Naxalgan

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. What you need to know 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. Many different 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 affect the patient's physical and social functioning and overall quality of life.

Epilepsy:

Naxalgan is used to treat a certain type of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Naxalgan if your current treatment does not fully control your condition. Naxalgan should always be used in addition to your current treatment. Naxalgan must not be used as a sole treatment (monotherapy), but as an add-on therapy to other anti-epileptic medicines.

Generalized anxiety disorder:

Naxalgan is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive, and anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge, or irritability, difficulty concentrating or feeling like your mind goes blank, sleep disturbances, and other physical symptoms. These symptoms are different from the stress and tension of everyday life.

2. What you need to know 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, as well as a rash. If you experience any of these symptoms, contact your 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 seek medical help immediately: severe skin rash, blisters, or peeling of the skin.
• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injury (falls) in elderly patients. Therefore, you should exercise caution 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, contact your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to have their antidiabetic treatment adjusted.
• Certain side effects, such as dizziness and somnolence, may be more frequent in patients with spinal cord injury, as they may be taking other medicines that have similar side effects to pregabalin, and the frequency of these side effects may be higher when these medicines are taken together.
• There have been reports of heart failure in some patients taking pregabalin; these patients were mostly elderly with pre-existing cardiovascular conditions.

Before taking this medicine, tell your doctor if you have ever had 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, contact your doctor, as stopping the medicine may improve this symptom.
• A small number of patients taking antiepileptic drugs, such as pregabalin, have had thoughts of harming themselves or ending their lives or have exhibited unusual changes in behavior. If you have ever had such thoughts or behaviors, contact your doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as certain pain medicines), gastrointestinal problems (such as constipation, obstruction, or paralytic ileus) may occur. 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; this may increase the risk of dependence on Naxalgan.
• There have been reports of seizures during pregabalin treatment or shortly after stopping treatment. If you experience seizures, contact your doctor immediately.
• There have been reports of brain disorders (encephalopathy) in some patients taking pregabalin who have other medical conditions. 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 nervous system disorders, breathing disorders, kidney disorders, or are over 65 years old, your doctor may prescribe a different dosage regimen. If you experience breathing difficulties or shallow breathing, contact your doctor.

Dependence
Some people may become dependent on pregabalin (need to continue taking the medicine). After stopping pregabalin, withdrawal symptoms may occur (see section 3 "How to take Naxalgan" and "Stopping Naxalgan"). If you are concerned about becoming dependent on pregabalin, 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 your 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 taken again
  If you experience any of these symptoms, 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 certain other medicines may affect each other (interact). Naxalgan taken with other medicines that have a sedating effect (such as opioids) may increase these effects and cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Naxalgan is taken with medicines containing:

• oxycodone (a pain medicine)
• lorazepam (a 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 birth defects that require medical treatment. A study in Scandinavian countries analyzed data from women who took pregabalin during the first three months of pregnancy and found birth defects in 6 out of 100 babies, while in women who did not take pregabalin, birth defects occurred in 4 out of 100 babies. The reported birth defects included facial defects (cleft lip or palate), eye, brain, kidney, and genital defects. Women of childbearing age should use effective contraception. If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Naxalgan contains lactose monohydrate

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

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.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as 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 it twice a day, take it in the morning and evening at the same time each day. If you take it three times a day, take it in the morning, at noon, and in the evening at 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.
Patient over 65 years should take Naxalgan as prescribed, unless they have kidney problems.
In patients with kidney problems, your doctor may prescribe a different dosage regimen and/or adjust the dose.
Swallow the capsule whole with water. Naxalgan should be taken for as long as your doctor prescribes it. Do not stop treatment unless your doctor tells you to do so.

If you take more Naxalgan than you should

Contact your doctor or go to the nearest hospital casualty department immediately. Take the medicine pack with you. After taking too much Naxalgan, you may feel drowsy, confused, agitated, or irritable. There have also been reports of seizures and loss of consciousness (coma).

If you forget to take 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. In this case, continue with your regular schedule. 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 do so. If your doctor decides to stop your treatment, they will tell you how to gradually reduce your dose over at least one week.
Be aware that after stopping short- or long-term treatment with Naxalgan, you may experience certain side effects, known as withdrawal symptoms. These symptoms include insomnia, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may be more frequent or more severe if you have taken Naxalgan for a longer period. If you experience withdrawal symptoms, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, abdominal distension
• Difficulty achieving an erection
• Edema (swelling of the body, including limbs)
• Feeling drunk, ataxia (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, agitation, mood changes, 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
• Visual disturbances, 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, tremors, changes in consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, periorbital edema, eye pain, decreased eye movements, lacrimation, eye irritation
• Cardiac disorders, tachycardia, hypotension, hypertension, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Breathing difficulties, dryness of 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, 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 edema, pruritus, urticaria, rhinitis, nasal congestion
• Painful menstruation
• Cold hands and feet

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

• Altered smell, sensation of movement of external objects, altered sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweat, tightness in the throat, tongue edema
• Pancreatitis
• Dysphagia
• Slow or reduced movements
• Difficulty writing
• Ascites
• Pulmonary edema
• Seizures
• Changes in ECG tracing indicating heart rhythm disorders
• Muscle damage
• Galactorrhea, gynecomastia, breast enlargement in men
• 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 severe skin reactions characterized by red, flat, target-like patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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: frequency cannot be estimated from the available data

• Dependence on pregabalin ("drug dependence")

Be aware that after stopping short- 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 blisters or peeling of the skin, seek medical help immediately.

Certain side effects, such as drowsiness, may be more frequent in patients with spinal cord injury, as they may be taking other medicines that have similar side effects to pregabalin, and the frequency of these side effects may be higher when these medicines are taken together.
After the medicine was marketed, the following side effects were also reported: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience 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 to the Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder. 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, maize starch, talc
Capsule 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 (PCW/PE/PVDC/Aluminum) of 30, 50, 60, 80, 90, or 120 hard capsules.
HDPE container with a PP cap and child-resistant closure, containing 56 hard capsules.
HDPE container with a PP cap and child-resistant closure, containing 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
vipharm@vipharm.com.pl
Date of last revision of the leaflet:26.05.2024