ГАБАПЕНТИН 100 МГ Капсулы

Содержание инструкции

1. Gabapentin Mylan Generics 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is Gabapentin Mylan Generics and what it is used for
   2. What you need to know before taking Gabapentin Mylan Generics
   3. How to take Gabapentin Mylan Generics
   4. Possible side effects
   5. How to store Gabapentin Mylan Generics
   6. Package Contents and Other Information

Gabapentin Mylan Generics 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

gabapentin

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gabapentin Mylan Generics is and what it is used for
• 2. What you need to know before you take Gabapentin Mylan Generics
• 3. How to take Gabapentin Mylan Generics
• 4. Possible side effects
• 5. How to store Gabapentin Mylan Generics
• 6. Contents of the pack and other information

1. What is Gabapentin Mylan Generics and what it is used for

Gabapentin Mylan Generics belongs to a group of medicines used for the treatment of epilepsy and peripheral neuropathic pain.

Epilepsy: Gabapentin Mylan Generics is used for the treatment of various forms of epilepsy (seizures initially limited to certain areas of the brain, whether the seizures spread to other parts of the brain or not). Your doctor will prescribe Gabapentin Mylan Generics as an adjunct to the treatment of epilepsy when the treatment you are already following does not fully control your condition. You must take Gabapentin Mylan Generics in addition to the ongoing treatment unless you receive other instructions. Gabapentin Mylan Generics can also be used alone for the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain:Gabapentin Mylan Generics is used for the treatment of long-lasting pain caused by nerve damage. A variety of different diseases can cause peripheral neuropathic pain (which occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling, numbness, pricking pains, etc.

2. What you need to know before taking Gabapentin Mylan Generics

Do not take Gabapentin Mylan Generics

• If you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Mylan Generics:

• if you have kidney problems
• if you are on hemodialysis (to remove waste products due to kidney failure).
• if you have nervous system/respiratory problems or are over 65 years of age. Your doctor may prescribe different doses.

Cases of abuse and dependence have been reported for gabapentin from post-marketing experience.
Tell your doctor if you have a history of abuse or dependence.

During treatment
If you develop symptoms such as persistent stomach pain, nausea and vomiting, contact
your doctor immediately as these may be symptoms of acute pancreatitis (inflammation
of the pancreas)
A small number of patients treated with antiepileptic drugs such as gabapentin have
developed thoughts of self-harm or suicide. If thoughts of this kind emerge at any time, contact
your doctor immediately.
An increase in seizures or new types of seizures have been observed in some patients
taking gabapentin. Talk to your doctor or pharmacist if you notice a change in your
condition.
If you experience signs or symptoms of dizziness and drowsiness (which may increase the risk of accidental
injuries), confusion, loss of consciousness and reduced mental state while taking
gabapentin, ask your doctor or pharmacist for advice.

Important information about potentially serious reactions
A small number of patients treated with Gabapentin have shown an allergic reaction or
potentially serious skin reactions which, if left untreated, can develop into more serious problems.
You need to know these symptoms so you can recognize them while taking gabapentin.
“stop taking Gabapentin Mylan Generics and tell your doctor immediately or
go to the nearest Emergency Room if you experience any of the following symptoms” after taking
this medicine, as they may be serious”.

Other medicines and Gabapentin Mylan Generics
Tell your doctor or pharmacist if you are taking, 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 other
neurological or psychiatric problems.
Medicines containing opioids such as morphine
If you are taking medicines that contain opioids (such as morphine), tell your doctor or
pharmacist because opioids can increase the effects of gabapentin. In addition, the combination
of gabapentin with opioids can cause symptoms such as drowsiness and/or decreased
breathing.
No interaction is expected between Gabapentin Mylan Generics and other antiepileptic medicines or with
birth control pills containing norethindrone or ethinyl estradiol.
Gabapentin Mylan Generics may interfere with some laboratory tests; if you need a urine test, tell your doctor or the hospital that you are taking Gabapentin Mylan Generics.
Antacids for indigestion
If Gabapentin and antacids containing aluminum and magnesium are taken together,
the absorption of gabapentin from the stomach may be reduced. It is therefore recommended to take
Gabapentin Mylan Generics at least two hours after taking the antacid.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning
a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Mylan Generics should not be taken during pregnancy unless your doctor
has told you otherwise. Women of childbearing potential should use effective contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but an increased risk of harm to the fetus has been reported for other medicines used to treat epileptic seizures, particularly when taken
simultaneously with more than one medicine for seizures. Therefore, if possible, and
only on medical advice, during pregnancy you should try to take only one medicine for
epilepsy.
Do not suddenly stop taking this medicine as this may cause
the sudden onset of seizures which may have serious consequences for you and your
baby.
Breastfeeding
Gabapentin passes into breast milk. As the effects on the newborn are unknown, it is recommended not to breastfeed while taking Gabapentin Mylan
Generics.

