Gabapentin teva pharmaceuticals

Package leaflet: Information for the patient

Gabapentyna Teva Pharmaceuticals, 100 mg, hard capsules
Gabapentyna Teva Pharmaceuticals, 300 mg, hard capsules
Gabapentyna Teva Pharmaceuticals, 400 mg, hard capsules
Gabapentinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. This medicine may harm others, 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.

Table of contents:

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

1. What Gabapentyna Teva Pharmaceuticals is and what it is used for

Gabapentyna Teva Pharmaceuticals 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 Gabapentyna Teva Pharmaceuticals is gabapentin.
Gabapentyna Teva Pharmaceuticals is used to treat:

• various forms of epilepsy (seizures that originate in specific areas of the brain and may or may not spread to the rest of the brain). Gabapentyna Teva Pharmaceuticals 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. Gabapentyna Teva Pharmaceuticals should be taken as an adjunctive treatment for epilepsy in adults and children aged 6 years and older, unless otherwise directed by a doctor. Gabapentyna Teva Pharmaceuticals may also be used as monotherapy in adults and children over 12 years of age.
• 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. Patients describe the pain they feel as burning, stabbing, shooting, pulsating, piercing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before taking Gabapentyna Teva Pharmaceuticals

When not to use Gabapentyna Teva Pharmaceuticals
if the patient is allergic to gabapentin or to any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Before starting treatment with Gabapentyna Teva Pharmaceuticals, 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 muscle pain and (or) weakness occurs,
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 over 65 years; 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 addictive substances; this may mean that the risk of becoming dependent on Gabapentyna Teva Pharmaceuticals is higher.
Dependence
Some people may develop dependence on Gabapentyna Teva Pharmaceuticals (a need to keep taking the medicine continuously). After stopping treatment with Gabapentyna Teva Pharmaceuticals, withdrawal symptoms may occur (see section 3, “How to take Gabapentyna Teva Pharmaceuticals” and “Stopping treatment with Gabapentyna Teva Pharmaceuticals”). If the patient is concerned about possibly becoming dependent on Gabapentyna Teva Pharmaceuticals, it is important to consult the doctor.
If, while taking Gabapentyna Teva Pharmaceuticals, the patient notices any of the following signs, 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 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 about harming themselves or ending their life. 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 occurred with gabapentin use. If any of the symptoms associated with serious skin reactions described in section 4 occur, stop taking gabapentin and contact the doctor immediately.
Please read the description of serious symptoms in section 4 “Contact the 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 due to abnormal breakdown of muscle fibres, which can be life-threatening and may lead to kidney problems. Changes in urine colour and changes in blood test results (markedly increased blood creatine kinase levels) may occur. If such subjective or objective symptoms occur, contact the doctor immediately.
Gabapentyna Teva Pharmaceuticals and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor (or pharmacist) about all 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 medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentyna Teva Pharmaceuticals.
Additionally, taking Gabapentyna Teva Pharmaceuticals together with opioids may cause drowsiness, sedation, respiratory depression or death.
Antacids used for indigestion
When Gabapentyna Teva Pharmaceuticals is taken together with antacids containing aluminium and magnesium, absorption of Gabapentyna Teva Pharmaceuticals from the stomach may be reduced. It is therefore recommended to take Gabapentyna Teva Pharmaceuticals at least two hours after taking an antacid.
Gabapentyna Teva Pharmaceuticals

• 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 this medicine.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or suspects she may be pregnant, contact the doctor immediately to discuss the potential risks 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 planning to breastfeed, consult the doctor or pharmacist before starting treatment with this medicine.

Pregnancy
Gabapentyna Teva Pharmaceuticals may be used during the first trimester of pregnancy if necessary.
If the patient is planning 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 of epilepsy may pose a risk to both the mother and her unborn child.
In a study including 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 premature delivery.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be increased when gabapentin is taken together with opioid pain medicines (medicines used to treat severe pain).
If pregnancy occurs, pregnancy is suspected or pregnancy is planned while taking Gabapentyna Teva Pharmaceuticals, contact the doctor immediately. Do not suddenly stop taking this medicine, as this may lead to the occurrence of seizures
and withdrawal symptoms, which may have serious consequences for both the pregnant woman and her child.
Breastfeeding
Gabapentin – the active substance in Gabapentyna Teva Pharmaceuticals – passes into breast milk. Because it is not known what effect it may have on the breastfed infant, breastfeeding is not recommended during treatment with Gabapentyna Teva Pharmaceuticals.
Fertility
No effect of the medicine on fertility was observed in animal studies.
Driving and operating machinery
Gabapentyna Teva Pharmaceuticals 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.
Gabapentyna Teva Pharmaceuticals 300 mg hard capsules contain Sunset Yellow FCF (E110)
This medicine may cause allergic reactions.

3. How to use Gabapentyna Teva Pharmaceuticals

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
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. Doses are usually increased gradually.
The most commonly used starting dose is 300 to 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 dose effective in controlling epilepsy typically ranges from 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.

