Lynagex 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
Please read 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 give it to anyone else. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Lynagex XR is and what it is used for
2. What you need to know 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 Lynagex XR is and what it is 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. Various conditions such as diabetes or shingles can cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, stabbing, tingling, aching, pulsing, cramping, numbness, or pins and needles. 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.

2. Important information before using Lynagex XR

When not to use Lynagex XR
Do not use 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 treatment with Lynagex XR, discuss this with your doctor or pharmacist.

• Some patients taking Lynagex XR have experienced symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.
• Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of pregabalin. If the patient develops any symptoms of severe skin reactions listed in section 4, pregabalin should be discontinued immediately and medical help should be sought without delay.
• The use of pregabalin, the active substance in Lynagex XR, has been associated with dizziness and drowsiness, which may increase the risk of accidental injury (e.g. falls) in elderly patients. Therefore, caution should be exercised until the patient's response to the medicine is known.
• This medicine may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. 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 required.
• Certain adverse effects such as drowsiness may be more frequent, as patients with spinal cord injury may be taking other medications (e.g. painkillers or muscle relaxants) that have similar side effects to pregabalin, and the combined effect may be greater when such medicines are taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin, particularly elderly patients with cardiovascular disorders. Before using this medicine, inform your doctor if you have ever had heart disease.
• Cases of kidney failure have been reported in some patients taking pregabalin. If the patient notices a decrease in the frequency of urination while taking 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 have exhibited suicidal behaviour. If such thoughts or behaviours occur at any time, contact your doctor immediately.
• If this medicine is used together with other medicines that may cause constipation (such as certain painkillers), gastrointestinal problems (e.g. constipation, bowel obstruction, or intestinal paralysis) may occur. Inform your doctor if the patient experiences constipation, especially if there is a history of constipation.
• 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, as this may indicate an increased risk of dependence on this medicine.
• 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 illnesses who were treated with pregabalin. Inform your doctor about all previous serious illnesses, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction, or is aged 65 years or older, the doctor may recommend an alternative dosing regimen. If the patient develops breathing difficulties or shallow breathing, contact your doctor.

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

• Needing to take the medicine for a longer period than prescribed by the doctor
• Feeling the need to take a higher dose than prescribed
• Taking the medicine for reasons other than those for which it was prescribed
• Repeated unsuccessful attempts to stop or control taking the 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 discontinue treatment 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.

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

• Oxycodone – (a painkiller)
• Lorazepam – (a medicine used for anxiety)
• Alcohol

Lynagex XR may be used together with oral contraceptives.

Taking Lynagex XR with food, drink, and alcohol
Alcohol should not be consumed while taking Lynagex XR. For information on taking Lynagex XR in relation to meals, please refer to section 3, "How to use Lynagex XR".

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding unless otherwise directed by a doctor. Use of pregabalin during the first trimester of pregnancy may cause congenital malformations in the unborn child requiring treatment. A Scandinavian study analyzing data from women who took pregabalin during the first trimester of pregnancy showed congenital malformations 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.

Driving and operating machinery
Lynagex XR 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 is known.

3. How to use Lynagex XR

This medicine should always be taken exactly as instructed by the doctor. If in doubt, consult
the doctor or pharmacist.
Lynagex XR is intended for oral use only. The patient should take Lynagex XR once daily,
immediately after the evening meal. Tablets should be swallowed whole with water. Do not
divide, crush, or chew the tablets. Do not break the tablets, as this may affect the extended-release
properties.
The doctor will determine the appropriate dose for the patient.

• The patient should take the number of tablets prescribed by the doctor.
• The recommended dose for the patient will range from 165 mg to 660 mg per day.

If the patient feels that Lynagex XR is too strong or not strong enough, they should inform the
doctor or pharmacist.
Patients over 65 years of age should take Lynagex XR according to the recommended regimen,
unless they have kidney disease.
In patients with impaired renal function, the doctor may decide on a different dosing regimen
and/or adjust the dose of the medicine.
Lynagex XR should be taken for as long as the doctor recommends. Treatment should only be
discontinued on the doctor's advice.
Switching from immediate-release pregabalin to extended-release pregabalin, such as Lynagex XR
When switching from immediate-release pregabalin to extended-release pregabalin, such as
this medicine, the doctor will instruct the patient how to do so. The doctor will inform the patient
about the following steps:

• take the morning dose of immediate-release pregabalin as directed,
• start treatment with Lynagex XR after the evening meal.

