Gabapentin Fidia: detailed information

Package Leaflet: Information for the User

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

Gabapentin
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gabapentin Fidia is and what it is used for
What you need to know before taking Gabapentin Fidia
How to take Gabapentin Fidia
Possible side effects
How to store Gabapentin Fidia
Contents of the pack and other information

1. What Gabapentin Fidia is and what it is 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 nerve damage).
This medicine is indicated for the treatment of:

various forms of epilepsy (epileptic seizures initially limited to certain areas of the brain or spreading to other parts of the brain). In adults and children over 6 years of age, your doctor may prescribe Gabapentin Fidia as an add-on to your current treatment. Gabapentin Fidia may also be used alone for the treatment of adults and children over 12 years of age;
long-lasting pain caused by nerve damage (peripheral neuropathic pain), occurring mainly in the legs or arms, which can be due to various diseases such as diabetes or following a viral infection (herpes zoster), also known as shingles. Symptoms of this condition include sensations of heat, burning, throbbing, shooting pain, stabbing pain, sharp pain, cramping pain, discomfort, tingling, numbness, prickling pain, etc.

2. What you need to know before taking Gabapentin Fidia

Do not take Gabapentin Fidia

if you are allergic to gabapentin or to any of the ingredients of this medicine (listed in section 6);
if the person taking 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 kidney problems;
if you are undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or muscle weakness;
if you experience symptoms such as persistent stomach pain, nausea and vomiting, contact your doctor immediately, as these may be signs of acute pancreatitis (inflammation of the pancreas);
if you suffer from conditions characterised by sudden loss of consciousness (absence seizures), as this medicine is not effective in treating them and may even worsen your condition;
if you have neurological or respiratory disorders or are over 65 years of age, your doctor may prescribe different doses;
before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal substances, as this may indicate that you have a higher risk of developing dependence on Gabapentin Fidia.

A number of patients treated with antiepileptic medicines such as Gabapentin Fidia have developed suicidal thoughts or self-harming thoughts. If you experience any such thoughts at any time, contact your doctor immediately.
Gabapentin Fidia may cause heart and circulatory problems (depressive effects on blood pressure and heart rate), with all the possible consequences that may arise.
Serious skin rashes have been reported in association with gabapentin treatment, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using gabapentin and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Discontinue 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 severe allergic reaction) (see section 4 “Possible side effects”).
Muscle weakness, tenderness or pain, particularly if accompanied by feeling unwell and fever, may be caused by muscle injury which can be life-threatening and may lead to kidney problems. You may also notice discolouration of the urine and abnormalities in blood tests (particularly increased creatine phosphokinase). If any of these signs or symptoms occur, 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 dependence on Gabapentin Fidia (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop taking 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 dependence on Gabapentin Fidia, talk to your doctor.
If you notice any of the following signs while taking Gabapentin Fidia, you may have developed dependence on the medicine:

You feel the need to take the medicine longer than prescribed by your doctor
You feel the need to take a higher dose than recommended
You are using the medicine for reasons different from those for which it was prescribed
You have made repeated unsuccessful attempts to stop or control use of the medicine
You feel unwell when you stop taking the medicine and feel better when you take it again

If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when and how to safely discontinue use.

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, inform your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or other neurological or psychiatric conditions.

Medicines containing opioids such as morphine
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin Fidia. In addition, the combination of Gabapentin Fidia with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion
If Gabapentin Fidia and antacids containing aluminium and magnesium are taken together, the absorption of Gabapentin Fidia from the stomach may be reduced. It is therefore recommended to take Gabapentin Fidia no sooner than two hours after taking an antacid.

Gabapentin Fidia:

Is not expected to interact with other antiepileptic medicines or with oral contraceptives.
May interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless your doctor considers it necessary and advises otherwise.
If you are of childbearing age, make sure to use an effective method of contraception during treatment with this medicine.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted. However, for other medicines used to treat epileptic seizures, an increased risk of harm to the baby has been reported, particularly when more than one antiepileptic medicine is taken at the same time. Therefore, whenever possible and only on medical advice, you should try to take only one antiepileptic medicine during pregnancy.
Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.
If used during pregnancy, gabapentin may 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 during treatment with this medicine, as gabapentin is excreted in breast milk and may cause undesirable effects in your baby.

Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
This medicine may affect your ability to drive or use machinery. You must not drive or operate machinery if you experience symptoms such as dizziness, drowsiness, or fatigue.

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

3. How to take Gabapentin Fidia

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult 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.
Your doctor will determine 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, your doctor will gradually increase your dose. The recommended starting dose is 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 your doctor will instruct you to take this dose in three 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 as directed by your doctor. Usually, your doctor will gradually increase your dose. The recommended starting dose is 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 your doctor will instruct you to take this dose in three 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 determined by the doctor based on the child's body weight. Treatment starts 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 three single administrations, taking the capsules three times a day—typically once in the morning, once in the afternoon, and once 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 patients with kidney problems or undergoing haemodialysis
If you have kidney problems or are undergoing haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.
The capsules can be taken with or without food and must always be swallowed whole with a sufficient amount 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 suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Take the remaining capsules, the packaging, and the package leaflet with you so that hospital staff can easily identify the medicine you have taken.
Since this medicine may cause drowsiness, it is recommended to ask someone else to drive you to the doctor or to the hospital, or to call an ambulance.
Taking more than the recommended dose may lead to an increase in adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, lethargy (deep sleep), and moderate diarrhoea.