Driving and using machines
Gabapentin Mylan Generics can cause dizziness, drowsiness and fatigue. Do not drive,
use machines or engage in other potentially dangerous activities until you know
how this medicine affects you.

Gabapentin Mylan Generics contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor
before taking this medicine.

3. How to take Gabapentin Mylan Generics

Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
The doctor will establish the appropriate dose for you.
If you feel that the effect of Gabapentin Mylan Generics is too strong or too weak,
inform your doctor or pharmacist.
If you have kidney problems, your doctor may prescribe a different dosing schedule for the medicine
and/or a different dose.
The capsules must always be swallowed whole with plenty of water. This
medicine can be taken with or without food.
Continue treatment with Gabapentin Mylan Generics until your doctor tells you to
stop it.

Epilepsy:
Use in adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually the doctor will gradually increase the
dose. The initial dose will generally be between 300 mg and 900 mg per day.
Subsequently, the dose may be gradually increased up to a maximum of 3600 mg per
day and your doctor will tell you to take this dose in 3 administrations, i.e. once in the morning,
once in the afternoon and once in the evening.

Use in children aged 6 years and over:
The dose to be administered to the child will be established by the doctor because it is calculated based on the weight of the
child. Treatment is started with a low initial dose which is gradually
increased over approximately 3 days.
The recommended dose for controlling epilepsy is 25-35 mg/kg per day. The dose is
usually administered divided into 3 doses, taking the capsule every day generally
once in the morning, once in the afternoon and once in the evening.
The use of Gabapentin Mylan Generics is not recommended in children under 6 years of age.

Peripheral neuropathic pain:
Take the number of capsules prescribed by your doctor. Usually the doctor will gradually increase the dose
gradually.
The recommended initial dose will generally be between 300 mg and 900 mg per day.
Subsequently, the dose may be gradually increased up to a maximum of 3600 mg per
day and your doctor will tell you to take this dose in 3 administrations, e.g. once in the
morning, once in the afternoon and once in the evening.

Elderly patients
If you are elderly (over 65 years of age) you should take Gabapentin Mylan Generics normally,
unless you have kidney problems.

Patients with kidney problems or undergoing hemodialysis
If you have kidney problems or are undergoing hemodialysis, your doctor may prescribe a different dosing schedule
for the medicine and/or a different dose.

If you take more Gabapentin Mylan Generics than you should
If you or someone else has accidentally taken too many capsules, or if you think a child has
ingested them, contact your doctor or go to the nearest emergency room immediately. Bring with you
easily which medicine you have taken.
Since this medicine can cause drowsiness, it is recommended to ask someone else to
drive you to the doctor or hospital or to call an ambulance. The symptoms of a
overdose include dizziness, double vision, slurred speech, loss of
consciousness, drowsiness and moderate diarrhea.

If you forget to take Gabapentin Mylan Generics
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 the missed capsule.

If you stop taking Gabapentin Mylan Generics
Do not stop treatment with Gabapentin Mylan Generics unless your doctor has told you to
do so. Discontinuation of treatment must occur gradually over at least 1
week. If you suddenly stop treatment with gabapentin or if you stop it before
it has been established by your doctor, the risk of seizures increases.
If you have any questions about 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 everyone gets them.

Stop taking this medicine and tell your doctor immediately or go to the nearest Emergency Room if any of the following symptoms appear after you have taken this medicine, because they may be serious:
Common(may affect up to 1 in 10 people)

• serious chest infection that can cause fever, chills, shortness of breath, cough, phlegm and occasionally blood (pneumonia)
• convulsions
• decrease in white blood cells (leukopenia) which can cause more frequent infections, e.g. sore throat, fever, chills and mouth ulcers, etc.

Rare(may affect up to 1 in 1,000)

• loss of consciousness
• breathing problems that, if severe, may require emergency and intensive care to allow you to continue breathing normally.

Not known(frequency cannot be estimated from the available data)

• anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat and tongue and low blood pressure requiring urgent medical treatment) severe skin reactions requiring immediate attention, such as swelling of the lips and face, rash and redness (these can be symptoms of a severe allergic reaction)
• skin rashes potentially life-threatening (Stevens-Johnson Syndrome) which initially appear on the chest as red blotches with concentric rings or circular patches often with a central blister. Other signs to look for include ulcers on the

mouth, throat, nose, genitals and conjunctiva (red and swollen eyes). The rash may evolve with widespread blisters or skin detachment.

• a severe skin condition (erythema multiforme) that can affect the mouth and other parts of the body, the signs include red spots often itchy, similar to a measles rash, starting on the limbs and sometimes on the face and the rest of the body. The spots may have blisters or develop to form raised, red patches with a pale center. Those affected have fever, sore throat, headache and/or diarrhea
• inflamed pancreas which can cause stomach pain (radiating to the back) and vomiting.
• Kidney disease leading to less urine than usual, nausea or vomiting, feeling confused (acute renal failure)
• destruction of muscle fibers associated with muscle cramps, muscle pain, fever and reddish-brown urine (rhabdomyolysis).

