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

Pregabalin

Read all of 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Linefor is and what it is used for

Linefor belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Neuropathic pain peripheral and central

Linefor is used to treat long-term pain caused by damage to the nerves. Many different diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The pain can be described as hot, burning, throbbing, shooting, stabbing, sharp, crampy, aching, heavy, or tender. 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.

Epilepsy

Linefor is used to treat certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Linefor if your current treatment is not fully effective. Linefor is added to your current treatment. Linefor should not be used alone but should always be used in combination with other anti-epileptic medicines.

Generalized anxiety disorder

Linefor is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge, difficulty concentrating, or feeling "empty" in the head, irritability, increased muscle tone, or sleep disturbances. These symptoms are different from the stresses and tensions of everyday life.

2. What you need to know before you take Linefor

Do not take Linefor:

• if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Linefor, talk to your doctor or pharmacist.

• Some patients taking pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, contact your doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the symptoms of severe skin reactions listed in section 4, stop taking pregabalin and seek medical help immediately.
• Pregabalin has been associated with dizziness and somnolence, which may lead to an increased risk of accidental injury (falls) in elderly patients. Therefore, caution should be exercised until the effects of the medicine are known.
• Pregabalin may cause blurred vision, double vision, or other changes in vision. If you experience any changes in vision, contact your doctor immediately.
• In patients with diabetes, weight gain may occur during treatment with pregabalin. This may require a change in antidiabetic treatment.
• Some side effects, such as dizziness and drowsiness, may be more frequent when pregabalin is taken with other medicines that have similar side effects, such as pain relief medicines or medicines that reduce muscle spasms.
• There have been reports of heart failure in some patients taking pregabalin; these patients were mostly elderly with underlying cardiovascular conditions.

Before taking this medicine, tell your doctor if you have ever had heart problems.

• There have been reports of kidney failure in some patients taking pregabalin. If you experience a decrease in urination while taking Linefor, contact your doctor, as stopping the medicine may improve this symptom.
• Some patients taking antiepileptic medicines such as Linefor have had thoughts of harming themselves or others or have developed suicidal thoughts or behaviors. If you have ever had these thoughts or behaviors, contact your doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as certain pain relief medicines), gastrointestinal disturbances (such as constipation, obstruction, or paralytic ileus) may occur. Tell your doctor if you experience constipation, especially if you are prone to it.

Dependence
Some people may become dependent on Linefor (need to continue taking the medicine). After stopping treatment with Linefor, withdrawal symptoms may occur (see section 3 "How to take Linefor" and "Stopping Linefor"). If you are concerned that you may become dependent on Linefor, talk to your doctor.
If you experience any of the following symptoms while taking Linefor, it may indicate dependence:

• Need to take the medicine for a longer period than prescribed by your doctor
• Need to take a higher dose than prescribed
• Taking the medicine for reasons other than those for which it was prescribed
• Repeatedly trying to stop or control the use of the medicine but being unable to do so
• Feeling unwell when the medicine is stopped and feeling better when it is restarted
  If you experience any of these symptoms, talk to your doctor to discuss the best course of treatment, including when 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.

Linefor and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Linefor and some other medicines may affect each other (interact). When taken with other medicines that have a sedating effect (such as opioids), Linefor may increase these effects and cause respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Linefor is taken with medicines containing:

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

Linefor may be taken with oral contraceptives.

Linefor with food, drink, and alcohol

Linefor capsules can be taken with or without food.
Do not drink alcohol while taking Linefor.

Pregnancy and breastfeeding

Do not take Linefor if you are pregnant or breastfeeding unless your doctor decides that it is necessary. Taking pregabalin during the first three months of pregnancy may cause birth defects in the unborn child. A study in Scandinavian countries analyzed data from women who took pregabalin during the first three months of pregnancy and found 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, brain and spinal cord defects, kidney and genital defects. Women of childbearing age should use effective contraception. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Linefor may cause dizziness, drowsiness, and decreased concentration. Do not drive, operate complex machinery, or perform other potentially hazardous activities until you know how this medicine affects your ability to perform these activities.

Linefor contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Linefor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not take more than the prescribed dose.
Your doctor will determine the dose that is right for you.
Linefor is for oral use only.

Neuropathic pain peripheral and central, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as prescribed by your doctor.
• The dose will be between 150 mg and 600 mg per day.
• Your doctor will tell you to take Linefor either twice or three times a day. If you take it twice a day, take it once in the morning and once in the evening, at the same time each day. If you take it three times a day, take it in the morning, afternoon, and evening, at the same time each day.

