Gabapentin Teva

Package leaflet: Information for the user

Gabapentin Teva 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 they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Gabapentin Teva belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance of Gabapentin Teva is gabapentin.
Gabapentin Teva is used to treat:

• Various forms of epilepsy (epileptic 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 Teva for you or your child aged 6 years or older as an add-on treatment for epilepsy if the current treatment is not fully controlling the condition. You or your child aged 6 years or older should take Gabapentin Teva in addition to the ongoing treatment, unless otherwise instructed by your doctor. Gabapentin Teva may also be used as monotherapy in adults and adolescents aged over 12 years.
• Peripheral neuropathic pain (long-lasting pain caused by nerve damage). A wide variety of diseases can cause peripheral neuropathic pain (occurring primarily in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations are described in various ways, such as warmth, burning, throbbing pain, shooting pain, sharp, stabbing, cramping, dull, prickling, numbness, tingling, etc.

2. What you need to know before taking Gabapentin Teva

Do not take Gabapentin Teva:

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

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

• if you have kidney problems. In this case, your doctor may prescribe you a different dosage
• if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, feeling unwell or malaise, contact your doctor immediately, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• if you suffer from disorders of the nervous or respiratory system 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 developed dependence on alcohol, prescription medicines or illegal drugs; in this case, you may have an increased risk of becoming dependent on Gabapentin Teva.

Dependence
Some people may develop dependence on Gabapentin Teva (a need to continue taking the medicine). These individuals may experience withdrawal effects when they stop taking Gabapentin Teva (see section 3, “How to take Gabapentin Teva” and “If you stop taking Gabapentin Teva”). If you are concerned about possibly developing dependence on Gabapentin Teva, it is important to consult your doctor.
If you notice any of the following signs while taking Gabapentin Teva, this could indicate that you have developed dependence:

• If you feel the need to take the medicine for longer than prescribed by your doctor
• If you think you need to take a higher dose than recommended
• If you are using the medicine for reasons different from those for which it was prescribed
• If you have tried multiple times without success to stop or control your use of the medicine
• If you feel unwell when you stop taking the medicine and feel better when you start taking it again

If you notice any of these signs, talk to your doctor to discuss the best treatment plan for you, including the appropriate time to stop treatment and how to do so safely.
A small number of patients treated with antiepileptic medicines such as gabapentin have experienced suicidal thoughts or self-harm. If you have thoughts of this kind at any time, contact your doctor immediately.
Important information about potentially serious reactions
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with gabapentin. Stop taking gabapentin and contact your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.
Please read the description of these symptoms in section 4 of this leaflet under “Contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they could be serious”.
Muscle weakness, tenderness or pain, especially if you also feel unwell and have a fever, may be caused by muscle injury, which can be life-threatening and may lead to kidney problems. You may also notice discoloured urine and abnormalities in blood tests (particularly an increase in creatine phosphokinase). If any of these signs or symptoms occur, contact your doctor immediately.
Other medicines and Gabapentin Teva
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 (e.g. morphine), inform your doctor or pharmacist, as opioids may enhance the effect of Gabapentin Teva. In addition, combining Gabapentin Teva with opioids may cause symptoms such as drowsiness, sedation, reduced breathing or death.
Antacids for indigestion
If Gabapentin Teva and antacids containing aluminium and magnesium are taken at the same time, the absorption of Gabapentin Teva from the stomach may be reduced. It is therefore recommended to take Gabapentin Teva at least two hours after taking an antacid.
Gabapentin Teva

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

Gabapentin Teva with food
Gabapentin Teva can be taken with or without food.
Pregnancy, breastfeeding and fertility

• If you are pregnant or suspect you may be pregnant, you must immediately inform your doctor about the medicine you are taking and discuss possible risks to the fetus.
• Do not stop treatment without talking to your doctor.
• If you are planning a pregnancy, speak to your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin Teva may be used during the first trimester of pregnancy, if necessary.
Speak to your doctor immediately if you are planning a pregnancy, are pregnant or think you may be pregnant.
If you are pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as stopping treatment could worsen your condition. Worsening of epilepsy could put you and your unborn baby at risk.
In a study examining data from women in Nordic countries who took gabapentin during the first three months of pregnancy, the risk of birth defects or problems with brain function development (neurodevelopmental disorders) was not found to be increased. However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm birth.
Contact your doctor immediately if you become pregnant, think you may be pregnant or are planning a pregnancy while being treated with Gabapentin Teva. Do not suddenly stop taking this medicine, as this could cause sudden onset of epileptic seizures, which may have serious consequences for you and your baby.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Breastfeeding
Gabapentin, the active ingredient of Gabapentin Teva, passes into human breast milk. As the effect on the infant is unknown, breastfeeding is not recommended during treatment with Gabapentin Teva.
Fertility
Animal studies have shown no effect on fertility.
Driving and using machines
Gabapentin Teva may cause dizziness, drowsiness and fatigue. Therefore, do not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.
Gabapentin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Gabapentin Teva

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the most suitable dose for you.