If you forget to take Gabapentin Fidia
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Gabapentin Fidia
Do not stop treatment with Gabapentin Fidia suddenly. If you wish to discontinue treatment with Gabapentin Fidia, discuss this first with your doctor, who will explain how to proceed. If treatment is to be stopped, it should be done gradually over a period of at least 1 week. After stopping short- or long-term treatment with Gabapentin Fidia, you should be aware that you may experience certain adverse effects known as withdrawal symptoms. These may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling abnormal, dizziness, and general malaise. These effects usually occur within 48 hours of stopping Gabapentin Fidia. If you experience withdrawal symptoms, contact your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabapentin Fidia may cause side effects, although not everyone experiences them.
Stop taking gabapentin and contact a doctor immediately if you develop allergic reactions and experience any of the following symptoms, which may affect the skin or any other part of the body such as the liver or blood:

circular or target-shaped reddish skin patches, not raised, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 may cause breathing difficulties (angioedema);
skin rash and redness, 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 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 normal breathing.

These symptoms may be the first signs of a serious reaction. You must see a doctor to determine whether you should continue taking Gabapentin Fidia.

If you are on haemodialysis, inform your doctor if you experience muscle pain and/or weakness.

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

frequent viral infections;
drowsiness, 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 white blood cell count (leucopenia);
loss of appetite (anorexia), increased appetite;
anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty in thinking;
seizures, convulsive movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, altered skin sensation, reduced sensation, coordination difficulties, abnormal eye movements (nystagmus), increased, decreased, or absent reflexes;
vision changes (amblyopia), double vision (diplopia);
dizziness;
high blood pressure, facial flushing, or dilation of blood vessels;
breathing difficulties, bronchitis, sore throat, cough, nasal inflammation/irritation;
vomiting, nausea, dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, increased intestinal gas (flatulence);
facial swelling, bruising following physical trauma, skin rash, itching, acne;
joint pain, muscle pain, back pain, muscle spasms;
incontinence;
erection problems (impotence);
swelling of legs and arms, or swelling affecting the face, trunk, and limbs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms;
reduced white blood cells, weight gain;
accidental injuries, fractures, abrasions.

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

slowed movements (hypokinesia);
falls;
mental impairment;
increased heart rate;
abnormal blood test results suggesting liver problems;
allergic reactions such as hives;
elevated blood sugar levels (observed more frequently in patients with diabetes);
agitation (a state of chronic restlessness and unintentional, purposeless movements);
difficulty swallowing.

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

reduced platelet count (blood cells responsible for clotting);
loss of consciousness;
hallucinations;
movement disorders such as convulsive restlessness, convulsive movements, and stiffness;
persistent ringing in the ears (tinnitus);
liver inflammation (hepatitis), yellowing of the skin and eyes (jaundice);
severe kidney problems (acute kidney failure);
adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, nausea, pain, sweating), chest pain;
low blood sugar levels (observed more frequently in patients with diabetes);
breathing difficulties, shortness of breath (respiratory depression).

The following side effects have been reported after marketing of Gabapentin Fidia
Not known (frequency cannot be estimated from the available data):

allergic reactions with symptoms such as fever, redness and skin rash, liver problems (hepatitis), swollen lymph nodes (lymphadenopathy), increased eosinophil count (a type of white blood cell – eosinophilia);
anaphylaxis (a severe, potentially fatal allergic reaction including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring emergency treatment);
muscle fibre damage (rhabdomyolysis);
abnormalities in blood tests (increased creatine phosphokinase);
sexual function problems including inability to achieve orgasm, delayed ejaculation;
involuntary and sudden muscle contractions (myoclonus);
breast enlargement in women (mammary hypertrophy) and breast growth in men (gynaecomastia);
low sodium levels in the blood (hyponatraemia);
becoming dependent on Gabapentin Fidia (“drug dependence”). After stopping short- or long-term treatment with Gabapentin Fidia, you should be aware that you may experience certain side effects known as withdrawal effects (see “If you stop taking Gabapentin Fidia”).
suicidal thoughts.

Respiratory tract infections, otitis media, seizures, and bronchitis have been reported only in clinical studies conducted in children. In addition, aggressive behaviour and hyperkinesia have been commonly reported in clinical studies in children.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp. ".
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Medicines must 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. Package contents 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 components are: maize 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 components are: maize 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 components are: maize 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
Box of 50 hard capsules of 100 mg in blister
Box of 50 hard capsules of 300 mg in blister
Box of 30 hard capsules of 400 mg in blister

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