Linagex Xr

Leaflet accompanying the packaging: 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

You should carefully read the contents of the leaflet 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 adult patients.
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, pulsating, shooting, stabbing, sharp pain, cramps, soreness, tingling, or numbness. 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.

2. Important information before taking Lynagex XR

When not to take Lynagex XR

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 Lynagex XR, the patient should discuss it with their doctor or pharmacist.

• In some patients taking Lynagex XR, symptoms suggesting an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin use. If the patient experiences any of the symptoms of severe skin reactions listed in section 4, they should stop taking pregabalin and seek medical attention immediately.
• Pregabalin, the active substance of Lynagex XR, has been associated with dizziness and somnolence: this may increase the frequency of accidental injuries (falls) in the elderly. Therefore, caution should be exercised until the patient is aware of the possible effects of the medicine.
• This medicine may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the patient should inform their doctor immediately.
• In patients with diabetes who gain weight during pregabalin treatment, a change in anti-diabetic treatment may be necessary.
• Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to pregabalin, and the intensity of these effects may be greater when such medicines are taken concomitantly.
• Heart failure has been reported in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders.

Before taking this medicine, the patient should inform their doctor about any history of heart disease.

• Renal failure has been reported in some patients taking pregabalin. If the patient notices a decrease in urine output while taking pregabalin, they should inform their 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 the patient has ever had such thoughts or behaviors, they should contact their doctor immediately.
• If this medicine is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (e.g., constipation, obstruction, or paralysis of the intestines) may occur. The patient should inform their doctor if they experience constipation, especially if they are prone to it.
• Before starting to take this medicine, the patient should inform their doctor if they 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.
• Seizures have been reported during pregabalin treatment or shortly after discontinuation. If seizures occur, the patient should contact their doctor immediately.
• Encephalopathy has been reported in some patients with underlying conditions who took pregabalin. The patient should inform their doctor about all serious illnesses they have had, including liver or kidney disease.
• Breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney disorders, or is over 65 years old, their doctor may recommend a different dosing schedule. If the patient experiences breathing difficulties or shallow breathing, they should contact their doctor.

Dependence
Some people may become dependent on pregabalin (need to continue taking the medicine).
After stopping Lynagex XR, the patient may experience withdrawal symptoms (see section 3 "How to take Lynagex XR" and "Stopping Lynagex XR"). If the patient is concerned that they may become dependent on this medicine, they should talk to their doctor.
If the patient experiences 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 or control

taking this medicine

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

If the patient experiences any of these symptoms, they should talk to their 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 Lynagex XR 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might 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, somnolence, 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

While taking Lynagex XR, the patient should not drink alcohol. For information on taking Lynagex XR with food, the patient should refer to section 3, "How to take Lynagex XR".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy or breastfeeding, unless the doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby that require treatment. A Scandinavian study analyzing data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of every 100 babies born, whereas in women who did not take 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, central 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, somnolence, and decreased concentration. The patient should not drive, operate complex machinery, or perform potentially hazardous activities until they have determined how this medicine affects their ability to perform these activities.

3. How to take Lynagex XR

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Lynagex XR is for oral use only. The patient should take Lynagex XR once a day, immediately after the evening meal. The tablets should be swallowed whole with water. The tablets should not be divided, crushed, or chewed. The tablets should not be broken, as this may affect the prolonged-release properties.
The doctor will determine the dose that is right for the patient.

• The patient should take the number of tablets prescribed by the doctor.
• The recommended dose for the patient will be between 165 mg and 660 mg per day.

If the patient feels that Lynagex XR is too strong or too weak, they should inform their doctor or pharmacist.
Patient over 65 years old should take Lynagex XR as prescribed, unless they have kidney problems.
In patients with impaired renal function, the doctor may decide on a different dosing schedule and/or adjust the dose of the medicine.
Lynagex XR should be taken for as long as the doctor prescribes, and the treatment should only be stopped on the doctor's advice.
Switching from immediate-release pregabalin to prolonged-release pregabalin, such as Lynagex XR

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

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

The patient should not change medicines unless their doctor tells them to. The doctor will also indicate the appropriate dose, depending on the patient's condition.
If the patient has any further questions or doubts about taking this medicine, they should talk to their doctor.

Taking a higher dose of Lynagex XR than prescribed

The patient should inform their doctor or go to the nearest hospital emergency department immediately. They should take the packaging or container (bottle) of Lynagex XR with them. After taking a higher dose of Lynagex XR than prescribed, the patient may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

Missing a dose of Lynagex XR

It is important to take Lynagex XR regularly at the same times every day. If the patient misses a dose, they should take it as soon as possible, always after a meal, unless it is almost time for the next dose. In this case, the patient should continue with the prescribed schedule.
The patient should not take a double dose to make up for a missed dose.

Stopping Lynagex XR

The patient should not stop taking Lynagex XR suddenly. If the patient wants to stop taking Lynagex XR, they should first talk to their doctor. The doctor will tell them how to do it. If the treatment needs to be stopped, it should be done gradually over at least one week. The patient should be aware that after stopping short-term or long-term treatment with Lynagex XR, they may experience certain side effects, 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 more severe if the patient has taken Lynagex XR for a longer period. If the patient experiences withdrawal symptoms, they should contact their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

Dizziness, somnolence, headache.

Common - may affect up to 1 in 10 people:

• Increased appetite.
• Mood swings, 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.
• Peripheral vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension.
• Difficulty achieving an erection.
• Body swelling, including swelling of limbs.
• 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, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased libido, 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, feeling of burning, tremors 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.
• Cardiac arrhythmias, tachycardia, hypotension, hypertension, changes in heart rhythm, heart failure.
• Sudden flushing of the skin, hot flashes.
• 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 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 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, urticaria, rhinitis, epistaxis, cough, snoring.
• Painful menstruation.
• Cold hands and feet.

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

• Altered sense of smell, feeling of rocking, altered sense of depth, vivid vision, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, throat constriction, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slowed or restricted movements.
• Difficulty writing.
• Ascites.
• Fluid in the lungs.
• Seizures.
• Changes in ECG corresponding to arrhythmias.
• 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 trunk, often with blisters, peeling, ulcers, and erosions 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 (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 Lynagex XR ("drug dependence")

The patient should be aware that after stopping short-term or long-term treatment with Lynagex XR, they may experience certain side effects, known as withdrawal symptoms (see "Stopping Lynagex XR").

In case of swelling of the face or tongue, or redness of the skin and appearance of blisters or peeling, the patient should seek medical attention immediately.

Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to pregabalin, and the intensity 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lynagex XR

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the carton or bottle after EXP. The expiry date refers to the last day of the month.
HDPE container
Lynagex XR 82.5 mg
The patient should not store the medicine at temperatures above 30°C.
Lynagex XR 165 mg and Lynagex XR 330 mg
There are no special precautions for storage.

• Al/OPA/Al/PVC blisters in a carton box.
• There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. These measures will help protect the environment.

6. Contents of the packaging and other information

What Lynagex XR contains

The active substance of Lynagex XR 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 ester copolymer, crospovidone, magnesium stearate, colloidal silica, 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 score 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 score 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 score 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 closure and a desiccant in a carton box. The packaging contains 30 prolonged-release tablets.
• Al/OPA/Al/PVC blisters in a carton box. The packaging 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 Yoanna 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