Gabapentin teva

Package leaflet: Information for the patient

Gabapentin Teva, 100 mg, hard capsules
Gabapentin Teva, 300 mg, hard capsules
Gabapentin Teva, 400 mg, hard capsules
Gabapentinum
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Gabapentin Teva is and what it is used for
2. What you need to know before you take 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 in the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Gabapentin Teva is gabapentin.
Gabapentin Teva is used to treat:

• various forms of epilepsy (seizures that start in a specific part of the brain and may or may not spread to other areas). Gabapentin Teva is prescribed for adults and children aged 6 years and older as an add-on therapy when previous treatment has not fully controlled seizures. Gabapentin Teva should be taken as an additional medicine in the treatment of epilepsy in adults and children aged 6 years and older, unless otherwise directed by your doctor. Gabapentin Teva may also be used as monotherapy in adults and adolescents aged 12 years and older.
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral pain (occurring mainly in the lower and/or upper limbs) is caused by various conditions such as diabetes or shingles. This pain may be described as burning, stinging, pulsing, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Information before using Gabapentin Teva

When not to use Gabapentin Teva
if the patient is allergic to gabapentin or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before starting treatment with Gabapentin Teva, discuss this with your doctor or pharmacist
if the patient has kidney disease, the doctor may recommend a different dosing regimen,
if the patient is undergoing haemodialysis (to remove metabolic waste products due to kidney failure), inform the doctor if pain and/or muscle weakness occur,
if the patient experiences persistent abdominal pain, nausea and vomiting, contact the doctor immediately, as these may be symptoms of acute pancreatitis,
if the patient has neurological or respiratory disorders or is aged 65 years or older; the doctor may recommend an alternative dosing regimen,
before starting treatment with this medicine, inform the doctor if the patient has ever misused or been dependent on alcohol, prescription medicines or illicit drugs; this may mean that the risk of becoming dependent on Gabapentin Teva is higher.
Dependence
Some people may develop dependence on Gabapentin Teva (a need to continue taking the medicine). After stopping Gabapentin Teva, withdrawal symptoms may occur (see section 3, “How to take Gabapentin Teva” and “Stopping Gabapentin Teva”). If the patient is concerned about becoming dependent on Gabapentin Teva, it is important to consult the doctor.
If, while taking Gabapentin Teva, the patient notices any of the following signs, this may indicate the development of dependence:

• Feels compelled to take the medicine longer than prescribed by the doctor
• Feels compelled to take a higher dose than prescribed
• Uses the medicine for purposes other than prescribed
• Has made multiple unsuccessful attempts to stop or control use of the medicine
• Feels unwell after stopping the medicine and feels better after resuming it

If the patient notices any of the above behaviours, they should speak with their doctor to discuss the best treatment approach, including when and how to safely stop taking the medicine.
A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If the patient ever has such thoughts, contact the doctor immediately.
Important information about potentially serious side effects
Serious skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with gabapentin use. Treatment with gabapentin must be discontinued and medical advice sought immediately if any of the symptoms associated with serious skin reactions described in section 4 occur.
Please read the description of serious symptoms in section 4 “Contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they may be serious.”
Muscle weakness, tenderness or pain, especially when accompanied by malaise and high fever, may be due to abnormal breakdown of muscle fibres (rhabdomyolysis), which can be life-threatening and lead to kidney problems. Changes in urine colour and changes in blood test results (markedly increased blood creatine kinase levels) may occur. If such symptoms occur, contact the doctor immediately.
Gabapentin Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, and any medicines the patient plans to take. In particular, inform the doctor (or pharmacist) about any medicines currently or recently used to treat seizures, sleep disorders, depression, anxiety or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patients taking any opioid-containing medicines (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effects of Gabapentin Teva.
In addition, concomitant use of Gabapentin Teva and opioids may cause somnolence, sedation, respiratory depression or death.
Antacids for indigestion
When Gabapentin Teva is taken together with antacids containing aluminium and magnesium, 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 affect the results of certain laboratory tests; if undergoing urine testing, inform the doctor or hospital that you are taking this medicine.

