GABAPENTIN 100 mg Hard Capsules

Зміст інструкції

1. Gabapentin Zentiva 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is Gabapentin Zentiva and what it is used for
   2. What you need to know before taking Gabapentin Zentiva
   3. How to take Gabapentin Zentiva
   4. Possible side effects
   5. How to store Gabapentin Zentiva
   6. Package contents and other information

Gabapentin Zentiva 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, 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 Zentiva is and what it is used for
• 2. What you need to know before you take Gabapentin Zentiva
• 3. How to take Gabapentin Zentiva
• 4. Possible side effects
• 5. How to store Gabapentin Zentiva
• 6. Contents of the pack and other information

1. What is Gabapentin Zentiva and what it is used for

Gabapentin Zentiva belongs to a group of medicines used for:
The treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by
damage to the nerves).
The active ingredient in Gabapentin Zentiva is gabapentin.

Gabapentin Zentiva is 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 Gabapentin Zentiva as an adjunct to your epilepsy treatment when the treatment you are already receiving does not fully control your condition. You should take Gabapentin Zentiva in addition to your ongoing treatment unless you receive other instructions. Gabapentin Zentiva can also be used alone for the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). A variety of different diseases can cause peripheral neuropathic pain (it occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling, numbness, pricking pains, etc.

2. What you need to know before taking Gabapentin Zentiva

Do not take Gabapentin Zentiva:

• if you are allergic (hypersensitive) 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 Zentiva

• if you have kidney problems, your doctor may prescribe a different dosage,
• if you are on hemodialysis (to remove waste products due to kidney failure), tell your doctor if you develop muscle pain and/or weakness,
• if you develop symptoms such as persistent stomach pain, nausea and vomiting, 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.
• before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs or illegal substances, as this may indicate that you are at a higher risk of developing a dependence on Gabapentin Zentiva.

Dependence
Some people may develop a dependence on Gabapentin Zentiva (a need to continue taking the
medicine). They may experience withdrawal effects when stopping the use of Gabapentin Zentiva
(see section 3, “How to take Gabapentin Zentiva” and “If you stop taking Gabapentin
Zentiva”).
If you are concerned about the possibility of developing a dependence on Gabapentin Zentiva, talk to your doctor.
If you notice any of the following signs while taking Gabapentin Zentiva, you may have developed
a dependence on the medicine.

• You feel the need to take the medicine for longer than prescribed by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine you do not feel well and you feel better when you take it again If you notice any of these signs, talk to your doctor to discuss the best treatment plan for you, including when it is appropriate to stop taking it and how to do so safely.

Cases of abuse and dependence have been reported for gabapentin from post-marketing experience.
Tell your doctor if you have a history of abuse or dependence.
A small number of patients treated with antiepileptic medicines like gabapentin have developed
thoughts of suicide or self-harm. If at any time you should develop these thoughts, contact
your doctor immediately.

Important information about potentially serious reactions
Severe skin reactions have been reported in association with treatment with gabapentin, including
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with
eosinophilia and systemic symptoms (DRESS). Stop using gabapentin and contact a
doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

doctor if you notice any of the following symptoms after taking this medicine because they can be serious”
Muscle weakness, soreness or pain and especially if at the same time you do not feel well 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 increased creatine phosphokinase). If you experience any of these signs or symptoms, please contact
your doctor immediately.

Other medicines and Gabapentin Zentiva
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 or have recently taken
medicines for convulsions, sleep disorders, depression, anxiety or other neurological or
psychiatric problems.
Medicines containing opioids such as morphine
If you are taking medicines that contain opioids (such as morphine), tell your doctor or pharmacist
because opioids can increase the effect of Gabapentin Zentiva. Also, the combination of Gabapentin
Zentiva with opioids can cause drowsiness, sedation, decreased breathing or death.
Antacids for indigestion
If Gabapentin Zentiva and antacids containing aluminum and magnesium are taken together, the absorption
of Gabapentin Zentiva from the stomach may be reduced. It is therefore recommended to take Gabapentin
Zentiva no sooner than two hours after taking the antacid.
Gabapentin Zentiva:

• is not expected to interact with other antiepileptic medicines or with the contraceptive pill.
• Gabapentin Zentiva may interfere with some laboratory tests; if you need a urine test, tell your doctor or the hospital what you are taking.

