Prospect: information for the user

Gabapentina Korhispana 400 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

Epilepsy:Gabapentina Korhispana is used to treat certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). 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 instructed.

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

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 pain sensation could be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles etc.

Do not take Gabapentina Korhispana

• if you are allergic to the active ingredient or to any of the other components of this medication (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 persistent stomach pain, feel dizzy or nauseous, 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 severe skin reaction, which can become more serious if not treated. You need to know these symptoms, which may appear while taking Gabapentina Korhispana.

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

Taking Gabapentina Korhispana with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

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

No interaction is expected between Gabapentina Korhispana and other antiepileptic medications or oral contraceptive pills.

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

If you take Gabapentina Korhispana at the same time as antacids containing aluminum or magnesium, the absorption of Gabapentina Korhispana in the stomach may be reduced. It is therefore 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 medication.

You should not take Gabapentina Korhispana during pregnancy, unless your doctor has indicated it. A reliable contraceptive method should be used in fertile women.

No specific studies have been conducted on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage has been reported, particularly when more than one medication 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 medication for seizures during pregnancy.

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

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

Gabapentin, the active ingredient 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 operating machinery

Gabapentina Korhispana may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until it is known whether this medication affects your ability to perform these activities.

Gabapentina Korhispana contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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

Your doctor will determine the appropriate dose for you.

If you estimate that the effect of Gabapentina Korhispana is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), take Gabapentina Korhispana normally, except if you have kidney problems.

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

Swallow the capsules whole with a sufficient amount of water.

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

Peripheral neuropathic pain:

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be between 300 to 900 mg per day. Therefore, the dose can 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 as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be between 300 to 900 mg per day. Therefore, the dose can 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 or older:

Your doctor will decide on 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 for controlling epilepsy is 25-35 mg/kg/day. The dose is usually administered through ingestion of the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Korhispana in children under 6 years old.

If you take more Gabapentina Korhispana than you should:

Consult your doctor immediately, call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital. Bring any remaining capsules, along with the packaging and label, so that the hospital can easily identify the medication 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 compensate for the missed doses.

If you interrupt treatment with Gabapentina Korhispana:

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

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

Like all medications, Gabapentina Korhispana may have side effects, although not everyone will experience them.

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

• Viral infection.
• Drowsiness, dizziness, discoordination.
• Feeling tired, fever.

The 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.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, convulsions, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensations, coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Dizziness.
• Increased blood pressure, redness or dilation of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, nasal dryness.
• Vomiting (dizziness), nausea (dizziness), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.
• Swelling of the face, hives, rash, itching, acne.
• Joint pain, muscle pain, back pain, spasms.
• Incontinence.
• Difficulty with erection.
• Swelling in the legs and arms or swelling that may affect the face, trunk, and limbs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

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

• Decreased platelets (blood clotting cells).
• Allergic reaction such as urticaria.
• Hallucinations.
• Abnormal movement problems such as contortions, convulsions, and rigidity.
• Tinnitus in the ears.
• Increased heart rate.
• Pancreatitis inflammation.
• Hepatitis inflammation, yellowish skin and eye discoloration.
• Severe skin reactions requiring immediate medical attention, swelling of the lips and face, skin rash, and redness, hair loss.
• Acute renal failure.
• Side effects after sudden discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Fluctuations in blood glucose in patients with diabetes, abnormal blood test results that may indicate liver problems.

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

Gabapentina Korhispana may cause a severe or potentially life-threatening allergic reaction that may 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 this type of allergic reaction, hospitalization or discontinuation of Gabapentina Korhispana may be necessary.

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

• skin rashes
• urticaria
• fever
• inflammation of the glands that does not subside
• swelling of the lips and tongue
• yellowish skin or eye discoloration
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (https://www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGabapentina Korhispana

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

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 content of the packaging

Hard capsules.

Gabapentina Korhispana is presented in boxes with 90 capsules.

Holder of the marketing authorization and responsible for manufacturing

KORHISPANA, S.L.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

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

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/