GABAPENTIN 100 mg Hard Capsules

Зміст інструкції

1. GABAPENTIN FIDIA 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is Gabapentin Fidia and what is it used for
   2. What you need to know before you take Gabapentin Fidia
   3. How to take Gabapentin Fidia
   4. Possible side effects
   5. How to store Gabapentin Fidia
   6. Contents of the pack and other information

GABAPENTIN FIDIA 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Gabapentin

Generic medicine

Read this leaflet carefully before you start taking this medicine because 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 they have the same symptoms as you, as it may 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 Fidia is and what it is used for
• 2. What you need to know before you take Gabapentin Fidia
• 3. How to take Gabapentin Fidia
• 4. Possible side effects
• 5. How to store Gabapentin Fidia
• 6. Contents of the pack and other information

1. What is Gabapentin Fidia and what is it used for

Gabapentin Fidia belongs to a group of medicines used for the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).
This medicine is indicated for the treatment of:

• various forms of epilepsy(seizures initially limited to certain areas of the brain or that spread to other parts of the brain). In adults and children over 6 years of age, the doctor may prescribe Gabapentin Fidia in addition to the treatment you are already following. Gabapentin Fidia can also be used alone for the treatment of adults and children over 12 years of age;
• long-lasting pain caused by damage to the nerves (peripheral neuropathic pain), which occurs mainly in the legs or arms and can be caused by various diseases such as diabetes or following a viral infection (herpes zoster), also known as shingles. The sensations of this condition are heat, burning, pulsations, shooting pains, stabbing pains, acute pains, cramping pains, suffering, tingling, numbness, pricking pains, etc.

2. What you need to know before you take Gabapentin Fidia

Do not take Gabapentin Fidia

• if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6);
• if the person who needs to take this medicine is a child under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Fidia.

• if you have problems with your kidneys;
• if you are on hemodialysis (to remove waste products due to kidney failure), tell your doctor if you develop pain and/or muscle weakness;
• if you develop signs such as persistent stomach pain, nausea and vomiting, contact your doctor immediately as these may be symptoms of acute pancreatitis (inflammation of the pancreas);
• if you suffer from disorders characterized by sudden loss of consciousness (absence seizures), because this medicine is not effective in treating them and may even worsen your condition.
• If you suffer from nervous system/respiratory diseases or are over 65 years of age, your doctor may prescribe different doses.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs or illegal substances, as this may indicate that you are at greater risk of developing a dependence on Gabapentin Fidia.

A number of patients treated with antiepileptic drugs such as Gabapentin Fidia have developed thoughts of self-harm or suicide. If thoughts of this kind emerge at any time, contact your doctor immediately.
Gabapentin Fidia can cause heart and blood circulation disorders (depressive action on blood pressure and heart rate) with all the possible consequences that may result from it.
Severe skin reactions have been reported in association with treatment with gabapentin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using gabapentin and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Stop treatment with this medicine and inform your doctor if you experience symptoms such as fever and swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction) (see section 4 “Possible side effects”).
Muscle weakness, soreness or pain, and especially if at the same time you do not feel well and have a fever, may be caused by muscle injury that can be life-threatening and can lead to kidney problems. Discoloration of the urine and abnormalities in blood tests (in particular, increased creatine phosphokinase) may also occur. If you experience any of these signs or symptoms, please contact your doctor immediately.

Children
The use of Gabapentin Fidia is not recommended in children under 6 years of age.

Dependence
Some people may develop a dependence on Gabapentin Fidia (a need to continue taking the medicine). They may experience withdrawal effects when they stop using Gabapentin Fidia (see section 3, “How to take Gabapentin Fidia” and “If you stop taking Gabapentin Fidia”).
If you are concerned about the possibility of developing a dependence on Gabapentin Fidia, talk to your doctor.
If you notice any of the following signs while taking Gabapentin Fidia, you may have developed a dependence on the medicine.

• You feel the need to take the medicine for longer than prescribed by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine you do not feel well and feel better when you take it again. If you notice any of these signs, talk to your doctor to discuss the best treatment plan for you, including when it is appropriate to stop taking it and how to do so safely.

