600 mg, 800 mg film-coated tablet
gabapentin
1. What Gabapentin 1A Farma is and what it is used for
Gabapentin 1A Farma 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 1A Farma is gabapentin.
Gabapentin 1A Farma 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 aged 6 years or older may prescribe Gabapentin 1A Farma 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 1A Farma as a supplement to the current treatment, unless your doctor tells you otherwise. Gabapentin 1A Farma can also be used as the only medicine for adults and children from 12 years.
- Peripheral neuropathic pain (prolonged pain caused by nerve damage) in adults. Many different diseases can cause peripheral neuropathic pain (which mainly affects the legs and / or arms), including diabetes or shingles . The pain can be described as a hot, burning, throbbing, flashing, stinging, sharp, cramping, aching, burning, numbness or ant crawling.
Gabapentin contained in Gabapentin 1A Farma 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.
2. What you need to know before you use Gabapentin 1A Farma
Do not use Gabapentin 1A Farma
- if you are allergic to gabapentin, soy, peanut or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Gabapentin 1A Farma
- If you suffer from kidney problems, your doctor may prescribe a different dosing schedule.
- If you are on hemodialysis (to cleanse your blood of waste products due to kidney failure ), tell your doctor if you experience muscle pain and / or muscle weakness.
- If you develop symptoms such as persistent stomach pain, nausea and vomiting, consult a 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 after marketing. Talk to your doctor if you have a history of addiction or dependence.
A small number of people who are treated with antiepileptic drugs such as gabapentin has 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 of those taking Gabapentin 1A Farma have an allergic reaction or a potentially serious skin reaction, which can develop into a more serious condition if left untreated. You must be aware of these symptoms so that you can be aware of them while taking Gabapentin 1A Farma.
Read the description of these symptoms in section 4 of this leaflet, under ” Contact a 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 fever, can 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 1A Farma
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 opioid-containing medicines (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of Gabapentin 1A Farma. In addition, the combination of Gabapentin 1A Farma with opioids may cause symptoms such as drowsiness and/or decreased breathing.
Antacids (antacids) for indigestion
If Gabapentin 1A Farma is taken together with antacids containing aluminum and magnesium, the uptake of Gabapentin 1A Farma from the stomach may decrease. Gabapentin 1A Farma should therefore be taken no earlier than two hours after taking the antacid.
Gabapentin 1A Farma
- 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 1A Farm with food
Gabapentin 1A Farma 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 1A Farma should not be taken during pregnancy unless your doctor tells you otherwise. An effective contraceptive must be used by women who can have children.
There have been no studies specifically examining the use of gabapentin in pregnant women, but other drugs used to treat epilepsy have been reported to increase the risk of harm to the growing fetus, especially if more than one epilepsy drug is taken at the same time. Therefore, if possible, try to take only one epilepsy medicine during pregnancy and only according to the doctor’s instructions.
Contact a doctor immediately if you become pregnant, think you may be pregnant, or are planning to become pregnant while taking Gabapentin 1A Farma. Do not abruptly stop taking this medicine. This can lead to breakthrough seizures and have serious consequences for you and your child.
Breast-feeding
Gabapentin, the active substance in Gabapentin 1A Farma, is excreted in human milk. As the effect of gabapentin on infants is not known, breastfeeding is not recommended during treatment with Gabapentin 1A Farma.
Fertility
No effect on fertility has been seen in animal studies.
Driving and using machines
Gabapentin 1A Farma may cause dizziness, drowsiness, and fatigue. You should not drive, use complicated machines or engage in other activities that may be dangerous until you know how the medicine affects your ability to perform those 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. 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 1A Farma contains soy lecithin
If you are allergic to peanuts or soy, do not use this medicine.
How to use Gabapentin 1A Farma
Always use 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 will usually increase the dose gradually. The starting dose is generally between 300 mg and 900 mg per day. Thereafter, the dose can be increased according to the doctor’s instructions up to a maximum of 3,600 mg per day, and the doctor will instruct you to take three separate doses, ie. in the morning, in the afternoon, and the evening.
Children from 6 years of age
The doctor decides which dose to give to your child and it is calculated based on the child’s weight. The treatment begins with a low starting dose that is gradually increased over about three days. The usual dose to control epilepsy is 25-35 mg per kg per day. It is usually given in three separate doses by taking the tablets every day, usually in the morning, in the afternoon, and the evening.
Not all dosage recommendations can be implemented with this form of medicine. Other more suitable forms of gabapentin are available.
Gabapentin 1A Farma is not recommended for use in children below 6 years of age.
