Naxalgan

Package Leaflet: Information for the Patient

Naxalgan, 75 mg, hard capsules

Naxalgan, 150 mg, hard capsules

Naxalgan, 300 mg, hard capsules

Pregabalin

It is very important that you read the contents of this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Naxalgan is and what it is used for
• 2. Important information before you take Naxalgan
• 3. How to take Naxalgan
• 4. Possible side effects
• 5. How to store Naxalgan
• 6. Contents of the pack and other information

1. What Naxalgan is and what it is used for

Naxalgan belongs to a group of medicines used to treat epilepsy, neuropathic pain and generalized anxiety disorder in adults.
Neuropathic pain:
Naxalgan is used to treat long-lasting pain caused by damage to the nerves. A variety of diseases such as diabetes or shingles can cause peripheral neuropathic pain. The pain can be described as hot, burning, throbbing, shooting, stabbing, sharp, crampy, aching, heavy, or tender. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances, fatigue, which can have an impact on the patient's physical and social functioning and overall quality of life.

Epilepsy:

Naxalgan is used to treat a certain form of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor will prescribe Naxalgan for you to take in addition to your current treatment for epilepsy. Naxalgan should not be taken on its own but should always be taken in combination with other anti-epileptic medicines.

Generalized anxiety disorder:

Naxalgan is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include feeling anxious or worried and these feelings are present for most of the time, being unable to control these feelings and having at least three of the following: restlessness, feeling "on edge", being easily irritated, having difficulty concentrating, feeling afraid that something bad might happen, difficulty sleeping, feeling sweaty, nausea, and having to go to the toilet frequently. These symptoms are persistent and last for at least 6 months.

2. Important information before you take Naxalgan

When not to take Naxalgan:

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

Warnings and precautions

Before taking Naxalgan, tell your doctor or pharmacist if:

• Some patients taking pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, and difficulty breathing. If you experience any of these symptoms, you should contact a doctor immediately.
• Pregabalin has been associated with a severe form of skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you develop any of the following symptoms, stop taking pregabalin and contact a doctor immediately: severe skin rash, blisters, sores in the mouth, throat, nose, genitals, and eyes, redness and peeling of the skin (exfoliation), fever, and/or swollen lymph nodes.
• Pregabalin has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be cautious until you are used to the effects of the medicine.
• Pregabalin may cause blurred vision, double vision or other changes in your vision. If you experience any changes in your vision, you should immediately contact your doctor.
• There have been reports of heart failure in some patients taking pregabalin. If you have heart problems or are taking other medicines that may affect your heart, you should tell your doctor before taking pregabalin.
• There have been reports of kidney failure in some patients taking pregabalin. If you have kidney problems or are taking other medicines that may affect your kidneys, you should tell your doctor before taking pregabalin.
• Some patients with diabetes who gain weight while taking pregabalin may need to have their diabetes treatment adjusted.
• Some side effects such as dizziness, drowsiness, confusion, and difficulty concentrating may be more common in patients with spinal cord injury. This is because patients with spinal cord injury may be taking other medicines that have similar side effects to pregabalin.
• There have been reports of seizures in patients taking pregabalin. If you have a history of seizures, you should tell your doctor before taking pregabalin.
• There have been reports of encephalopathy (brain disease) in some patients taking pregabalin. If you have a history of brain disease, you should tell your doctor before taking pregabalin.
• There have been reports of respiratory failure in some patients taking pregabalin. If you have a history of respiratory disease, you should tell your doctor before taking pregabalin.

Before taking this medicine, tell your doctor if you have a history of heart disease.

• There have been reports of kidney failure in some patients taking pregabalin. If you experience a decrease in urine output while taking pregabalin, you should tell your doctor, as stopping the medicine may improve the condition.
• A small number of patients taking anti-epileptic medicines such as pregabalin have had thoughts of harming themselves or have attempted suicide or suicide. If you have ever had such thoughts, you should tell your doctor before taking pregabalin.
• If pregabalin is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (such as constipation, obstruction, or paralytic ileus) may occur. You should tell your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs, as this may increase the risk of dependence on Naxalgan.
• There have been reports of seizures in patients taking pregabalin or shortly after stopping treatment. If you experience seizures, you should contact a doctor immediately.
• There have been reports of brain disease (encephalopathy) in some patients taking pregabalin who have other medical conditions. You should tell your doctor about any serious medical conditions you have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have a neurological disorder, respiratory disease, kidney disease, or are over 65 years old, your doctor may prescribe a different dose. If you experience breathing difficulties or shallow breathing, you should contact a doctor.