Taking Gabapentin Teva with food
Gabapentin Teva can be taken independently of meals.
Pregnancy, breastfeeding and fertility

• If the patient is pregnant or suspects she may be pregnant, contact the doctor immediately to discuss the potential risk to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with the doctor.
• If the patient plans to become pregnant, discuss treatment with the doctor or pharmacist as early as possible before conception.
• If the patient is breastfeeding or plans to breastfeed, contact the doctor or pharmacist before starting this medicine.

Pregnancy
Gabapentin Teva may be used during the first trimester of pregnancy if necessary.
If the patient plans to become pregnant, is pregnant or suspects she may be pregnant, contact the doctor immediately.
If the patient becomes pregnant and has epilepsy, it is important not to stop taking the medicine without first consulting the doctor, as this could worsen the condition. Worsening seizures may pose a risk to both the pregnant woman and her unborn child.
In a study involving data from women in Scandinavian countries who took gabapentin during the first three months of pregnancy, no increased risk of congenital malformations or problems with brain development (neurodevelopmental disorders) was observed. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and preterm birth.
If pregnancy occurs, is suspected or is planned during treatment with Gabapentin Teva, contact the doctor immediately. Do not suddenly stop taking this medicine, as this may lead to withdrawal seizures, which could have serious consequences for both the pregnant woman and her child.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be increased if gabapentin is taken together with opioid pain medicines (medicines used to treat severe pain).
Breastfeeding
Gabapentin, the active substance in Gabapentin Teva, passes into human milk. As the effect on a breastfed infant is unknown, breastfeeding is not recommended during treatment with Gabapentin Teva.
Fertility
In animal studies, no effect of the medicine on fertility has been observed.
Driving and operating machinery
Gabapentin Teva may cause dizziness, drowsiness and fatigue. Until the patient knows how this medicine affects their ability to drive, operate complex machinery or perform other potentially hazardous activities, such activities should be avoided.
Gabapentin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered “sodium-free”.

3. How to use Gabapentin Teva

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. Do not take more medicine than prescribed.
The appropriate dose for each patient is determined by the doctor.
Epilepsy – recommended dose
Adults and adolescents
Take the number of capsules as prescribed by your doctor. Your doctor will usually increase the dose
gradually. The most commonly used starting dose ranges from 300 mg to 900 mg per day. The dose may then be
gradually increased, according to your doctor's instructions, up to a maximum dose of 3600 mg per day, which
your doctor will advise dividing into 3 separate doses (one in the morning, one in the afternoon, and one in the evening).
Use in children
Children aged 6 years and older
The dose to be given to a child is determined by the doctor based on the child's body weight. Treatment
begins with a low initial dose, which is gradually increased over a period of 3 days. The usual effective dose for
controlling epilepsy is 25 to 35 mg/kg body weight/day. The medicine is usually taken in three divided doses
daily – one capsule (or capsules) in the morning, one in the afternoon, and one in the evening.
Gabapentin Teva is not recommended for use in children under 6 years of age.
Peripheral neuropathic pain – recommended dose
Adults
Take the number of capsules as prescribed by your doctor. Your doctor will usually increase the dose
gradually. The most commonly used starting dose ranges from 300 mg to 900 mg per day. The dose may then be
gradually increased, according to your doctor's instructions, up to a maximum dose of 3600 mg per day, which
your doctor will advise dividing into 3 separate doses (one in the morning, one in the afternoon, and one in the evening).
Use in patients with kidney disease or undergoing hemodialysis
For patients with kidney problems or those undergoing hemodialysis, your doctor may recommend a different
dosing schedule and/or a different dose.
Elderly patients (over 65 years of age)
Elderly patients (over 65 years of age) should take Gabapentin Teva according to the standard recommended
dosing regimen, unless they have kidney problems. For patients with kidney problems, your doctor may
recommend a different dosing schedule and/or a different dose.
If you feel that the effect of Gabapentin Teva is too strong or too weak, you should consult your doctor or
pharmacist as soon as possible.
Method of administration
Gabapentin Teva should be taken orally. Capsules must always be swallowed whole with a large amount of water.
Gabapentin Teva may be taken with or without food.
Do not stop taking Gabapentin Teva unless your doctor tells you to do so.
Taking more Gabapentin Teva than recommended
Taking more than the recommended dose may increase the risk of adverse effects, including loss of consciousness,
dizziness, double vision, slurred speech, drowsiness, and diarrhoea. If you take more Gabapentin Teva than you
should, contact your doctor immediately or go to the nearest hospital emergency department (A&E).
Take all remaining capsules, the packaging, and the leaflet with you so that hospital staff can immediately identify
which medicine has been taken.
If you miss a dose of Gabapentin Teva
If you miss 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 missed dose.
Stopping Gabapentin Teva
Do not suddenly stop taking Gabapentin Teva. If you wish to discontinue treatment, you should first discuss this
with your doctor. Your doctor will advise you on how to proceed. The medicine should be withdrawn gradually over
a period of at least 1 week. After stopping short-term or long-term treatment with Gabapentin Teva, be aware that
certain adverse effects, known as withdrawal symptoms, may occur. These may include seizures, anxiety,
difficulty sleeping, nausea, pain, sweating, tremor, headache, depression, feeling unwell, dizziness, and general
malaise. These symptoms usually occur within 48 hours after stopping Gabapentin Teva. If withdrawal symptoms
occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Gabapentin Teva and contact your doctor immediately
if any of the following symptoms occur after taking the medicine:

