Gabapentin teva

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Gabapentin Teva (Gabapentine Teva), 400 mg, hard capsules
Gabapentinum
Gabapentin Teva and Gabapentine Teva are different brand names of the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Gabapentin Teva is and what it is used for
2. Important information 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 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 area of the brain and may spread to other parts of the brain or remain localized). Gabapentin Teva is prescribed for adults and children aged 6 years and older as an add-on treatment for epilepsy 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 a doctor. Gabapentin Teva may also be used as monotherapy in adults and children 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 diseases, such as diabetes or shingles. Patients describe this pain as burning, stinging, pulsating, shooting, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important 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 waste products due to kidney failure), inform the doctor if pain and/or muscle weakness occur,
• if the patient experiences symptoms such as persistent abdominal pain, nausea and vomiting, contact the doctor immediately, as these may be signs of acute pancreatitis,
• if the patient has neurological disorders, respiratory disorders or is aged 65 years or older, the doctor may recommend a different dosing regimen,
• before starting treatment with this medicine, inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines or illegal drugs; this may mean that the risk of becoming dependent on Gabapentin Teva is higher.

Cases of abuse and dependence have been reported with gabapentin following marketing authorization. If the patient has previously abused medicines or been dependent on medicines, inform the doctor.
Dependence
Some people may develop dependence on Gabapentin Teva (a need to keep 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 possibly becoming dependent on Gabapentin Teva, it is important to consult the doctor.
If the patient notices any of the following signs while taking Gabapentin Teva, this may indicate developing dependence:

• Feels the need to take the medicine longer than prescribed by the doctor
• Feels the need 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 taking it again.

If the patient notices any of the above behaviours, they should speak with their doctor to discuss the best treatment approach, including when it might be appropriate to stop taking the medicine and how to do so safely.
A small number of people taking antiepileptic medicines containing gabapentin have had thoughts of harming themselves or of suicide. If such thoughts occur at any time, contact the doctor immediately.
Important information about potentially serious side effects
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with gabapentin. If any of the symptoms associated with serious skin reactions described in section 4 occur, stop taking gabapentin and contact a doctor immediately.
Please read the description of the above symptoms in section 4 of this leaflet “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 general malaise and high fever, may be caused by abnormal breakdown of muscle fibres, which can be life-threatening and lead to kidney problems. Changes in urine colour and blood test results (markedly increased blood creatine kinase levels) may occur. If such subjective or objective symptoms occur, contact a doctor immediately.
Gabapentin Teva with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Especially inform the doctor (or pharmacist) about all medicines recently or currently used to treat seizures, sleep disorders, depression, anxiety disorders or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patients taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentin Teva.
Additionally, concomitant use of Gabapentin Teva and opioids may cause somnolence, sedation, respiratory depression or death.
Antacids used 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 a urine test, inform the doctor or hospital that you are taking this medicine.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Gabapentin Teva should not be taken during pregnancy unless the doctor advises otherwise. Women of childbearing potential must use an effective method of contraception.
Although no studies have evaluated the use of gabapentin in pregnant women, increased risk of harm to the developing baby has been reported with other antiepileptic medicines, especially when several antiepileptic medicines are used together. Whenever possible, and only in consultation with the doctor, pregnant women should take a single antiepileptic medicine.
Do not stop taking this medicine suddenly, as this may trigger breakthrough seizures, which could lead to serious consequences for both the pregnant woman and her baby.
If pregnancy occurs, is suspected or is planned while taking Gabapentin Teva, contact the doctor immediately.
Do not stop taking this medicine suddenly, as this may lead to withdrawal seizures, which could lead to serious consequences for both the pregnant woman and her baby.
Use of gabapentin during pregnancy may lead to withdrawal symptoms in newborns. This risk may increase 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 breast milk. As it is not known what effect it may have on the breastfed infant, breastfeeding is not recommended during treatment with Gabapentin Teva.
Fertility
No effect of the medicine on fertility was observed in animal studies.
Driving and using machines
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.

3. How to use Gabapentin Teva

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Gabapentin Teva is available in the following strengths: 100 mg, 300 mg, 400 mg.
Your doctor will determine the appropriate dose for you.

Epilepsy – recommended dose
Adults and adolescents
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually.
The usual starting dose is between 300 mg and 900 mg per day. This may then be gradually increased
to a maximum dose of 3600 mg per day, divided into 3 smaller doses (one in the morning, one in the
afternoon, and one in the evening).

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 starts with a low initial dose, which is gradually increased over a period of 3 days.
The usual effective dose for controlling epilepsy ranges from 25 to 35 mg/kg body weight per day.
The medicine is usually taken in three divided doses daily: one capsule (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 gradually increase
the dose.
The usual starting dose is between 300 mg and 900 mg per day. This may then be gradually
increased up to a maximum dose of 3600 mg per day, taken as directed by your doctor, in 3 divided
doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or patients undergoing haemodialysis
For patients with kidney disease or those undergoing haemodialysis, your doctor may prescribe
a different dosing schedule and/or dose.

