Linagex Xr

Package Leaflet: Information for the User

Lynagex XR, 82.5 mg, prolonged-release tablets

Lynagex XR, 165 mg, prolonged-release tablets

Lynagex XR, 330 mg, prolonged-release tablets

Pregabalin

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lynagex XR and what is it used for

Lynagex XR belongs to a group of medicines used to treat neuropathic pain in adults.
Lynagex XR is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. The pain can be described as a feeling of heat, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.

2. Important information before taking Lynagex XR

When not to take Lynagex XR

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

Warnings and precautions

Before taking Lynagex XR, discuss it with your doctor or pharmacist.

• Some patients taking Lynagex XR have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread rash. If any of these symptoms occur, 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 symptoms of severe skin reactions listed in section 4, stop taking pregabalin and seek medical attention immediately.
• Pregabalin, the active substance in Lynagex XR, has been associated with dizziness and somnolence: this may increase the risk of accidental injury (falls) in the elderly. Therefore, caution should be exercised until the effects of the medicine are known.
• This medicine may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If you experience any changes in vision, tell your doctor immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust their anti-diabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the severity of these effects may be greater when such medicines are taken concomitantly.
• There have been reports of heart failure in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disease.

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, tell your doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as pregabalin, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If you have ever had such thoughts or behavior, tell your doctor immediately.
• If this medicine is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (such as constipation, obstruction, or paralysis of the intestine) 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 drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on this medicine.
• There have been reports of seizures during pregabalin treatment or shortly after discontinuation. If you experience seizures, contact your doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases who took pregabalin. Tell your doctor about all serious illnesses you have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have nervous system disorders, breathing disorders, kidney function disorders, or are over 65 years old, your doctor may recommend a different dosing schedule. 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 Lynagex XR, withdrawal symptoms may occur (see section 3 "How to take Lynagex XR" and "Stopping Lynagex XR"). If you are concerned that you may become dependent on this medicine, you must talk to your doctor.
If you experience any of the following symptoms while taking Lynagex XR, it may indicate dependence:

• need to take the medicine for a longer period than prescribed by the doctor
• feeling the need to take a higher dose than recommended
• taking the medicine for reasons other than prescribed
• repeatedly attempting to stop taking or control the use of

the medicine

• feeling unwell after stopping the medicine and feeling better after taking it again.

If you experience any of these symptoms, talk to your doctor to discuss the best course of treatment, including when to stop the treatment and how to do it safely.

Children and adolescents

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

Lynagex XR and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Lynagex XR and some medicines may interact with each other (interactions). When taken with other medicines with a sedating effect (e.g., opioids), Lynagex XR may enhance these effects and cause respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Lynagex XR is taken with medicines containing:

• oxycodone - (painkiller)
• lorazepam - (medicine used in anxiety disorders)
• alcohol

Lynagex XR may be taken with oral contraceptives.

Taking Lynagex XR with food, drink, and alcohol

Do not drink alcohol while taking Lynagex XR. For information on taking Lynagex XR with food, see section 3, "How to take Lynagex XR".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby. A study in Scandinavian countries analyzed data from women who took pregabalin during the first 3 months of pregnancy and found birth defects in 6 out of every 100 babies born, while in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects included facial defects (cleft lip and palate), eye defects, nervous system defects (including brain defects), kidney defects, and genital defects.
Women of childbearing age should use effective contraception.

Driving and using machines

Lynagex XR may cause dizziness, drowsiness, and decreased concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until you have determined how this medicine affects your ability to perform these activities.

3. How to take Lynagex XR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Lynagex XR is for oral use only. You should take Lynagex XR once a day, immediately after an evening meal. Swallow the tablets whole with water. Do not split, crush, or chew the tablets. Do not break the tablets, as this may affect the prolonged-release properties.
Your doctor will determine the dose that is right for you.

• Take the number of tablets prescribed by your doctor.
• The dose recommended for you will be between 165 mg and 660 mg per day.

If you feel that the effect of Lynagex XR is too strong or too weak, talk to your doctor or pharmacist.
Patient over 65 years should take Lynagex XR as prescribed, 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 of the medicine.
Take Lynagex XR for as long as your doctor prescribes it. The treatment can only be stopped on the advice of a doctor.
Switching from immediate-release pregabalin to prolonged-release pregabalin, such as Lynagex XR

If you are switching from immediate-release pregabalin to prolonged-release pregabalin, such as Lynagex XR, your doctor will instruct you on how to do it. The doctor will inform you about the following steps:

• take the morning dose of immediate-release pregabalin as prescribed,
• start taking Lynagex XR after the evening meal.

Do not change medicines unless your doctor tells you to. The doctor will also indicate the appropriate dose, depending on your condition.
If you have any further questions or concerns, talk to your doctor.

Taking more Lynagex XR than prescribed

Tell your doctor or go to the nearest hospital emergency department immediately. Take the package or container (bottle) with you. After taking more Lynagex XR than prescribed, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Lynagex XR

It is important to take Lynagex XR regularly at the same time every day. If you miss a dose, take it as soon as possible, always after a meal, unless it is almost time for the next dose. In this case, continue treatment as prescribed.
Do not take a double dose to make up for a missed dose.

