GABAPENTIN 100 mg Hard Capsule

Зміст інструкції

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

Gabapentin Hexal A/S 100 mg hard capsules, 300 mg hard capsules

Gabapentin Hexal A/S 400 mg hard capsules
gabapentin

Generic medicine
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 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 Hexal A/S is and what it is used for
• 2. What you need to know before you take Gabapentin Hexal A/S
• 3. How to take Gabapentin Hexal A/S
• 4. Possible side effects
• 5. How to store Gabapentin Hexal A/S
• 6. Contents of the pack and other information

1. What is Gabapentin Hexal A/S and what it is used for

Gabapentin Hexal A/S belongs to a group of medicines used for the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Gabapentin Hexal A/S is gabapentin.
Gabapentin Hexal A/S is used to treat:

Various forms of epilepsy(both seizures initially limited to certain areas of the brain, and seizures that do or do not spread to other parts of the brain). The doctor treating you or your child aged 6 years or older will prescribe Gabapentin Hexal A/S as an adjunct to the treatment of epilepsy when the treatment you are already following does not fully control your condition. You or your child aged 6 years or older must take Gabapentin Hexal A/S in addition to the ongoing treatment, unless you receive other instructions. Gabapentin Hexal A/S 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 nerve damage). A variety of different diseases can cause peripheral neuropathic pain (occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling, numbness, pricking pains, etc.

2. What you need to know before taking Gabapentin Hexal A/S

Do not take Gabapentin Hexal A/S

• 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 Hexal A/S

• if you have kidney problems 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 develop signs of 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 diseases of the nervous/respiratory system or are over 65 years of age, your doctor may prescribe different doses.

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 antiepileptics like gabapentin have developed suicidal thoughts or self-harm. If you should have these thoughts at any time, contact
your doctor immediately.
Important information about potentially serious reactions
A small number of people taking Gabapentin Hexal A/S have developed an allergic reaction or a
potentially serious skin reaction, which if left untreated can develop into more serious problems. It is
important to know these symptoms to prevent them while taking Gabapentin Hexal A/S.

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as

they may be serious'.
Muscle weakness, tenderness or pain, and especially if at the same time you do not feel well or have a fever,
may be caused by abnormal muscle damage 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 Hexal A/S
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription. 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 Hexal A/S.
In addition, the combination of Gabapentin Hexal A/S with opioids can cause symptoms such as drowsiness and/or
difficulty breathing.

Antacids for indigestion
If Gabapentin Hexal A/S and antacids containing aluminum and magnesium are taken together,
the absorption of Gabapentin Hexal A/S from the stomach may be reduced. It is therefore recommended to take
Gabapentin Hexal A/S no earlier than two hours after taking the antacid.

Gabapentin Hexal A/S

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

Gabapentin Hexal A/S with food
Gabapentin Hexal A/S can 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 Hexal A/S should not be taken during pregnancy unless your doctor has told you otherwise. Women of childbearing potential should use effective contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but for
other medicines used to treat seizures, an increased risk of
harm to the development of the baby has been reported, especially when taking more than one medicine for
seizures at the same time. Therefore, if possible, you should try to take only one medicine for epilepsy
during pregnancy 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 Hexal A/S.
Do not suddenly stop taking this medicine as this can cause the sudden onset of seizures which may have serious consequences for you and the baby.

Breastfeeding
Gabapentin, the active ingredient of Gabapentin Hexal A/S, passes into breast milk. As the
effects of breastfeeding on the baby are unknown, it is recommended not to breastfeed during
treatment with Gabapentin Hexal A/S.

Fertility
No effects on fertility have been observed in studies on animals.

Driving and using machines
Gabapentin Hexal A/S can cause dizziness, drowsiness and fatigue. Do not drive, use complex machinery or engage in other potentially dangerous activities until you know how this medicine
may affect your ability to perform these activities.

Gabapentin Hexal A/S contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Gabapentin Hexal A/S

Take this medicine exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
The doctor will establish the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually the 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 gradually increased up to a maximum of 3600 mg per day; your doctor will tell you to take this
dose in 3 separate administrations (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 established by the doctor because it is calculated based on the child's weight. Treatment is started with a low initial dose which is gradually increased over approximately 3
days. The usual dose for controlling epilepsy is 25-35 mg/kg per day. The dose 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.

