Gabapentin Tecnigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 GABAPENTIN TECNIGEN IS AND WHAT IT IS USED FOR

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

• Various forms of epilepsy (epileptic seizures initially limited to certain areas of the brain, whether or not they spread to other parts of the brain). Your doctor will prescribe GABAPENTIN TECNIGEN as an add-on treatment for epilepsy when your current therapy does not fully control your condition. You must take GABAPENTIN TECNIGEN in addition to your ongoing treatment unless otherwise instructed. GABAPENTIN TECNIGEN may also be used as monotherapy 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 (occurring mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, throbbing, electric shocks, shooting pain, sharp pain, cramping pain, discomfort, tingling, numbness, stabbing pain, etc.

2. WHAT YOU SHOULD KNOW BEFORE TAKING GABAPENTIN TECNIGEN

Do not take GABAPENTIN TECNIGEN

• if you are allergic to gabapentin or to any of the excipients 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.
• if you are on hemodialysis (to remove waste products due to kidney failure), contact 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 signs of acute pancreatitis (inflammation of the pancreas).
• if you suffer from neurological/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses.

Cases of abuse and dependence have been reported with gabapentin in post-marketing experience. Inform your doctor if you have a history of substance abuse or dependence.
A small number of patients treated with antiepileptic medicines such as gabapentin have experienced suicidal thoughts or self-harming behavior. If you experience any such thoughts at any time, contact your doctor immediately.

Important information about potentially serious reactions
A small number of patients taking GABAPENTIN TECNIGEN may develop an allergic reaction or a potentially serious skin reaction, which, if not properly treated, could lead to more severe complications. You should be aware of these symptoms while taking GABAPENTIN TECNIGEN.
Please read the description of these symptoms in section 4 of this leaflet under “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, especially if associated with malaise and fever, may be due to muscle injury, which can be life-threatening and may lead to kidney problems.
Discoloration of urine and blood test abnormalities (particularly increased creatine phosphokinase) may also occur. If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and GABAPENTIN TECNIGEN
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or other neurological or psychiatric conditions.

Medicines containing opioids such as morphine
Inform your doctor or pharmacist if you are taking medicines containing opioids (such as morphine), because opioids may enhance the effect of GABAPENTIN TECNIGEN. Moreover, the combination of GABAPENTIN TECNIGEN with opioids may cause symptoms such as drowsiness and/or reduced breathing.

Antacids for indigestion
If GABAPENTIN TECNIGEN is taken together with antacids containing aluminium and magnesium, the absorption of GABAPENTIN TECNIGEN from the stomach may be reduced. Therefore, it is recommended to take GABAPENTIN TECNIGEN no sooner than two hours after taking an antacid.

GABAPENTIN TECNIGEN:

• is not expected to interact with other antiepileptic drugs or with oral contraceptives.
• may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
GABAPENTIN TECNIGEN should not be taken during pregnancy unless your doctor has advised otherwise. Women of childbearing potential should use an effective method of contraception.
Specific studies evaluating the use of gabapentin in pregnant women have not been conducted. However, with other medicines used to treat epileptic seizures, an increased risk of developmental harm to the unborn child has been reported, particularly when more than one antiepileptic medicine is taken simultaneously. Therefore, whenever possible, only one antiepileptic medicine should be used during pregnancy, and only under medical supervision.
Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while being treated with GABAPENTIN TECNIGEN. Do not stop taking this medicine suddenly, as this may trigger sudden epileptic seizures, which could have serious consequences for both you and your baby.

Breastfeeding
Gabapentin, the active ingredient in GABAPENTIN TECNIGEN, passes into breast milk. Since the effects on the infant are unknown, breastfeeding is not recommended during treatment with GABAPENTIN TECNIGEN.

Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
GABAPENTIN TECNIGEN may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects you.

GABAPENTIN TECNIGEN contains lactose (a type of sugar). If your doctor has informed you that you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE GABAPENTIN TECNIGEN

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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. Your doctor will gradually increase
your dose. The initial dose is generally 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 instruct you to take this dose in three separate administrations (once in the morning, once in the afternoon, and once in the evening).
Use in children aged 6 years and older
The dose for the child will be determined by the doctor, based on the child's body 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 three divided doses, taking the capsule or tablet once daily in the morning, once in the afternoon, and once in the evening.
GABAPENTIN TECNIGEN is not recommended for children under 6 years of age.
Peripheral Neuropathic Pain, the recommended dose is:
Adults
Take the number of capsules prescribed by your doctor. Your doctor will gradually increase
your dose. The initial dose is generally 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 instruct you to take this dose in three separate administrations (once in the morning, once in the afternoon, and once in the evening).
If you have kidney problems or are on dialysis
If you have kidney problems or are undergoing dialysis, your doctor may prescribe a different dosing schedule 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 and/or a different dose.
If you feel that the effect of GABAPENTIN TECNIGEN is too strong or too weak, inform your
doctor or pharmacist as soon as possible.
Method of administration
GABAPENTIN TECNIGEN is taken orally. Always swallow the capsules whole with
a generous amount of water.
Continue treatment with GABAPENTIN TECNIGEN until your doctor tells you to stop.
If you take more GABAPENTIN TECNIGEN than you should
If you or someone else accidentally takes too many capsules, or if you suspect a child has
swallowed them, contact your doctor or go immediately to the nearest emergency room. Gabapentin
capsules may cause drowsiness; it is therefore advisable to ask someone else to drive you to the doctor or hospital, or to call an ambulance. Bring with you any unused capsules, the packaging, and the leaflet so that hospital staff can easily identify the medicine you have taken.
Symptoms of overdose include 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 almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking GABAPENTIN TECNIGEN
Do not stop treatment with GABAPENTIN TECNIGEN unless your doctor tells you to. Discontinuation of treatment should be done gradually over at least one week. If you stop treatment with GABAPENTIN TECNIGEN suddenly or before your doctor has instructed you to do so, your risk of epileptic seizures increases.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they could be serious:

