Gabapentin Mylan Generics

Patient Information Leaflet

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

gabapentin
Generic medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Gabapentin Mylan Generics is 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 to treat various forms of epilepsy (seizures initially limited to certain areas of the brain, whether or not they spread to other parts of the brain). Your doctor will prescribe Gabapentin Mylan Generics as an add-on treatment for epilepsy when your current therapy does not fully control your condition. You must take Gabapentin Mylan Generics in addition to your ongoing treatment, unless otherwise instructed. Gabapentin Mylan Generics may also be used alone for the treatment of adults and children over 12 years of age.
Peripheral neuropathic pain: Gabapentin Mylan Generics is used to treat long-lasting pain caused by nerve damage. A variety of different diseases can cause peripheral neuropathic pain (which mainly affects the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, electric shocks, shooting pain, stabbing pain, cramping pain, discomfort, tingling, numbness, prickling, 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 to any of the excipients 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 undergoing haemodialysis (to remove waste products due to kidney failure)
• if you have neurological or respiratory disorders or are over 65 years of age. Your doctor may prescribe different doses.
• 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 Mylan Generics. Cases of abuse and dependence have been reported with gabapentin in post-marketing experience. Inform your doctor if you have a history of abuse or dependence.

Dependence
Some people may develop dependence on Gabapentin Mylan Generics (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop taking Gabapentin Mylan Generics (see section 3, “How to take Gabapentin Mylan Generics” and “If you stop taking Gabapentin Mylan Generics”).
If you are concerned about the possibility of developing dependence on Gabapentin Mylan Generics, speak to your doctor.
If you notice any of the following signs while taking Gabapentin Mylan Generics, you may have developed 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 different from those for which it was prescribed
• You have made repeated unsuccessful attempts to stop or control your use of the medicine
• When you stop taking the medicine, you feel unwell 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 and how to safely stop taking the medicine.

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 medicines such as gabapentin have developed suicidal thoughts or self-harming thoughts. If such thoughts occur 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 any change in your condition.
If you experience signs or symptoms of dizziness and drowsiness (which may increase the risk of accidental injury), confusion, loss of consciousness, or reduced mental status while taking gabapentin, consult your doctor or pharmacist.

Important information about potentially serious reactions
Serious skin rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with gabapentin treatment. Stop taking gabapentin and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of these symptoms in section 4 of this leaflet, under the section “Stop taking Gabapentin Mylan Generics and contact your doctor immediately or go to the nearest Emergency Room if any of the following symptoms occur after taking this medicine, as they may be serious.”

Other medicines and Gabapentin Mylan Generics
Inform 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, because opioids may increase the effects of gabapentin. In addition, the combination of gabapentin with opioids may cause drowsiness, sedation, and/or decreased breathing or death.

No interaction is expected between Gabapentin Mylan Generics and other antiepileptic medicines or contraceptive pills containing norethisterone and ethinylestradiol.

Gabapentin Mylan Generics may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital that you are taking Gabapentin Mylan Generics.

Antacids for indigestion
If gabapentin and antacids containing aluminium 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 an antacid.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Gabapentin Mylan Generics may be used during the first trimester of pregnancy, if necessary.
If you are planning a pregnancy, are pregnant, or think you may be pregnant, contact your doctor immediately.
If you are pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy can have serious consequences for you and your unborn child.
In a study examining data from women in Nordic countries who took gabapentin during the first three months of pregnancy, no increased risk of birth defects or problems in brain function development (neurodevelopmental disorders) was observed.
However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm birth.
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.
When 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
Gabapentin passes into breast milk. Since the effects of breastfeeding on the newborn are unknown, it is recommended not to breastfeed while taking Gabapentin Mylan Generics.

Driving and using machines
Gabapentin Mylan Generics may cause dizziness, drowsiness, and fatigue. Do not drive, operate machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these activities.

Gabapentin Mylan Generics hard capsules contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Gabapentin Mylan Generics hard capsules contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is essentially “sodium-free”.

3. How to take Gabapentin Mylan Generics

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine 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 and/or a different dose.
The capsules must always be swallowed whole with a generous amount of water. This
medicine can be taken with or without food.
Continue treatment with Gabapentin Mylan Generics until your doctor tells you to stop.

Epilepsy:
Use in adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually, your doctor will gradually increase your
dose. The initial 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 3 administrations, i.e., once in the morning,
once in the afternoon, and once in the evening.

Use in children aged 6 years and older:
The dose for a child will be determined by the doctor based on the child's weight. 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 in three divided 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, your doctor will gradually increase your dose.
The recommended initial 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 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 on haemodialysis
If you have kidney problems or are on haemodialysis, your doctor may prescribe a different dosing schedule 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 any,
contact your doctor or go to the nearest emergency department immediately. Bring the remaining
capsules, the packaging, and the package leaflet with you, so that hospital staff can easily identify
which medicine has been taken.
Since this medicine may cause drowsiness, it is recommended to ask someone else to drive you to the doctor or hospital, or to call an ambulance. Symptoms of overdose may include dizziness, double vision, slurred speech, loss of consciousness, drowsiness, and moderate diarrhoea.