Epilepsy, the recommended dose is
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 increased, as directed by your doctor, up to a maximum of 3600 mg per day. Your doctor will instruct you to take this dose in three separate administrations: once in the morning, once in the afternoon, and once in the evening.

Use in children
Children aged 6 years and older
The dose to be administered to the child will be determined by the doctor, as it is calculated based on the child's body weight. Treatment starts with a low initial dose, which is then gradually increased over approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg/day. This is usually given in three divided doses, taking the capsule(s) every day, typically once in the morning, once in the afternoon, and once in the evening.
The use of Gabapentin Teva is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is
Adults
Take the number of capsules as instructed 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 increased, as directed by your doctor, up to a maximum of 3600 mg per day. Your doctor will instruct you to take this dose in three separate administrations: once in the morning, once in the afternoon, and once in the evening.

If you have kidney problems or are on haemodialysis
If you have kidney problems or are undergoing haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.

If you are an elderly patient (over 65 years of age)
You should take the normal dose of Gabapentin Teva unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing schedule and/or a different dose.
If you feel that the effect of Gabapentin Teva is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration
Gabapentin Teva is taken orally. Always swallow the capsules whole with plenty of water.
Gabapentin Teva can be taken with or without food.
Continue treatment with Gabapentin Teva until your doctor tells you to stop.

If you take more Gabapentin Teva than you should
Taking more than the recommended dose may increase the risk of side effects, including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea. If you have taken more Gabapentin Teva than prescribed, contact your doctor immediately or go to the nearest emergency room. Bring any unused capsules, the container, and the label with you so that hospital doctors can quickly identify which medicine you have taken.

If you forget to take Gabapentin Teva
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 Teva
Do not stop taking Gabapentin Teva suddenly. If you wish to discontinue treatment with Gabapentin Teva, discuss this first with your doctor. Your doctor will advise you on what to do. Discontinuation of treatment should be gradual, over a period of at least one week.
You should know that, after stopping short- or long-term treatment with Gabapentin Teva, you may experience certain side effects known as withdrawal symptoms. These may include epileptic seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, altered sensations, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping Gabapentin Teva.
If you experience withdrawal symptoms, contact your doctor immediately.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Gabapentin Teva and contact your doctor immediately if you notice any of the
following symptoms:

• Flat, red spots resembling targets or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, or eyes. 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).

Contact your doctor immediately if any of the following symptoms occur after taking this
medicine, as they may be serious:

• Persistent stomach pain, feeling unwell or malaise, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• Breathing problems, which, if severe, may require emergency and intensive treatment to allow normal breathing
• Gabapentin Teva may cause a serious or life-threatening allergic reaction affecting the skin or any other part of the body, such as the liver or blood. This type of reaction may or may not involve skin rashes. It may lead to hospitalization or discontinuation of treatment with Gabapentin Teva. Call your doctor immediately if you experience any of the following symptoms:
• Skin rashes, redness, and/or hair loss
• Hives (urticaria)
• Fever
• Swollen lymph nodes that do not go away
• Swelling of the lips, face, and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Sudden muscle pain
• Frequent infections

These symptoms may be early signs of a serious allergic reaction. You must be examined by a
doctor to determine whether you can continue taking Gabapentin Teva.

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

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

Common (may affect up to 1 in 10 people)

• Pneumonia, respiratory infections, urinary tract infections, ear inflammation, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, jerky movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, reduced sensation (numbness), difficulty with coordination, abnormal eye movements, exaggerated, diminished, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing, or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dry nose
• Vomiting (feeling unwell), nausea (sensation of feeling unwell), dental problems, inflamed gums, diarrhea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle cramps
• Difficulty with erection (impotence)
• Swelling of arms and legs, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical studies conducted in children, aggressive behavior and jerky movements were commonly reported.
Uncommon (may affect up to 1 in 100 people)

• Agitation (a state of chronic restlessness and involuntary, unmotivated movements)
• Allergic reactions such as hives
• Reduced movement
• Rapid heartbeat
• Difficulty swallowing
• Swelling that may affect the face, trunk, and limbs
• Abnormal blood test results suggesting liver problems
• Mental impairment
• Falls
• Increased blood glucose levels (more frequently observed in patients with diabetes)

Rare (may affect up to 1 in 1000 people)

