Linefor

Package leaflet: Information for the patient

Linefor, 25 mg, hard capsules
Linefor, 50 mg, hard capsules
Linefor, 75 mg, hard capsules
Linefor, 100 mg, hard capsules
Linefor, 150 mg, hard capsules
Linefor, 200 mg, hard capsules
Linefor, 225 mg, hard capsules
Linefor, 300 mg, hard capsules
Pregabalinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Linefor is and what it is used for

Linefor belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain,
and generalized anxiety disorders (GAD) in adults.
Peripheral and central neuropathic pain
Linefor is used to treat long-term pain caused by nerve damage. Various diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, pulsing, stabbing, tingling, or numbness, as well as sharp pain, cramps, aching, 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.
Epilepsy
Linefor is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Linefor if previous treatment has not been fully effective. Linefor is given as an add-on to current therapy. Linefor should not be used alone, but always in combination with other antiepileptic medicines.
Generalized anxiety disorders
Linefor is used in the treatment of generalized anxiety disorders (GAD). Symptoms of GAD include prolonged, excessive anxiety and worry that are difficult to control. GAD may also cause motor restlessness, nervousness or feeling keyed up, easy fatigability, difficulty concentrating or feeling of mental "blanking", irritability, increased muscle tension, or sleep disturbances. These symptoms are distinct from the stresses and strains associated with everyday life.

2. Important information before using Linefor

When not to use Linefor:

• 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 Linefor, discuss this with your doctor or pharmacist.

• Some patients taking pregabalin have experienced symptoms indicating 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 reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with 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.

• Pregabalin has been associated with dizziness and drowsiness, which may increase the risk of accidental injuries (falls), especially in elderly patients. Therefore, caution should be exercised until the patient knows how this medicine affects them.

• Pregabalin 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 pregabalin treatment, adjustment of antidiabetic therapy may be necessary.

• Certain side effects such as drowsiness may occur more frequently, as patients with spinal cord injury may also be taking other medications (e.g. painkillers or muscle relaxants) that have similar side effects to pregabalin, and the severity of these effects may increase when such medicines are taken concomitantly.

• Cases of heart failure have been reported in some patients taking pregabalin, particularly elderly patients with cardiovascular disorders. Before using this medicine, inform your doctor if you have a history of heart disease.

• Cases of renal failure have been reported in some patients taking pregabalin. If the patient notices a decrease in frequency of urination while taking Linefor, inform the doctor immediately, as discontinuation of the medicine may lead to resolution of this symptom.

• Some patients taking antiepileptic medicines such as Linefor have had thoughts of self-harm or suicide or exhibited suicidal behaviour. If such thoughts or behaviours occur at any time, contact your doctor immediately.

• If pregabalin is taken concomitantly with other medicines that may cause constipation (such as certain painkillers), gastrointestinal disorders (e.g. constipation, intestinal obstruction, or paralytic ileus) may occur. Inform the doctor if the patient experiences constipation, especially if they are prone to it.

• 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; this may indicate an increased risk of dependence on Linefor.

• 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 medical conditions who were taking pregabalin. Inform your doctor about all serious medical conditions the patient has had, including liver or kidney disease.

• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction, or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient develops difficulty breathing or shallow breathing, contact the doctor immediately.

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

• Need to take the medicine for longer 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 use of this medicine
• Feeling unwell after stopping the medicine and feeling better after restarting it

If the patient notices any of these symptoms, they should speak with their doctor to discuss the best treatment approach, including when and how to stop taking this medicine safely.

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

Linefor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Linefor and certain medicines may interact with each other. When taken together with other central nervous system depressants (including opioids), Linefor may enhance these effects and cause respiratory depression, coma, and death. The severity of dizziness, drowsiness, and reduced concentration may increase when Linefor is taken concomitantly with medicines containing:

• oxycodone (a painkiller);
• lorazepam (a medicine used for anxiety);
• alcohol.

Linefor may be used concomitantly with oral contraceptives.

Linefor with food, drink, and alcohol
Linefor capsules may be taken with or without food.
Alcohol should not be consumed during treatment with Linefor.

Pregnancy and breastfeeding
Linefor should not be used during pregnancy or breastfeeding unless otherwise directed by a doctor. Use of pregabalin during the first three months of pregnancy may cause congenital malformations in the unborn child requiring medical treatment. In a study from Scandinavian countries, data analysis 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 and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Linefor may cause dizziness, drowsiness, and reduced concentration. Do not drive, operate complex machinery, or perform other potentially hazardous activities until the effect of this medicine on the ability to perform such tasks has been determined.

Linefor contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Linefor

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist. Do not take a higher dose than prescribed.
The doctor will determine the dose most suitable for the individual patient.
Linefor is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy or generalized anxiety disorders:

• Take as many capsules as prescribed by your doctor.
• The dose selected according to the patient's condition usually ranges between 150 mg and 600 mg per day.
• Your treating doctor will advise whether to take Linefor twice or three times daily. If taken twice daily, Linefor should be taken in the morning and evening at the same time each day. If taken three times daily, Linefor should be taken in the morning, at midday and in the evening at the same time each day.

