GABAPENTINA ALTER 800 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentina Alter 800 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Gabapentina Alter 800 mg film-coated tablets are and what they are used for
2. Before taking Gabapentina Alter 800 mg film-coated tablets
3. How to take Gabapentina Alter 800 mg film-coated tablets
4. Possible side effects
5. Storage of Gabapentina Alter 800 mg film-coated tablets
6. Further information

1. What Gabapentina Alter 800 mg film-coated tablets are and what they are used for

Gabapentina Alter 800 mg film-coated tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain.

Epilepsy:Gabapentina Alter 800 mg film-coated tablets are used to treat certain types of epilepsy (seizures that initially are 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 is no longer fully controlling your condition. You should take it in addition to your current treatment unless told otherwise. It can also be administered as the sole treatment for adults and children over 12 years of age.

Peripheral neuropathic pain:Gabapentina Alter 800 mg film-coated tablets are used to treat long-standing 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, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

2. Before taking Gabapentina Alter 800 mg film-coated tablets

Do not take Gabapentina Alter 800 mg

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

Take special care with Gabapentina Alter 800 mg

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 faint, inform your doctor immediately.
• A small number of people taking antiepileptics, such as Gabapentina Alter, have had thoughts of harming themselves 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 drugs, or illegal drugs; you may have a greater risk of developing dependence on Gabapentina.

Dependence

Some people may develop dependence (need to continue taking the medicine) on Gabapentina. They may experience withdrawal symptoms when they stop taking Gabapentina (see section 3, "How to take" and "If you stop taking Gabapentina Alter"). If you are concerned about developing dependence on Gabapentina, it is important 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 longer 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 the best course of treatment is for you, including when it is appropriate to stop treatment and how to do it safely.

Additional information about potentially serious reactions

Severe skin reactions 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 immediate medical attention 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 “Contact 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.

It is not expected that gabapentina will interact with other antiepileptic medicines or with the oral contraceptive pill.

Gabapentina may interfere with some laboratory tests, so if you need a urine test, inform your doctor or hospital that you are taking gabapentina.

If you take gabapentina at the same time as antacids that contain aluminum or magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that Gabapentina Alter 800 mg film-coated tablets be taken at least two hours after taking an antacid.

Taking Gabapentina Alter 800 mg with food and drinks

Gabapentina Alter 800 mg film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You should not take Gabapentina Alter 800 mg film-coated tablets during pregnancy, unless your doctor has told you to do so. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies of 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. 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 greater when gabapentina is taken with opioid analgesics (drugs for the treatment of intense pain).

Do not stop taking this medicine suddenly, as this may cause a seizure, which could have serious consequences for you and your baby.

Tell your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Alter 800 mg film-coated tablets.

Gabapentina passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Alter 800 mg film-coated tablets, as the effect on the baby is unknown.

Driving and using machines

Gabapentina Alter 800 mg film-coated tablets may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

3. How to take Gabapentina Alter 800 mg film-coated tablets

Follow the instructions for administration of Gabapentina Alter 800 mg film-coated tablets exactly as your doctor has told you. Consult your doctor or pharmacist if you have any doubts. Do not take a higher dose than prescribed.

Your doctor will determine the dose that is right for you.

If you think that the effect of Gabapentina Alter is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Gabapentina Alter 800 mg film-coated tablets normally, unless you have kidney problems.

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

Always swallow the tablets with sufficient water.

The tablet can be divided into equal doses.

Continue taking Gabapentina Alter 800 mg film-coated tablets until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of tablets that your doctor has told you to take. 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 in the evening.

Epilepsy:

Adults and adolescents:

Take the number of tablets that your doctor has told you to take. 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 in the evening.

Children 6 years of age 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 three days. The normal dose for controlling epilepsy is 25-35 mg/kg/day. The normal dose is usually administered by taking the tablets, divided into 3 equal doses per day, normally one in the morning, one at noon, and one in the evening.

Gabapentina Alter 800 mg film-coated tablets are not recommended for use in children under 6 years of age.

If you take more Gabapentina Alter 800 mg film-coated tablets than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: (91) 562 04 20. Bring any remaining tablets, along with the packaging and label, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Alter 800 mg film-coated tablets

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

If you stop taking Gabapentina Alter 800 mg film-coated tablets

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

These effects include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Red patches without relief and with a target or circular shape on the torso, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 800 mg film-coated tablets can cause side effects, although not everybody gets them.

Gabapentina Alter may cause a severe allergic reaction or 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 be accompanied by a rash or not. 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 rash
• 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 that, if severe, may require emergency medical attention to breathe normally.

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

The following adverse reactions are described in relation to their frequency of occurrence:

Very common (affects more than 1 in 10 people):

• Viral infection.
• Feeling of sleepiness, dizziness, lack of coordination.
• Feeling of fatigue, fever.

Common (affects between 1 and 10 in 100 people):

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation.
• Low white blood cell count.
• Anorexia, increased appetite.
• Feelings of anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty concentrating.
• Seizures, jerks, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitivity to the skin, decreased sensations, difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Dizziness.
• Increased blood pressure, redness 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.
• Swelling of the face, bruising, rash, itching, acne.
• Joint pain, muscle pain, back pain, cramps.
• Incontinence.
• Difficulty with 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.
• Decrease in white blood cells, weight gain.
• Accidental overdoses, fractures, abrasions.

Uncommon (affects at least 1 in 100):

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

Rare (affects between 1 and 10 in 10,000 people):

• Decrease in platelets (blood clotting cells).
• Allergic reaction such as hives (itching).
• Hallucinations.
• Abnormal movement problems such as contortions, jerks, and stiffness.
• Ringing in the ears.
• Accelerated heartbeat.
• Pancreatitis.
• Hepatitis, 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.
• Adverse effects after sudden discontinuation of treatment with gabapentina (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Variations in blood glucose levels 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 the available data):

• Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure that requires urgent treatment).
• Suicidal thoughts
• Developing dependence on Gabapentina Alter ("drug dependence")

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

In addition, in clinical trials in children, aggressive behavior and jerks were reported as common side effects.

Reporting of side effects

If you experience any of the side effects, talk to 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 800 mg tablets

Keep out of the reach and sight of children.

Do not use Gabapentina Alter 800 mg tablets after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Gabapentina Alter 800 mg

• The active ingredient is Gabapentina. Each film-coated tablet contains 800 mg of Gabapentina.

• The other components are: Macrogol 4000, pregelatinized starch, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, lecithin, and xanthan gum.

Product appearance and packaging content

White, oblong, film-coated tablets, scored on both sides.

The tablet can be divided into equal doses.

Gabapentina Alter 800 mg film-coated tablets: packaging with 90 film-coated tablets. The tablets are packaged in PVC/Aluminum blisters.

Marketing authorization holder and manufacturer

Holder

LABORATORIOS ALTER S.A

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/Solana, 26,

Torrejón de Ardoz,

28850 Madrid

Spain

This leaflet was approved in 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