• Reddish, non-elevated flat or round spots on the trunk, often with blisters in the center, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, and 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)

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

• Persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• Breathing difficulties, which may, especially in severe cases, require immediate and intensive medical care to restore normal breathing
• Gabapentin Teva may cause severe or life-threatening allergic reactions affecting the skin or other parts of the body, such as the liver or blood cells. During such reactions, a rash may or may not appear. The above symptoms may lead to hospitalization or the need to discontinue treatment with Gabapentin Teva. You should contact your doctor immediately if any of the following symptoms occur:
• Skin rash and redness of the skin, and (or) hair loss
• Urticaria (hives)
• Fever
• Swollen lymph nodes that do not resolve
• Swelling of the lips, face, and tongue
• Yellowing of the skin or the whites (sclera) of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections

The above symptoms may be the first signs of a serious reaction. Your doctor should examine you and decide whether treatment with Gabapentin Teva should be continued.

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

Other adverse reactions include:
Very common (may occur in more than 1 in 10 people):

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling of fatigue, fever

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

• Pneumonia, respiratory tract infections, urinary tract infections, ear infection, or other infections
• Low white blood cell count
• Loss of appetite, increased appetite
• Irritability, confusion, mood swings, depression, anxiety, restlessness, difficulty thinking
• Seizures, sudden muscle jerks, speech problems, memory loss, tremor, sleep disturbances, headache, increased skin sensitivity, reduced sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, redness or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• Vomiting, nausea, dental problems, gingivitis, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating with passing wind
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle twitching
• Erectile dysfunction (impotence)
• Swelling of hands and feet, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

Additionally, in clinical trials, aggressive behavior and sudden limb jerks were commonly reported in children.
Uncommon (may occur in up to 1 in 100 people):

• Agitation (a state of constant restlessness and involuntary, purposeless movements)
• Allergic reactions, e.g., urticaria
• Reduced mobility
• Rapid heartbeat
• Difficulty swallowing
• Swelling affecting the face, trunk, and limbs
• Abnormal blood test results suggesting liver problems
• Psychiatric disorders
• Falls
• Increased blood glucose levels (most commonly observed in diabetic patients)

Rare (may occur in up to 1 in 1000 people):

• Low blood glucose levels (most commonly observed in diabetic patients)
• Loss of consciousness
• Breathing difficulties, shallow breathing (respiratory depression)

Following the introduction of gabapentin into clinical use, the following adverse reactions have been reported:

• Decreased platelet count (cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting of limbs, sudden jerks, and stiffness
• Ringing in the ears (tinnitus)
• Yellowing of the skin and eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue overgrowth, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, nausea, pain, excessive sweating), chest pain
• Rhabdomyolysis (breakdown of muscle fibers)
• Changes in blood test results (elevated creatine kinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylactic reactions (severe, potentially life-threatening allergic reactions involving breathing difficulties, swelling of lips, throat, and tongue, and hypotension requiring immediate treatment)
• Risk of developing dependence on Gabapentin Teva ("drug dependence").