If the patient feels that Linefor is too strong or not strong enough, they should inform their
doctor or pharmacist.
Patients over 65 years of age should take Linefor according to the above schedule 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.
The capsule should be swallowed whole with water.
Linefor should be taken for as long as directed by the doctor. Treatment may only be stopped
on the doctor's advice.
Taking more Linefor than prescribed
Inform your doctor or go immediately to the nearest hospital emergency department.
Bring the Linefor medicine packaging with you. After taking more than the prescribed dose of
Linefor, the patient may feel drowsy, confused, agitated or restless.
Seizures and loss of consciousness (coma) have also been reported.
Missing a dose of Linefor
It is important to take Linefor regularly at the same times each day. If a dose is missed, it should
be taken as soon as possible, unless it is almost time for the next dose. In that case, continue
treatment according to the prescribed schedule. Do not take a double dose to make up for a
missed dose.
Stopping treatment with Linefor
Do not suddenly stop taking Linefor. If the patient wishes to discontinue treatment with Linefor,
they should first discuss this with their doctor. The doctor will advise how this should be done.
If treatment needs to be stopped, it should be done gradually over at least one week.
The patient should know that after stopping short- or long-term treatment with Linefor, certain
adverse effects may occur, known as withdrawal symptoms. These include sleep disturbances,
headache, nausea, feelings of anxiety, diarrhoea, flu-like symptoms, seizures, restlessness,
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 been taking Linefor
for a prolonged period.
If withdrawal symptoms occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If swelling of the face or tongue occurs, or if redness of the skin appears accompanied by
blisters or peeling, medical advice must be sought immediately.
Some adverse effects, such as drowsiness, may occur more frequently because patients
with spinal cord injury may also be taking other medicines, e.g. painkillers or
medicines reducing increased muscle tone, which have similar adverse effects as Linefor,
and the intensity of these effects may be greater when such medicines are taken concomitantly.
Other adverse effects
Very common (affects more than 1 in 10 people):

• Dizziness, drowsiness, headache

Common (affects less than 1 in 10 people):

• Increased appetite
• Euphoria, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremor,

difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, feeling
of fatigue, unusual feeling

• Blurred vision, double vision
• Dizziness, balance disorders, fall
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension
• Difficulty achieving erection
• Body swelling, including limbs
• Feeling of alcohol intoxication, abnormal gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon (affects less than 1 in 100 people):

• Loss of appetite, weight loss, low blood sugar concentration, high blood sugar concentration
• Changes in self-perception, psychomotor agitation, depression, excitement, mood changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased sexual interest, sexual disorders, 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 in upright position, 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, weakness of eye movements, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of the facial skin, sudden hot flushes
• Breathing difficulties, dryness in the nose, blocked nose sensation
• 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 and liver function results (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare (affects less than 1 in 1,000 people):

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

Very rare (affects less than 1 in 10,000 people):

• Liver failure
• Hepatitis

Frequency not known (frequency cannot be estimated from available data):

• Dependence on Linefor (‘drug dependence’)

It should be noted that after discontinuation of short- or long-term treatment with Linefor,
certain adverse effects may occur, known as withdrawal symptoms (see section “Discontinuing
treatment with Linefor”).
Following the introduction of the medicine to the market, the following adverse effects have also been reported: breathing difficulties, shallow breathing.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Linefor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Linefor contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are: lactose monohydrate, corn starch, talc, titanium dioxide (E 171), gelatin, shellac 45% in ethanol, ferric oxide black (E 172), propylene glycol, ammonium hydroxide. Linefor 75 mg, 100 mg, 200 mg, 225 mg and 300 mg hard capsules also contain ferric oxide red (E 172) and ferric oxide yellow (E 172).

What Linefor looks like and contents of the pack
White, gelatin hard capsule with the imprint “25” on the body
25 mg capsules
Capsule size No. 4.
White, gelatin hard capsule with the imprint “50” on the body
50 mg capsules
Capsule size No. 3.
Gelatin hard capsule with a white body imprinted “75”
75 mg capsules
and a red-brown cap. Capsule size No. 3.
100 mg capsules Red-brown, gelatin hard capsule with the imprint “100”
on the body of the capsule. Capsule size No. 1.
150 mg capsules White, gelatin hard capsule with the imprint “150” on the body
Capsule size No. 1.
200 mg capsules Light brown, gelatin hard capsule with the imprint “200” on the
body of the capsule. Capsule size No. 0.
Gelatin hard capsule with a white body imprinted “225”
225 mg capsules and a light brown cap. Capsule size No. 0.
Gelatin hard capsule with a white body imprinted “300”
300 mg capsules
and a red-brown cap. Capsule size No. 0.
Linefor 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are
packaged in blisters made of Aluminium/PVC/PVDC, placed in a cardboard box.
Linefor is available in pack sizes of 14, 21, 56, 60 or 84 hard capsules.
Linefor 50 mg, 75 mg and 150 mg are also available in pack sizes of 28 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

This medicinal product is authorised in the European Economic Area member states under the following names:
Bulgaria: Линефор 50 mg, 75 mg, 150 mg твърди капсули
Netherlands: Linefor 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg harde capsules
Lithuania: Linefor 75 mg kietosios kapsulės
Latvia: Linefor 75 mg cietās kapsulas
Poland: Linefor, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg, kapsułki, twarde