GABAPENTIN 100 mg Hard Capsule

Зміст інструкції

1. What is Gabapentin Teva Pharma and what it is used for
2. What you need to know before taking Gabapentin Teva Pharma
3. How to take Gabapentin Teva Pharma
4. Possible side effects
5. How to store Gabapentin Teva Pharma
6. Package Contents and Other Information

Gabapentin Teva Pharma 100 mghard capsules

Gabapentin Teva Pharma 300 mg hard capsules

Gabapentin Teva Pharma 400 mg hard capsules
Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gabapentin belongs to a group of medicines used for the treatment of epilepsy and peripheral neuropathic pain
( . The active ingredient is gabapentin.

Gabapentin Teva Pharmais used to treat:

• Various forms of epilepsy(seizures initially limited to certain areas of the brain, whether the seizures spread to other parts of the brain or not). Your doctor will prescribe GabapentinTeva Pharmaas an adjunct to epilepsy treatment if the treatment you are already following is not able to completely control your condition. You should take Gabapentin Teva Pharmain addition to the ongoing treatment, unless otherwise prescribed by your doctor. Gabapentin Teva Pharmacan also be used alone to treat adults and children over 12 years of age.
• Peripheral neuropathic pain(treatment of long-lasting pain caused by nerve damage). A wide variety of diseases can cause peripheral neuropathic pain (it occurs primarily at the level of legs and/or arms), such as diabetes or herpes zoster. Painful sensations are described in various ways, such as heat, burning, throbbing, stabbing, piercing, cramping, dull, burning, with numbness, tingling, etc.

2. What you need to know before taking Gabapentin Teva Pharma

Do not takeGabapentin Teva Pharma

• if you are allergic to gabapentin or 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 Pharma

• if you have kidney problems. In this case, your doctor may prescribe a different dosage
• if you are undergoing hemodialysis (to remove waste products due to kidney failure), tell your doctor if you develop muscle pain and/or weakness
• if you experience symptoms such as persistent stomach pain, feeling unwell or being unwell, contact your doctor immediately as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• if you suffer from neurological/respiratory diseases or are over 65 years of age, your doctor may prescribe different doses.

Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Tell your doctor if you have a history of abuse or dependence.
A small number of patients treated with antiepileptic drugs such as Gabapentin Teva Pharmahave experienced thoughts of self-harm or suicide. If you experience such thoughts at any time, contact your doctor immediately.

Important information about potentially serious reactions
A small number of patients treated with Gabapentin Teva Pharmahave shown an allergic reaction or potentially serious skin reactions which, if left untreated, can develop into more serious problems. You should be aware of these symptoms so that you can recognize them while taking Gabapentin Tevaand immediately contact your doctor if you experience any of the following symptoms after taking this medicine, as they may be serious”.
Weakness, tenderness or muscle pain, especially if you also feel unwell and have a fever, may be caused by muscle injury that can be life-threatening and can lead to kidney problems. You may also experience discoloration of the urine and abnormalities in blood tests (in particular, an increase in creatine phosphokinase). If you experience any of these signs or symptoms, contact your doctor immediately.

Other medicines andGabapentin Teva Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking medicines for seizures, sleep disorders, depression, anxiety or other neurological or psychiatric problems.
Medicines containing opioids such as morphine
If you are using medicines that contain opioids (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of Gabapentin Teva Pharma.
Also, the combination of Gabapentin Teva Pharmawith opioids can cause symptoms such as drowsiness and/or decreased breathing.
If Gabapentin Teva Pharmaand antacids containing aluminium and magnesium are taken simultaneously, the absorption of Gabapentin Teva Pharmafrom the stomach may be reduced.
It is therefore recommended to take Gabapentin Teva Pharmaat least two hours after taking the antacid.

Gabapentin Teva Pharma

• is not expected to interact with other antiepileptics or with the contraceptive pill.
• may interfere with some laboratory tests; therefore, if you need to perform a urine test, tell your doctor or the hospital that you are using Gabapentin Teva Pharma.

