Gabapentin Almus 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GABAPENTIN ALMUS 400 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Gabapentin Almus is and what it is used for.
2. What you need to know before taking Gabapentin Almus.
3. How to take Gabapentin Almus.
4. Possible side effects.
5. How to store Gabapentin Almus.

Pack contents and additional information

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

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

Epilepsy: Gabapentin is used to treat various forms of epilepsy (seizures or fits that initially affect only certain parts of the brain, whether or not the seizure spreads to other areas of the brain). Your doctor will prescribe Gabapentina Almus to help manage your epilepsy when your current treatment does not fully control your condition. You should take Gabapentina Almus in addition to your current treatment, unless otherwise instructed. Gabapentina Almus may be used alone to treat adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentina Almus is used to treat long-lasting pain caused by nerve damage. A variety of conditions can cause this type of peripheral neuropathic pain, which mainly affects the legs and/or arms, such as diabetes or herpes (shingles). Pain sensations may be described as heat, burning, throbbing, stabbing, tingling, pressure, pins and needles, numbness, or prickling sensations.

2. What you need to know before taking Gabapentin Almus

Do not take Gabapentin Almus:

If you are allergic to gabapentin or to any of the other ingredients of this medicine.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Gabapentin Almus:

• 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 greater risk of developing dependence on Gabapentin Almus.
• If you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

Dependence:

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

If you experience any of the following signs while taking Gabapentin Almus, this may indicate that you have developed dependence:

• You feel the need to take the medicine for 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 to 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.

Take special care with Gabapentin Almus:

If you have kidney problems.

If you develop symptoms such as persistent stomach pain, discomfort, or feeling unwell, contact your doctor immediately.

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.

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

Additional 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 symptoms related to these serious skin reactions described in section 4.

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

Taking Gabapentin Almus with other medicines:

Inform 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 medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

If you are using other medicines containing morphine, please tell your doctor, as morphine may increase the effect of gabapentin.

Interactions between gabapentin and other antiepileptic medicines or oral contraceptives are not expected.

Gabapentin may interfere with certain laboratory tests. If you need to have a urine test, inform your doctor or laboratory staff that you are taking gabapentin.

If gabapentin is taken at the same time as antacids containing aluminium and 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 the antacid.

Taking Gabapentin Almus with food and drink:

Gabapentin may be taken with or without food.

Pregnancy and breastfeeding:

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

Gabapentin should not be used during pregnancy unless your doctor has specifically advised otherwise. Adequate contraceptive measures should be used if there is a possibility of becoming pregnant.

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).

There are no specific studies with gabapentin in pregnant women, but other medicines used to treat seizures have been associated with an increased risk of harm to the fetus, particularly when more than one seizure medicine is taken at the same time. Therefore, whenever possible and only following your doctor’s recommendations, only one seizure medicine should be used during pregnancy.

Do not stop treatment with this medicine abruptly, as this may cause rebound seizures, which could have serious consequences for you and your baby.

Inform your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while taking gabapentin.

Gabapentin is excreted in breast milk. Since the effect on the infant is unknown, breastfeeding is not recommended while taking gabapentin.

Driving and using machines:

Gabapentin may cause dizziness, drowsiness, and fatigue. Do not drive or operate machinery or engage in potentially dangerous activities until you know how this medicine affects your ability to perform these activities.

Important information about some of the ingredients of Gabapentin Almus:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before using this medicine.

3. How to take Gabapentin Almus

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

If you think the effect of Gabapentin Almus is too strong or too weak, consult your doctor or pharmacist.

If you are elderly (over 65 years of age), you should normally take gabapentin unless you have kidney problems.

Your doctor may prescribe you a different dose if you have kidney problems.

Swallow the capsules whole with sufficient water.

Continue taking gabapentin until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of capsules your doctor has indicated. Your doctor will gradually increase your dose. The initial dose will normally be between 300 and 900 mg per day. Afterwards, the dose will be increased step by step up to a maximum of 3600 mg per day. Your doctor will instruct you to take it in three divided doses, for example: one in the morning, one in the afternoon, and one at night.

Epilepsy:

Adults and adolescents:

Take the number of capsules your doctor has indicated. Your doctor will gradually increase your dose. The initial dose will normally be between 300 and 900 mg per day. Afterwards, the dose will be increased step by step up to a maximum of 3600 mg per day. Your doctor will instruct you to take it in three divided doses, for example: one in the morning, one in the afternoon, and one at night.