The use of Gabapentin Hexal A/S is 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
gradually. The initial dose will generally be between 300 mg and 900 mg per day. Subsequently, the
dose may be increased at the doctor's advice up to a maximum of 3600 mg per day; your doctor will tell you
to take this dose in 3 separate administrations (once in the morning, once in the afternoon and once in the
evening).

If you have kidney problems or are undergoing hemodialysis
Your doctor may prescribe a different dosage regimen and/or dose if you have kidney problems or are undergoing
hemodialysis.

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

Method of administration
Gabapentin Hexal A/S is taken orally. Always swallow the capsules with plenty of
water.
Continue treatment with Gabapentin Hexal A/S until your doctor tells you to stop it.

If you take more Gabapentin Hexal A/S than you should
Doses higher than those recommended can lead to an increase in undesirable effects including loss of
consciousness, dizziness, double vision, speech disorders, drowsiness and diarrhea. Contact your doctor or go
immediately to the nearest emergency room if you take more Gabapentin Hexal A/S than prescribed by
so that the hospital can easily understand which medicine you have taken.

If you forget to take Gabapentin Hexal A/S
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 a missed dose.

If you stop treatment with Gabapentin Hexal A/S
Do not stop treatment with Gabapentin Hexal A/S unless your doctor has told you to. The
suspension of treatment must take place gradually over at least 1 week. If you suddenly stop treatment with Gabapentin Hexal A/S or if you stop it before it has been prescribed to you
by your doctor, the risk of epileptic seizures increases.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately if you experience any of the following symptoms after taking this
medicine as they may be serious:

• severe skin reactions requiring immediate medical attention, swelling of the lips and face, skin rashes, redness and/or hair loss (these may be symptoms of a severe allergic reaction)
• persistent stomach pain, nausea and vomiting as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• breathing problems which, if severe, may require emergency and intensive care to allow you to breathe normally
• Gabapentin Hexal A/S can cause severe allergic or life-threatening reactions that can affect the skin or other parts of the body, such as the liver or blood cells. A rash may or may not occur when you have this type of reaction. This can cause hospitalization or discontinuation of treatment with Gabapentin Hexal A/S. Tell your doctor immediately if you experience any of the following symptoms:
• skin rash
• hives
• fever
• swollen glands that do not heal
• swelling of the lips and tongue
• yellowing of the skin or the whites of the eyes
• bruising or unusual bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections.

These symptoms may be the first signs of a serious reaction. Your doctor should check you to
decide if you need to continue taking Gabapentin Hexal A/S.
If you are on hemodialysis, tell your doctor if you develop muscle pain and/or weakness.

Other side effects include:
Very common side effects (may affect more than 1 in 10 people):

• viral infections
• feeling sleepy, dizziness, lack of coordination
• feeling tired, fever

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

• pneumonia, respiratory infections, urinary tract infections, 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 disturbances, headache, skin sensitivity, reduced sensation (numbness), difficulty with coordination, abnormal eye movements, increased, decreased or absent reflexes
• blurred vision, double vision
• dizziness
• high blood pressure, facial flushing or widening of blood vessels
• difficulty breathing, bronchitis, sore throat, cough, runny nose
• vomiting (feeling sick), nausea (feeling unwell), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, intestinal gas (flatulence)
• swelling of the face, bruising, skin rash, itching, acne
• joint pain, muscle pain, back pain, muscle contractions
• erection problems (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, in clinical studies in children, aggressive behavior and jerky movements were commonly reported.