• 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, 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 treatment to allow you to continue breathing normally.

GABAPENTIN TECNIGEN may cause severe or even fatal allergic reactions affecting the skin or other parts of the body such as the liver or blood cells. A skin rash may or may not appear when this type of reaction occurs. This could lead to hospitalization or discontinuation of GABAPENTIN TECNIGEN. Contact your doctor if you experience any of the following symptoms:

• Skin rash;
• Hives;
• Fever;
• Persistent swelling 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 early signs of a serious reaction. Your doctor should examine you to determine whether you should continue taking GABAPENTIN TECNIGEN.
If you are undergoing hemodialysis, inform your doctor if you experience muscle pain and/or weakness.

Other adverse reactions include:
Very common (may affect more than 1 in 10 people):
o Viral infections.
o Drowsiness, 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 Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty in thinking.
o Seizures, convulsive movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation, coordination difficulties, abnormal eye movements, increased, decreased, or absent reflexes.
o Blurred vision, double vision.
o Dizziness.
o High blood pressure, facial flushing, or dilation of blood vessels.
o Breathing difficulties, bronchitis, sore throat, cough, dry nose,
o Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach ache, indigestion, constipation, dry mouth or throat, intestinal gas (flatulence).
o Facial swelling, bruising, skin rash, itching, acne.
o Joint pain, muscle pain, back pain, muscle spasms.
o Erectile dysfunction (impotence).
o Swelling of the arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
o Reduced white blood cell count, weight gain.
o Accidental injuries, fractures, abrasions.

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

Uncommon (may affect up to 1 in 100 people):
o Allergic reactions such as hives.
o Reduced movement.
o Rapid heartbeat.
o Swelling that may affect the face, trunk, and limbs.
o Abnormal blood test results suggesting liver problems.
o Falls.
o Impaired mental function.
o Increased blood glucose levels (observed more frequently in patients with diabetes).
o Agitation (a state of chronic restlessness and unintentional, purposeless movements).
o Difficulty swallowing.

Rare (may affect up to 1 in 1,000 people):
Loss of consciousness.
Decreased blood glucose levels (observed more frequently in patients with diabetes).
Breathing difficulties, shortness of breath (respiratory depression).

Frequency not known:
Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring emergency treatment).

After marketing authorization, the following adverse reactions have been reported:
o Reduced platelet count (blood cells responsible for clotting).
o Hallucinations.
o Problems with abnormal movements such as convulsive restlessness, convulsive movements, and stiffness.
o Ringing in the ears.
o A group of adverse reactions, including swollen lymph nodes (small nodules under the skin), fever, skin rash, and liver inflammation, which may occur simultaneously.
o Yellowing of the skin and eyes (jaundice).
o Liver inflammation.
o Acute kidney failure, incontinence.
o Increase in breast tissue, breast enlargement.
o Adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain.
Muscle fiber damage (rhabdomyolysis).
Abnormalities in blood tests (increased creatine phosphokinase).
Sexual dysfunction including inability to reach orgasm, delayed ejaculation.
Low sodium levels in the blood (hyponatremia).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, 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 stated on the carton after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original packaging 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 no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What GABAPENTIN TECNIGEN contains

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

Capsule contents:
Monohydrate lactose, maize starch, talc.
Capsule coating:
The shell of the 100 mg capsule (size 3, light green and ivory) contains:
Quinoline yellow (E104)
Indigo carmine (E132)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Gelatin
The shell of the 300 mg capsule (size 0, dark green and white) contains:
Iron oxide yellow (E172)
Indigo carmine (E132)
Titanium dioxide (E171)
Gelatin
The shell of the 400 mg capsule (size 0, green and white) contains:
Iron oxide yellow (E172)
Indigo carmine (E132)
Titanium dioxide (E171)
Gelatin

Description of the appearance of GABAPENTIN TECNIGEN and contents of the package
Hard capsules
GABAPENTIN TECNIGEN is packaged in PVC+PVD/Al blisters.
Available pack sizes 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 Authorization Holder
AIC Holder:
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

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 medicine is authorized in the European Economic Area countries under the following names:
Italy: Gabapentin TecniGen
Portugal: Gabapentina Farmoz
Spain: Gabapentina Tecnigen
United Kingdom: Gabapentin 100 mg, Gabapentin 300 mg, Gabapentin 400 mg.