GABAPENTINA ALTER 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Alter 400 mg Hard Capsules EFG

Contents of the Package Leaflet:

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

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

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

Epilepsy:Gabapentina Alter is used to treat certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe Gabapentina Alter to help treat your epilepsy when your current treatment does not fully control the disease. You should take Gabapentina Alter in addition to your current treatment unless otherwise indicated by your doctor. Gabapentina Alter can also be administered as the only drug in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain:Gabapentina Alter is used to treat chronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing pain, flashing pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and sensation of pins and needles, etc.

2. Before taking Gabapentina Alter 400 mg

Do not take Gabapentina Alter:

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

Be careful 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 dizzy, inform your doctor immediately
• A small number of people who were being treated with antiepileptics 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 old, 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 medications, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina.

Dependence

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

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

• You feel that you need to take the medicine for a longer period than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than your prescription.
• 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, talk to your doctor to decide what is the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

Additional information about potentially serious reactions

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

Read the description of these symptoms in section 4 of this leaflet in “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

Tell your doctor or pharmacist if you are using or have recently used 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 problem.

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

Gabapentina Alter is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.

Gabapentina Alter may interfere with some laboratory tests, so if you need 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 that contain aluminum or magnesium, the absorption of Gabapentina Alter in the stomach may be reduced. Therefore, it is recommended that Gabapentina Alter be taken at least two hours after taking an antacid.

Taking Gabapentina Alter 400 mg with food and drinks

Gabapentina Alter can 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 indicated it. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentina in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of fetal damage has been reported, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one medicine for seizures during pregnancy.

If taken during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (pain-relieving medications).

Do not stop taking this medicine abruptly, as this may cause an anticipation of the seizure, 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.

Gabapentina, the active ingredient of 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 hazardous activities until you know if this medicine affects your ability to perform these activities.

Important information about some of the components of Gabapentina Alter:

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

3. How to take Gabapentina Alter 400 mg

Follow the administration instructions of Gabapentina Alter given by your doctor. Consult your doctor or pharmacist if you have any doubts. Do not take a higher dose of the medicine than prescribed.

Your doctor will determine the appropriate dose for you.

If you think the effect of Gabapentina 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 Gabapentina 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 water intake.

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

Peripheral neuropathic pain:

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. Therefore, the dose may 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 noon, and one at night.

Epilepsy:

Adults and adolescents:

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. Therefore, the dose may 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 noon, and one at night.

Children 6 years and older:

Your doctor will decide the dose to be administered to your child based on the child's weight. Treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25-35 mg/kg/day. The usual dose is administered by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

Gabapentina Alter is not recommended for use in children under 6 years of age.

If you take more Gabapentina Alter than you should

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

You can also call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Gabapentina Alter

If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for the forgotten doses.

If you stop treatment with Gabapentina Alter

Do not stop taking Gabapentina Alter suddenly. If you want to stop taking Gabapentina Alter, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting short-term or long-term treatment with Gabapentina Alter. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Alter. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible side effects

Stop taking Gabapentina Alter and seek medical attention immediately if you notice any of these symptoms:

• red patches without relief and with a target or circular shape on the trunk, often with blisters in the center; peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Like all medicines, Gabapentina Alter 400 mg can cause side effects, although not everyone gets them.

Gabapentina Alter may cause a severe allergic reaction or a potentially life-threatening reaction that can affect the skin or other parts of the body, such as the liver or blood cells. When this type of reaction occurs, it may or may not be accompanied by a rash. In the event of such an allergic reaction, you may need to be hospitalized or stop taking Gabapentina Alter.

After the marketing of Gabapentina Alter, the following side effects have been reported:

Tell your doctor if you have 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 the whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Breathing problems that, if severe, may require urgent medical attention to breathe normally.

These symptoms may be the first signs of a serious reaction. Your doctor will examine you to decide if you should continue taking Gabapentina Alter.

Very common side effects that may affect more than 1 in 10 people are:

• Viral infection
• Sleepiness, dizziness, lack of coordination
• Feeling of fatigue, fever

Common side effects that may affect more than 1 in 100 people are:

• 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, tremors, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensations, difficulty coordinating, abnormal eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing or dilation of blood vessels
• Breathing difficulties, bronchitis, sore throat, cough, dry nose
• Vomiting (nausea), nausea (feeling of nausea), 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
• Difficulty getting an erection
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, bruises

Uncommon side effects that may affect less than 1 in 100 people are:

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

Rare side effects that may affect less than 1 in 1,000 people are:

• Decrease in platelets (blood clotting cells)
• Allergic reaction such as hives
• Hallucinations
• Abnormal movement problems such as contortions, tremors, and stiffness
• Ringing in the ears
• Accelerated heart rate
• Pancreatitis
• Liver inflammation, yellowing of the skin and eyes
• Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash, and redness, hair loss
• Acute kidney failure
• Side effects after sudden discontinuation of treatment with gabapentina (anxiety, difficulty sleeping, feeling dizzy, pain, and sweating), chest pain
• Fluctuations in blood sugar levels in patients with diabetes, abnormal blood test results that may indicate liver problems
• Breathing problems, shallow breathing (respiratory depression).

Frequency not known (cannot be estimated from the available data):- Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).

• Suicidal thoughts
• Developing dependence on Gabapentina Alter ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting short-term or long-term treatment with Gabapentina Alter (see "If you stop treatment with Gabapentina Alter").

Additionally, in clinical trials in children, aggressive behavior and tremors were reported as common side effects.

Reporting side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es

5. Storage of Gabapentina Alter 400 mg

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

Do not use Gabapentina Alter 400 mg after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Additional Information

Composition of Gabapentina Alter 400 mgcapsules

• The active ingredient is gabapentina. Each hard capsule contains 400 mg of gabapentina.

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

Appearance of the product and packaging content

Hard capsules.

The hard gelatin capsules are orange in color. They are presented in blisters, in packages 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

Date of text revision: May 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/