Gabapentin Teva Pharmawith food and drink

Gabapentin Teva Pharmacan be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

Gabapentin Teva Pharmashould not be taken during pregnancy unless otherwise prescribed by your doctor.
Women of childbearing potential should use effective contraceptive methods.
No studies have been conducted on the specific use of gabapentin in pregnancy, but with other medicines used to treat epilepsy, an increased risk of developmental damage to the child has been found, especially if more than one antiepileptic drug is taken at the same time. Therefore, if possible, during pregnancy you should try to take only one drug for epilepsy, and only under medical advice.
Contact your doctor immediately if you are pregnant, think you may be pregnant or are planning a pregnancy while taking Gabapentin Teva Pharma. Do not suddenly stop taking this medicine, as this can cause the sudden onset of seizures which can have serious consequences for you and your baby.
Breastfeeding
Gabapentin, the active ingredient of Gabapentin Teva Pharma, passes into human breast milk. As the effect on the infant is unknown, breastfeeding is not recommended during the use of Gabapentin Teva Pharma.
Fertility
Animal studies have shown no effect on fertility

Driving and using machines

Gabapentin Teva Pharmacan cause dizziness, drowsiness and fatigue. Therefore, you should not drive, use complex machinery or engage in other potentially dangerous activities before knowing if this medicine can impair your ability to perform these activities.

Gabapentin Teva Pharmacontains lactose
and the capsules contain lactose (a type of sugar). If you know you have an intolerance to certain sugars, contact your doctor before taking this medicine

3. How to take Gabapentin Teva Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The doctor will determine the most appropriate dose for you. For higher dosages, which cannot be quantified with these
formulations, other formulations with different dosages are available.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules that your doctor has prescribed for you. Usually the doctor will gradually increase the dose
for you. The initial dose will generally be 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, and your doctor will tell you to take this dose in 3 separate administrations, i.e. once in the
morning, once in the afternoon and once in the evening.
Children aged 6 years and over:
The dose to be administered to the child is established by the doctor, as it is calculated based on the child's body weight
. Treatment begins 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. The dose is
usually divided into 3 separate administrations, taking the capsule(s) every day generally
once in the morning, once in the afternoon and once in the evening.
The use of Gabapentin Teva Pharmais not recommended in children under 6 years of age.

Peripheral Neuropathic Pain, the recommended dose is
Adults:
Take the number of capsules following your doctor's instructions. Usually the doctor will gradually increase the dose
for you. The initial dose will generally be 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, and your doctor will tell you to take this dose in 3 separate administrations, i.e. once in the
morning, once in the afternoon and once in the evening.

If you have kidney problems or are undergoing hemodialysis
If you have kidney problems or are undergoing hemodialysis, your doctor may prescribe a different dosing schedule for
the medicine and/or a different dose.

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

Method of administration

Gabapentin Teva Pharmais taken orally. Always swallow the capsules whole with plenty of
water.
Continue treatment with Gabapentin Teva Pharmauntil your doctor tells you to stop.

If you take moreGabapentin Teva Pharmathan you should
If you, or someone else, have accidentally taken more capsules, or if you think a child has swallowed
some, contact your doctor immediately or go to the emergency room of the nearest hospital. Because

Gabapentin Teva Pharmacan cause drowsiness, it is advisable to ask someone else to take you to your
doctor or the nearest hospital, or to call an ambulance. The symptoms of an overdose are
dizziness, double vision, difficulty speaking, loss of consciousness, drowsiness and mild diarrhea.
Bring with you the capsules you have not taken together with the container and the label, so as to allow the doctors
at the hospital to immediately recognize which medicine you have taken.

If you forget to takeGabapentin Teva Pharma
If you forget to take a dose, take it as soon as you remember, unless it is already time to take the next dose.
Do not take a double dose to make up for the missed dose.

If you stop takingGabapentin Teva Pharma
Do not stop taking Gabapentin Teva Pharmaunless advised by your doctor. Discontinuation of
treatment must occur gradually, over a period of at least 1
week. If you suddenly stop taking Gabapentin Teva Pharmaor if you discontinue it before
as indicated by your doctor, there is a risk of an increase in epileptic seizures.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

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

• Anaphylaxis (a severe allergic reaction that is potentially life-threatening and includes difficulty breathing, swelling of the lips, throat and tongue, and low blood pressure, resulting in the need for emergency treatment)
• Severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a severe allergic reaction)
• Persistent stomach pain, feeling and being unwell, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin Teva Pharmacan cause a severe or life-threatening allergic reaction, which can affect the skin or any other part of the body, such as the liver or blood. When affected by this type of reaction, you may or may not have a skin rash. This may lead to hospitalization or discontinuation of treatment with Gabapentin Teva Pharma. Call your doctor immediately if you experience any of the following symptoms:
• skin rash
• hives
• fever
• swollen lymph nodes that tend not to go away
• swelling of the lips and tongue
• yellowing of the skin or the whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• sudden muscle pain
• frequent infections
• breathing problems that, if severe, may require emergency and intensive care to allow you to breathe normally.

