GABAPENTIN 100 mg Kapsułki Twarde

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1. GABAPENTIN TECNIGEN 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. WHAT IS GABAPENTIN TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN TECNIGEN
   3. HOW TO TAKE GABAPENTIN TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GABAPENTIN TECNIGEN

GABAPENTIN TECNIGEN 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT IS GABAPENTIN TECNIGEN AND WHAT IT IS USED FOR

GABAPENTIN TECNIGEN 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 of GABAPENTIN TECNIGEN is gabapentin.
GABAPENTIN TECNIGEN is used for the treatment of:

• 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 TECNIGEN as an adjunct to epilepsy treatment when the treatment you are already following does not fully control your condition. You should take GABAPENTIN TECNIGEN in addition to the treatment you are already undergoing unless you receive other instructions. GABAPENTIN TECNIGEN 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 (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 YOU TAKE GABAPENTIN TECNIGEN

Do not take GABAPENTIN TECNIGEN

• 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, pharmacist or nurse before taking GABAPENTIN TECNIGEN :

• if you have kidney problems your doctor may prescribe a different dosing schedule for the medicine.
• if you are on hemodialysis (to remove waste products from kidney failure) tell your doctor if you experience 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 system diseases 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 antiepileptic drugs such as gabapentin have developed
thoughts of self-harm or suicide. If thoughts of this kind emerge at any time, contact
your doctor immediately.

Important information about potentially serious reactions
A small number of patients treated with GABAPENTIN TECNIGEN experience an
allergic reaction or a potentially serious skin reaction which, if not properly treated, can lead to
more serious problems. You need to pay attention to these symptoms while you are
taking GABAPENTIN TECNIGEN.

Read the description of these symptoms in section 4 of this leafletin the “Contact
your doctor immediately if you experience any of the following symptoms after taking this medicine
because they may be serious”.
Muscle weakness, soreness or pain, in p a rticular if associated with feeling unwell and
fever, may be due to muscle injury which can be life-threatening and can lead to
kidney problems.
You m a y also experience discoloration of the urine and abnormalities in blood tests (in p a rticular
increased creatine phosphokinase). If you
experience any of these signs or symptoms, please c o ntact your doctor immediately.

Other medicines and GABAPENTIN TECNIGEN
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 seizures, sleep disorders, depression, anxiety or other
neurological or psychiatric problems.

Medicines containing opioids such as morphine
Tell your doctor or pharmacist if you are taking medicines that contain opioids (such as morphine)
because opioids can increase the effect of GABAPENTIN TECNIGEN. In addition, the
combination of GABAPENTIN TECNIGEN w i th opioids can cause symptoms such as drowsiness
and/or slowed breathing.

Antacids for indigestion
If GABAPENTIN TECNIGEN and antacids containing aluminium and magnesium are taken
together, the absorption of GABAPENTIN TECNIGEN from the stomach may be reduced. It is
therefore recommended to take GABAPENTIN TECNIGEN not less than two hours after taking the
antacid.

GABAPENTIN TECNIGEN:

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

GABAPENTIN TECNIGEN with food
GABAPENTIN TECNIGEN can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
GABAPENTIN TECNIGEN 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 an increased risk of harm to the developing baby has been reported for other medicines used to treat
seizures, particularly when taken together with more than one medicine for seizures. Therefore, if
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 TECNIGEN. Do not suddenly stop taking this medicine as this
may cause sudden seizures which can have serious consequences for you and the baby.
Breastfeeding
Gabapentin, the active ingredient of GABAPENTIN TECNIGEN, passes into breast milk. As the effects
on the baby are unknown, it is recommended not to breastfeed during treatment with
GABAPENTIN TECNIGEN.
Fertility
Animal studies have shown no effects on fertility.

Driving and using machines
GABAPENTIN TECNIGEN 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 affects you.

GABAPENTIN TECNIGENcontains lactose(a type of sugar). If your doctor has told you that
you are intolerant to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE GABAPENTIN TECNIGEN

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask 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. 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 (once
in the morning, once in the afternoon, and once in the evening).

Use in children aged 6 years and over
The dose to be administered to the child will be established by the doctor, who will calculate it based on the child's weight.
Treatment is started with a low initial dose, which is gradually increased
over approximately 3 days. The recommended dose for controlling epilepsy is 25-35 mg per kg of
body weight per day. The dose is usually administered in 3 separate doses, taking the
capsule or tablet each day generally once in the morning, once in the afternoon, and once in the
evening.

GABAPENTIN TECNIGEN is not recommended in children under 6 years of age.
Peripheral Neuropathic Pain, the recommended dose is:
Adults
Take the number of capsules prescribed by your doctor. 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 (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
GABAPENTIN TECNIGEN, 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 GABAPENTIN TECNIGEN is too strong or too weak, tell your
doctor or pharmacist as soon as possible.

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

If you take more GABAPENTIN TECNIGEN than you should
If you or someone else accidentally takes too many capsules, or if you think a child has
swallowed them, contact your doctor or go immediately to the nearest emergency room. Gabapentin
capsules can cause drowsiness; it is advisable to ask someone else to drive to reach the
doctor or hospital, or to call an ambulance. Bring with you the capsules that you did not take along with the
taken ones.
The symptoms of an overdose are dizziness, double vision, difficulty speaking, loss of consciousness,
drowsiness, and mild diarrhea.

If you forget to take GABAPENTIN TECNIGEN
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 taking GABAPENTIN TECNIGEN
Do not stop treatment with GABAPENTIN TECNIGEN unless your doctor has told you to.
Discontinuation of treatment must occur gradually over at least 1
week. If you suddenly stop treatment with GABAPENTIN TECNIGEN or if you
stop it before it has been prescribed by your doctor, the risk of seizures increases.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist, or
nurse.

