GABAPENTINA KORHISPANA 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Korhispana 400 mg hard capsules EFG

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 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. See section 4.

Contents of the pack

1. What is Gabapentina Korhispana and what is it used for
2. What you need to know before you take Gabapentina Korhispana
3. How to take Gabapentina Korhispana
4. Possible side effects
5. Storage of Gabapentina Korhispana
6. Contents of the pack and further information

1. What is Gabapentina Korhispana and what is it used for

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

Epilepsy:Gabapentina Korhispana 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 Korhispana to help treat your epilepsy when your current treatment does not fully control the disease. You must take Gabapentina Korhispana in addition to your current treatment unless otherwise indicated by your doctor.

Gabapentina Korhispana can also be administered as a single drug in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain:Gabapentina Korhispana 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, pulsating pain, flashing pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and sensation of pinching, etc.

2. What you need to know before you take Gabapentina Korhispana

Do not take Gabapentina Korhispana

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Korhispana.

Be especially careful with Gabapentina Korhispana:

• if you have kidney problems
• if you develop symptoms such as persistent stomach pain, feel dizzy or dizzy, inform your doctor immediately.

Additional information about potentially serious reactions

A small number of people taking Gabapentina Korhispana may have an allergic reaction or potentially serious skin reaction, which can become more serious if not treated. You need to know these symptoms, which may appear while you are taking Gabapentina Korhispana.

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”.

Taking Gabapentina Korhispana with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

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

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

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

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

Taking Gabapentina Korhispana with food, drinks, and alcohol

Gabapentina Korhispana can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking a medicine.

Do not take Gabapentina Korhispana 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 gabapentin 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.

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 Korhispana.

Gabapentina, the active substance of Gabapentina Korhispana, is excreted in breast milk. Breastfeeding is not recommended while taking Gabapentina Korhispana, as the effect on infants is unknown.

Driving and using machines

Gabapentina Korhispana may cause dizziness, drowsiness, and fatigue. Do 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.

Gabapentina Korhispana contains lactose

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 Korhispana

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine what dose is suitable for you.

If you think the effect of Gabapentina Korhispana is too strong or too weak, tell your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Gabapentina Korhispana 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 Korhispana until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of capsules that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will generally 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 that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will generally 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.

Use in children 6 years of age or 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 normal dose to control epilepsy is 25-35 mg/kg/day. The normal dose is usually administered by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

The use of Gabapentina Korhispana is not recommended in children under 6 years of age.

If you take more Gabapentina Korhispana than you should

Consult your doctor immediately, call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested, or go to the emergency department of the nearest hospital. Bring any remaining capsules, along with the packaging and label, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Korhispana

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 forgotten doses.

If you stop taking Gabapentina Korhispana

Do not stop taking Gabapentina Korhispana unless your doctor tells you to. If you are going to stop treatment, it should be done gradually over a minimum of one week. If you stop taking Gabapentina Korhispana abruptly or before your doctor indicates it, there is an increased risk of seizures.

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

4. Possible side effects

Like all medicines, Gabapentina Korhispana can cause side effects, although not everybody gets them.

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

• Viral infection.
• Feeling of sleep, dizziness, discoordination.
• Feeling of fatigue, fever.

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

• Pneumonia, respiratory infection, urinary 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, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Dizziness.
• Increased blood pressure, flushing or dilation of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, dry nasal passages.
• Vomiting (nausea), nausea (feeling of 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, spasms.
• Incontinence.
• Difficulty with erections.
• Swelling in the legs and arms or swelling that can affect the face, trunk, and limbs, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased white blood cells, weight gain.
• Accidental injuries, fractures, abrasions.

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.
• Problems with abnormal movements such as contortions, tremors, and rigidity.
• Ringing in the ears.
• Accelerated heart rate.
• 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.
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain.
• Fluctuations in blood sugar levels in patients with diabetes, abnormal blood test results that may indicate liver problems.

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

Gabapentina Korhispana may cause a serious or potentially life-threatening allergic 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. If this type of allergic reaction occurs, you may need to be hospitalized or stop taking Gabapentina Korhispana.

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

• skin rash
• hives
• fever
• swelling of the glands that does not disappear
• 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

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

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentina Korhispana

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Gabapentina Korhispana

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

The other components are lactose monohydrate, cornstarch, and talc. The capsule is composed of gelatin, yellow iron oxide (E-172), red iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the product and pack contents

Hard capsules.

Gabapentina Korhispana is presented in packs of 90 capsules.

Marketing authorization holder and manufacturer

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the last revision of this leaflet: January 2020.

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