Gabapentin Zentiva with food
Gabapentin Zentiva can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Zentiva should not be taken during pregnancy unless your doctor has told you to do so.
Women of childbearing potential should use effective contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but an increased risk for
the development of the baby has been reported for other medicines used to treat seizures, especially when taking more than one medicine for
seizures.
Therefore, when possible, during pregnancy you should try to take only one medicine for epilepsy and
only on medical advice.
Contact your doctor immediately if you are pregnant, think you may be pregnant or are planning
a pregnancy while taking Gabapentin Zentiva. Do not suddenly stop taking
this medicine, as this may cause the sudden onset of seizures which can have
serious consequences for you and the baby.
If used during pregnancy, gabapentin can cause withdrawal symptoms in newborns. The risk may
be increased when gabapentin is taken together with opioid analgesics (pain relievers).
Breastfeeding
Gabapentin, the active ingredient of Gabapentin Zentiva, passes into breast milk. As the effect
on the baby is unknown, it is recommended not to breastfeed while taking Gabapentin Zentiva.
Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
Gabapentin Zentiva can cause dizziness, drowsiness and fatigue. Do not drive vehicles, use complex machines or engage in other potentially dangerous activities until you know how this
medicine affects your ability to perform these activities.

Gabapentin Zentiva contains lactose
Gabapentin Zentiva capsules contain lactose (a type of sugar). If your doctor has diagnosed you with
lactose intolerance, contact him/her before taking this medicine.

3. How to take Gabapentin Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is
Adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually your doctor will gradually increase the dose
gradually. 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 3,600 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 will be determined by the doctor because it is calculated based on the child's weight. The
treatment is started with a low initial dose which is gradually increased over about 3
days. The usual dose for controlling epilepsy is 25-35 mg/kg/day. It is usually administered
in 3 separate doses, taking the capsule every day generally once in the morning, once in the afternoon and
once in the evening.
Gabapentin Zentiva is not recommended for children under the age of 6 years.

Peripheral neuropathic pain, the recommended dose is
Adults:
Take the number of capsules following your doctor's instructions. Usually your doctor will gradually increase the dose
gradually. 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 3,600 mg per
day and your doctor will tell you to take the medicine in 3 separate doses, i.e. once in the morning, once in the
afternoon and once in the evening.

If you have kidney problems or are on hemodialysis
If you have kidney problems or are on hemodialysis, your doctor may prescribe a different dosing regimen 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 Gabapentin Zentiva, unless
you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing regimen for
the medicine and/or a different dose.
If you feel that the effect of Gabapentin Zentiva is too strong or too weak, tell your doctor or
pharmacist as soon as possible.

Method of administration
Gabapentin Zentiva is taken orally. Always swallow the capsules whole with plenty of
water.
Continue treatment with Gabapentin Zentiva until your doctor tells you to stop.

If you take more Gabapentin Zentiva than you should
A dose higher than the recommended one may lead to an increase in side effects including
loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness and diarrhea.
Contact your doctor immediately or go to the nearest emergency room if you take more Gabapentin Zentiva than
prescribed by your doctor. Bring with you the capsules you have not taken, together with the packaging and the leaflet
so that the hospital can easily understand what you have taken.

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

If you stop taking Gabapentin Zentiva
Do not suddenly stop treatment with Gabapentin Zentiva. If you wish to stop the
treatment with Gabapentin Zentiva, talk to your doctor first, who will explain how to do it. The suspension
of treatment must occur gradually over at least 1 week. After stopping a
short- or long-term treatment with Gabapentin Zentiva, you should know that you may experience some
side effects, called withdrawal effects. These effects may include seizures, anxiety,
difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression,
feeling of abnormality, dizziness and a general feeling of discomfort. These effects usually occur
within 48 hours of stopping Gabapentin Zentiva. If you experience withdrawal effects, you should contact your
doctor.
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.
Stop using Gabapentin Zentiva and contact your doctor immediately if you notice any of the following symptoms:

• Circular or target-shaped, reddish, non-raised patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals 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).

