk to your doctor or pharmacist before using Gabapentin Accord.
- Your doctor may prescribe a different dosing schedule if you have kidney problems.
- If you are undergoing hemodialysis (to remove waste products due to impaired kidney function), tell your doctor if you experience muscle pain and / or muscle weakness.
- If you get symptoms such as persistent abdominal pain, nausea and vomiting, contact your doctor immediately, as this may be a symptom of acute pancreatitis ( inflammation of the pancreas).
- If you have nervous system diseases, 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 antiepileptic drugs such as e.g. 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 Accord have a severe reaction or a potentially severe skin reaction, which can develop into more serious problems if left untreated. the symptoms you should be aware of when taking gabapentin.
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. They can 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.
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 opioid-containing medicines (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of Gabapentin Accord. In addition, a combination of Gabapentin Accord and opioids can cause drowsiness, sedation, difficulty breathing, or death.
Antacids (so-called antacids) for digestive problems
If Gabapentin Accord is taken together with antacids containing aluminum and magnesium, the absorption of the Gabapentin Accord from the stomach may decrease. Gabapentin Accord should therefore be taken no earlier than two hours after taking antacids.
Gabapentin Accord:
- 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.
Taking Gabapentin with food
Gabapentin Accord 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 Accord should not be taken during pregnancy unless your doctor tells you otherwise. Women of childbearing potential must use effective contraception.
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. Therefore, whenever possible you should only take an epilepsy medicine 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 Accord. Do not suddenly stop taking this medicine. It can lead to breakthrough cramps and have serious consequences for you and your child.
Breast-feeding
Gabapentin, the active substance in Gabapentin Accord, is excreted in human milk. As the effect on the baby is unknown, you should not breastfeed while being treated with Gabapentin Accord.
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
No effect on fertility has been observed in animal studies.
Driving and using machines
Gabapentin Accord 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 increased 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. 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.
3. HOW TO USE GABAPENTIN ACCORD
Always take Gabapentin Accord 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 adolescents:
Take the number of tablets prescribed by your doctor. Your doctor may increase the dose one by one.
The starting dose is normally between 300 mg and 900 mg daily. Thereafter, the dose can be increased up to a maximum of 3,600 mg daily according to your doctor’s instructions, divided into 3 separate doses, 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/kg/day.
The tablets are usually taken at 3 separate doses each day, once in the morning, once in the afternoon, and once in the evening.
Gabapentin Accord is not recommended for children under 6 years of age.
Peripheral neuropathic pain, the usual dose is:
Adults:
Take the number of tablets prescribed by your doctor. Your doctor may increase the dose one by one.
The starting dose is normally between 300 mg and 900 mg daily.
Thereafter, the dose can be increased up to a maximum of 3,600 mg daily according to the doctor’s instructions, divided into 3 separate doses, ie. once in the morning, once in the afternoon, and once in the evening.
If you have kidney problems or undergo hemodialysis
Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems or undergo hemodialysis.
If you are older (over 65 years)
you should take the normal dose of Gabapentin Accord 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.
How to take Gabapentin Accord
Gabapentin Accord should be swallowed. Always swallow the capsules or tablets together with plenty of water.
Continue to take Gabapentin Accord until your doctor tells you to stop.
If you use more Gabapentin Accord than you should
A higher dose than recommended can lead to increased side effects, including unconsciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. 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.
Bring the tablets you may have left with you, the packaging, and the label so that the staff can easily see which medicine you have taken.
If you forget to take Gabapentin Accord
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 dose.
If you stop using Gabapentin Accord
Do not stop taking Gabapentin Accord unless your doctor tells you to. If you end your treatment, it should be done gradually for at least a week.
If you stop taking Gabapentin Accord 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, Gabapentin Accord 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. They can be serious:
- Severe skin reactions that require immediate medical attention, swollen lips and face, skin rash and redness and / or hair loss (this may be a sign of a severe allergic reaction ).
- Persistent abdominal pain, nausea, 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 Accord 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 Accord. 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 Accord.
If you are on hemodialysis, tell your doctor if you experience muscle pain and/or muscle weakness.