4. POSSIBLE SIDE EFFECTS

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

Contact 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 rash and 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 continue breathing normally.

GABAPENTIN TECNIGEN can cause serious or sometimes fatal allergic reactions, affecting the skin
or other parts of the body such as the liver or blood cells. It may or may not have a rash when this type of reaction occurs. This may result in hospitalization or
stopping GABAPENTIN TECNIGEN. See your doctor if you experience any of the following symptoms:

• skin rash;
• hives;
• fever;
• persistent enlargement of the lymph glands;
• swelling of the lips or tongue;
• yellowing of the skin or whites of the eyes;
• unusual bruising or bleeding;
• severe fatigue or weakness;
• unexpected muscle pain;
• frequent infections.

These symptoms may be the first signs of a serious reaction. Your doctor should examine you to
decide whether to continue taking GABAPENTIN TECNIGEN.
If you are on hemodialysis, tell your doctor if you experience muscle pain and/or weakness.
Other side effects include:

Very common (may affect more than 1 in 10 people:
o Viral infections.
o Feeling sleepy, dizziness, lack of coordination.
o Feeling tired, fever.

Common (may affect up to 1 in 10 people):
o Pneumonia, respiratory infections, urinary tract infections, various infections, ear inflammation or other infections.
o Low white blood cell count.
o Loss of appetite, increased appetite.
o Anger towards other people, confusion, mood changes, depression, anxiety, nervousness,
difficulty thinking.
o Convulsions, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation, difficulty coordinating, abnormal eye movements, increased, decreased or absent reflexes.
o Blurred vision, double vision.
o Dizziness.
o High blood pressure, flushing of the face or widening of blood vessels.
o Difficulty breathing, bronchitis, sore throat, cough, nasal dryness,
o Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion,
constipation, dry mouth or throat, intestinal gas (flatulence).
o Swelling of the face, bruising, skin rash, itching, acne.
o Joint pain, muscle pain, back pain, muscle contractions.
o Problems with erection (impotence).
o Swelling of the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
o Decreased white blood cells, weight gain,
o Accidental injuries, fractures, abrasions.
In addition, aggressive behavior and jerky movements have been commonly reported in clinical studies conducted in children.

Uncommon (may affect up to 1 in 100 people):
o Allergic reactions such as hives.
o Reduced movement.
o Fast heartbeat.
o Swelling that can affect the face, trunk and limbs.
o Altered blood test values suggesting liver problems.
o Falls.
o Mental impairment.
o Increased blood glucose levels (observed more often in patients with diabetes).
o Agitation (chronic state of restlessness and involuntary and aimless movements).
o 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).

Frequency not known:
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 with a consequent need for emergency treatment).
The following side effects have been reported after marketing authorization:
o Decreased platelets (cells that clot blood).
o Hallucinations.
o Problems with abnormal movements such as convulsive jerks, jerky movements and rigidity.
o Tinnitus (ringing in the ears).
o A group of side effects, including swollen lymph nodes (small lumps under the skin), fever, rash and liver inflammation, which can occur
simultaneously.
o Yellowing of the skin and eyes (jaundice).
o Liver inflammation.
o Acute kidney failure, incontinence.
o Enlargement of breast tissue, breast enlargement.
o Adverse events that occur after sudden discontinuation of gabapentin (anxiety, sleep disorders, feeling unwell, pain, sweating), chest pain
Muscle fiber injury (rhabdomyolysis).
Blood test abnormalities (increased creatine phosphokinase).
Sexual dysfunction including inability to reach orgasm,
delayed ejaculation.
Low sodium levels in the blood (hyponatremia).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.a ge nz ia fa r m ac o. go v. i t /c o nt e nt / co m e -
segna la r e- una- s o sp e t ta- re a zi o ne- a v ve rs a. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE GABAPENTIN TECNIGEN

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 Scad. The expiry
date refers to the last day of the month.
Do not store at a temperature above 30°C. Store in the original package to protect the
medicine from light and moisture.
Do not dispose of any medicine via 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 TECNIGEN contains

• The active ingredient is gabapentin. Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
• The other ingredients of GABAPENTIN TECNIGEN capsules are:

Capsule content:
Lactose monohydrate, Corn starch, Talc.
Capsule shell:
The capsule shell of 100 mg (No. 3, light green and ivory) contains:
Quinoline Yellow (E104)
Indigo Carmine (E132)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatin
The capsule shell of 300 mg (No. 0, dark green and white) contains:
Yellow iron oxide (E172)
Indigo Carmine (E132)
Titanium dioxide (E171)
Gelatin
The capsule shell of 400 mg (No. 0, green and white) contains:
Yellow iron oxide (E172)
Indigo Carmine (E132)
Titanium dioxide (E171)
Gelatin

Description of the appearance of GABAPENTIN TECNIGEN and package contents
Hard capsules
GABAPENTIN TECNIGEN is packaged in PVC+PVD/Al blisters.
The available packs are:
100 mg: 20, 50, 60, 90, 100 or 500 hard capsules
300 mg and 400 mg: 30, 50, 60, 90, 100 or 500 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

MAH:
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, 2700 – 486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
Tecnimede – Sociedade Técnico-Medicinal, S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos, Portugal
Farmalabor – Produtos Farmacêuticos, S.A.
Zona Industrial de Condeixa-a-Nova
3150-194 Condeixa-a-Nova
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Gabapentin TecniGen
Portugal: Gabapentina Farmoz
Spain: Gabapentina Tecnigen
United Kingdom: Gabapentin 100 mg, Gabapentin 300 mg, Gabapentin 400 mg.