GABAPENTINA KERN PHARMA 400 mg HARD CAPSULES

2. What you need to know before you take Gabapentina Kern Pharma

Do not take Gabapentina Kern Pharma

• If you are allergic to gabapentina or any of the other ingredients of this medicine (listed in section 6).

Additional information about potentially serious reactions

Severe skin reactions have been reported 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 serious 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".

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Gabapentina Kern Pharma.

• If you have kidney problems.
• If you develop symptoms such as persistent stomach pain, feel dizzy or dazed, inform 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 higher risk of developing dependence on Gabapentina Kern Pharma.

Dependence

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

If you experience any of the following signs while taking Gabapentina Kern Pharma, 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 its prescription.
• You have tried to stop taking the medicine or control how you take it several times, 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 on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people who were being treated with antiepileptics such as Gabapentina Kern Pharma have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

Using Gabapentina Kern Pharma with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicines. In particular, 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 using any medicine that contains morphine, inform your doctor or pharmacist, as morphine may increase the effect of Gabapentina Kern Pharma.

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

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

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

Using Gabapentina Kern Pharma with food and drinks

Gabapentina Kern Pharma can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Gabapentina Kern Pharma 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.

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

If gabapentina is taken during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (drugs for the treatment of intense pain).

Gabapentina, the active ingredient of Gabapentina Kern Pharma, is excreted in breast milk. Breastfeeding is not recommended while taking Gabapentina Kern Pharma, as its effect on infants is unknown.

Driving and using machines

Gabapentina Kern Pharma may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Gabapentina Kern Pharma contains lactose.

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

3. How to take Gabapentina Kern Pharma

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. Do not take more medicine than prescribed.

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

If you think that the effect of Gabapentina Kern Pharma 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 Kern Pharma 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 enough water.

Continue taking Gabapentina Kern Pharma until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of capsules that your doctor has told you. 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:

Take the number of capsules that your doctor has told you. 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.

Use in children and adolescents

Your doctor will decide the dose to be given 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 given in three equal doses per day, normally one in the morning, one at noon, and one at night.

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

If you take more Gabapentina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gabapentina Kern Pharma

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 Kern Pharma

Do not stop taking Gabapentina Kern Pharma suddenly. If you want to stop taking Gabapentina Kern Pharma, 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 Kern Pharma. These 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 Kern Pharma. 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 Adverse Effects

Stop taking Gabapentina Kern Pharma and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Expanded rash, high body temperature, and increased lymph node size (DRESS or drug hypersensitivity syndrome).

Like all medicines, gabapentina can produce adverse effects, although not all people suffer from them.

Gabapentina may cause a severe 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. In the event of such an allergic reaction, you may need to be hospitalized or stop taking gabapentina.

Inform your doctor immediately if you have any of the following symptoms.

• skin rash
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lips and tongue
• yellowish color 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 severe reaction. Your doctor will examine you to decide if you should continue taking gabapentina.

The very common adverse effects that may affect more than 1 person in 10 are:

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

The common adverse effects that may affect more than 1 person in 100:

• 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, jerks, 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, redness or dilation of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, nasal dryness.
• Vomiting (feeling nauseous), nausea (feeling dizzy), 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 with erections.
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, abrasions.

The uncommon adverse effects that may affect between 1 and 10 out of every 1,000 patients are:

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

The rare adverse effects that may affect less than 1 person in 1,000 are:

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

Other possible adverse effects: their frequency cannot be estimated from the available data:

• Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires urgent treatment).
• Suicidal thoughts.
• Developing dependence on Gabapentina Kern Pharma ("drug dependence").

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

Additionally, in clinical trials in children, aggressive behavior and jerks were reported as frequent adverse effects.

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gabapentina Kern Pharma

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

Do not store above 25°C.

Do not use Gabapentina Kern Pharma 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. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Kern Pharma

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

• The other ingredients are anhydrous lactose, cornstarch, and talc. The ingredients of the gelatin capsule are gelatin, yellow iron oxide (E-172), red iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Hard capsules. The hard gelatin capsules are orange in color.

Each normal package contains 30 or 90 capsules. Each clinical package contains 500 capsules.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: January 2023

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