Gabapentin Teva-Ratiopharm 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Teva-ratiopharm 100 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gabapentin Teva-ratiopharm is and what it is used for
2. What you need to know before taking Gabapentin Teva-ratiopharm
3. How to take Gabapentin Teva-ratiopharm
4. Possible side effects
5. How to store Gabapentin Teva-ratiopharm
6. Contents of the pack and other information

1. What Gabapentina Teva-ratiopharm is and what it is used for

Gabapentina Teva-ratiopharm belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Gabapentina Teva-ratiopharm is gabapentin.

Gabapentina Teva-ratiopharm is used to treat:

• Certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor aged 6 years or older may prescribe gabapentin to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment, unless otherwise instructed. Gabapentin may also be given as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles. The sensation of pain may be described as heat, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and pins and needles, etc.

2. What you need to know before taking Gabapentin Teva-ratiopharm

Do not take Gabapentin Teva-ratiopharm

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

Warnings and precautions

Talk to your doctor or pharmacist before taking gabapentin

• if you have kidney problems, your doctor may prescribe you a different dosage regimen.
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you experience muscle pain and/or weakness.
• if you develop symptoms such as persistent stomach pain, dizziness or vertigo, contact your doctor immediately, as these may be signs of acute pancreatitis (inflamed pancreas).
• if you have a nervous system disorder or a respiratory disorder, or if you are over 65 years of age, 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 medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentin Teva-ratiopharm" and "If you stop taking Gabapentin Teva-ratiopharm"). If you are concerned about developing dependence on gabapentin, it is important to consult your doctor.

If you experience any of the following signs while taking gabapentin, it may indicate that you have developed dependence:

• You feel the need to take the medicine longer than prescribed.
• You feel the need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• You have tried several times to stop taking the medicine or control how you take it, without success.
• You feel unwell when you stop taking the medicine and feel better when you start taking it again.

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor immediately.

Important information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin 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 “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious”.

Muscle weakness, tenderness or pain on palpation, especially if accompanied by feeling unwell or fever, could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may be life-threatening. You may also experience discoloration of urine and changes in blood test results (significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentin Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform 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 conditions.

Medicines containing opioids such as morphine

If you are taking a medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of gabapentin.

In addition, combining gabapentin with opioids may cause symptoms such as drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

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

Gabapentin Teva-ratiopharm

• No interaction is expected with other antiepileptic medicines or with oral contraceptive pills.
• It may interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital that you are taking gabapentin.

Taking Gabapentin Teva-ratiopharm with food

This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility

• If you are pregnant or think you may be pregnant, you must inform your doctor immediately to discuss the possible risks that the medicine you are taking may pose to the fetus.
• You should not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should review your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin may be used during the first trimester of pregnancy if necessary.

If you are planning to become pregnant, are pregnant, or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy may put both you and your unborn baby at risk.

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentin. Do not stop taking this medicine abruptly, as this may trigger epileptic seizures, which could have serious consequences for both you and your baby.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Breastfeeding

Gabapentin, the active substance in this medicine, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as the effect on infants is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin Teva-ratiopharm may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these activities.

Teva-ratiopharm Gabapentin contains sodium

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

3. How to take Gabapentina Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take a higher dose than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules as prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, under medical supervision, up to a maximum dose of 3,600 mg per day, divided into three separate doses, for example, one in the morning, one at midday, and one at night.

Use in children

Children aged 6 years or older

Your doctor will decide the dose for your child based on the child's weight. Treatment will start 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. This dose is normally administered by taking the capsules, divided into three separate doses per day, usually one in the morning, one at midday, and one at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules as prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems or are undergoing hemodialysis treatment.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of gabapentin, unless you have kidney problems. Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

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

Method of administration

Gabapentina Teva-ratiopharm is administered orally.

Always swallow the capsules whole with sufficient water.

Gabapentina Teva-ratiopharm may be taken with or without food.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Teva-ratiopharm than you should

Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, numbness, and diarrhea.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department if you take more gabapentin than prescribed by your doctor. Bring any unused capsules, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Teva-ratiopharm

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

If you stop taking Gabapentina Teva-ratiopharm

Do not stop taking gabapentin suddenly. If you wish to discontinue gabapentin, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week. Be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with gabapentin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping gabapentin treatment. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions about 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 everyone experiences them.

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

• Red, non-raised patches with a target-like or circular shape on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged 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 may be serious:

• Persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)

• Breathing difficulties, which, if severe, may require emergency medical treatment to maintain normal breathing

• Gabapentin may cause a serious or potentially life-threatening allergic reaction that may affect the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require discontinuation of gabapentin or even hospitalization. Contact your doctor immediately if you experience any of the following symptoms:

• Skin rash, redness, and/or hair loss

• Hives

• Fever

• Persistent swelling of the glands

• Swelling of the lips, face, and tongue

• Yellowing of the skin or whites of the eyes

• Unusual bruising or bleeding

• Severe fatigue or weakness

• Unexpected muscle pain

• Frequent infections

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking gabapentin.

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

Other adverse effects include

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

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

• 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, jerking movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, decreased sensation (numbness), coordination difficulties, 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, nasal dryness
• Vomiting (feeling sick), nausea (nauseated feeling), 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
• Erectile difficulties (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, abrasions

Additionally, in clinical trials in children, the following were reported as common adverse effects:

sudden movements and aggressive behavior

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

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Allergic reaction such as hives
• Decreased movement
• Increased heart rate
• Difficulty swallowing
• Swelling that may affect face, trunk, and limbs
• Abnormal blood test results suggesting liver problems
• Progressive mental impairment
• Falls
• Increased blood glucose levels (observed more frequently in patients with diabetes)

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

• Decreased blood glucose levels (observed more frequently in patients with diabetes)
• Loss of consciousness
• Breathing problems, shallow breathing (respiratory depression)

The following adverse effects have been reported after marketing of the medicine:

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as: twisting movements, spasmodic movements, and rigidity
• Ringing in the ears
• Yellowish appearance of skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Breast tissue growth, breast enlargement
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Development of dependence on gabapentin ("drug dependence")

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with gabapentin (see "If you stop taking Gabapentin Teva-ratiopharm").

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Teva-ratiopharm

• The active substance is gabapentin.

Each hard capsule contains 100 mg of gabapentin.

• The other components are:

Capsule contents: maize starch, mannitol (E421), talc (E553b)

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), purified water, sodium lauryl sulfate.

Printing ink:

Black printing ink: shellac (E904), black iron oxide (E172)

White printing ink: shellac (E904), titanium dioxide (E171)

Appearance of the product and contents of the pack

Hard capsules (approximately 16 mm in length), with an opaque white body printed in black with TV 3494 and a light brown cap printed in white with TV 3494.

Available in blisters containing 20, 30, 50, 60, 90, 100 or 200 hard capsules; in pre-scored single-dose blisters containing 20x1, 30x1, 50x1, 60x1, 90x1, 100x1 or 200x1 hard capsules; or in bottles containing 50, 100 or 200 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80, 31-546,

Krakow, Poland

or

Teva Nederland BV

Swensweg 5,

2031 GA Haarlem

The Netherlands

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Date of latest revision of this summary: December 2024

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html