Other medicines and Gabapentin Fidia
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 convulsions, 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 effect of Gabapentin Fidia. In addition, the combination of Gabapentin Fidia with opioids can cause drowsiness, sedation, decreased breathing or death.
Antacids for indigestion
If Gabapentin Fidia and antacids containing aluminum and magnesium are taken together, the absorption of Gabapentin Fidia from the stomach may be reduced. It is therefore recommended to take Gabapentin no sooner than two hours after taking the antacid.
Gabapentin Fidia:

• is not expected to interact with other antiepileptic medicines or with the contraceptive pill.
• may interfere with some laboratory tests; if you need a urine test, tell your doctor or the hospital what you are taking.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy unless your doctor considers it necessary and has given different instructions.
If you are of childbearing potential, make sure to use effective contraception during treatment with this medicine.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but an increased risk of harm to the baby has been reported for other medicines used to treat epilepsy, particularly when taken simultaneously with more than one antiepileptic medicine.
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.
If used during pregnancy, gabapentin can cause withdrawal symptoms in newborns. The risk may be increased when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Breastfeeding
Avoid breastfeeding while taking this medicine as gabapentin is excreted in breast milk and may have undesirable effects on your baby.
Fertility
Animal studies have shown no effects on fertility.

Driving and using machines
This medicine can affect your ability to drive and use machines. Do not drive vehicles and use machines if you experience symptoms such as dizziness, drowsiness and fatigue.

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

3. How to take Gabapentin Fidia

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. Do not take more medicine than prescribed.
This medicine can be taken with or without food. Swallow the capsules whole with a glass of
water.
The doctor will establish the appropriate dose for you.

• Treatment of epilepsy in adults and adolescents (over 12 years of age):Take the number of capsules prescribed by your doctor. Usually the doctor will gradually increase the dose. The recommended initial doseis generally 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 the doctor will tell you to take this dose in 3 administrations (once in the morning, once in the afternoon and once in the evening).
• Treatment of peripheral neuropathic pain:Take the number of capsules or tablets following your doctor's instructions. Usually the doctor will gradually increase the dose. The recommended initial doseis generally 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 the doctor will tell you to take this dose in 3 administrations (once in the morning, once in the afternoon and once in the evening).

Use in children over 6 years of age

• Treatment of epilepsy:The dose to be administered to the child will be established by the doctor based on the child's body weight. Treatment begins with a low dose which is gradually increased over approximately 3 days. The recommended dose for controlling epilepsy is 25-35 mg per kg of body weight per day. The dose is usually divided into 3 single administrations, taking the capsules 3 times a day generally one in the morning, one in the afternoon and one in the evening, and the maximum interval between doses should not exceed 12 hours.

The use of Gabapentin Fidia is not recommended in children under 6 years of age.

Use in people with kidney problems or on hemodialysis
If you have kidney problems or are on hemodialysis, your doctor may prescribe a different dosing schedule for
the medicine and/or a different dose.
The capsules can be taken with or without food and must always be swallowed whole with
plenty of water.
Continue treatment with Gabapentin Fidia until your doctor tells you to stop.

If you take more Gabapentin Fidia than you should
If you (or someone else) have taken an excessive dose of Gabapentin Fidia or if you think a child may
have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital.
easily what medicine was taken.
Because this medicine can cause drowsiness, it is recommended to ask someone else to drive to
the doctor or to the hospital or to call an ambulance.
A higher than recommended dose may lead to an increase in side effects including
loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, lethargy (deep sleep) and
moderate diarrhea.

If you forget to take Gabapentin Fidia
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 missed dose.

If you stop taking Gabapentin Fidia
Do not suddenly stop treatment with Gabapentin Fidia. If you wish to stop
treatment with Gabapentin Fidia, talk to your doctor first, who will explain how to do it. If treatment
is stopped, this must happen gradually over at least 1 week. After stopping
short-term or long-term treatment with Gabapentin Fidia, you should know that you may experience some
side effects, called withdrawal effects. These effects may include seizures, anxiety,
difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache,
depression, feeling abnormal, dizziness and a general feeling of discomfort. These effects usually
occur within 48 hours of stopping Gabapentin Fidia. If you experience withdrawal effects, you should
contact your doctor.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabapentin Fidia can cause side effects, although not everybody gets them.
Stop taking gabapentin and see your doctor immediately if you notice the appearance of

allergic reactionsand experience any of the following symptoms, which can affect the skin or any
other part of the body such as the liver or the blood:

• circular or target-shaped, reddish, flat patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• swelling of the lips, face and tongue that can cause difficulty breathing (angioedema);
• rash and redness of the skin, hives, hair loss;
• persistent stomach pain, nausea and vomiting, as these may be symptoms of acute pancreatitis (inflammation of the pancreas);
• fever, swollen lymph glands that do not tend to go away;
• yellowing of the skin or the whites of the eyes (jaundice);
• unusual bleeding or bruising;
• severe fatigue or weakness, sudden muscle pain;
• frequent infections;
• breathing problems which, if severe, may require emergency and intensive care to allow you to continue breathing normally.