Gabapentin can cause a severe or life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. When affected by this type of reaction, you may or may not have a rash. This may cause you to be hospitalized or to stop treatment with Gabapentin Mylan Generics.
Call your doctor immediately if you experience any of the following signs:

• rash
• hives
• fever
• swollen glands that do not go away
• swelling of the lips and tongue
• yellowing of the skin or the whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• sudden muscle pain
• frequent infections

These may be the first signs of a severe reaction. A doctor should see you to decide whether to continue taking Gabapentin Mylan Generics.

Other possible side effects:
Very common:(may affect more than 1 in 10 people)

• viral infections
• feeling sleepy, dizziness, lack of coordination
• feeling tired

Common(may affect more than 1 in 100

• urinary tract infections, general infections, ear inflammation
• loss of appetite or increased appetite
• anger towards other people, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• convulsive movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, numbness, tingling or pins and needles sensation, decreased sensitivity, difficulty with coordination
• rapid and unusual eye movements, increased, decreased or absent reflexes
• blurred vision, double vision
• feeling dizzy (vertigo)
• high blood pressure, hot flushes or widening of blood vessels
• shortness of breath, chest infection (bronchitis), sore throat and difficulty swallowing, cough, dry or runny nose
• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, intestinal gas (flatulence)
• swelling of the face, bruising, acne
• joint pain, muscle pain, back pain, muscle contractions
• problems getting and maintaining an erection
• swelling of the legs and arms, difficulty walking, pain, general feeling of discomfort, flu-like symptoms
• weight gain
• accidental injuries such as bone fractures, scrapes and bruises.

Uncommon(may affect up to 1 in 100)

• accelerated heartbeat
• unusual reduction or slowness of body movements
• swelling which may involve the chest
• increased levels of liver enzymes and bilirubin observed with blood tests
• falls
• difficulty thinking
• elevated blood sugar levels (observed more often in patients with diabetes)
• hives or itchy rash
• agitation (a state of chronic restlessness and involuntary and afinalistic movements)

Rare(may affect up to 1 in 1,000)

• low blood sugar levels (observed more often in patients with diabetes)
• loss of consciousness.
• difficulty breathing, short breath (respiratory depression).

Not known(frequency cannot be estimated from the available data)

• seeing things that are not real (hallucinations)
• ringing in the ears
• problems with abnormal movements such as twisting movements, convulsive movements and rigidity affecting eyes, head, neck and body
• hair loss
• uncontrolled urination
• increased breast tissue, breast enlargement in males
• problems with sexual function, including decreased sexual desire, inability to achieve orgasm, delayed ejaculation
• signs that occur after suddenly stopping gabapentin (anxiety, sleep disturbances, nausea, pain, sweating), chest pain
• increased creatine phosphokinase, observed in a blood test
• low levels of sodium in the blood.

Additional side effects in children
Aggressive behavior has been reported commonly.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Mylan Generics

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, the carton or the
bottle after Exp. The expiry date refers to the last day of that month.
Do not store the capsules at a temperature above 25ºC.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: Store in the original packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Gabapentin Mylan Generics Contains
The active ingredient is gabapentin.
Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
The excipients are:
Capsule content: anhydrous lactose (see section 2 “Gabapentin contains lactose”), corn starch
and talc,
Capsule shell content: gelatin, sodium lauryl sulfate.
The 100 mg capsules contain the colorant titanium dioxide (E171); the 300 mg capsules
contain the colorants titanium dioxide (E171) and yellow iron oxide (E172); and the 400 mg capsules
contain the colorants titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide
(E172).

Description of the Appearance of Gabapentin Mylan Generics and Package Contents
Each gelatin capsule contains a white powder.
Capsule, body and cap: the 100 mg capsules are white, the 300 mg capsules are
yellow and the 400 mg capsules are orange.
Gabapentin Mylan Generics capsules are available in blisters of: 10, 20, 30, 50, 60, 90, 100, 200,
250, 500 or 1000 capsules or in bottles of 50, 100, 200 or 250 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20 – 20124 Milan, Italy

Manufacturer Responsible for Batch Release
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road – IR-Dublin 13 Ireland
Generics UK Ltd
Station close
Potters Bar, Hertfordshire,
EN6 1TL
United Kingdom
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium - Gabapentine Mylan 100mg, 300mg, & 400mg capsules
Denmark- Gabatifin, Gabamed, Pentagab 100mg, 300mg & 400mg capsules, hard
Germany - Gabapentin dura 100mg, 300mg & 400mg hard capsules
Italy - Gabapentin Mylan Generics 100mg, 300mg & 400mg hard capsules
United Kingdom - Gabapentin 100mg, 300mg & 400mg Capsules