GABAPENTINE SANDOZ 400 mg HARD CAPSULES

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

Do not takeGabapentinaSandoz

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

Warnings and precautions

Talk to your doctor or pharmacist before taking gabapentina:

• if you have kidney problems, your doctor may prescribe a different dosage regimen,
• if you are on hemodialysis (to remove waste products due to kidney failure), tell your doctor if you experience muscle pain and/or weakness,
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell your doctor immediately as these can be symptoms of acute pancreatitis (inflamed pancreas),
• if you have nervous system disorders, respiratory disorders, or if you are over 65 years old, your doctor may prescribe a different dosage regimen,
• 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.

There have been reports of abuse and dependence on gabapentina from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

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 Gabapentina Sandoz" and "If you stop taking Gabapentina Sandoz"). If you are concerned about developing dependence on gabapentina, it is important that you talk to 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 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 treated with antiepileptics such as gabapentina have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Important 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 medical attention immediately 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"Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious".

Muscle weakness, sensitivity, or pain on palpation, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, which can lead to kidney problems and put your life at risk. You may also experience urine discoloration and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medicines containing opioids such as morphine

If you are taking any medicine that contains opioids (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of gabapentina. Additionally, the combination of gabapentina with opioids can cause symptoms such as drowsiness and/or decreased breathing.

Antacids for digestion

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. It is recommended that gabapentina be taken at least two hours after taking an antacid.

Gabapentina Sandoz:

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill,
• may interfere with some laboratory tests, so if you need a urine test, tell your doctor or hospital what you are taking.

TakingGabapentinaSandozwith food

Gabapentina Sandoz can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take gabapentina during pregnancy, unless your doctor has told you to. 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 other medicines used to treat seizures have been reported to increase the risk of harm to the developing baby, particularly when used at the same time as more than one medicine to treat seizures. If you take gabapentina during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (drugs for treating intense pain). Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina. Do not stop taking this medicine suddenly, as this can cause your seizures to happen more often, which could have serious consequences for you and your baby.

Breastfeeding

Gabapentina, the active substance in Gabapentina Sandoz, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Sandoz, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina Sandoz can cause dizziness, drowsiness, and fatigue. Do 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.

Gabapentina Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free".

3. How to take Gabapentina Sandoz

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again. Do not take a larger amount of medicine than prescribed.

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

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of capsules that your doctor has told you. Normally, your doctor will gradually increase your dose.

The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as directed by your doctor, 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 of age or older:

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, which will be gradually increased over a period of approximately 3 days.

The usual dose for controlling epilepsy is 25-35 mg/kg/day. The usual dose is administered by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

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

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules that your doctor has told you. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as directed by your doctor, 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.

If you have kidney problems or if you are on hemodialysis

Your doctor may prescribe a different dosage regimen and/or dose if you have kidney problems or if you are on hemodialysis.

If you are an elderly patient (over 65 years of age), you should take the normal dose of gabapentina, unless you have kidney problems. Your doctor may prescribe a different dosage regimen or dose if you have kidney problems.

If you think that the effect of gabapentina is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina is administered orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking gabapentina until your doctor tells you to stop.

If you take moreGabapentinaSandozthan you should

Doses higher than recommended may lead to an increase in side effects, including loss of consciousness, dizziness, double vision, difficulty speaking, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital. Bring any capsules you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to takeGabapentinaSandoz

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 takingGabapentinaSandoz

Do not stop taking gabapentina suddenly. If you want to stop taking gabapentina, 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 stopping short-term or long-term treatment with gabapentina. 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. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking gabapentina and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief with a target or circular shape on the trunk, 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),
• widespread rash, high body temperature, and swelling of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious:

• severe skin reactions that require immediate attention, lip and face swelling, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction),
• persistent stomach pain, vomiting, and nausea, as these can be symptoms of acute pancreatitis (inflammation of the pancreas),
• respiratory problems, which if severe may require emergency intensive care to breathe normally,
• gabapentina can 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. It may or may not have appeared as a rash when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization. Contact 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,
• yellowish color of the skin or the whites of the eyes,
• unusual bleeding or bruising,
• severe fatigue or weakness,
• unexpected muscle pain,
• frequent infections.

These symptoms can be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking gabapentina.

If you are on hemodialysis, inform your doctor if you start to feel muscle pain and/or weakness.

Other adverse effects include:

Very common (may affect more than 1 in 10 people):

• viral infection,
• drowsiness, dizziness, lack of coordination,
• fatigue, fever.

