Gabapentin Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Generic medicine
Please read all of 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gabapentin Zentiva is and what it is used for
What you need to know before taking Gabapentin Zentiva
How to take Gabapentin Zentiva
Possible side effects
How to store Gabapentin Zentiva
Contents of the pack and other information

1. What Gabapentin Zentiva is 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 nerve damage).
The active substance 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 or not they spread to other parts of the brain). Your doctor or your child’s paediatrician will prescribe Gabapentin Zentiva as an add-on treatment for epilepsy when the current treatment does not fully control the condition. You or your child aged 6 years or older must take Gabapentin Zentiva in addition to the ongoing treatment, unless otherwise instructed. Gabapentin Zentiva may 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 (which mainly occurs in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as warmth, burning, stabbing, shooting, sharp, cramping, discomfort, tingling, numbness, prickling, etc.

2. What you need to know before taking Gabapentin Zentiva

Do not take Gabapentin Zentiva:

if you are allergic (hypersensitive) to gabapentin or to 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 you a different dosage,
if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or muscle weakness,
if you develop signs 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 have nervous system/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses,
if you have myasthenia gravis (a disease causing muscle weakness), as this medicine could worsen your symptoms,
before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal substances, as this may indicate that you have a higher risk of developing dependence on Gabapentin Zentiva.

Dependence
Some people may develop dependence on Gabapentin Zentiva (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop taking Gabapentin Zentiva or reduce the dose (see section 3, “How to take Gabapentin Zentiva” and “If you stop taking Gabapentin Zentiva”).
If you are concerned about the possibility of developing dependence on Gabapentin Zentiva, talk to your doctor.
If you notice any of the following signs while taking Gabapentin Zentiva, you may have developed 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 different from those for which it was prescribed
You have made repeated but unsuccessful attempts to stop or control your use of the medicine
You do not feel well when you stop taking the medicine and 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 and how to safely stop taking the medicine.

A small number of patients treated with antiepileptic medicines such as gabapentin have had suicidal thoughts or thoughts of self-harm. If at any time you experience such thoughts, contact your doctor immediately.

Important information about potentially serious reactions
Serious 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 taking gabapentin and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of serious symptoms in section 4 of this leaflet under “Contact your doctor immediately if you notice any of the following symptoms after taking this medicine, as they may be serious”
Muscle weakness, tenderness or pain, especially if you also feel unwell and have a fever, may be caused by muscle injury which can be life-threatening and may lead to kidney problems.
You may also notice discoloured urine and abnormalities in blood tests (particularly increased creatine phosphokinase). If any of these signs or symptoms occur, 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, 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
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin Zentiva. In addition, the combination of Gabapentin Zentiva with opioids may cause drowsiness, sedation, reduced breathing or death.

Antacids for indigestion
If Gabapentin Zentiva and antacids containing aluminium 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 an antacid.

Gabapentin Zentiva:

is not expected to interact with other antiepileptic medicines or with oral contraceptives.
Gabapentin Zentiva may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about 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 or think you may be pregnant, you must inform your doctor immediately and discuss the possible risks that the medicine you are taking may pose to your unborn child.
You must not stop treatment without discussing it with your doctor.
If you are planning a pregnancy, you should discuss your treatment with your doctor or pharmacist as early as possible before starting a pregnancy.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin Zentiva, if necessary, may be used during the first trimester of pregnancy. If you are planning a pregnancy, or if you are pregnant or think you may be pregnant, contact your doctor immediately. If you become pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Worsening of your epilepsy may put you and your unborn child at risk. In a study examining data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, no increased risk of birth defects or problems with brain function development (neurological developmental disorders) was observed. However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm delivery.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. The risk may be increased when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Gabapentin Zentiva. Do not suddenly stop taking this medicine, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.

Breastfeeding
Gabapentin, the active substance in Gabapentin Zentiva, passes into breast milk. Since the effect on the infant is unknown, breastfeeding is not recommended during treatment with Gabapentin Zentiva.

Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
Gabapentin Zentiva may cause dizziness, drowsiness and fatigue. You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know how this medicine affects you.

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

3. How to take Gabapentin Zentiva

Take this medicine exactly as instructed by your doctor or pharmacist. 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, recommended dose is
Adults and adolescents
Take the number of capsules prescribed by your doctor. Usually, 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 on your doctor's advice up to a maximum of 3,600 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.

Children aged 6 years and older
The dose for a 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 usual dose for control of epilepsy is 25–35 mg per kg per day. It is usually administered in
three 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 6 years of age.

Peripheral neuropathic pain, recommended dose is
Adults
Take the number of capsules as directed by your doctor. Usually, 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 on your doctor's advice up to a maximum of 3,600 mg per
day, and your doctor will instruct you to take the medicine in three separate doses: once in the morning, once in the afternoon, and once in the evening.

If you have kidney problems or are on haemodialysis
If you have kidney problems or are on haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.

If you are an elderly patient (age over 65 years)
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 schedule and/or a different dose.
If you feel that the effect of Gabapentin Zentiva is too strong or too weak, inform your doctor or pharmacist as soon as possible.

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

If you take more Gabapentin Zentiva than you should
Taking more than the recommended dose may lead to an increase in side effects, including loss of
consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea.
Contact your doctor immediately or go to the nearest emergency department if you take more Gabapentin Zentiva than prescribed. Bring with you any unused capsules, together with the packaging and the leaflet, so that hospital staff can quickly identify 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 almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gabapentin Zentiva
Do not stop treatment with Gabapentin Zentiva suddenly or reduce your dose abruptly. If you wish to stop treatment with Gabapentin Zentiva or reduce your dose, speak to your doctor first, who will advise you on how to do so. Stopping treatment or reducing the dose should be done gradually over a period of at least 1 week.
After stopping short-term or long-term treatment with Gabapentin Zentiva or after reducing the dose, you should be aware that you may experience certain side effects known as withdrawal effects. These effects may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling of abnormality, dizziness, and general malaise. These effects usually occur within 48 hours of stopping or reducing the dose of Gabapentin Zentiva. If you experience withdrawal effects, contact your doctor.

If you have any questions 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.
Stop using Gabapentin Zentiva and contact a doctor immediately if you notice any of the following symptoms:

Circular or target-shaped, reddish, flat spots 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 experience any of the following symptoms after taking this medicine, as they may be serious:

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 Zentiva can cause a serious or life-threatening allergic reaction affecting the skin or any other part of the body such as the liver or blood. When experiencing this type of reaction, you may or may not develop a skin rash. This may lead to hospitalization or discontinuation of treatment with Gabapentin Zentiva.

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

Skin rashes, redness, and/or hair loss.
Hives (urticaria).
Fever.
Swollen lymph nodes that do not go away.
Swelling of the lips, face, and tongue.
Yellowing of the skin or whites of the eyes.
Unusual bleeding or bruising.
Severe tiredness or weakness.
Sudden muscle pain.
Frequent infections.

These symptoms may be early signs of a serious reaction. Your doctor must examine you to decide whether 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.
Drowsiness, 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 white blood cell count.
Loss of appetite, increased appetite.
Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty in thinking.
Seizures, jerky movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, skin sensitivity, reduced sensation (numbness), coordination difficulties, abnormal eye movements, increased, decreased, or absent reflexes.
Blurred vision, double vision.
Dizziness.
High blood pressure, facial flushing, or dilation of blood vessels.
Breathing difficulties, bronchitis, sore throat, cough, dry nose.
Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence.
Swelling of the face, bruising, skin rash, itching, acne.
Joint pain, muscle pain, back pain, muscle spasms.
Erectile problems (impotence).
Swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
Reduced white blood cell count, weight gain.
Accidental injuries, fractures, abrasions. In addition, in clinical studies conducted in children, aggressive behavior and convulsive movements were commonly reported.

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

Agitation (a state of chronic restlessness and unintentional, purposeless movements).
Allergic reaction such as hives.
Reduced movement.
Increased heart rate.
Difficulty swallowing.
Swelling affecting the face, trunk, and limbs.
Abnormal blood test results suggesting liver problems.
Mental impairment.
Falls.
Increased blood glucose levels (more frequently observed in patients with diabetes).

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

Decreased blood glucose levels (more frequently observed in patients with diabetes).
Loss of consciousness.
Breathing difficulties, shortness of breath (respiratory depression).

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

Reduced platelet count (cells responsible for blood clotting).
Suicidal thoughts, hallucinations.
Movement disorders such as convulsive agitation, jerky movements, and stiffness.
Ringing in the ears (tinnitus).
Yellowing of the skin and eyes (jaundice), liver inflammation.
Acute kidney failure, incontinence.
Increased breast tissue, breast enlargement.
Adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain.
Muscle fiber damage (rhabdomyolysis).
Abnormal blood tests (elevated creatine phosphokinase).
Sexual dysfunction including inability to reach orgasm, delayed ejaculation.
Low sodium levels in the blood.
Anaphylaxis (a severe, potentially life-threatening allergic reaction including breathing difficulties, swelling of lips, throat, and tongue, and hypotension requiring emergency treatment).
Becoming dependent on Gabapentin Zentiva (“drug dependence”).
Worsening of myasthenia gravis (a condition causing muscle weakness).

After stopping short- or long-term treatment with Gabapentin Zentiva or reducing the dose, you should be aware that you may experience certain side effects known as withdrawal effects (see “If you stop taking Gabapentin Zentiva”).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.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 below 25°C.
Keep the container tightly closed and store the blister in the original packaging.
Do not use this medicine after the expiry date stated on the cardboard box. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Zentiva contains

The active substance is gabapentin (100 mg, 300 mg or 400 mg per hard capsule).
The other ingredients are: anhydrous lactose, maize starch and talc.
The capsule coating consists of: gelatin. Gabapentin Zentiva 100 mg capsules contain the colour E171 (titanium dioxide), Gabapentin Zentiva 300 mg capsules contain the colours E171 (titanium dioxide) and E172 (yellow iron oxide), Gabapentin Zentiva 400 mg capsules contain the colours E171 (titanium dioxide) and E172 (red and yellow iron oxide).

Description of the appearance of Gabapentin Zentiva and contents of the pack
This medicine is presented as 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.
Pack sizes:
Blister packs:
10, 20, 30, 50, 90, 100, 200 (2x100), 250 hard capsules
Hospital packs: 500 (5x100), 1000 (10x100) hard capsules
Unit dose packs: 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
Italy

Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Pharmadox Healthcare Limited
Address: KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta

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