NAXALGAN 300 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Naxalgan, 75 mg, hard capsules
3. Naxalgan, 150 mg, hard capsules
4. Naxalgan, 300 mg, hard capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What Naxalgan is and what it is used for
   1. Epilepsy:
   2. Generalized anxiety disorder:
6. Before you take Naxalgan
   1. Do not take Naxalgan:
   2. Warnings and precautions
   3. Before taking this medicine, tell your doctor if you have ever had any heart problems.
   4. Children and adolescents
   5. Naxalgan and other medicines
   6. Taking Naxalgan with food, drink, and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Naxalgan contains lactose
7. How to take Naxalgan
   1. Neuropathic pain peripheral and central, epilepsy, or generalized anxiety disorder:
   2. What to do if you take more Naxalgan than you should
   3. What to do if you miss a dose of Naxalgan
   4. Stopping Naxalgan
8. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Uncommon (may affect up to 1 in 100 people):
   4. Rare (may affect up to 1 in 1,000 people):
   5. Very rare (may affect up to 1 in 10,000 people):
   6. Frequency not known: frequency cannot be estimated from the available data
   7. If you experience swelling of the face or tongue or redness of the skin and blistering or peeling of the skin, you should seek medical attention immediately.
9. How to store Naxalgan
10. Contents of the pack and other information
    1. What Naxalgan contains
    2. What Naxalgan looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Naxalgan, 75 mg, hard capsules

Naxalgan, 150 mg, hard capsules

Naxalgan, 300 mg, hard capsules

Pregabalin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 and other information

• 1. What Naxalgan is and what it is used for
• 2. 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 peripheral and central:
Naxalgan is used to treat long-term 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 may 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 certain types 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 symptoms can cause disturbances in sleep and restlessness. GAD can also cause feelings of fear, anxiety, or avoidance of everyday activities, which can have an impact on the patient's physical and social functioning and overall quality of life.

2. Before you take Naxalgan

Do not 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 severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the following symptoms, stop taking pregabalin and contact a doctor immediately: blistering or peeling of the skin, mouth, or eyes, or any other serious skin reaction.
• Pregabalin has been associated with dizziness and somnolence, which may increase the occurrence of accidental injury (falls) 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 vision. If you experience any changes in your vision, you should contact a doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to have their blood sugar (glucose) levels checked more often and the dose of their diabetes medicine adjusted.
• Some side effects, such as dizziness and drowsiness, have been reported more frequently in patients taking other medicines that can cause these side effects as well as pregabalin.
• There have been reports of heart failure in some patients taking pregabalin; these patients were mostly elderly with pre-existing heart conditions.

Before taking this medicine, tell your doctor if you have ever had any heart problems.

• 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 contact a doctor immediately.
• A small number of patients taking anti-epileptic drugs, such as pregabalin, have had thoughts of harming themselves or others or have attempted to harm themselves or others. If you have ever had such thoughts or behaviors, you should contact a doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as certain pain medicines), there may be an increased risk of gastrointestinal problems (such as constipation, obstruction, or paralytic ileus). You should tell your doctor if you experience constipation, especially if you have a history of constipation.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs; this may increase the risk of dependence on Naxalgan.
• There have been reports of seizures in patients taking pregabalin or shortly after stopping pregabalin. If you experience seizures, you should contact a doctor immediately.
• There have been reports of decreased brain function (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 in patients taking pregabalin. If you experience breathing difficulties or shallow breathing, you should contact a doctor immediately.