These symptoms may be early signs of a severe allergic reaction. A doctor should examine you to
decide if you can continue to take Gabapentin Teva Pharma.

• If you are on hemodialysis, tell your doctor if you experience pain and/or muscle weakness

Other possible side effects include:

Very common (may affect more than 1 in 10 people)

• Viral infection
• Feeling sleepy, 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 number of white blood cells
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Convulsions, jerky movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, reduced sensation (numbness), difficulty coordinating, abnormal eye movements, increased, decreased or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (feeling unwell), nausea (feeling sick), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, bruising, skin rash, itching, acne
• Joint pain, muscle pain, back pain, muscle spasms
• Difficulty getting an erection (impotence)
• Swelling of legs and arms, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

In addition, aggressive behavior and convulsive movements have been commonly reported in clinical studies conducted in children.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions such as hives
• Reduced movement
• Fast heartbeat
• Swelling that can involve the face, trunk and limbs
• Altered blood test values suggesting liver problems
• Mental impairment
• Falls
• Increased blood glucose levels (observed more often in patients with diabetes)

Rare (may affect up to 1 in 1,000 people)

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

The following side effects have been reported after marketing authorization:

Uncommon (may affect up to 1 in 100 people)

• Agitation (a chronic state of restlessness and purposeless involuntary movements)

Not known: (frequency cannot be estimated based on available data)

• Decreased platelets (cells for blood clotting)
• Hallucinations
• Abnormal movements such as contortions, jerky movements and rigidity -
• Ringing in the ears
• A group of side effects, including swollen lymph nodes (small nodules under the skin), fever, rash, and liver inflammation, which can occur together
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events following abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling unwell, pain, sweating), chest pain
• Muscle fiber injury (rhabdomyolysis)
• Abnormalities in blood tests (increased creatine phosphokinase)
• Sexual dysfunction including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Gabapentin Teva Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
the abbreviation EXP. The expiry date refers to the last day of the month.
Do not store at a temperature above 25ºC.
Store in the original packaging.
Do not dispose of any medicine in 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 the medicine containsGabapentin Teva Pharma

• The active ingredient is gabapentin. Each capsule contains 100 mg/300 mg/400 mg of gabapentin.
• The excipients are Capsule content: Anhydrous lactose Corn starch Talc Capsule shell coating: Gelatin Furthermore, in Gabapentin Teva Pharma 100 mg hard capsules :Titanium dioxide (E171)

Furthermore, in Gabapentin Teva Pharma 300 mg hard capsules:
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Furthermore, in Gabapentin Teva Pharma 400 mg hard capsules:
Titanium dioxide (E 171)
Yellow iron oxide (E 172)
Red iron oxide (E 172)
Printing ink:
Shellac
Propylene glycol
Ammonia solution
Potassium hydroxide
Black iron oxide

Description of the appearance ofGabapentin Teva Pharmaand contents of the pack

Gabapentin 100 mg hard capsules:
The capsules are white in color with “100” printed on one side and “G” on the other.

Gabapentin 300 mg hard capsules:
The capsules are yellow in color with “300” printed on one side and “G” on the other.

Gabapentin 400 mg hard capsules:
The capsules are orange in color with “400” printed on one side and “G” on the other.
Pack sizes:
10, 20, 30, 50, 90, 100, 200 (2x100), 250 hard capsules
Hospital pack: 500 (5x100), 1000 (10x100) hard capsules
Unit dose: 20x1, 60x1, 100x1 hard capsule
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem Netherlands

Manufacturer responsible for batch release
Merckle GmbH, Ludwig- Merckle- Strasse 3 - 89143 Blaubeuren (Germany)
Teva UK Limited Company, Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG, United
Kingdom
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
denominations:
Denmark Gabaratio 100 mg capsules
Germany Gabapentin AbZ 100 mg hard capsules
Italy Gabapentin Teva Pharma 100 mg hard capsules
Portugal Gabapentina ratiopharm 100 mg capsules
United Kingdom Gabapentin ratiopharm 100mg Capsules
Denmark Gabaratio 300 mg capsules
Germany Gabapentin AbZ 300 mg hard capsules
Italy Gabapentin Teva Pharma 300 mg hard capsules
Portugal Gabapentina ratiopharm 300 mg capsules
United Kingdom Gabapentin ratiopharm 300 mg Capsules
Denmark Gabaratio 400 mg capsules
Germany Gabapentin AbZ 400 mg hard capsules
Italy Gabapentin Teva Pharma 400 mg hard capsules
Portugal Gabapentina ratiopharm 400 mg capsules
United Kingdom Gabapentin ratiopharm 400mg Capsules