For peripheral neuropathic pain, the recommended dose is:
Adults
Take the number of tablets prescribed by your doctor. Your doctor will usually increase the dose gradually. The starting dose is generally between 300 mg and 900 mg per day. Thereafter, the dose can be increased according to the doctor’s instructions up to a maximum of 3,600 mg per day, and the doctor will instruct you to take three separate doses, ie. one in the morning, one in the afternoon, and one in the evening.
If you have kidney problems or receive hemodialysis
Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems or hemodialysis.
If you are older (over 65 years), you should take Gabapentin 1A Farma at the normal dose, unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems.
If you have the impression that the effect of Gabapentin 1A Farma is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
How to take Gabapentin 1A Farma
Gabapentin 1A Farma is for oral use. Always swallow the tablets whole with plenty of water.
Keep taking Gabapentin 1A Farma until your doctor tells you to stop.
If you use more Gabapentin 1A Farma than you should
A higher dose than recommended can lead to increased side effects such as unconsciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or poison information center for risk assessment and advice. 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 use Gabapentin 1A Farma
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 1A Farma
Do not stop taking Gabapentin 1A Farma 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 1A Farma 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 a 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 treatment, such as swelling of the lips and face, 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 1A Farma can cause a serious or life-threatening allergic reaction that can affect the skin or other parts of the body, including the liver or blood cells . You may get a rash if you get this type of reaction. It may mean that you have to be hospitalized or stop taking Gabapentin 1A Farma.Contact a doctor immediately if you get any of the following symptoms:
- rash
- hives
- fever
- swollen glands that do not pass
- swelling of the lips and tongue
- yellowing of the skin or whites of the eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- unexpected muscle pain
- frequent infection you
These symptoms may be the first signs of a severe reaction. A doctor should examine you to determine if you should continue to take Gabapentin 1A Farma.
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
- Feeling drowsy, dizzy, impaired coordination
- 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
- Loss of appetite, increased appetite
- Aggression against others, confusion, mood swings, depression, anxiety, nervousness, difficulty clear thinking
- Seizures, jerky movements, difficulty speaking, 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 / dilation of blood vessels
- Difficulty breathing, bronchitis , sore throat, cough, runny nose
- Vomiting, nausea, teeth problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth and 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, in clinical trials in children, aggressive behavior and jerky movements have been reported as common side effects.
Uncommon (may affect up to 1 in 100 people):
- Agitation (a state of constant restlessness and involuntary, meaningless movements)
- Allergic reaction such as hives
- Reduced mobility
- Palpitation
- Swelling of, for example, face, torso, legs and arms
- Abnormal results in blood tests that indicate liver problems
- Mental disability
- Fall accidents
- Increased blood sugar level (most commonly seen in patients with diabetes )
- Difficulty swallowing
Rare (may affect up to 1 in 1,000 people):
- Decreased blood sugar level (most commonly seen in patients with diabetes )
- Unconsciousness
- Shortness of breath, shallow breathing ( respiratory depression )
In the post-marketing setting, the following side effects have been reported:
Has been reported (occurs in an unknown number of users) :
- Decreased platelet count (cells important for coagulation )
- Hallucinations
- Abnormal movements, such as winding, jerky movements and stiffness
- Earrings
- A group of side effects that may include swollen lymph nodes (isolated small, raised lumps under the skin), fever, rash and hepatitis that occur simultaneously
- Yellowing of the skin and whites of the eyes (jaundice), hepatitis
- Acute renal failure , incontinence
- Enlargement of the breast tissue, breast growth
- Side effects after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, aches, sweating), chest pain
- Degradation of muscle tissue ( rhabdomyolysis )
- Alteration of blood test results (increased creatine phosphokinase)
- Problems with sexual function, including inability to reach sexual climax, delayed ejaculation
- Low sodium 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)
Other possible side effects are
In very rare cases, soy lecithin may cause allergic reactions.
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 1A Farma
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 and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° 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. One film-coated tablet contains 600 mg or 800 mg of gabapentin.
Other ingredients are:
Tablet core: macrogol 4000, pregelatinized starch, colloidal anhydrous silica, magnesium stearate.
Film coating: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, xanthan gum.
What the medicine looks like and contents of the pack
Film-coated tablet.
Gabapentin 1A Farma 600 mg film-coated tablets: White, capsule-shaped, film-coated tablets with pressure (600) on one side.
Gabapentin 1A Farma 800 mg film-coated tablets: White, capsule-shaped, film-coated tablets.
PVC / aluminum blister with 20 (sample pack), 50, 60, 90, 100, 200 and 2×100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.
Manufacturer
Zambon SpA, Via Della Chimica 9, 36100 Vicenza, Italy
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany