Gabapentin Alter: detailed information

Patient Information Leaflet

GABAPENTIN ALTER 300 mg hard capsules, 400 mg hard capsules

Gabapentin
Generic 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 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 yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Gabapentin Alter belongs to a group of medicines used to treat epilepsy and
peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance of Gabapentin Alter is gabapentin.
Gabapentin Alter 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 will prescribe Gabapentin Alter as an add-on treatment for your epilepsy when your current therapy does not fully control your condition. You must take Gabapentin in addition to your ongoing treatment unless otherwise instructed. Gabapentin 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 (occurring mainly in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, electric shocks, shooting pain, stabbing pain, cramping pain, discomfort, tingling, numbness, pricking pain, etc.

2. What you should know before taking Gabapentin Alter

Do not take Gabapentin Alter

if you are allergic 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 Alter.

If you suffer from nervous or respiratory system 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 its 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 Alter.
Be especially careful with Gabapentin Alter:

if you have kidney problems;
if you develop signs such as persistent stomach pain, nausea, and vomiting, contact your doctor immediately.

Be especially careful with Gabapentin:

if you have kidney problems, your doctor may prescribe a different dosage;
if you are undergoing haemodialysis (to remove waste 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).

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

You feel the need to take the medicine 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 unsuccessful attempts to stop or control use of the medicine
When you stop taking the medicine, you feel unwell 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 developed suicidal thoughts or self-harming behaviour. If you have ever had such thoughts, contact your doctor immediately.

Other medicines and Gabapentin Alter
Inform 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 morphine
If you are taking medicines containing morphine, inform your doctor or pharmacist, as morphine may increase the effect of Gabapentin Alter.

Antacids for indigestion
If Gabapentin Alter and antacids containing aluminium and magnesium are taken together, the absorption of Gabapentin from the stomach may be reduced. It is therefore recommended to take Gabapentin Alter no sooner than two hours after taking an antacid.

Gabapentin Alter:
No interaction with other antiepileptic medicines or with oral contraceptives is expected.
It may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Gabapentin Alter with food and drink
Gabapentin Alter can be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Gabapentin Alter should not be taken during pregnancy unless your doctor has advised otherwise. Women of childbearing age should use an effective method of contraception.
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).
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but for other medicines used to treat epileptic seizures, an increased risk of fetal harm has been reported, particularly when more than one medicine for epileptic seizures is taken simultaneously. Therefore, whenever possible and only on medical advice, during pregnancy you should try to take only one medicine for epilepsy.
Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.
Gabapentin, the active substance in Gabapentin Alter, is excreted in breast milk. Since the effects of breastfeeding on the infant are unknown, it is recommended not to breastfeed during treatment with Gabapentin Alter.

Driving and using machines
Gabapentin Alter may cause dizziness, drowsiness, and fatigue. You should not drive, operate complex machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

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

Important information about potentially serious reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with gabapentin treatment. 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 these symptoms in section 4 of this patient information leaflet below:
"contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they could be serious"

3. How to take Gabapentin Alter

Take this medicine exactly as prescribed 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.
If you feel that the effect of Gabapentin Alter is too strong or too weak, inform your doctor or pharmacist as soon as possible.
If you are elderly (over 65 years of age), you should take the normal dosage of Gabapentin Alter, unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing schedule and/or a different dose.
Continue treatment with Gabapentin Alter until your doctor tells you to stop.

Method and route of administration
Gabapentin Alter is taken orally. Swallow the capsules whole with plenty of water.

Epilepsy, the 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, as directed by your doctor, up to a maximum of 3600 mg per day, divided into three separate doses—once in the morning, once in the afternoon, and once in the evening.

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 usual dose for controlling epilepsy is 25–35 mg/kg per day. This dose is usually given in three separate doses, taken every day—once in the morning, once in the afternoon, and once in the evening.
The use of Gabapentin Alter is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:
Adults
Take the number of capsules as instructed 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, as directed by your doctor, up to a maximum of 3600 mg per day, divided into 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 take more Gabapentin Alter than you should
Taking more than the recommended dose may increase the risk of 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 Alter than prescribed. Bring with you any unused capsules, the packaging, and the patient information leaflet so that hospital staff can easily determine how much medicine you have taken.

If you forget to take Gabapentin Alter
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 the missed dose.

If you stop taking Gabapentin Alter
Do not stop treatment with Gabapentin Alter suddenly or reduce the dose without consulting your doctor. If you wish to stop treatment or reduce the dose, talk 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 treatment with Gabapentin Alter, whether after short-term or long-term use, or after reducing the dose, you should be aware that you may experience certain side effects known as withdrawal symptoms. These may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling of abnormality, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping or reducing the dose of Gabapentin Alter. If you experience withdrawal symptoms, 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 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 care to allow you to continue breathing normally
Gabapentin Alter may cause a severe or life-threatening allergic reaction, which may affect 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 Alter.

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

skin rashes
hives
fever
swollen lymph nodes that do not go away
swelling of the lips and tongue
yellowing of the skin or 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 allergic reaction. A doctor should examine you to determine whether you should continue taking Gabapentin Alter.
Stop using Gabapentin Alter 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, mouth, throat, nose, genital or eye ulcers. 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).

If you are undergoing hemodialysis, inform your doctor if you experience muscle pain and/or weakness.
Other side effects include:
Very common side effects
(may occur in more than 1 out of 10 people):

viral infections
drowsiness, dizziness, lack of coordination
feeling tired, fever

Common side effects
(may occur in more than 1 out of 100 people):

pneumonia, respiratory infections, urinary tract infections, ear inflammation, or other infections
low white blood cell count
anorexia, increased appetite
anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
seizures, convulsive movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), coordination problems, eye movement abnormalities, 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 pain, indigestion, constipation, dry mouth or throat, flatulence
facial swelling, bruising, skin rash, itching, acne
joint pain, muscle pain, back pain, muscle spasms
erection 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 have been commonly reported.
Uncommon side effects
(may occur in more than 1 out of 1,000 people):

allergic reaction such as hives
reduced movement
increased heart rate
swelling affecting the face, trunk, and limbs
abnormal blood test results suggesting liver problems
falls
difficulty thinking
elevated blood glucose levels (more frequently observed in diabetic patients)
difficulty swallowing

Rare side effects (may occur in fewer than 1 out of 1,000 people):

low blood glucose levels (more frequently observed in diabetic patients)
loss of consciousness
breathing difficulties, shortness of breath (respiratory depression)

During post-marketing surveillance, the following side effects have been reported:

reduced platelet count (cells that clot blood)
hallucinations
movement disorders such as convulsive restlessness, convulsive movements, and rigidity
ringing in the ears
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
Stevens-Johnson syndrome, erythema multiforme
hyponatremia

Side effects Frequency not known (frequency cannot be estimated from available data)

Becoming dependent on Gabapentin Alter (“drug dependence”)
Worsening of myasthenia gravis (a disease causing muscle weakness)

After stopping short- or long-term treatment with Gabapentin Alter or after reducing the dose, you should be aware that you may experience certain side effects, known as withdrawal effects
(see “If you stop taking Gabapentin Alter”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store Gabapentin Alter hard capsules at temperatures above 30°C.
Medicines must not be disposed of 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 Alter contains
The active substance is gabapentin. Each hard capsule contains 300 mg or 400 mg of gabapentin.
The other components of Gabapentin Alter capsules are:
corn starch, lactose monohydrate, talc, gelatin.
The 300 mg capsules contain the colouring agents E171 (titanium dioxide) and E172 (yellow iron oxide),
and the 400 mg capsules contain the colouring agent E171 (titanium dioxide).

Description of the appearance of Gabapentin Alter and contents of the pack
Hard capsules.
The 300 mg capsules are hard and yellow in colour.
The 400 mg capsules are hard and white in colour.
Blister packs containing 50 hard capsules (300 mg) and 30 hard capsules (400 mg).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratori Alter S.r.l. – Via Egadi 7 - 20144 Milan
Manufacturer:
LABORATORIO FARMACEUTICO C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)

This leaflet was last updated on
January 2026