Common (may affect up to 1 in 10 people):

• pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections,
• low white blood cell count,
• anorexia, increased appetite,
• irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking,
• seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes,
• blurred vision, double vision,
• vertigo,
• increased blood pressure, flushing, or dilation of blood vessels,
• breathing difficulties, bronchitis, sore throat, cough, runny nose,
• vomiting, 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, tremors,
• difficulty with erection (impotence),
• swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
• decreased leukocytes, weight gain,
• accidental injuries, fractures, abrasions.

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent adverse effects.

Uncommon (may affect up to 1 in 100 people):

• agitation (a state of chronic restlessness and involuntary, purposeless movements),
• allergic reactions such as hives,
• decreased movement,
• accelerated heart rate,
• swelling that can affect the face, trunk, and extremities,
• abnormal blood test results that may indicate liver problems,
• progressive mental damage,
• falls,
• increased blood glucose levels (observed more frequently in patients with diabetes),
• difficulty swallowing.

Rare (may affect up to 1 in 1,000 people):

• decreased blood glucose levels (observed more frequently in patients with diabetes),
• loss of consciousness,
• respiratory problems, shallow breathing (respiratory depression).

After marketing, the following adverse effects have been reported:

Frequency not known (cannot be estimated from the available data):

• decrease in platelets (blood clotting cells),
• hallucinations,
• suicidal thoughts,
• problems with abnormal movements such as contortions, spasmodic movements, and stiffness,
• ringing in the ears,
• yellowish appearance of the skin and eyes (jaundice), liver inflammation,
• acute kidney failure, incontinence,
• increase in breast tissue, breast enlargement,
• adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling dizzy, pain, and sweating), chest pain,
• muscle fiber rupture (rhabdomyolysis),
• changes in blood test results (elevated creatine phosphokinase),
• problems with sexual activity, such as inability to reach orgasm and delayed ejaculation,
• low sodium levels in the blood,
• anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires urgent treatment),
• developing dependence on gabapentina ("drug dependence").

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

Reporting of adverse effects

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

5. Conservation of Gabapentina Sandoz

Keep this medicine out of sight and reach of children.

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

Store below 25°C.

Blister: Keep in the original packaging to protect it from moisture.

Bottle: Keep the bottle tightly closed to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Sandoz

• The active ingredient is gabapentina.

Each hard capsule contains 300 mg or 400 mg of gabapentina.

• Other components are:
  • Capsule content: pregelatinized corn starch, corn starch, talc, and anhydrous colloidal silica.
  • Capsule: consists of gelatin, sodium lauryl sulfate, colored with titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172) (only the 400 mg capsules).

Appearance of Gabapentina Sandoz and Package Contents

Gabapentina Sandoz 300 mg are hard gelatin capsules with a yellow opaque body and cap.

Gabapentina Sandoz 400 mg are hard gelatin capsules with a brown opaque body and cap.

The hard capsules are packaged in PVC/PE/PVDC//Alu blisters or HDPE bottles with child-resistant closures, inside a cardboard box.

Package sizes:

Blister: 20, 30, 50, 60, 90, 100, 200, and 500 hard capsules.

Bottle: 50 and 100 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

or

Lek S.A.

Ul. Domaniewska 50 C,

02-672 Warsaw

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d

Verovskova 57

SI - 1526 Ljubljana

Slovenia

or

Lek Pharmaceutical d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria:Gabapentin Sandoz 300 mg – Hard Capsules

Gabapentin Sandoz 400 mg – Hard Capsules

Belgium: Gabapentine Sandoz 300 mg hard capsules

Gabapentine Sandoz 400 mg hard capsules

Czech Republic: Gabanox 300 mg hard capsules

Gabanox 400 mg hard capsules

Denmark: Gabapentin Sandoz 300 mg hard capsules

Finland: Gabapentin Sandoz 300 mg capsule, hard

Gabapentin Sandoz 400 mg capsule, hard

Iceland: Gabapentin Sandoz 300 mg hard shell

Gabapentin Sandoz 400 mg hard shell

Italy: Gabapentin Sandoz GmbH 300 mg hard capsules

Gabapentin Sandoz GmbH 400 mg hard capsules

Netherlands: Gabapentine Sandoz 300 mg, hard capsules

Gabapentine Sandoz 400 mg, hard capsules

Sweden: Gabapentin 1A-Farma 300 mg, hard capsules

Gabapentin 1A-Farma 400 mg, hard capsules

United Kingdom: Gabapentin 300 mg Capsules

Gabapentin 400 mg Capsules

Date of the last revision of this prospectus:May 2023

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