These symptoms may be the first signs of a serious reaction. Your doctor needs to examine you to decide
whether to continue taking Gabapentin Fidia.

• If you are on hemodialysis, tell your doctor if you experience pain and/or muscle weakness.

The following side effects may also occur:

Very common(may affect more than 1 in 10 people):

• frequent viral infections;
• feeling sleepy, dizziness, lack of muscle coordination (ataxia);
• feeling tired, fever.

Common(may affect up to 1 in 10 people):

• pneumonia, respiratory tract infections, urinary tract infections, ear inflammation or other infections;
• low number of white blood cells (leukopenia);
• loss of appetite, increased appetite;
• anger towards other people, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking;
• convulsions, jerky movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, altered skin sensation, reduced sensation, difficulty with coordination, abnormal eye movements (nystagmus), increased, decreased or absent reflexes
• vision impairment (amblyopia), double vision (diplopia);
• dizziness;
• high blood pressure, flushing of the face or widening of blood vessels;
• difficulty breathing, bronchitis, sore throat, cough, nasal inflammation/irritation;
• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, difficulty digesting, constipation, dry mouth or throat, increased intestinal gas (flatulence);
• swelling of the face, bruising following physical trauma, skin rash, itching, acne;
• joint pain, muscle pain, back pain, muscle contractions;
• incontinence;
• erection problems (impotence);
• swelling of the legs and arms or swelling that can affect the face, trunk and limbs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms;
• decreased white blood cells, weight gain;
• accidental injuries, fractures, abrasions.

Uncommon(may affect up to 1 in 100 people):

• slowing of movements (hypokinesia).
• falls
• mental impairment;
• increased heart rate;
• altered blood test values suggesting liver problems;
• allergic reaction such as hives;
• elevated blood sugar levels (observed more often in patients with diabetes)
• agitation (chronic state of restlessness and unintentional and afinalistic movements)
• difficulty swallowing

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

• reduced platelets (cells that coagulate blood);
• loss of consciousness;
• hallucinations;
• problems with abnormal movements such as convulsive agitations, jerky movements and rigidity;
• ringing in the ears (tinnitus);
• liver inflammation (hepatitis), yellowing of the skin and eyes (jaundice);
• serious kidney problems (acute renal failure);
• adverse events that occur after sudden discontinuation of gabapentin (anxiety, sleep disturbances, nausea, pain, sweating), chest pain;
• low blood sugar levels (observed more often in patients with diabetes);
• difficulty breathing, shortness of breath (respiratory depression)

After marketing of Gabapentin Fidia, the following side effects have been reported
Not known(whose frequency cannot be established on the basis of available data):

• allergic reactions with symptoms such as fever, redness and rash, liver problems (hepatitis), swollen lymph nodes (lymphadenopathy), increased number of eosinophils (a type of white blood cells - eosinophilia);
• anaphylaxis (a severe allergic reaction that is potentially fatal and includes difficulty breathing, swelling of the lips, throat and tongue and low blood pressure with consequent need for emergency treatment)
• muscle fiber injury (rhabdomyolysis);
• abnormalities in blood tests (increased creatine phosphokinase);
• problems with sexual function including inability to reach orgasm, delayed ejaculation.
• involuntary and sudden muscle contractions (myoclonus);
• increased breast volume in women (hypertrophy of the breast) and breast growth in men (gynecomastia);
• low sodium levels in the blood (hyponatremia)
• becoming dependent on Gabapentin Fidia (“drug dependence”). After stopping short- or long-term treatment with Gabapentin Fidia, you should know that you may experience some side effects, called withdrawal effects (see “If you stop taking Gabapentin Fidia”).
• suicidal thoughts.

Respiratory tract infections, otitis media, convulsions and bronchitis have only been reported during
clinical studies conducted in children. In addition, aggressive behavior and hyperkinesia have been commonly
reported in clinical studies conducted in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Gabapentin Fidia

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 packaging after “ Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Fidia contains

Gabapentin Fidia 100 mg hard capsules

• The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171).

Gabapentin Fidia 300 mg hard capsules

• The active substance is gabapentin. Each hard capsule contains 300 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172). Gabapentin Fidia 400 mg hard capsules
• The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.
• The other ingredients are: corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171), red iron oxide and yellow iron oxide (E 172).

Description of the appearance of Gabapentin Fidia and contents of the pack
Pack of 50 hard capsules of 100 mg in blisters
Pack of 50 hard capsules of 300 mg in blisters
Pack of 30 hard capsules of 400 mg in blisters

Marketing Authorisation Holder and Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A – 35031-Abano Terme (PD)