Elderly patients (over 65 years of age) should take Gabapentin Teva according to the normally
recommended dosing schedule, unless they have kidney problems. In patients with kidney disease,
the doctor may prescribe a different dosing schedule and/or dose.

If you feel that the effect of Gabapentin Teva is too strong or too weak, consult your doctor or
pharmacist.

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 independently of meals.

Do not stop taking Gabapentin Teva unless your doctor tells you to do so.

Taking more Gabapentin Teva than prescribed
Taking more than the prescribed 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 any remaining capsules, the packaging, and the leaflet with you so that hospital staff can
immediately identify which medicine has been taken.

Missing 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 stop taking Gabapentin Teva suddenly. If you wish to discontinue treatment, you should first
discuss this with your doctor. Your doctor will advise you on how to do this properly. 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 of 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.
Due to the possible serious health consequences, you must stop taking the medicine
Gabapentin Teva and contact your doctor immediately if any of the following symptoms occur after taking Gabapentin Teva:

• Reddish, non-elevated flat or round spots on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, 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:

• Severe skin reactions requiring immediate medical attention, swelling around the mouth and face, skin rash and redness, and (or) hair loss (these may be symptoms of a severe allergic reaction)
• 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 Gabapentin Teva. Contact your doctor if any of the following symptoms occur:
• Rash
• Urticaria (hives)
• Fever
• Persistent swelling of lymph nodes
• Swelling of lips and tongue
• Yellowing of the skin or sclera (whites) of the eye
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections.

The above symptoms may be the first signs of a severe reaction. Your doctor should decide whether continuing treatment with Gabapentin Teva is necessary.
If the patient is undergoing hemodialysis, inform the doctor if muscle pain and (or) weakness occurs.
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 not more than 1 in 10 people):

• Pneumonia, respiratory tract infections, urinary tract infections, infection, ear infection, or other infections
• Decreased white blood cell count
• Loss of appetite, increased appetite
• Irritability towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• Seizures, sudden muscle movements, speech problems, memory loss, tremor, sleep disturbances, headache, increased skin sensitivity, reduced sensation (numbness), coordination problems, unusual eye movements, exaggerated, weakened, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing, or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• Vomiting, nausea, dental problems, gum inflammation, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle twitching
• Erectile dysfunction
• Swelling of legs and hands, 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 not more than 1 in 100 people):

• Agitation (a state of constant restlessness and unintentional, aimless 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 not more than 1 in 1000 people):

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

Frequency not known: frequency cannot be estimated from available data

• Development of drug dependence ("drug addiction").

After discontinuation of short-term or long-term treatment, be aware that certain adverse reactions may occur, known as withdrawal symptoms (see "Discontinuing Gabapentin Teva").
The following adverse reactions have been reported after Gabapentin Teva was introduced into the market:

• Decreased platelet count (cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting limbs or sudden jerking and stiffness
• Tinnitus (ringing in the ears)
• Yellowing of the skin and eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue enlargement, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep problems, nausea, pain, excessive sweating), chest pain
• Changes in blood glucose levels in diabetic patients
• Rhabdomyolysis (muscle fiber breakdown)
• Changes in blood test results (increased creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Hyponatremia (low sodium levels in blood)
• Anaphylactic reactions (severe, potentially life-threatening reactions involving breathing difficulties, swelling of lips, throat, and tongue, and hypotension requiring immediate treatment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the 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 packaging. The expiry date refers to the last day of the specified month.
Do not store above 25°C. Store in the original packaging.
Keep blister packs in the outer packaging.
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. Contents of the pack and other information

What Gabapentin Teva contains
The active substance is gabapentin.
Each hard capsule contains 400 mg of gabapentin.
The other ingredients are:
Capsule core: talc, pregelatinized starch.
Capsule cap and body: gelatin, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171).
Printing ink: shellac (E 904), black iron oxide (E 172), propylene glycol.

What Gabapentin Teva looks like and contents of the pack
Hard gelatin capsule with a brown cap and body, filled with white or almost white powder in small aggregates. Numbers “93” and “40” are printed on the cap and body.
The pack contains 10, 20, 30, 50, 90, 100, 200, 500 or 1000 hard capsules.
For further information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Teva BV, Swensweg 5, 2031 GA Haarlem, the Netherlands

Manufacturer:
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, the Netherlands

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Relabelled and/or repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in the Netherlands, country of export: RVG 31982
Parallel Import Licence Number: 233/24

This medicinal product is authorised in the following European Economic Area countries under the following names:
Norway Gatonin 400 mg capsules, hard
Germany GABAPENTIN-TEVA 400 mg hard capsules
Czech Republic Gabapentin-Teva 400 mg
Poland Gabapentin Teva
Portugal Gabapentina Teva 400 mg Capsule
Slovakia Gabapentin-Teva 400 mg