LINDONE 82.5 mg Extended-release tablet

Зміст інструкції

1. Lindone 82.5 mg prolonged-release tablets, 165 mg prolonged-release tablets, 330 mg prolonged-release tablets
   1. What is Lindone and what it is used for
   2. What you need to know before taking Lindone
   3. How to take Lindone
   4. Possible side effects
   5. How to store Lindone
   6. Package contents and other information

Lindone 82.5 mg prolonged-release tablets, 165 mg prolonged-release tablets, 330 mg prolonged-release tablets

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lindone is and what it is used for
• 2. What you need to know before you take Lindone
• 3. How to take Lindone
• 4. Possible side effects
• 5. How to store Lindone
• 6. Contents of the pack and other information

1. What is Lindone and what it is used for

Lindone belongs to a group of medicines used to treat neuropathic pain in adults.
Lindone is used to treat chronic, long-lasting pain caused by damage to the nervous system.
Several diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, throbbing, pulsating pain, shooting pain, sharp pain, cramping pain, suffering, tingling, numbness,
stinging pain. Peripheral and central neuropathic pain can also be associated with changes
in mood, sleep disturbances, fatigue (tiredness) and can have an impact on physical and social activity and
on overall quality of life.

2. What you need to know before taking Lindone

Do not take Lindone
if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lindone.

• In some patients treated with Lindone, symptoms indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with pregabalin. Stop taking the medicine and contact your doctor immediately if you develop any of the symptoms related to these serious skin reactions, described in section 4.
• Pregabalin, the active ingredient in Lindone, has been associated with dizziness and drowsiness, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should

be careful until you are familiar with the effects the medicine may have on you.

• This medicine can cause blurred or loss of vision or other changes in vision, many of which are transient. If you experience any changes in vision, contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust their diabetes medications.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of pregabalin and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with pregabalin; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with thismedicine, you should inform your doctor.
• There have been reports of kidney failure in some patients treated with pregabalin. If you notice a decrease in urination during treatment with this medicine, you should inform your doctor, as stopping the use of this medicine may improve this condition.
• A small number of patients treated with antiepileptic medicines such as pregabalin have experienced suicidal thoughts and self-harm or shown suicidal behaviour. At any time, if you have thoughts or behaviours of this kind, contact your doctor immediately.
• When this medicine is used together with other medicines that can cause constipation (such as some types of pain medicines), gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, tell your doctor if you have a history of alcohol, prescription drug or illegal substance abuse or dependence, as this may indicate that you are at greater risk of becoming dependent on this medicine.
• Cases of seizures have been reported when taking pregabalin or shortly after stopping it. If you experience seizures, contact your doctor immediately.
• Cases of decreased brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other conditions. Tell your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of difficulty breathing have occurred. If you suffer from nervous system disorders, respiratory diseases, kidney impairment or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Tell your doctor if you have difficulty breathing or shallow breathing.

Dependence
Some people may become dependent on pregabalin (i.e., feel the need to
continue taking the medicine). They may experience withdrawal effects when they stop
using this medicine (see section 3, “How to take Lindone” and “If you stop taking
Lindone”). If you are concerned about the possibility of developing a dependence on this
medicine, it is important that you talk to your doctor.
If you notice any of the following signs while taking Lindone, it could be a sign that
you have developed a dependence on the medicine:

• You feel the need to take the medicine for longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine, you do not feel well and feel better when you start taking it again. If you notice any of these signs, talk to your doctor to discuss the best course of treatment

for you, including when it is appropriate to stop taking it and how to do so safely.

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

Other medicines and Lindone
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Lindone and other medicines can influence each other (interaction). When taken
together with other medicines that have sedative effects (including opioids), Lindone can enhance
these effects and may cause respiratory failure, coma and death. The intensity of dizziness,
drowsiness and reduced concentration may increase if Lindone is taken
together with other medicines containing:

• Oxycodone - (used as a pain reliever)
• Lorazepam - (used to treat anxiety)
• Alcohol

Lindone can be taken at the same time as oral contraceptives.

Lindone with food, drinks and alcohol
Do not drink alcohol while taking this medicine.
For information regarding treatment with Lindone in relation to food, see section 3,
“How to take Lindone”.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be taken during pregnancy or breastfeeding, unless your doctor has told
you otherwise. Use of pregabalin during the first 3 months of pregnancy may cause birth defects in
the unborn child that require medical care. In one study examining data from women in Nordic
countries who had taken pregabalin during the first 3 months of pregnancy, 6 children out of 100
had these birth defects, compared with 4 children out of 100 born to women not treated with
pregabalin in the study. Anomalies of the face (orofacial clefts), eyes, nervous system (including the
brain), kidneys and genitals have been reported.
Women of childbearing potential should use effective contraception.