After discontinuation of short-term or long-term treatment with Gabapentin Teva, it should be recognized that certain adverse reactions, known as withdrawal symptoms, may occur (see "Stopping Gabapentin Teva").
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity or its representative.
Reporting adverse reactions helps to gather 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 cardboard box,
blister pack, or bottle after "Expiry date" or "EXP". The expiry date refers to the last day
of the stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Gabapentin Teva contains

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

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

What Gabapentin Teva looks like and contents of the pack

Gabapentin Teva 100 mg are hard capsules (approximately 16 mm in length), with an opaque white body printed in black with TV 3494 and a light brown opaque cap printed in white with TV 3494.

Gabapentin Teva 300 mg are hard capsules (approximately 19 mm in length), with an opaque yellow body printed in black with TV 3495 and a light brown opaque cap printed in black with TV 3495.

Gabapentin Teva 400 mg are hard capsules (approximately 22 mm in length), with an opaque orange body printed in black with TV 3496 and a light brown opaque cap printed in black with TV 3496.

Gabapentin Teva is available in blister packs containing 20, 30, 50, 60, 90, 100 or 200 hard capsules in a cardboard carton, in single-dose perforated blisters containing 20x1, 30x1, 50x1, 60x1, 90x1, 100x1 or 200x1 hard capsules in a cardboard carton, or in bottles containing 50, 100 or 200 hard capsules in a cardboard carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA, Haarlem
The Netherlands

Manufacturer
TEVA Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Teva Nederland BV
Swensweg 5
2031 GA Haarlem
The Netherlands

For detailed information, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00

This medicinal product is authorised for sale in the European Economic Area countries under the following names:

Austria: Gabapentin ratiopharm GmbH 100 mg Hartkapseln
Gabapentin ratiopharm GmbH 300 mg Hartkapseln
Gabapentin ratiopharm GmbH 400 mg Hartkapseln

Belgium: Gabapentine Teva 100 mg harde capsules/gélules/Hartkapseln
Gabapentine Teva 300 mg harde capsules/gélules/Hartkapseln
Gabapentine Teva 400 mg harde capsules/gélules/Hartkapseln

Czech Republic: Gabapentin Teva B.V.

Germany: Gabapentin Teva 100, 300, 400 mg Hartkapseln

Denmark: Gabapentin Teva

Estonia: Gabapentin Teva

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

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

Ireland: Gabapentin Teva 100 mg, 300 mg & 400 mg hard capsules

Iceland: Gabapentin Teva

Italy: Gabapentin Teva

Lithuania: Gabapentin Teva 300 mg kietosios kapsulės
Gabapentin Teva 400 mg kietosios kapsulės

Latvia: Gabapentin Teva 300 mg cietās kapsulas
Gabapentin Teva 400 mg cietās kapsulas

The Netherlands: Gabapentine ratiopharm 100 mg, harde capsules
Gabapentine ratiopharm 300 mg, harde capsules
Gabapentine ratiopharm 400 mg, harde capsules

Poland: Gabapentin Teva

Portugal: Gabapentina ratiopharm

Romania: Gabapentină Teva 100 mg capsule
Gabapentină Teva 300 mg capsule
Gabapentină Teva 400 mg capsule

Sweden: Gabapentin Teva B.V.

Slovakia: Gabapentin Teva B.V. 100 mg
Gabapentin Teva B.V. 300 mg
Gabapentin Teva B.V. 400 mg