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:

• Needing to take the medicine for a longer period than prescribed by your doctor
• Feeling a need to take more of the medicine than prescribed
• Taking the medicine for reasons other than those for which it was prescribed
• Repeatedly trying to stop taking the medicine or control the amount taken
• 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 (such as opioids) may increase the sedating effect and can cause respiratory failure, coma, and death. The risk of dizziness, drowsiness, and decreased concentration may increase if Naxalgan is taken with other medicines that can cause these side effects, including:

• Oxycodone (a pain medicine)
• Lorazepam (a medicine used to treat 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 that it is necessary. Taking pregabalin during the first three months of pregnancy may cause birth defects in the unborn baby. A study in the Scandinavian countries found that babies born to women who took pregabalin during the first three months of pregnancy had birth defects (such as cleft lip or cleft palate, eye problems, brain problems, kidney problems, or genital problems) in 6 out of every 100 births, compared to 4 out of every 100 births in women who did not take pregabalin. Women of childbearing age should use effective contraception.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and decreased concentration. Do not drive, operate complex machinery, or engage in other potentially hazardous activities until you know how this medicine affects you.

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 peripheral and central, epilepsy, or generalized anxiety disorder:

• Take the number of capsules prescribed by your doctor.
• The dose will be between 150 mg and 600 mg per day.
• Your doctor will tell you to take Naxalgan either twice or three times a day. If you take Naxalgan twice a day, take it once in the morning and once in the evening, at about the same time each day. If you take Naxalgan three times a day, take it once in the morning, once in the afternoon, and once in the 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 have a higher risk of side effects and may need a dose adjustment. If you have kidney problems, your doctor may prescribe a different dose.

What to do if you take more Naxalgan than you should

Contact a doctor or go to the nearest hospital casualty department immediately. Take the medicine pack with you. If you have taken more Naxalgan than prescribed, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

What to do if you miss a dose of Naxalgan

It is important to take Naxalgan regularly at the same time 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 usually recommend that you reduce the dose gradually over at least one week. You may experience side effects when you stop taking Naxalgan, including trouble sleeping, headache, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These symptoms may be more common or more severe if you have been taking Naxalgan for a long time. If you experience any of these symptoms, you should contact a 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, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
• Blurred vision, double vision
• Dizziness, balance disorder, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• Difficulty achieving an erection
• Edema (swelling)
• Feeling drunk, ataxia
• Weight gain
• Muscle spasms, arthralgia, 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, agitation, mood swings, difficulty finding words, hallucinations, abnormal 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 on standing, hypersensitivity, loss of taste, burning sensation, jerky movements, changes in consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
• Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
• Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
• Increased salivation, heartburn, feeling of numbness around the mouth
• Increased 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, chest tightness
• Changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium)
• Hypersensitivity, facial swelling, itching, hives, rhinitis, nosebleeds, coughing, snoring
• Painful menstruation
• Coldness of hands and feet

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

• Changes in smell, feeling of swaying, changes in depth perception, bright lights, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or reduced movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG readings indicating heart rhythm disturbances
• Muscle damage
• Spontaneous milk production, breast enlargement, gynecomastia
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal ideation, suicidal attempts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by red, flat, target-like patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals, 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 such as tremor, slow movement (reduced mobility), and stiffness (muscle stiffness)

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

• Liver failure
• Hepatitis

Frequency not known: frequency 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 (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, you should seek medical attention immediately.

Some side effects, such as drowsiness, may be more common in patients with spinal cord injury who are taking other medicines that can cause these side effects as well as pregabalin.

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.
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, maize starch, talc
Cap shell: titanium dioxide (E 171), gelatin
Black ink 10A2 Black: shellac, iron oxide black (E 172), propylene glycol, ammonia solution concentrated, 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, white, opaque cap, filled with white or almost white powder.
Naxalgan 150 mg hard capsules
Size 2, white, opaque body with "150" printed in black ink, white, opaque cap, filled with white or almost white powder.
Naxalgan 300 mg hard capsules
Size 0, white, opaque body with "300" printed in black ink, orange, opaque cap, filled with white or almost white powder.
Carton containing blisters of PVC/PVDC/Aluminum foil, each 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: (+4822) 679-51-35
fax: (+4822) 678-92-87
[email protected]
Date of last revision of the leaflet:26.05.2024