Naxalgan

Package leaflet: Information for the patient

Naxalgan, 75 mg, hard capsules
Naxalgan, 150 mg, hard capsules
Naxalgan, 300 mg, hard capsules
Pregabalinum
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Naxalgan is and what it is used for
2. Important information before taking 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 in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorders in adults.

Peripheral and central neuropathic pain:
Naxalgan is used to treat long-lasting pain caused by nerve damage. Various conditions, such as diabetes or shingles, can cause peripheral neuropathic pain. The pain may be described as burning, shooting, stabbing, throbbing, electric shock-like, tingling, numbness, or aching. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, which can affect the patient's physical and social functioning and overall quality of life.

Epilepsy:
Naxalgan is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Naxalgan if previous treatment has not fully controlled the condition. Naxalgan should always be used as an add-on therapy to current treatment. Naxalgan should not be used as monotherapy (as the sole treatment), but always in combination with other antiepileptic medicines.

Generalized anxiety disorder (GAD):
Naxalgan is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD include persistent, excessive anxiety and worry that are difficult to control. GAD may also cause physical restlessness, feeling keyed up or on edge, easy fatigability, difficulty concentrating or mind going blank, irritability, increased muscle tension, or sleep disturbances. These symptoms are distinct from the stress and tension associated with everyday life.

2. Information before using Naxalgan

When not to use Naxalgan:

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

Warnings and precautions
Before starting to take Naxalgan, discuss this with your doctor or pharmacist:

• In some patients taking pregabalin, symptoms suggesting an allergic reaction have occurred. These symptoms include swelling of the face, lips, tongue, and throat, as well as generalized skin rash. If any of these symptoms occur, contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. If the patient experiences any of the symptoms of serious skin reactions listed in section 4, treatment with pregabalin must be discontinued and immediate medical help sought.
• Pregabalin may cause dizziness and somnolence: this may lead to an increased risk of accidental injury (falls) in elderly patients. Therefore, caution should be exercised until the patient knows how the medicine affects them.
• Pregabalin may cause blurred vision, loss of vision, or other visual disturbances, most of which are transient. If any changes in vision occur, inform your doctor immediately.
• In diabetic patients who gain weight during treatment with pregabalin, adjustment of antidiabetic therapy may be necessary.
• Some adverse effects such as somnolence may occur more frequently, as patients with spinal cord injury may be taking other medications, e.g. analgesics or muscle relaxants, which have similar adverse effects to pregabalin, and the severity of these effects may be greater when such drugs are taken concomitantly.
• Cases of heart failure have been reported in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders. Before using this medicine, inform your doctor if you have ever had heart disease.
• Cases of renal failure have been reported in some patients taking pregabalin. If the patient notices a decrease in frequency of urination during treatment with pregabalin, inform your doctor, as discontinuation of the medicine may lead to resolution of this symptom.
• A small number of patients taking antiepileptic medicines such as pregabalin have had thoughts of self-harm or suicide or exhibited suicidal behavior. If such thoughts or behaviors occur at any time, contact your doctor immediately.
• If pregabalin is used concomitantly with other medicines that may cause constipation (such as some analgesics), gastrointestinal problems (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform your doctor if the patient experiences constipation, especially if the patient is prone to it.
• Before starting treatment with this medicine, inform your doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances; this may indicate an increased risk of dependence on the medicinal product Naxalgan.
• Seizures have been reported during treatment with pregabalin or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of worsening brain function (encephalopathy) have been reported in some patients with other underlying diseases who were taking pregabalin. Inform your doctor about all serious illnesses the patient has had, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction, or is over 65 years of age, the doctor may recommend an adjusted dosing regimen. If the patient develops breathing difficulties or shallow breathing, contact your doctor.

Dependence
Some individuals may become dependent on pregabalin (need to continue taking the medicine). Withdrawal symptoms may occur after stopping pregabalin (see section 3 "How to take Naxalgan" and "Stopping Naxalgan"). If the patient is concerned about possibly becoming dependent on pregabalin, they should definitely discuss this with their doctor.
If the patient notices any of the following symptoms while taking Naxalgan, this may indicate dependence:

• Need to take the medicine for longer than prescribed by the doctor
• Feeling the need to take a higher dose than recommended
• Taking the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control taking this medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it
  If the patient notices any of these symptoms, they should talk to their doctor to discuss the best treatment approach, including when and how to stop taking this medicine safely.

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

Naxalgan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Naxalgan and certain medicines may interact with each other. Naxalgan taken together with other centrally acting sedative medicines (including opioids) may enhance these effects and cause respiratory depression, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if Naxalgan is taken together with medicines containing:

• oxycodone – (analgesic)
• lorazepam – (medication used for anxiety)
• alcohol

Naxalgan may be taken with oral contraceptives.

Taking Naxalgan with food, drink, and alcohol
Naxalgan capsules may be taken with food or independently of meals. Do not consume alcohol while taking Naxalgan.

Pregnancy and breastfeeding
Pregabalin should not be used during pregnancy or breastfeeding unless otherwise decided by a doctor. Taking pregabalin during the first three months of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a Scandinavian countries study analyzing data from women who took pregabalin during the first three months of pregnancy, congenital malformations were observed in 6 out of every 100 live births, compared to 4 out of every 100 live births in women not treated with pregabalin. Reported congenital malformations involved the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
Pregabalin may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until the effect of this medicine on the ability to perform such tasks has been determined.