Driving and operating machinery
Lindone can cause dizziness, drowsiness and reduced concentration. You should not drive,
operate complex machinery or engage in potentially dangerous activities until you
have determined whether this medicine affects your ability to perform these activities.

3. How to take Lindone

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Lindone is for oral use only. Take Lindone once a day, in the evening, directly after the evening
meal. Swallow the tablet whole with water. Do not break, crush or chew the tablet. The tablet must not be
broken as this could affect its characteristics.
The doctor will determine the appropriate dose for you.

• Take the number of tablets prescribed by your doctor.
• The dose, which has been adapted for you and your condition, generally ranges from 165 mg to 660 mg per day.

If you feel that the effect of Lindone is too strong or too weak, talk to your doctor or
pharmacist.
If you are elderly (over 65 years of age), you should take this medicine normally unless you have
kidney problems.
The doctor may prescribe you a different dosage and/or a different dose if you have kidney problems.
Continue to take Lindone until your doctor tells you to stop treatment.

Switching from immediate-release pregabalin medicines to prolonged-release pregabalin
medicines such as Lindone:
When switching from immediate-release pregabalin to prolonged-release pregabalin, such as this
medicine, your doctor will explain how to do it. They will tell you to follow these steps:

• take the morning dose of immediate-release pregabalin as prescribed
• then start taking Lindone after the evening meal Do not switch from one medicine to another unless your
  doctor has told you to do so. They will also prescribe you the appropriate dose for your condition. If you
  have further questions or concerns, talk to your doctor.

If you take more Lindone than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring with you the
box or container (bottle) of Lindone tablets. You may feel sleepy, confused, agitated or restless, as you
have taken more Lindone than you should have. Seizures and loss of consciousness (coma) have also
been reported.

If you forget to take Lindone
It is important to take Lindone tablets regularly every day at the same time. If you forget to take a dose,
take it as soon as you remember, always after some food, unless it is time to take the next dose. In this
case, take the next dose as scheduled. Do not take a double dose to make up for a missed dose.

If you stop taking Lindone
Do not suddenly stop taking Lindone. If you want to stop taking this medicine, talk to your doctor first.
The doctor will explain how to do it. If treatment is stopped, it must be done gradually over at least
1 week. You should know that after stopping long-term and short-term treatment with Lindone, you may
experience some undesirable effects, so-called withdrawal effects. These effects include sleep
disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness,
depression, suicidal or self-harm thoughts, pain, sweating and dizziness. These effects may occur
more frequently or severely if you have taken Lindone for a longer period of time. If you experience
withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability.
• Disturbances in attention, clumsiness, impaired memory, memory loss, tremor, difficulty speaking, sensation of tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea and abdominal bloating.
• Difficulty in erection.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, abnormalities in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in the limbs.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty with ideation, increased sexual interest, sexual problems, including inability to reach orgasm, delayed ejaculation.
• Changes in vision, abnormalities in eye movement, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, tearing, eye irritation.
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Flushing, hot flashes.
• Difficulty breathing, nasal dryness, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, swollen joints, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, incontinence.
• Weakness, thirst, feeling of tightness in the chest.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine-aminotransferase, increased aspartate-aminotransferase, reduced platelet count, neutropenia, increased creatinine, reduced potassium).
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rare: may affect up to 1 in 1,000

• Alteration of smell, sensation of oscillation of the visual field, altered depth perception, visual brilliance, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, feeling of constriction in the throat, swelling of the tongue.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing appropriately.
• Increased fluid in the abdomen.
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast growth in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions, which may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by reddish, non-raised patches on the trunk, shaped like targets or circles, often with central blisters, skin exfoliation, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes)
• Parkinsonism, i.e. symptoms similar to Parkinson's disease such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).

Very rare: may affect up to 1 in 10,000:

• Liver failure.
• Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated based on available data

• Becoming dependent on Lindone (“drug dependence”).

After stopping short- or long-term treatment with this medicine, you should know that
you may experience some side effects, so-called discontinuation effects (see “If
you stop taking Lindone”).

In case of swelling of the face or tongue, or in case of redness of the skin and the onset of
blisters and skin exfoliation, seek immediate medical attention.
Some side effects, such as drowsiness, may be more common because patients with
spinal cord injury may be treated with other medicines to treat, for example,
pain or spasticity, which have side effects similar to those of pregabalin and the severity of
these effects may increase when these medicines are taken together.
The following adverse reaction has been reported in the post-marketing phase of the medicine:
difficulty breathing, shallow breaths.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lindone

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 package or container
(bottle). The expiry date refers to the last day of that month.