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 almost time for your next dose. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Gabapentin Mylan Generics
Do not stop treatment with Gabapentin Mylan Generics suddenly. If you wish to discontinue treatment with Gabapentin Mylan Generics, discuss this with your doctor first, who will explain how to do so safely. Discontinuation should be done gradually over at least 1 week. After stopping short-term or long-term treatment with Gabapentin Mylan Generics, you should be aware that you may experience certain unwanted 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 symptoms usually occur within 48 hours of stopping Gabapentin Mylan Generics. 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, this medicine can cause side effects, although not everybody gets them.
Stop taking Gabapentin Mylan Generics and contact your doctor immediately or go to the nearest Emergency Room
if any of the following symptoms occur after taking this medicine, as they may be serious:

Common (may affect up to 1 in 10 people)

• severe chest infection which may cause fever, chills, shortness of breath, cough, phlegm, and occasionally blood (pneumonia)
• seizures
• decrease in white blood cells (leucopenia) which may lead to more frequent infections, e.g. sore throat, fever, chills, and mouth ulcers, etc.

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

• loss of consciousness
• breathing problems which, if severe, may require emergency and intensive treatment to maintain normal breathing.

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 hypotension, requiring emergency treatment)
• severe skin reactions requiring immediate attention, such as swelling of lips and face, rash and redness (these may be symptoms of a severe allergic reaction)
• circular or target-shaped, flat red patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious 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)
• severe skin reactions requiring immediate attention such as swelling of lips and face, rash and redness (these may be signs of a severe allergic reaction)
• a serious skin condition (erythema multiforme) which may affect the mouth and other body parts; signs include red spots, often itchy, measles-like rash starting on the limbs and sometimes on the face and rest of the body. The spots may develop blisters or evolve into raised, red patches with pale centers. Affected individuals may have fever, sore throat, headache and/or diarrhoea
• inflamed pancreas which may cause stomach pain (radiating to the back) and vomiting
• kidney disease leading to urinating less than usual, nausea or vomiting, feeling confused (acute renal failure)
• destruction of muscle fibres associated with muscle cramps, muscle pain, fever and red-brown discoloration of urine (rhabdomyolysis)

Gabapentin may cause a severe or life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. When experiencing this type of reaction, you may or may not have a rash. This may require hospitalization or discontinuation of 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 lips and tongue
• yellowing of the skin or whites of the eyes
• unusual bleeding or bruising
• severe tiredness or weakness
• sudden muscle pain
• frequent infections

These may be early signs of a serious reaction. A doctor should examine 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
• drowsiness, dizziness, lack of coordination
• feeling tired

Common (may affect more than 1 in 100 people)

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

Uncommon (may affect up to 1 in 100 people)

• increased heart rate
• unusual reduction or slowness of body movements
• swelling which may involve the chest
• increased liver enzymes and bilirubin levels observed in blood tests
• falls
• difficulty in thinking
• elevated blood sugar levels (observed more frequently in patients with diabetes)
• hives or itchy rash
• agitation (a state of chronic restlessness and unintentional, purposeless movements)
• difficulty swallowing

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

• low blood sugar levels (observed more frequently in patients with diabetes)
• loss of consciousness
• breathing difficulties, shortness of breath (respiratory depression)

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

• suicidal thoughts
• sensing things that are not real (hallucinations)
• ringing in the ears
• movement disorders such as abnormal movements including twisting movements, convulsive movements and stiffness affecting eyes, head, neck and body
• hair loss
• uncontrolled urination
• increase in breast tissue, breast enlargement in males
• sexual function problems, including changes in sexual desire, inability to reach orgasm, delayed ejaculation
• symptoms occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, nausea, pain, sweating), chest pain
• increased creatine phosphokinase levels, observed in a blood test
• low sodium levels in the blood
• becoming dependent on Gabapentin Mylan Generics (“drug dependence”)

After stopping short-term or long-term treatment with Gabapentin Mylan Generics, you should be aware that you may experience some unwanted effects called withdrawal effects (see “If you stop taking Gabapentin Mylan Generics”).

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system. 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, or bottle after "Exp". The expiry date refers to the last day of that month.
Do not store the capsules above 25°C.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: Store in the original packaging.
Do not dispose of any medicine 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 Mylan Generics contains
The active substance 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"), maize starch and talc.
Capsule shell: gelatin, sodium lauryl sulfate.
The 100 mg capsules contain the colouring agent titanium dioxide (E171); the 300 mg capsules contain the colouring agents titanium dioxide (E171) and yellow iron oxide (E172); and the 400 mg capsules contain the colouring agents 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.
Hard 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, 90, 100 or 250 capsules,
multi-pack blisters consisting of 2 boxes, each containing 100 capsules,
hospital multi-pack blisters consisting of 5 or 10 boxes, each containing 100 capsules,
unit-dose divisible blisters of 20, 60 or 100, each containing 1 capsule,
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 Milano, Italy

Manufacturer(s)
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road – IR-Dublin 13, Ireland
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium – Gabapentine Viatris 100mg, 300mg, & 400mg capsules
Denmark – Gabamed 100mg, 300mg & 400mg kapsler, harde
Italy – Gabapentin Mylan Generics 100mg, 300mg & 400mg capsule rigide
United Kingdom (NI) – Gabapentin 100mg, 300mg & 400mg Capsules