Dependence
Some people may become dependent on pregabalin (need to continue taking the medicine). After stopping pregabalin, you may experience withdrawal symptoms (see section 3 "How to take Naxalgan" and "Stopping Naxalgan"). If you are concerned about becoming dependent on pregabalin, you should talk to your doctor.
If you experience any of the following symptoms while taking Naxalgan, it may indicate dependence:

• Need to take the medicine for a longer period than prescribed by the doctor
• Need to take a higher dose than prescribed
• Taking the medicine for reasons other than prescribed
• Repeatedly trying to stop or control the use of the medicine but being unable to do so
• Feeling unwell when the medicine is stopped and feeling better when it is restarted
  If you experience any of these symptoms, you should talk to your doctor to discuss the best course of treatment, including when to stop taking the medicine and how to do so safely.

Children and adolescents

The safety and effectiveness of Naxalgan in children and adolescents (under 18 years of age) have not been established, and therefore pregabalin should not be used in this age group.

Naxalgan and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Naxalgan and some other medicines may affect each other. Naxalgan taken with other medicines that have a sedating effect (e.g., opioids) may increase these effects and lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Naxalgan is taken with medicines that contain:

• oxycodone - (painkiller)
• lorazepam - (medicine used for anxiety)
• alcohol

Naxalgan can be taken with oral contraceptives.

Taking Naxalgan with food, drink, and alcohol

Naxalgan capsules can be taken with or without food. Do not drink alcohol while taking Naxalgan.

Pregnancy and breastfeeding

Pregabalin should not be taken during pregnancy or breastfeeding unless your doctor decides it is necessary. Taking pregabalin during the first three months of pregnancy may cause harm to the unborn baby. A study in Scandinavian countries found that the risk of birth defects was higher in babies born to women who took pregabalin during the first three months of pregnancy (6 out of 100 babies) compared to women who did not take pregabalin (4 out of 100 babies). The birth defects reported included cleft lip or palate, eye problems, brain problems (including brain malformation), kidney problems, and genital problems. Women of childbearing age should use effective contraception. 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.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and decreased concentration. Do not drive, operate complex machinery, or perform other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Naxalgan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Naxalgan

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not take more than the recommended dose.
Your doctor will determine the dose that is right for you.
Naxalgan is for oral use only.

Neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as instructed by your doctor.
• The dose will be between 150 mg and 600 mg each day.
• Your doctor will tell you to take Naxalgan either twice or three times a day. If you take it twice a day, take it once in the morning and once in the evening, at about the same time each day. If you take it three times a day, take it in the morning, afternoon, and evening, at about the same time each day.

If you think that the effect of Naxalgan is too strong or too weak, talk to your doctor or pharmacist.
Patients over 65 years of age may need to take a lower dose. Patients with kidney problems may need to take a lower dose. Your doctor may need to adjust the dose and/or frequency of your medicine.
Swallow the capsule whole with water. Do not chew or crush it. Continue taking Naxalgan until your doctor tells you to stop.

Overdose

If you take more Naxalgan than you should, contact a doctor or go to the nearest hospital emergency department immediately. Take the medicine pack with you. After taking too much Naxalgan, you may feel drowsy, confused, agitated, or have difficulty breathing.

Missed dose

It is very important that you take Naxalgan regularly at the same times each day. If you miss 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 a forgotten dose.

Stopping Naxalgan

Do not stop taking Naxalgan unless your doctor tells you to. If your doctor decides to stop your treatment, they will tell you how to reduce the dose gradually over at least one week.
You should be aware that after stopping short-term or long-term treatment with Naxalgan, you may experience certain side effects, known as withdrawal symptoms. These include insomnia, headache, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These symptoms usually occur within 1 week of stopping the treatment and may be more severe if you have been taking Naxalgan for a longer period. If you experience any of these symptoms, you should contact your doctor.