For 82.5 mg: Do not store at a temperature above 30°C.

For 165 mg and 330 mg: This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lindone contains
The active ingredient is pregabalin.

Lindone 82.5 mg prolonged-release tablet
Each prolonged-release tablet contains 82.5 mg of pregabalin.

Lindone 165 mg prolonged-release tablet
Each prolonged-release tablet contains 165 mg of pregabalin.

Lindone 330 mg prolonged-release tablet
Each prolonged-release tablet contains 330 mg of pregabalin.
The other ingredients are:

• Tablet contents :hypromellose, hydroxypropyl cellulose (E 463), basic butylated methacrylate copolymer (E 1205), crospovidone (Type A), magnesium stearate (E 470b), anhydrous colloidal silica (E 551),
• Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E171), macrogol (E 1521) and talc (E 553b). Lindone 165 mg prolonged-release tabletalso contains yellow iron oxide (E 172) and red iron oxide (E 172)

Lindone 330 mg prolonged-release tablet
also contains red iron oxide (E 172) and black iron oxide (E 172)

• Ink: Shellac, black iron oxide (E172), propylene glycol (E1520)

Description of the appearance of Lindone and package contents

Lindone 82.5 mg prolonged-release tablet
White, oval tablet, without markings, without writing on one side and imprinted “ALV 379” with
black ink on the other side, with a length of 19 mm, width of 12 mm and thickness
of approximately 7 mm.

Lindone 165 mg prolonged-release tablet
Yellow, oval tablet, without markings, without writing on one side and imprinted “ALV 380” with
black ink on the other side, with a length of 19 mm, width of 12 mm and thickness
of approximately 7 mm.

Lindone 330 mg prolonged-release tablet
Pink, oval tablet, without markings, without writing on one side and imprinted “ALV 381” with
black ink on the other side, with a length of 19 mm, width of 12 mm and thickness
of approximately 8 mm.
Lindone is available in:

• Cardboard box containing a white HDPE round bottle with a wide mouth and child-resistant closure with lining and desiccant cylinder.
• Original packaging with 30 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Kevaro Group Ltd
9 Tzaritza Elenora Str., Office 23
Sofia, 1618, Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria Lynagex 82.5 mg Retardtabletten
Lynagex165 mg Retardtabletten
Lynagex 330 mg Retardtabletten
Belgium Lynagex 82.5 mg Retardtabletten/comprimés à libération
prolongée/tabletten met verlengde afgifte
Lynagex 165 mg Retardtabletten/comprimés à libération
prolongée/tabletten met verlengde afgifte
Lynagex 330 mg Retardtabletten/comprimés à libération
prolongée/tabletten met verlengde afgifte
Denmark Lusama 82.5 mg depottabletter
Lusama 165 mg depottabletter
Lusama 330 mg depottabletter
Finland Lusama 82.5 mg depottabletti
Lusama 165 mg depottabletti
Lusama 330 mg depottabletti
France Neudolox 82.5 mg comprimé à libération prolongée
Neudolox 165 mg comprimé à libération prolongée
Neudolox 330 mg comprimé à libération prolongée
Italy Lindone
Norway Lusama 82.5 mg depottabletter
Lusama 165 mg depottabletter
Lusama 330 mg depottabletter
Netherlands Lynagex 82.5 mg tabletten met verlengde afgifte
Lynagex 165 mg tabletten met verlengde afgifte
Lynagex 330 mg tabletten met verlengde afgifte
Poland Lynagex XR 82.5 mg tabletki o przedłużonym uwalnianiu
Lynagex XR 165 mg tabletki o przedłużonym uwalnianiu
Lynagex XR 330 mg tabletki o przedłużonym uwalnianiu
Portugal Sindocron 82.5 mg Comprimido de libertação prolongada
Sindocron 165 mg Comprimido de libertação prolongada
Sindocron 330 mg Comprimido de libertação prolongada
Romania Lynagex 82.5 mg comprimate cu eliberare prelungită
Lynagex 165 mg comprimate cu eliberare prelungită
Lynagex 330 mg comprimate cu eliberare prelungită
Slovakia Neudolox 82.5 mg tablety s predĺženým uvoľňovaním
Neudolox 165 mg tablety s predĺženým uvoľňovaním
Neudolox 330 mg tablety s predĺženým uvoľňovaním
Sweden Lusama 82.5 mg depottabletter
Lusama 165 mg depottabletter
Lusama 330 mg depottabletter