Uncommon side effects (may affect up to 1 in 100 people):

• Agitation (a state of chronic restlessness and purposeless, involuntary movements)
• Allergic reactions such as hives
• Decreased movement
• Fast heartbeat
• Swelling that can involve the trunk, face and limbs
• Abnormal blood test results suggesting liver problems
• Changes in thinking
• Falls
• High blood sugar levels (more often observed in patients with diabetes)
• Difficulty swallowing

Rare side effects (may affect up to 1 in 1000)

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

The following side effects have been reported after marketing:
Not known (frequency cannot be estimated from available data):

• decreased platelets (cells that clot blood)
• hallucinations
• problems with abnormal movements such as convulsive jerks, jerky movements and rigidity
• ringing in the ears
• a group of side effects that may include swollen lymph nodes (small lumps under the skin), fever, skin rashes, and liver inflammation that occur together
• yellowing of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• increase in breast tissue, breast enlargement
• adverse events that occur after sudden discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• muscle fiber breakdown (rhabdomyolysis)
• changes in blood test results (increased creatine phosphokinase)
• problems with sexual function including inability to reach orgasm, delayed ejaculation
• low sodium levels in the blood
• anaphylaxis (a severe allergic reaction potentially life-threatening that includes difficulty breathing, swelling of lips, throat and tongue and low blood pressure with subsequent need for emergency treatment).

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

5. How to store Gabapentin Hexal A/S

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 pack after “Exp.’’.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C
Blisters: Store in the original package to protect the medicine from moisture.
Tablet container: Keep the container tightly closed to protect the medicine from moisture.
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 Gabapentin Hexal A/S contains

• The active ingredient is gabapentin. Gabapentin Hexal A/S: Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
• The other components of the capsules are: capsule content: pregelatinized corn starch, corn starch, talc, anhydrous colloidal silica. Capsule shell: gelatin, sodium lauryl sulfate, colored with titanium dioxide (E171) and yellow iron oxide (E172) (300 mg and 400 mg capsules) and red iron oxide (E172) (400 mg capsules).

Description of the appearance of Gabapentin Hexal A/S and package contents
Hard capsules
Gabapentin Hexal A/S 100 mg hard capsules are hard gelatin capsules, with an opaque white body and cap.
Gabapentin Hexal A/S 300 mg hard capsules are hard gelatin capsules, with an opaque yellow body and cap.
Gabapentin Hexal A/S 400 mg hard capsules are hard gelatin capsules, with an opaque brown body and cap.
Gabapentin Hexal A/S 100 mg hard capsules
PVC/PE/PVDC/Alu blisters: 20, 30, 50, 90, 100, 200 and 500 hard capsules
Gabapentin Hexal A/S 300 mg hard capsules
PVC/PE/PVDC/Alu blisters: 20, 30, 50, 90, 100, 200 and 500 hard capsules
HDPE container with child-resistant closure: 50 and 100 hard capsules.
Gabapentin Hexal A/S 400 mg hard capsules
PVC/PE/PVDC/Alu blisters: 20, 30, 50, 90, 100, 200 and 500 hard capsules
HDPE container with child-resistant closure: 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder:
Hexal A/S - Edvard Thomsens Vej 14 - 2300 Copenhagen - Denmark
Representative for Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH – Otto-von-Guericke-Allee 1 – 39179 Barleben (Germany)
LEK SA – Ul. Domaniewska 50 C – 02-672 Warszawa (Poland)
Sandoz GmbH - Biochemiestrasse 10, 6250 Kundl (Austria)
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana (Slovenia)
LEK Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava (Slovenia)

This medicinal product is authorised in the Member States of the European Economic Community with the following
names:
Austria: Gabapentin Hexal 100 mg – Hard capsules
Gabapentin Hexal 300 mg - Hard capsules
Gabapentin Hexal 400 mg - Hard capsules
Germany: Gabapentin Hexal 100 mg Hard capsules
Gabapentin Hexal 300 mg Hard capsules
Gabapentin Hexal 400 mg Hard capsules
Italy: GABAPENTIN HEXAL A/S 100 mg hard capsules
GABAPENTIN HEXAL A/S 300 mg hard capsules
GABAPENTIN HEXAL A/S 400 mg hard capsules
Luxembourg: Gabapentin HEXAL 100 mg Hartkapseln
Gabapentin HEXAL r 300 mg Hartkapseln
Gabapentin HEXAL r 400 mg Hartkapseln
Netherlands: Gabapentine Sandoz capsules 100 mg
Gabapentine Sandoz capsules 300 mg
Gabapentine Sandoz capsules 400 mg
Spain: Gabapentina Bexal 300 mg cápsulas EFG
Gabapentina Bexal 400 mg cápsulas EFG

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