Lindone

PACKAGE LEAFLET

Package leaflet: Information for the user

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

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 Lindone is 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 long-lasting chronic pain caused by damage to the nervous system.
Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster.
Pain sensations may be described as heat, burning, pulsations, throbbing pain, shooting pain, sharp pain, cramping pain, discomfort, tingling, numbness, and stabbing pain. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may impact physical and social activities and overall quality of life.

2. What you should know before taking Lindone

Do not take Lindone
if you are allergic to pregabalin or to any of the other ingredients of this medicine (listed in
paragraph 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lindone.

• In some patients treated with Lindone, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these reactions occur, you must contact your doctor immediately.

• Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking the medicine and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, described in section 4.

• Pregabalin, the active substance in Lindone, has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you must
  exercise caution until you become familiar with the effects this
  medicine may have.

• This medicine may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbance, contact your doctor immediately.

• In some diabetic patients who gain weight during treatment with pregabalin, it may be necessary to adjust their diabetes medications.

• Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to 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; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicine, you must inform your doctor.

• There have been reports of kidney failure in some patients treated with pregabalin. If during treatment with this medicine you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of the medicine.

• A small number of patients treated with antiepileptic medicines such as pregabalin have experienced suicidal thoughts and self-harming thoughts or exhibited suicidal behaviour. If at any time you have thoughts or behaviours of this kind, contact your doctor immediately.

• When this medicine is used together with other medicines that may cause constipation (such as certain types of pain medication), gastrointestinal problems (e.g. constipation, bowel obstruction or paralysis) may occur. Inform your doctor if you have constipation, especially if you are prone to this problem.

• Before taking this medicine, inform your doctor if you have a history of alcohol, prescription medicine, or illegal substance abuse or dependence, as this may indicate that you are at higher risk of becoming dependent on this medicine.

• Cases of seizures have been reported while taking pregabalin or shortly after discontinuation. If seizures occur, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have occurred in some patients taking pregabalin when they have other conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.

• Cases of breathing difficulties have been reported. If you suffer from nervous system disorders, respiratory conditions, kidney impairment, or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform 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 symptoms 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 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 dependence on the medicine:

• You feel the need to take the medicine longer than recommended by your doctor

• You feel the need to take a higher dose than recommended

• You are using the medicine for reasons different from those for which it was prescribed

• You have made repeated unsuccessful attempts to stop or control use of the medicine

• When you stop taking the medicine, you feel unwell and feel better when you start taking it again
  If you notice any of these signs, talk to your doctor to discuss the best treatment approach
  for you, including when it is appropriate to stop taking the medicine 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
  Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
  Lindone and other medicines may interact with each other. When taken together with other medicines that have sedative effects (including opioids), Lindone may enhance these effects and could 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 painkiller)

• Lorazepam – (used to treat anxiety)

• Alcohol

Lindone may be taken together with oral contraceptives.
Lindone with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment with 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the newborn that require medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations, compared to 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including the brain), kidney, and genital abnormalities have been reported.
Women of childbearing potential must use an effective method of contraception.
Driving and using machines
Lindone may 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 impairs your ability to perform these tasks.

3. How to take Lindone

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Lindone is for oral use only. Take Lindone once daily in the evening, immediately after your evening meal. Swallow the tablet whole with water. Do not split, crush, or chew the tablet. The tablet must not be broken, as this could affect its properties.
Your doctor will determine the appropriate dose for you.

• Take the number of tablets prescribed by your doctor.
• The dose, which has been tailored to you and your condition, generally ranges between 165 mg and 660 mg daily.

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

Switching from immediate-release pregabalin medicines to extended-release pregabalin medicines such as Lindone:
When switching from immediate-release pregabalin to extended-release pregabalin, such as this medicine, your doctor will explain how to do so. You will be instructed to follow these steps:

• take your 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. Your doctor will also prescribe the appropriate dose for your condition. If you have any further questions or doubts, speak with your doctor.

If you take more Lindone than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the box or container (bottle) of Lindone tablets with you. You may feel drowsy, confused, agitated, or restless because you have taken more Lindone than you should. 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 almost time for your next dose. In that case, take the next dose as scheduled. Do not take a double dose to make up for the forgotten dose.

If you stop taking Lindone
Do not stop taking Lindone suddenly. If you wish to stop taking this medicine, talk to your doctor first. Your doctor will advise you on how to do this. If treatment is to be discontinued, the discontinuation must be carried out gradually over at least 1 week. You should know that after stopping long-term or short-term treatment with Lindone, you may experience some unwanted effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, depression, suicidal thoughts or self-harm, 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 must contact your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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.
• Attention disturbances, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea and abdominal swelling.
• Erectile dysfunction.
• Swelling of the body, including hands and feet.
• Feeling of drunkenness, abnormalities in 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.
• Altered perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation.
• Visual disturbances, eye movement abnormalities, visual alterations including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling of malaise.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Flushing, hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood test results and liver function tests (increased serum creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

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

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatic inflammation.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disorders.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Disrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions, which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated reddish patches on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious 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 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 (inflammation of the liver).

Not known: frequency cannot be estimated from the available data

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

After stopping short-term or long-term treatment with this medicine, you should be aware that you might experience certain side effects, known as withdrawal effects (see “If you stop taking Lindone”).
If you experience swelling of the face or tongue, or if you develop skin redness, blisters and skin peeling, seek immediate medical attention.
Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to pregabalin, and the severity of these effects may increase when these medicines are taken together.
The following adverse reaction has been reported during the post-marketing phase of the medicine:
breathing difficulties, shallow breathing.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the system at
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 stated on the packaging or container (bottle). The expiry date refers to the last day of that month.
For 82.5 mg: Do not store above 30°C.
For 165 mg and 330 mg: This medicine does not require any special storage conditions.
Do not dispose of any medicine via 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 substance 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 components are:

• Tablet core: hypromellose, hydroxypropylcellulose (E 463), basic butyl methacrylate copolymer (E 1205), crospovidone (Type A), magnesium stearate (E 470b), anhydrous colloidal silica (E 551),
• Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521) and talc (E 553b). Lindone 165 mg prolonged-release tablet also 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 (E 172), propylene glycol (E 1520).

Description of the appearance of Lindone and contents of the pack
Lindone 82.5 mg prolonged-release tablet
White, oval tablet, unmarked, without score line, with no writing on one side and imprinted “ALV 379” in black ink on the other side, with a length of 19 mm, width of 12 mm and approximate thickness of 7 mm.
Lindone 165 mg prolonged-release tablet
Yellow, oval tablet, unmarked, without score line, with no writing on one side and imprinted “ALV 380” in black ink on the other side, with a length of 19 mm, width of 12 mm and approximate thickness of 7 mm.
Lindone 330 mg prolonged-release tablet
Pink, oval tablet, unmarked, without score line, with no writing on one side and imprinted “ALV 381” in black ink on the other side, with a length of 19 mm, width of 12 mm and approximate thickness of 8 mm.
Lindone is available in:

• Carton box containing a container (bottle) made of white HDPE, round, wide-mouth, with child-resistant cap, liner and drying cylinder.
• Original pack containing 30 prolonged-release tablets.

It is possible that not all pack sizes are marketed.
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
Austria Lynagex 82.5 mg Retardtabletten
Lynagex 165 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