4. Possible side effects

Like all medicines, Naxalgan can cause side effects, although not everybody gets them.

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

• Dizziness, drowsiness, headache

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

• Increased appetite
• Mood changes, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory impairment, loss of memory, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
• Blurred vision, double vision
• Dizziness, balance disorder, fall
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• Difficulty achieving an erection
• Edema (swelling of hands, feet, or face)
• Feeling drunk, unsteady gait
• Weight gain
• Muscle spasms, joint pain, back pain, limb pain
• Sore throat

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

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in perception, restlessness, depression, excitement, mood swings, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased libido, sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision, including tunnel vision, flashes of light, jerky movements, decreased reflexes, increased activity, dizziness when standing up, increased sensitivity of the skin, loss of taste, burning sensation, tremors when moving, changes in consciousness, loss of consciousness, fainting
• Dry eyes, eye swelling, eye pain, decreased eye movements, tearing, eye irritation
• Abnormal heart rhythm, rapid heartbeat, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of the skin of the face, sudden hot flushes
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
• Increased salivation, heartburn, feeling of numbness around the mouth
• Excessive sweating, rash, chills, fever
• Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
• Chest pain
• Difficulty urinating or painful urination, urinary incontinence
• Weakness, thirst, tightness in the chest
• Changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels, decreased potassium levels)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

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

• Changes in smell, feeling of swaying, changes in depth perception, bright vision, loss of vision
• Dilated pupils, squint
• Cold sweats, tightness in the throat, swelling of the tongue
• Pancreatitis
• Difficulty swallowing
• Slow or limited movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG readings indicating heart rhythm disorders
• Muscle damage
• Nipple discharge, breast enlargement, gynecomastia (breast enlargement in men)
• Amenorrhea (absence of menstruation)
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by red, flat, target-like patches on the trunk, often with central blisters, skin peeling, mouth sores, genital sores, and eye inflammation. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and whites of the eyes)
• Parkinsonian syndrome, which includes symptoms similar to Parkinson's disease, such as tremors, slow movements (reduced mobility), and stiffness (muscle stiffness).

Very rare (may affect up to 1 in 10,000 people):

• Liver failure
• Hepatitis

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

• Dependence on pregabalin ("drug dependence")

You should be aware that after stopping short-term or long-term treatment with Naxalgan, you may experience certain side effects, known as withdrawal symptoms (see section "Stopping Naxalgan").

If you experience swelling of the face or tongue or redness of the skin and blistering or peeling of the skin, seek medical attention immediately.

Some side effects such as drowsiness may be more common in patients with spinal cord injury because these patients may be taking other medicines that have similar side effects to pregabalin, and the severity of these effects may be greater when these medicines are taken together.
After the medicine was approved, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naxalgan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Shelf life after first opening of the HDPE container: 98 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Naxalgan contains

The active substance is pregabalin. Each hard capsule contains 75, 150, or 300 mg of pregabalin.
The other ingredients are lactose monohydrate, cornstarch, talc
Cap shell: titanium dioxide (E 171), gelatin
Black ink 10A2 Black: shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia solution, potassium hydroxide.
Naxalgan 75 mg and 300 mg also contain iron oxide red (E 172) and iron oxide yellow (E 172).

What Naxalgan looks like and contents of the pack

Naxalgan 75 mg hard capsules
Size 4, white, opaque body with "75" printed in black ink, with an orange, opaque cap, filled with a white or almost white powder.
Naxalgan 150 mg hard capsules
Size 2, white, opaque body with "150" printed in black ink, with a white, opaque cap, filled with a white or almost white powder.
Naxalgan 300 mg hard capsules
Size 0, white, opaque body with "300" printed in black ink, with an orange, opaque cap, filled with a white or almost white powder.
Carton containing blisters of PVC/PVDC/Aluminum foil, each blister containing 30, 50, 60, 80, 90, or 120 hard capsules.
HDPE container with a PP cap, containing 56 or 98 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel: (+48 22) 679-51-35
fax: (+48 22) 678-92-87
[email protected]
Date of last revision of the leaflet:26.05.2024