Stopping Lynagex XR

Do not stop taking Lynagex XR suddenly. If you want to stop taking Lynagex XR, talk to your doctor first. The doctor will tell you how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. You should know that after stopping short-term or long-term treatment with Lynagex XR, certain side effects may occur, known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if you have taken Lynagex XR for a longer period. If you experience withdrawal symptoms, contact your doctor.
If you have any further questions or concerns about taking this medicine, 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 swings, confusion, disorientation, decreased sexual interest, irritability.
• Difficulty concentrating, clumsiness, memory impairment, loss of memory, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
• Blurred vision, double vision.
• Peripheral vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension.
• Difficulty achieving an erection.
• Body swelling, including limb swelling.
• Feeling of intoxication, ataxia.
• 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 self-perception, restlessness, depression, excitement, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation.
• Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, burning sensation, tremor when moving, impaired consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise.
• Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Sudden flushing of the face, sudden hot flushes.
• Breathing difficulties, feeling of dryness in the nasal mucosa, feeling of a blocked nose.
• Increased salivation, heartburn, feeling of numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle tremors, joint swelling, muscle stiffness, pain, including muscle pain, neck pain.
• Chest pain.
• Difficulty urinating or painful urination, urinary incontinence.
• Weakness, thirst, chest tightness.
• Blood test and liver function changes (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood).
• 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:

• Changed sense of smell, feeling of image rocking, changed sense of depth, bright vision, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, throat constriction, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slowed or limited movements.
• Difficulty writing.
• Ascites.
• Fluid in the lungs.
• Seizures.
• Changes in ECG corresponding to heart rhythm disturbances.
• Muscle damage.
• Breast discharge, breast hypertrophy, gynecomastia.
• Amenorrhea.
• 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, plate-like, or round patches on the torso, often with blisters, peeling, ulcers, and inflammation in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe 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 similar to Parkinson's disease, such as tremors, slowed movement (decreased 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 Lynagex XR ("drug dependence")

Be aware that after stopping short-term or long-term treatment with this medicine, certain side effects may occur, known as withdrawal symptoms (see "Stopping Lynagex XR").

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

Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the severity of these effects may be greater when such medicines are taken concomitantly.
After the marketing of pregabalin in the form of prolonged-release tablets, the following side effects have also been reported: breathing difficulties, shallow breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Lynagex XR

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.
HDPE container
Lynagex XR 82.5 mg
Do not store above 30°C.
Lynagex XR 165 mg and Lynagex XR 330 mg
There are no special storage instructions for this medicine.
Al-Al blisters
Lynagex XR 82.5 mg, Lynagex XR 165 mg, and Lynagex XR 330 mg
There are no special storage instructions for this medicine.
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 Lynagex XR contains

The active substance is pregabalin.
Lynagex XR, 82.5 mg, prolonged-release tablets
Each prolonged-release tablet contains 82.5 mg of pregabalin.
Lynagex XR, 165 mg, prolonged-release tablets
Each prolonged-release tablet contains 165 mg of pregabalin.
Lynagex XR, 330 mg, prolonged-release tablets
Each prolonged-release tablet contains 330 mg of pregabalin.
The other ingredients are:

• Tablet core:hypromellose type 2208, hydroxypropylcellulose, methacrylic acid butyl copolymer, crospovidone, magnesium stearate, colloidal silicon dioxide, anhydrous
• Tablet coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

Lynagex XR 165 mg, prolonged-release tabletsalso contain iron oxide, yellow (E172) and iron oxide, red (E172)
Lynagex XR 330 mg, prolonged-release tabletsalso contain iron oxide, red (E172) and iron oxide, black (E172)

• Printing ink:shellac (20% esterified) ethanol solution 45%, iron oxide, black (E172), propylene glycol.

What Lynagex XR looks like and contents of the pack

Lynagex XR, 82.5 mg, prolonged-release tablets
White, oval tablet without a dividing line, without printing on one side and with black printing "ALV 379" on the other side, 19 mm long, 12 mm wide, and approximately 7 mm thick.
Lynagex XR, 165 mg, prolonged-release tablets
Yellow, oval tablet without a dividing line, without printing on one side and with black printing "ALV 380" on the other side, 19 mm long, 12 mm wide, and approximately 7 mm thick.
Lynagex XR, 330 mg, prolonged-release tablets
Pink, oval tablet without a dividing line, without printing on one side and with black printing "ALV 381" on the other side, 19 mm long, 12 mm wide, and approximately 8 mm thick.
Lynagex XR is available:

• White, round HDPE container with a PP child-resistant cap and a desiccant in a carton box. The pack contains 30 prolonged-release tablets.
• Al/OPA/Al/PVC blisters in a carton box. The pack contains 30 prolonged-release tablets.

Marketing authorization holder and importer

Marketing authorization holder:

Exeltis Poland Sp. z o.o.
Szamocka Street 8
01-748 Warsaw
phone: +48 22 822 74 31

Importer:

KeVaRo Group Ltd
9 Tsaritsa Elenora Street
Office 23
1618 Sofia
Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal
Sindocron
France
Lusama LP
Italy
Lindone
Poland
Lynagex XR
Slovakia
Neudolox
Austria
Lynagex
Belgium
Lynagex
Romania
Lynagex
Netherlands
Lynagex
Date of last revision of the leaflet:05.2025