Other side effects that may occur are:
Very common (may affect more than 1 user in 10):
- Virus infection
- Dizziness
- Impaired coordination skills
- Virus infection
- Drowsiness
- Feeling tired
- Fever
Common (may affect more than 1 user in 100):
- Cramps
- Jerky movements
- Speech difficulties
- Memory loss
- Tremors
- Difficulty sleeping
- Headache
- Skin sensitivity
- Decreased feeling (numbness)
- Coordination difficulties
- Abnormal eye movements
- Increased / decreased or absent reflexes
- Pneumonia , respiratory infection, urinary tract infection, ear infection and inflammation you
- Low white blood cell count
- Anorexia
- Appetite increase
- Aggression against others
- Confusion
- Changing mood
- Depression
- Concern
- Nervousness
- Difficulty thinking
- Blurred vision, double vision
- Dizziness
- High blood pressure
- Redness or dilation of blood vessels
- Difficulty breathing, tracheitis , cough
- Sore throat
- Nasal dryness
- Vomiting, nausea
- Problems with the teeth, inflamed gums
- Diarrhea
- Abdominal pain
- Digestive problems
- Constipation
- Dry mouth or throat
- Gases
- Swelling of the face
- Bruises
- Rash, itching
- Acne
- Joint pain, muscle aches, back pain
- Twitching
- Erectile Dysfunction ( Impotence )
- Swelling in legs and arms
- Walking difficulties
- Weakness, pain
- Feeling sick
- Flu-like symptoms
- Decreased white blood cell count
- Weight gain
- Accidents, fractures , abrasions
In addition, aggressive behavior and jerky movements were reported in clinical trials in children.
Uncommon (may affect more than 1 in 1,000 people):
- Agitation (a state of constant restlessness and involuntary, meaningless movements)
- Allergic reactions such as hives
- Reduced movements
- Palpitation
- Swelling that may include face, torso, legs and arms
- Abnormal blood test results that indicate liver problems
- Psychological disorder
- Fall accidents
- Increased blood sugar level (most commonly seen in patients with diabetes )
- Difficulty swallowing
Rare (can occur in up to 1 in 1000 users):
- Decreased blood sugar level (most commonly seen in patients with diabetes )
- Loss of consciousness
- Shortness of breath, shallow breathing ( respiratory depression )
Frequency can not be calculated from the available data:
- Hyponatremia (low sodium levels )
Following the marketing authorization of the medicinal product, the following adverse reactions have been reported:
- Acute renal failure , incontinence
- Inflammation of the liver, yellowing of the skin and eyes
- Hallucinatines
- Abnormal movements, such as winding or jerky movements and stiffness
- Side effects after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, aches, sweating), chest pain
- Increase in breast tissue, breast augmentation
- Decreased platelet count (cells important for coagulation )
- Earrings
- A group of side effects can include swollen lymph nodes (occasional swollen rash under the skin), fever, rash and inflammation of the liver that occur simultaneously
- Fluctuations in blood sugar levels in patients with diabetes
- Degradation of muscle tissue ( rhabdomyolysis )
- Alteration of blood test results (elevated blood creatine phosphokinase)
- Sexual problems including inability to orgasm, delayed ejaculation
- Low sodium levels 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 ACCORD
Keep this medicine out of the sight and reach of children.
Store below 30 ° C.
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.
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
Content declaration
- The active substance is gabapentin. Each film-coated tablet contains either 600 mg or 800 mg of gabapentin.
- Other ingredients are:
Tablet core:
Maize starch, copovidone, poloxamer 407, hydroxypropyl cellulose (E463), magnesium stearate (E572)
Drag:
Hydroxypropylcellulose (E463), talc
Ink content
Propylene glycol, shellac, black iron oxide (E172), ammonium hydroxide
What the medicine looks like and contents of the pack
600 mg: The tablets are available as approximately 17.25 mm x 10.15 mm white to off-white, oval, film-coated tablets, marked with G1 on one side in black ink and unmarked on the other.
800 mg: The tablets are available as approximately 19.5 mm x 10 mm white to off-white, capsule-shaped, film-coated tablets, marked with G2 on one side in black ink and unmarked on the other.
Gabapentin Accord film-coated tablets are packaged in blister packs of PVC / PVdC aluminum with 20, 30, 50, 60, 90, 100, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex HA1 4HF,
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands