Gabapentin teva

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Gabapentin Teva (Gabapentina Teva)
800 mg, coated tablets
Gabapentinum
Gabapentin Teva and Gabapentina Teva are different brand names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you:

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you need advice or further information.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine 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 or pharmacist. See section 4.

Leaflet contents:

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 in the treatment of epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).
The active substance in Gabapentin Teva is gabapentin.
Gabapentin Teva is used to treat:

• various types of epilepsy (seizures initially localized in specific areas of the brain which may spread to the rest of the brain or not). Gabapentin Teva is prescribed for adults and children aged 6 years and older as an add-on therapy 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 above 12 years of age.
• peripheral neuropathic pain (chronic 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 the pain they feel as burning, stinging, pulsating, 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 to take Gabapentin Teva, discuss this with your doctor or
pharmacist

• if the patient has kidney disease, the doctor may recommend a different dosing schedule,
• if the patient is undergoing haemodialysis (to remove waste products due to kidney failure), inform the doctor if muscle pain or weakness occurs,
• if the patient experiences symptoms such as persistent abdominal pain, nausea or vomiting, contact the doctor immediately, as these may be signs of acute pancreatitis,
• if the patient has neurological disorders, respiratory disorders or is over 65 years of age; the doctor may recommend a different dosage,
• before starting this medicine, inform the doctor if the patient has ever misused 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 misuse and dependence have been reported with the use of gabapentin after the medicine was marketed. If the patient has previously misused medicines or been dependent on drugs, inform the doctor.
Dependence
Some people may develop dependence on Gabapentin Teva (a need to keep taking the medicine continuously). 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 the development of 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 those prescribed
• Has made repeated 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 would 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 taking their own life. If such thoughts ever occur, the patient should contact their 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 occurred with the use of gabapentin. If any of the symptoms associated with serious skin reactions described in section 4 occur, gabapentin should be stopped immediately and medical advice should be sought without delay.
Please read the description of the above symptoms in section 4 of this leaflet under: “Contact a 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 feeling unwell and high fever, may be due to 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 symptoms occur, contact a doctor immediately.
Gabapentin Teva and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as 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
If the patient is taking medicines containing opioids (such as morphine), they should inform their doctor or pharmacist, as opioids may enhance the effects of Gabapentin Teva.
Additionally, taking Gabapentin Teva together with opioids may cause drowsiness, 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. Therefore, it is 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 a urine test is to be performed, inform the doctor or hospital that the patient is taking Gabapentin Teva.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, thinks 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 effective contraception.
Although no studies have assessed the use of gabapentin in pregnant women, increased risk of harm to the developing baby has been reported with other antiepileptic medicines, particularly when several antiepileptic medicines are used together. Whenever possible, and only in consultation with the doctor, pregnant women should take a single antiepileptic medicine.
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 trigger breakthrough seizures, which could have 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 human 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 operating machinery
Gabapentin Teva may cause dizziness, drowsiness and fatigue. Until the patient knows how this medicine affects them, they should refrain from driving, operating complex machinery or engaging in any other potentially hazardous activities.

3. How to use Gabapentin Teva

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. Do not take more medicine than prescribed.
The dose appropriate for each patient is determined by the doctor.
Gabapentin Teva is available in the following strengths: 600 mg and 800 mg.

Epilepsy – recommended dose
Adults and adolescents
Take the number of tablets as directed by your doctor. Doses are usually increased gradually. The usual starting dose is between 300 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 is between 25 and 35 mg/kg body weight/day. The medicine is usually taken in three divided doses daily: one tablet (or tablets) 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 tablets as directed by your doctor. Your doctor will gradually increase the dose. The usual starting dose is between 300 and 900 mg per day. This may then be gradually increased up to a maximum dose of 3600 mg per day, taken in 3 divided doses as directed by your doctor (one in the morning, one in the afternoon, and one in the evening).
If a lower dose is required and these strengths are not suitable, other strengths and pharmaceutical forms are available.