Children over 6 years of age:

The dose to be given to the child will be decided by the doctor based on the child's weight. Treatment is started 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. It is usually given in three divided doses, for example: one in the morning, one in the afternoon, and one at night.

Gabapentin is not recommended for use in children under 6 years of age.

If you take more Gabapentin Almus than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420.

If you or someone else takes too many capsules by accident, or if you think your child has swallowed any, contact your doctor or go immediately to the nearest hospital emergency department. Since gabapentin may cause drowsiness, it is recommended that you ask someone to take you to the doctor or hospital, or call an ambulance. Symptoms of overdose include dizziness, double vision, slurred speech, loss of consciousness, drowsiness, and moderate diarrhea.

Take with you any capsules you have not taken, as well as the container or package leaflet, so that the doctor or emergency staff can easily identify the medicine taken.

If you forget to take Gabapentin Almus:

If you forget to take a dose, take it as soon as you remember, unless it is already time for your next dose. Do not take a double dose to make up for a missed dose; wait for your next scheduled dose.

If you stop taking Gabapentin Almus:

Do not stop taking gabapentin suddenly or reduce the dose without consulting your doctor. If you wish to stop taking Gabapentin Almus or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, it should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentin Almus or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentin Almus or reducing the dose. 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, Gabapentin Almus may cause adverse effects, although not everyone experiences them. Stop taking Gabapentin Almus and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-raised patches with a target or circular shape on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, and 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).

Very common adverse effects (may affect 1 or more people in 10):

• Viral infection
• Dizziness, drowsiness, lack of coordination
• Feeling tired, fever

Common adverse effects (may affect less than 1 person in 100):

• Pneumonia, respiratory infection, urinary tract infection, ear infection and inflammation
• Low blood cell count
• Anorexia, increased appetite
• Feelings of anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty concentrating
• Seizures, rapid movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes
• Blurred or double vision
• Dizziness
• Increased blood pressure, blood vessel dilation
• Difficulty breathing, bronchitis, sore throat, dry nose, common cold
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, skin rash, itching, redness, acne
• Joint, muscle, or back pain, muscle twitches
• Incontinence
• Difficulty achieving an erection
• Swelling of the legs, arms, or even face, neck, and lips; difficulty walking, weakness, general discomfort, and flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injury, fracture, abrasion

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

• Fall
• Difficulty thinking
• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Increased blood glucose levels (observed more frequently in patients with diabetes)
• Difficulty swallowing

Rare adverse effects (may affect less than 1 person in 1,000):

• Decreased platelet count (a type of blood cell)
• Allergic reaction
• Hallucinations
• Problems with abnormal movements such as twisting, jerking, and stiffness
• Ringing in the ears
• Rapid heartbeat
• Pancreatitis
• Liver inflammation, yellowing of eyes and skin
• Severe skin reactions requiring immediate medical attention, such as swelling of lips and face, itching and redness of the skin, and hair loss
• Acute kidney failure
• Adverse reactions following abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, malaise, pain, swelling), chest pain
• Abnormal blood test results indicating liver problems
• Decreased blood glucose levels (observed more frequently in patients with diabetes)
• Loss of consciousness
• Breathing problems, shallow breathing (respiratory depression)

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

• Low sodium levels in the blood
• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Suicidal thoughts
• Development of dependence on Gabapentin Almus ("drug dependence")
• Worsening of myasthenia gravis (a disease causing muscle weakness)

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

Additionally, in clinical trials in children, aggressive behavior and excessive movement were frequently reported.

Gabapentin Almus 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. When this type of reaction occurs, it may be accompanied by a rash or may occur without a rash. If this type of allergic reaction occurs, you may need to be hospitalized or stop taking Gabapentin Almus.

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

• Skin rashes
• Hives
• Fever
• Persistent gland swelling
• Swelling of lips and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Breathing problems, which, if severe, may require urgent medical attention to maintain normal breathing

These symptoms may be early signs of a serious reaction. Your doctor will examine you to determine whether you can continue taking Gabapentin Almus.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

5. Storage of Gabapentin Almus

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original, tightly closed container.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina Almus 400 mg capsules

• The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.
• The other components (excipients) are: Lactose, corn starch and talc. Capsule shell no. 0 contains: Indigo carmine (E132), Titanium dioxide (E171), Iron oxide yellow (E172) and Gelatin.

Appearance of the product and contents of the pack

Gabapentina Almus is presented as hard capsules. The capsules are green and white in color.

The capsules are packed in PVC/PVDC/Aluminum blisters.

Pack sizes contain 90 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Or

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares,

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

This patient information leaflet was approved in January 2026

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