Gabapentyna Teva Pharmaceuticals 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 300 to 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 hemodialysis
For patients with kidney disease or those undergoing hemodialysis, the doctor may recommend a
different dosing regimen and/or a different dose.

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

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

Method of administration
Gabapentyna Teva Pharmaceuticals should be taken orally. Capsules must always be swallowed whole,
with a large amount of water.

Gabapentyna Teva Pharmaceuticals may be taken independently of meals.
Do not stop taking Gabapentyna Teva Pharmaceuticals unless instructed to do so by your doctor.

Taking more Gabapentyna Teva Pharmaceuticals 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
Gabapentyna Teva Pharmaceuticals than prescribed, 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 Gabapentyna Teva Pharmaceuticals
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 Gabapentyna Teva Pharmaceuticals
Do not suddenly stop taking Gabapentyna Teva Pharmaceuticals. If you wish to discontinue treatment,
you should first discuss this with your doctor. Your doctor will advise you on how to do this. The medicine
should be withdrawn gradually over a period of at least 1 week. After short-term or long-term treatment
with Gabapentyna Teva Pharmaceuticals, 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, feelings of abnormality, dizziness, and general malaise.
These symptoms usually occur within 48 hours after stopping Gabapentyna Teva Pharmaceuticals.
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, treatment with
Gabapentyna Teva Pharmaceuticals should be discontinued and medical advice should be sought immediately if any of the following symptoms occur after taking
Gabapentyna Teva Pharmaceuticals:

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

Seek immediate medical advice 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
• Gabapentyna Teva Pharmaceuticals 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 Gabapentyna Teva Pharmaceuticals. Contact a doctor if any of the following symptoms occur:
• Skin rash and skin redness, and/or hair loss
• Urticaria (hives)
• Fever
• Persistent swelling of lymph nodes
• Swelling of lips, face, and tongue
• Yellowing of the skin or sclera (whites) of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections

The above symptoms may be early signs of a serious reaction. A doctor should decide whether continued treatment with Gabapentyna Teva Pharmaceuticals 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 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, infections, ear infections, or other infections
• Decreased white blood cell count
• 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, skin redness, or blood vessel dilation
• 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 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 affect up to 1 in 100 people):

• Agitation (a state of continuous restlessness and unintentional, 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 affect 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 marketing of gabapentin, 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 jerking, and stiffness
• Tinnitus (ringing in the ears)
• Yellowing of the skin and eyes (jaundice), hepatitis (liver inflammation)
• 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 (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 blood)
• Anaphylactic reactions (severe, potentially life-threatening reactions involving breathing difficulties, swelling of lips, throat, and tongue, and hypotension requiring immediate treatment)
• Risk of developing dependence on Gabapentyna Teva Pharmaceuticals ("drug dependence").

After discontinuation of short-term or long-term treatment with Gabapentyna Teva Pharmaceuticals,
be aware that certain adverse reactions, known as withdrawal effects, may occur (see "Discontinuation of Gabapentyna Teva Pharmaceuticals").
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gabapentyna Teva Pharmaceuticals

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer cardboard packaging after
"Expiry date:" or "EXP:". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Keep blisters in the outer packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Gabapentyna Teva Pharmaceuticals contains
The active substance is gabapentin.
Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, respectively.
The other ingredients are:

Gabapentyna Teva Pharmaceuticals, 100 mg hard capsules
Capsule core: talc, pregelatinized starch, corn starch
Capsule cap and body: gelatin, iron oxide black (E172), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol

Gabapentyna Teva Pharmaceuticals, 300 mg hard capsules
Capsule core: talc, pregelatinized starch, corn starch
Capsule cap and body: gelatin, erythrosine (E127), brilliant blue FCF (E110), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol

Gabapentyna Teva Pharmaceuticals, 400 mg hard capsules
Capsule core: talc, pregelatinized starch, corn starch
Capsule cap and body: gelatin, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol

What Gabapentyna Teva Pharmaceuticals looks like and contents of the pack
Gabapentyna Teva Pharmaceuticals, 100 mg, hard capsules
Hard gelatin capsule with grey cap and body, filled with white or almost white powder in small aggregates. Numbers “93” and “38” are printed on the cap and body.
Pack contains 10, 20, 28, 50, 90, 100, 200, 500, or 1000 hard capsules.

Gabapentyna Teva Pharmaceuticals, 300 mg, hard capsules
Hard gelatin capsule with orange cap and body, filled with white or almost white powder in small aggregates. Numbers “93” and “39” are printed on the cap and body.
Pack contains 10, 20, 28, 50, 90, 100, 200, 500, or 1000 hard capsules.

Gabapentyna Teva Pharmaceuticals, 400 mg, hard capsules
Hard gelatin capsule with 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.
Pack contains 10, 20, 28, 30, 50, 90, 100, 200, 500, or 1000 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw, Poland

Manufacturer
Pharmachemie B.V., Swensweg 5, 2031 GA 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

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