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

Elderly patients (over 65 years of age) should take Gabapentin Teva according to the normally recommended dosing schedule, unless they have kidney disease. In patients with kidney disease, the 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, consult your doctor or pharmacist immediately.

Method and route of administration
Gabapentin Teva should be taken orally. Tablets should always be swallowed whole with plenty of water.
Gabapentin Teva can be taken with or without food.
Do not stop taking Gabapentin Teva unless instructed to do so by your doctor.

Taking more Gabapentin Teva than prescribed
Taking higher than recommended doses 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 prescribed, contact your doctor immediately or go to the nearest hospital emergency department (A&E). Take any remaining tablets, the packaging, and the leaflet with you so that hospital staff can immediately identify which medicine has been taken.

Missed 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 stop taking the medicine, discuss this first with your doctor. Your doctor will advise you how to do this. The medicine should be discontinued 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 doubts regarding 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 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:

• red, non-elevated flat or round spots on the trunk, often with blisters in the center, skin peeling, 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 enlarged 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:

• 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 they 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 occur. The above symptoms may require hospitalization or discontinuation of 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 whites 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 decide whether
continuing treatment with Gabapentin Teva is necessary.
If you are undergoing hemodialysis, inform your doctor if you experience pain and (or)
muscle weakness.
Other adverse reactions include:
Very common (may affect more than 1 in 10 people):

• viral infections
• drowsiness, dizziness, lack of coordination
• feeling of fatigue, fever.

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

• pneumonia, respiratory tract infections, urinary tract infections, ear infection, or other infections
• decreased number of white blood cells
• loss of appetite, increased appetite
• irritability towards others, confusion, mood swings, depression, anxiety, restlessness, 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, reduced, 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 (impotence)
• swelling of hands and feet, difficulty walking, weakness, pain, malaise, flu-like symptoms
• decreased number of white blood cells, weight gain
• accidental injuries, bone fractures, skin abrasions.

Additionally, in clinical trials in children, aggressive behavior and sudden limb jerking were commonly reported.
Uncommon (may affect up to 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, which may affect the face, trunk, and limbs
• abnormal blood test results suggesting liver problems
• psychiatric disorders
• falls
• elevated blood glucose levels (most commonly observed in diabetic patients).

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

• low blood glucose levels (most commonly observed in diabetic patients)
• loss of consciousness
• breathing problems, 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 with Gabapentin Teva, be aware that certain adverse reactions, so-called withdrawal symptoms, may occur (see "Stopping Gabapentin Teva").
The following adverse reactions have been reported after marketing authorization:

• decreased number of platelets (cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as twisting of 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 disturbances, nausea, pain, excessive sweating), chest pain
• rhabdomyolysis (breakdown of muscle fibers)
• changes in blood test results (increased creatine kinase levels)
• sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• hyponatremia (low sodium levels in the 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 or pharmacist. 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 the 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 stated month.
Do not store above 30°C.
Store in the original packaging. Keep blisters in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Gabapentin Teva contains
The active substance is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.
The other ingredients are:
Tablet core: copovidone, microcrystalline cellulose, crospovidone, talc, magnesium stearate.
Coating: polyvinyl alcohol, talc, macrogol, titanium dioxide.

What Gabapentin Teva looks like and contents of the pack
Gabapentin Teva film-coated tablets are available in two strengths, distinguishable by the engraved numbers.
Gabapentin Teva 800 mg film-coated tablets are white or almost white, oval-shaped film-coated tablets with bevelled edges. On one side, the number "7174" is engraved, and on the other side, "93".
The film-coated tablets are available in blisters containing 100 tablets, packed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Portugal, the country of export:
Teva Pharma – Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5-A, Piso 2
2740-245 Porto Salvo
Portugal

Manufacturer:
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Portugal, the country of export: 5564588
Parallel Import Authorisation Number: 106/23

This medicinal product is authorised for marketing in the European Economic Area Member States under the following names: