Gabapentin Alter 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Alter 400 mg hard capsules EFG

Package leaflet contents:

1. What Gabapentin Alter 400 mg is and what it is used for
2. Before taking Gabapentin Alter 400 mg
3. How to take Gabapentin Alter 400 mg
4. Possible side effects
5. How to store Gabapentin Alter 400 mg
6. Further information

1. What Gabapentin Alter 400 mg is and what it is used for

Gabapentin Alter belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain.

Epilepsy: Gabapentin Alter is used to treat certain types of epilepsy (seizures initially limited to specific parts of the brain, whether or not the seizure spreads to other areas of the brain). Your doctor will prescribe Gabapentin Alter to help manage your epilepsy when your current treatment does not fully control the condition. You should take Gabapentin Alter as an add-on to your current treatment unless otherwise instructed. Gabapentin Alter may also be administered as monotherapy in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentin Alter is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles (herpes). The sensation of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, muscle spasms, continuous pain, tingling, numbness, or pins and needles, among others.

2. Before taking Gabapentina Alter 400 mg

Do not take Gabapentina Alter:

• if you are allergic (hypersensitive) to gabapentin or to any of the other components of Gabapentina Alter.

Take special care with Gabapentina Alter:

Consult your doctor or pharmacist before taking Gabapentina Alter:

• if you have kidney problems
• if you develop symptoms such as persistent stomach pain, feel dizzy or experience dizziness, inform your doctor immediately
• A small number of people who have been treated with antiepileptic medicines such as Gabapentina Alter have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.
• if you have a nervous system disorder or a respiratory disorder, or if you are over 65 years of age, your doctor may prescribe a different dose.
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on Gabapentina.
• If you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on Gabapentin. They may experience withdrawal symptoms when they stop taking Gabapentin or reduce the dose (see section 3, "How to take" and "If you stop treatment with Gabapentina Alter"). If you are concerned about developing dependence on Gabapentin, it is important that you consult your doctor.

If you experience any of the following signs while taking Gabapentin, it may indicate that you have developed dependence:

• You feel the need to take the medicine for longer than prescribed.
• You feel the need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• You have tried several times to stop taking the medicine or control how you take it, without success.
• When you stop taking the medicine, you feel unwell and feel better when you take it again.

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to discontinue treatment and how to do so safely.

Additional information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Read the description of these symptoms in section 4 of this leaflet under “Call your doctor immediately if you experience any of the following symptoms after taking this medicine, as it may be serious.”

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Especially, inform your doctor (or pharmacist) if you are taking or have recently taken any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

If you are taking any medicine containing morphine, inform your doctor or pharmacist, as morphine may increase the effect of Gabapentina Alter.

No interaction is expected between Gabapentina Alter and other antiepileptic medicines or oral contraceptive pills.

Gabapentina Alter may interfere with certain laboratory tests; therefore, if you require a urine test, inform your doctor or hospital that you are taking Gabapentina Alter.

If you take Gabapentina Alter at the same time as antacids containing aluminium or magnesium, the absorption of Gabapentina Alter in the stomach may be reduced. It is therefore recommended that Gabapentina Alter be taken at least two hours after taking an antacid.

Taking Gabapentina Alter 400 mg with food and drink

Gabapentina Alter may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

You should not take Gabapentina Alter during pregnancy unless your doctor has instructed you to do so. An effective method of contraception should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of fetal harm has been reported, particularly when more than one medicine is used simultaneously to treat seizures. Therefore, whenever possible and only under your doctor’s advice, you should try to use only one antiseizure medicine during pregnancy.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for severe pain).

Do not stop taking this medicine abruptly, as this may lead to an increased risk of seizures, which could have serious consequences for both you and your baby.

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Alter.

Gabapentin, the active substance in Gabapentina Alter, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Alter, as the effect on infants is unknown.

Driving and using machines

Gabapentina Alter may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these tasks.

Important information about some of the components of Gabapentina Alter:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gabapentin Alter 400 mg

Follow exactly the instructions for using Gabapentin Alter provided by your doctor. 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.

If you are an elderly patient (over 65 years of age), you should take Gabapentin Alter normally, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

Always swallow the capsules whole with sufficient fluid.

Continue taking Gabapentin Alter until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of capsules indicated by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. The dose may then be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Epilepsy:

Adults and adolescents:

Take the number of capsules indicated by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. The dose may then be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Children aged 6 years and older:

Your doctor will decide the dose for your child based on the child's body weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg/day. This dose is usually administered by taking the capsules, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.

The use of Gabapentin Alter is not recommended in children under 6 years of age.

If you take more Gabapentin Alter than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Take any remaining capsules with you, along with the container and the package leaflet, so that the hospital can easily identify the medicine you have taken.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20.

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 forgotten doses.

If you stop taking Gabapentin Alter

Do not stop taking Gabapentin Alter suddenly or reduce the dose without consulting your doctor first. If you wish to stop taking Gabapentin Alter or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a period of at least one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentin Alter or after reducing the dose. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentin Alter or reducing the dose. If you experience this withdrawal syndrome, contact your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Stop taking Gabapentin Alter and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, or eye ulcers (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medicines, Gabapentin Alter 400 mg may cause adverse effects, although not everyone experiences them.

Gabapentin Alter may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. This type of allergic reaction may occur with or without a rash. If such a reaction occurs, you may need to be hospitalized or stop taking Gabapentin Alter.

The following adverse effects have been reported since the marketing of Gabapentin Alter:

Inform your doctor if you experience any of the following symptoms:

• Skin rashes
• Hives
• Fever
• Persistent swelling of the glands
• Swelling of the lips and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Breathing difficulties, which, if severe, may require urgent medical attention to maintain normal breathing.

These symptoms may be early signs of a serious reaction. Your doctor will examine you to determine whether you should continue taking Gabapentin Alter.

Very common adverse effects (may affect more than 1 in 10 people):

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling of tiredness, fever

Common adverse effects (may affect more than 1 in 100 people):

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation
• Low white blood cell count
• Anorexia, increased appetite
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, jerking movements, difficulty speaking, memory loss, tremor, insomnia, headache, skin sensitivity, decreased sensation, coordination problems, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Increased blood pressure, redness or dilation of blood vessels
• Breathing difficulty, bronchitis, sore throat, cough, nasal dryness
• Vomiting (feeling nauseous), nausea (feeling of queasiness), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, spasms
• Incontinence
• Erectile difficulties
• Swelling in arms and legs or swelling affecting the face, trunk, and limbs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, abrasions

Uncommon adverse effects (may affect at least 1 in 100 people):

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Difficulty swallowing

Rare adverse effects (may affect less than 1 in 1,000 people):

• Decreased platelet count (blood clotting cells)
• Allergic reactions such as hives
• Hallucinations
• Abnormal movement problems such as twisting movements, jerking, and stiffness
• Ringing in the ears
• Rapid heartbeat
• Pancreatitis (inflammation of the pancreas)
• Liver inflammation, yellow appearance of skin and eyes
• Severe skin reactions requiring immediate medical attention, swelling of lips and face, skin rash and redness, hair loss
• Acute kidney failure
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, insomnia, dizziness, pain, and sweating), chest pain
• Blood glucose fluctuations in patients with diabetes, abnormal blood test results that may indicate liver problems
• Breathing difficulties, shallow breathing (respiratory depression)

Frequency not known (cannot be estimated from available data):

• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).
• Suicidal thoughts
• Development of dependence on Gabapentin Alter ("drug dependence")
• Worsening of myasthenia gravis (a disease causing muscle weakness)

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with Gabapentin Alter or after reducing the dose (see "If you stop taking Gabapentin Alter").

In addition, in clinical trials in children, aggressive behavior and jerking movements were reported as common adverse effects.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: Website: www.notificaRAM.es

5. Storage of Gabapentin Alter 400 mg

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Gabapentin Alter 400 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Gabapentin Alter 400 mg capsules

• The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.

• The other components of Gabapentin Alter 400 mg capsules are: anhydrous lactose, corn starch and talc.
  Capsule shell components: titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172) and gelatin.

Appearance of the product and contents of the package

Hard capsules.

The hard gelatin capsules are orange in color. Packaged in blisters, available in packs of 90 capsules.

Marketing Authorization Holder

Laboratorios ALTER, S.A.
Mateo Inurria, 30
28036 Madrid

Manufacturer

KERN PHARMA, S.L.
Polígono Industrial Colón II
C/ Venus, 72
08228 Terrassa (Barcelona)

or

Laboratorios ALTER, S.A.
Mateo Inurria, 30
28036 Madrid

Revision date of the text: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/