Do not change medications unless instructed by the doctor. The doctor will also determine the
appropriate dose based on the patient's condition.
If the patient has any further questions or doubts, they should speak with their doctor.
Taking more Lynagex XR than prescribed
Inform the doctor or go immediately to the nearest hospital emergency department. Bring the
packaging or container (bottle) of Lynagex XR with you. After taking more than the prescribed
dose of Lynagex XR, 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 time each day. If a dose is missed, it
should be taken as soon as possible, always after a meal, unless the next dose is due soon. In
that case, continue treatment according to the prescribed schedule. Do not take a double dose to
make up for a missed dose.
Stopping Lynagex XR
Do not suddenly stop taking Lynagex XR. If the patient wishes to discontinue Lynagex XR, they
should first discuss this with their doctor. The doctor will advise on how to do so. If treatment
needs to be stopped, it should be done gradually over at least one week. It should be known that
after stopping short- or long-term treatment with Lynagex XR, certain adverse effects, known as
withdrawal symptoms, may occur. These symptoms include sleep disturbances, headache, nausea,
feelings of anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of self-harm
or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or
severe if the patient has been taking Lynagex XR for a long time. If withdrawal symptoms occur,
contact the doctor.
If there are any further doubts regarding the use of this medicine, consult the 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 occur in more than 1 in 10 patients:

Dizziness, somnolence, headache.

Common – may occur in up to 1 in 10 patients:

• Increased appetite.
• Euphoria, confusion, disorientation, decreased libido, irritability.
• Difficulty concentrating, clumsiness, memory impairment, amnesia, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling.
• Blurred vision, double vision.
• Peripheral dizziness, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, feeling of abdominal bloating.
• Difficulty achieving erection.
• Swelling of the body, including limbs.
• Feeling of alcohol intoxication, abnormal gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon – may occur in up to 1 in 100 patients:

• 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 problems including inability to achieve orgasm, delayed ejaculation.
• Vision changes, abnormal eye movements, visual disturbances including tunnel vision, perception 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, eye swelling, eye pain, impaired eye movement, tearing, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Sudden facial flushing, sudden hot flushes.
• Breathing difficulties, dryness of nasal mucosa, sensation of blocked nose.
• Increased salivation, heartburn, 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 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 levels, decreased blood potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, catarrh, nosebleeds, cough, snoring.
• Painful menstruation.
• Cold hands and feet.

Rare – may occur in up to 1 in 1,000 patients:

• Altered sense of smell, sensation of image oscillation, altered depth perception, vivid vision, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slowed or limited movements.
• Difficulty with writing function.
• Ascites.
• Pulmonary edema.
• Seizures.
• ECG changes indicating disturbances in heart rhythm.
• Muscle damage.
• Nipple discharge, gynecomastia, breast enlargement in males.
• Absence of menstruation.
• Kidney failure, reduced urine volume, urinary retention.
• Decreased white blood cell count.
• Abnormal behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include breathing difficulties, eye inflammation (keratitis), and severe skin reactions characterised by red, flat, disc-shaped or circular rashes on the trunk, often with blisters in the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and around the eyes. Such 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).
• Parkinsonism, i.e. symptoms resembling Parkinson's disease, such as tremor, bradykinesia (reduced ability to move) and rigidity (muscle stiffness).

Very rare – may occur in up to 1 in 10,000 patients:

• Liver failure.
• Hepatitis.

Frequency unknown: frequency cannot be estimated from available data:

• Dependence on Lynagex XR (‘drug dependence’).

It should be noted that certain adverse reactions, known as withdrawal symptoms, may occur after short- or long-term discontinuation of this medicine (see section “Discontinuing treatment with Lynagex XR”).

If facial or tongue swelling, skin redness, blisters or skin peeling occur, seek immediate medical help.

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

Following the introduction of pregabalin in extended-release tablets, the following adverse reactions have also been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lynagex XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blister pack, or container (bottle) after EXP. The expiry date refers to the last day of the stated month.
HDPE container
Lynagex XR 82.5 mg
Do not store above 30°C.
Lynagex XR 165 mg and Lynagex XR 330 mg
No special storage instructions for this medicine.
Al-Al blisters
Lynagex XR 82.5 mg, Lynagex XR 165 mg and Lynagex XR 330 mg
No special storage instructions for this medicine.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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, basic butyl methacrylate copolymer, crospovidone, magnesium stearate, colloidal silicon dioxide, anhydrous
• Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

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

• Printing ink: shellac (20% esterified) ethanolic 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 break line, no printing on one side and black print "ALV 379" on the other side, 19 mm in length, 12 mm in width and approximately 7 mm thick.
Lynagex XR, 165 mg, prolonged-release tablets
Yellow, oval tablet without a break line, no printing on one side and black print "ALV 380" on the other side, 19 mm in length, 12 mm in width and approximately 7 mm thick.
Lynagex XR, 330 mg, prolonged-release tablets
Pink, oval tablet without a break line, no printing on one side and black print "ALV 381" on the other side, 19 mm in length, 12 mm in width and approximately 8 mm thick.

Lynagex XR is available as:

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

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
tel: +48 22 822 74 31

Importer:
KeVaRo Group Ltd
9 Tsaritsa Elenora Str.
Office 23
1618 Sofia
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Sindocron
France: Nelypra
Italy: Lindone
Poland: Lynagex XR
Slovakia: Lynagex
Austria: Lynagex
Belgium: Lynagex
Romania: Lynagex
Netherlands: Lynagex