Naxalgan contains monohydrate lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Naxalgan

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the dose most appropriate for you.
Naxalgan is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorders:

• Take the number of capsules prescribed by your doctor.
• The recommended dose will range from 150 mg to 600 mg per day.
• Your doctor will inform you whether Naxalgan should be taken twice or three times daily. If taken twice daily, Naxalgan should be taken in the morning and evening at approximately the same time each day. If taken three times daily, Naxalgan should be taken in the morning, at midday, and in the evening at approximately the same time each day.

If you feel that Naxalgan is too strong or not strong enough, inform your doctor or pharmacist.
Patients over 65 years of age should take Naxalgan as directed, unless they have kidney disease.
In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose.
Swallow the capsule whole with water.
Continue taking Naxalgan for as long as your doctor prescribes. Do not stop treatment without your doctor's instruction.
Taking more Naxalgan than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department. Take the medicine pack or bottle with you. After taking more than the prescribed dose of Naxalgan, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.
Missing a dose of Naxalgan
It is important to take Naxalgan regularly at the same times each day. If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. In that case, continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Naxalgan
Do not stop taking Naxalgan unless your doctor tells you to. If your doctor decides to discontinue treatment, they will recommend gradually reducing the dose over at least one week.
Be aware that after stopping short- or long-term treatment with Naxalgan, certain withdrawal symptoms may occur. These include: sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if you have been taking Naxalgan for a long time. If withdrawal symptoms occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common – may affect more than 1 in 10 people:

• Dizziness, somnolence (sleepiness), headache

Common – may affect up to 1 in 10 people:

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory disturbances, amnesia, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling
• Blurred vision, double vision
• Dizziness, balance disorders, fall
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension
• Erectile dysfunction
• Swelling of the body, including limbs
• Feeling of alcohol intoxication, unsteady gait
• Weight gain
• Muscle cramps, 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 levels, high blood sugar levels
• Changes in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased libido, sexual disorders, including inability to achieve orgasm, delayed ejaculation
• Visual disturbances, abnormal eye movements, visual disorders including tunnel vision, sensation of flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, tremor during movement, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, swelling around the eyes, eye pain, weakness of eye movements, tearing, eye irritation
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of the face, hot flushes
• Breathing difficulties, dry nose sensation, blocked nose sensation
• Increased salivation, heartburn, 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 urge to urinate, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• Hypersensitivity, facial swelling, itching, urticaria, rhinitis, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare – may affect up to 1 in 1,000 people:

• Altered sense of smell, sensation of image oscillation, altered depth perception, vivid vision, vision loss
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or limited movements
• Difficulty with writing function
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG recording corresponding to heart rhythm disturbances
• Muscle damage
• Nipple discharge, breast enlargement, gynaecomastia in men
• Absence of menstruation
• Kidney failure, reduced volume of urine output, urinary retention
• Decreased white blood cell count
• Abnormal behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and serious skin reactions characterised by red, flat, disc-shaped or round spots on the trunk, often with blisters in their centre, skin peeling, oral, throat, nose, genital or ocular ulcers. Such serious skin rashes 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)
• Parkinsonism, i.e. symptoms resembling Parkinson’s disease, such as tremor, bradykinesia (reduced ability to move) and rigidity (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

• Pregabalin dependence ("drug dependence")

It should be noted that after discontinuation of short- or long-term treatment with Naxalgan, certain adverse reactions, known as withdrawal symptoms, may occur (see section "Discontinuing treatment with Naxalgan").

If swelling of the face or tongue occurs, or if redness of the skin appears together with blisters or skin peeling, immediate medical help should be sought.

Some adverse reactions, such as somnolence (sleepiness), may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g. painkillers or muscle relaxants, which have similar adverse reactions to pregabalin, and the severity of these effects may be greater when such medicines are taken concomitantly.

After the medicine was placed on the market, the following adverse reactions have also been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Naxalgan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
bottle after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Shelf life after first opening the HDPE container: 98 days.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer used. This will help protect
the environment.

6. Contents of the package and other information

What Naxalgan contains
The active substance is pregabalin. Each hard capsule contains 75, 150, or 300 mg of pregabalin.
Other ingredients: monohydrate lactose, gelatinized corn starch, talc.
Capsule shell: titanium dioxide (E 171), gelatin.
Black ink 10A2 Black: shellac, iron oxide black (E 172), propylene glycol, concentrated ammonium hydroxide, 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, opaque white body printed with "75" in black ink, with an opaque orange cap, filled with white or almost white powder.

Naxalgan 150 mg hard capsules
Size 2, opaque white body printed with "150" in black ink, with an opaque white cap, filled with white or almost white powder.

Naxalgan 300 mg hard capsules
Size 0, opaque white body printed with "300" in black ink, with an opaque orange cap, filled with white or almost white powder.

Carton box containing PCW/PE/PVDC/Aluminium blisters with 30, 50, 60, 80, 90, or 120 hard capsules.
HDPE container with PP screw cap and child-resistant closure containing 56 hard capsules.
HDPE container with PP screw cap and child-resistant closure containing 98 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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]