Contact your doctor immediately if you notice any of the following symptoms after taking this medicine because they
may be serious:

• Severe skin reactions requiring immediate attention, swelling of the lips and face, rash and redness of the skin and/or hair loss (these may be symptoms of a severe allergic reaction).
• Persistent stomach pain, nausea and vomiting because these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin Zentiva can 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 skin rashes. This may cause hospitalization or discontinuation of treatment with Gabapentin Zentiva.
• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat and tongue and low blood pressure requiring emergency treatment).
• Breathing problems that, if severe, may require emergency and intensive care to allow you to continue breathing normally.

Call your doctor immediately if you experience any of the following symptoms:

• Rashes.
• Hives.
• Fever.
• Swollen lymph glands that do not 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.

These symptoms may be the first signs of a serious reaction. Your doctor needs to see you to decide if
you should continue taking Gabapentin Zentiva.

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

Other side effects include:

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

• Viral infections.
• Feeling sleepy, dizziness, lack of coordination.
• Feeling tired, fever.

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation or other infections,
• Low white blood cell count.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Convulsions, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, 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 of the face or widening of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, dry nose.
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.
• Swelling of the face, bruising, rash, itching, acne.
• Joint pain, muscle pain, back pain, muscle contractions.
• Erectile dysfunction (impotence).
• Swelling of the legs and arms, difficulty walking, weakness, pain, feeling unwell, 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 reaction such as hives.
• Reduced movement.
• Increased heart rate.
• Swelling that can affect 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).
• Agitation (a state of chronic restlessness and involuntary and aimless movements).
• Difficulty swallowing.

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).

Not known (frequency cannot be estimated from available data):

• Reduced platelets (cells that coagulate blood).
• Hallucinations, suicidal thoughts.
• Problems with abnormal movements such as convulsive jerks, jerky movements and rigidity.
• Tinnitus (ringing in the ears).
• Yellowing of the skin and eyes (jaundice), inflammation of the liver.
• Acute kidney failure, incontinence.
• Increase in breast tissue, breast enlargement.
• Adverse events that occur after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, 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.
• Becoming dependent on Gabapentin Zentiva (“drug dependence”)

After stopping short- or long-term treatment with , you should know that
you may experience some side effects, called withdrawal effects (see “If you stop taking Gabapentin Zentiva”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Zentiva

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25ºC.
Keep the container tightly closed and store the blister in the original packaging.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Gabapentin Zentiva contains

• The active ingredient is gabapentin (100 mg, 300 mg or 400 mg per hard capsule).
• The other ingredients are: anhydrous lactose, corn starch and talc.
• The capsule shell is composed of: gelatin. Gabapentin Zentiva 100 mg capsules contains the colorant E171 (titanium dioxide), Gabapentin Zentiva 300 mg capsules contains the colorants E171 (titanium dioxide) and E172 (yellow iron oxide), Gabapentin Zentiva 400 mg capsules contains the colorants E171 (titanium dioxide) and E172 (red and yellow iron oxide).

Description of the appearance of Gabapentin Zentiva and package contents
This medicine is presented in hard capsules.
Gabapentin Zentiva 100 mg hard capsules:
hard gelatin capsule (size 3), with opaque white body and cap.
Gabapentin Zentiva 300 mg hard capsules:
hard gelatin capsule (size 1), with opaque yellow body and cap.
Gabapentin Zentiva 400 mg hard capsules:
hard gelatin capsule (size 0), with opaque orange body and cap.
Packs:
Blisters:
10, 20, 30, 50, 90, 100, 200 (2x100), 250 hard capsules
Hospital pack: 500 (5x100), 1000 (10x100) hard capsules
Single dose: 20x1, 60x1, 100x1 hard capsules
Bottles:
50, 100, 250 hard capsules
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano

Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany

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