• Decreased blood glucose levels (more frequently observed in patients with diabetes)
• Loss of consciousness
• Difficulty breathing, weak breathing (respiratory depression)

The following side effects have been reported after gabapentin has been marketed:

• Decreased platelet count (cells involved in blood clotting)
• Suicidal thoughts, hallucinations
• Problems with abnormal movements such as twisting, jerky movements, and stiffness
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increase in breast tissue, breast enlargement
• Adverse events following abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling unwell, pain, sweating), chest pain
• Muscle fiber damage (rhabdomyolysis)
• Abnormal blood tests (elevated creatine phosphokinase)
• Sexual dysfunction including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (a serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, hypotension requiring emergency treatment)
• Development of dependence on Gabapentin Teva

After stopping short- or long-term treatment with Gabapentin Teva, you may develop certain side effects, known as withdrawal effects (see "If you stop taking Gabapentin Teva").
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 . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Gabapentin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister or bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Teva contains

• The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin. Each hard capsule contains 300 mg of gabapentin. Each hard capsule contains 400 mg of gabapentin.
• The other components are:

Capsule contents: maize starch, mannitol (E421), talc (E553b)
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), purified water, sodium lauryl sulfate
Printing inks:
Black printing ink: shellac (E904), black iron oxide (E172)
100 mg:
White printing ink: shellac (E904), titanium dioxide (E171)

Description of the appearance of Gabapentin Teva and package contents
Gabapentin Teva 100 mg are hard capsules (approximately 16 mm in length), with an opaque white body printed with "TV 3494" in black and an opaque light brown cap printed with "TV 3494" in white.
Gabapentin Teva 300 mg are hard capsules (approximately 19 mm in length), with an opaque yellow body printed with "TV 3495" in black and an opaque light brown cap printed with "TV 3495" in black.
Gabapentin Teva 400 mg are hard capsules (approximately 22 mm in length), with an opaque orange body printed with "TV 3496" in black and an opaque light brown cap printed with "TV 3496" in black.
Gabapentin Teva is available in blisters containing 20, 30, 50, 60, 90, 100 or 200 hard capsules, divisible blisters for single doses containing 20x1, 30x1, 50x1, 60x1, 90x1, 100x1 or 200x1 hard capsules, or in a bottle containing 50, 100 or 200 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, Debrecen H-4042, Hungary
Teva Nederland B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Operations Poland, Sp. z.o.o, ul. Mogilska 80, 31-546 Krakow, Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Gabapentin ratiopharm GmbH 100 mg Hard Capsules
Gabapentin ratiopharm GmbH 300 mg Hard Capsules
Gabapentin ratiopharm GmbH 400 mg Hard Capsules
Belgium Gabapentine Teva 100 mg hard capsules/gélules/Hartkapseln
Gabapentine Teva 300 mg hard capsules/gélules/Hartkapseln
Gabapentine Teva 400 mg hard capsules/gélules/Hartkapseln
Czech Republic Gabapentin Teva B.V.
Denmark Gabapentin Teva
Estonia Gabapentin Teva
Finland Gabapentin ratiopharm GmbH 300 mg kapseli, kova
Gabapentin ratiopharm GmbH 400 mg kapseli, kova
France Gabapentine Teva Santé 100 mg, gélule
Gabapentine Teva Santé 300 mg, gélule
Gabapentine Teva Santé 400 mg, gélule
Germany Gabapentin Teva 100, 300, 400 mg Hartkapseln
Ireland Gabapentin Teva 100 mg, 300 mg & 400 mg hard capsules
Iceland Gabapentin Teva
Italy Gabapentin Teva
Latvia Gabapentin Teva 300 mg cietās kapsulas
Gabapentin Teva 400 mg cietās kapsulas
Lithuania Gabapentin Teva 300 mg kietosios kapsulės
Gabapentin Teva 400 mg kietosios kapsulės
The Netherlands Gabapentine ratiopharm 100 mg, harde capsules
Gabapentine ratiopharm 300 mg, harde capsules
Gabapentine ratiopharm 400 mg, harde capsules
Poland Gabapentin Teva B.V.
Portugal Gabapentina ratiopharm
Romania Gabapentină Teva 100 mg capsule
Gabapentină Teva 300 mg capsule
Gabapentină Teva 400 mg capsule
Slovakia Gabapentin Teva B.V. 100 mg
Gabapentin Teva B.V. 300 mg
Gabapentin Teva B.V. 400 mg
Spain Gabapentina Teva-ratiopharm 100 mg cápsulas duras EFG
Gabapentina Teva-ratiopharm 300 mg cápsulas duras EFG
Gabapentina Teva-ratiopharm 400 mg cápsulas duras EFG
Sweden Gabapentin Teva B.V.