If you think that the effect of Linefor is too strong or too weak, talk to your doctor or pharmacist.
Patient over 65 years of age should take Linefor as prescribed unless they have kidney problems.
In patients with kidney problems, your doctor may prescribe a different dose and/or dose regimen.
Swallow the capsule whole with water.
Take Linefor for as long as your doctor prescribes it. Do not stop taking Linefor unless your doctor tells you to.

If you take more Linefor than you should

Contact your doctor or go to the nearest hospital emergency department immediately. Take the medicine pack with you.
After taking too much Linefor, you may feel drowsy, confused, agitated, or have difficulty breathing. There have also been reports of seizures and loss of consciousness (coma).

If you forget to take Linefor

It is important to take Linefor regularly at the same time each day. If you miss a dose, take it as soon as you remember unless it is time to take the next dose. In this case, continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Stopping Linefor

Do not stop taking Linefor suddenly. If you want to stop taking Linefor, talk to your doctor first. Your doctor will tell you how to stop taking the medicine safely. If treatment needs to be stopped, it should be done gradually over a minimum of one week.
You should be aware that after stopping short-term or long-term treatment with Linefor, you may experience certain side effects, known as withdrawal symptoms (see "Stopping Linefor"). 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 you have taken Linefor for a longer period. If you experience withdrawal symptoms, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience swelling of the face or tongue, or if you have redness of the skin with blisters or peeling, seek medical attention immediately.

Some side effects, such as dizziness and drowsiness, may be more frequent in patients with spinal cord injury who may also be taking other medicines that have similar side effects, such as pain relief medicines or muscle relaxants.

Other side effects

Very common (may affect more than 1 in 10 people):

• Dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people):

• Increased appetite
• Mood changes, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory impairment, loss of memory, tremors, difficulty speaking, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal

Blurred vision, double vision

• Dizziness, balance disorder, fall
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• Difficulty achieving an erection
• Edema of the body, including limbs
• Feeling drunk, 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 perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased libido, sexual dysfunction, 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 on standing, skin hypersensitivity, loss of taste, burning sensation, tremor on movement, altered consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye edema, eye pain, decreased eye movements, lacrimation, eye irritation
• Cardiac arrhythmias, tachycardia, hypotension, hypertension, changes in heart rate, heart failure
• Flushing, hot flushes
• Breathing difficulties, dryness in the nose, 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, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium)
• Hypersensitivity, facial edema, pruritus, urticaria, rhinitis, epistaxis, cough, snoring
• Painful menstruation
• Coldness of hands and feet

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

• Altered sense of smell, sensation of spinning, altered sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue edema
• Pancreatitis
• Dysphagia
• Slow or reduced movements
• Difficulty writing
• Ascites
• Pulmonary edema
• Seizures
• Changes in ECG tracing corresponding to arrhythmias
• Muscle damage
• Galactorrhea, gynecomastia, breast enlargement in men
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions, which may be characterized by difficulty breathing, eye inflammation (keratitis), and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. The onset of these severe skin reactions may be preceded by fever and flu-like symptoms.
• Jaundice (yellowing of the skin and whites of the eyes)
• Parkinsonian syndrome, characterized by symptoms similar to those of Parkinson's disease, such as tremors, slowed movements (reduced mobility), and stiffness (muscle stiffness).

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

• Liver failure
• Hepatitis

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

• Dependence on Linefor ("drug dependence")

Be aware that after stopping short-term or long-term treatment with Linefor, you may experience certain side effects, known as withdrawal symptoms (see "Stopping Linefor").
After the medicine was made available, the following side effects have also been reported: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the Department of Drug Safety, Ministry of Health
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Linefor

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 carton after EXP. The expiry date refers to the last day of that month.
The packaging is marked with the expiry date and batch number after EXP and LOT, respectively.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, maize starch, talc, titanium dioxide (E 171), gelatin, shellac 45% in ethanol, iron oxide black (E 172), propylene glycol, ammonium hydroxide. Linefor 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg hard capsules also contain iron oxide red (E 172) and iron oxide yellow (E 172).

What Linefor looks like and contents of the pack

25 mg capsules
White, hard gelatin capsule with "25" printed on the body of the capsule. Capsule size 4.
50 mg capsules
White, hard gelatin capsule with "50" printed on the body of the capsule. Capsule size 3.
75 mg capsules
Hard gelatin capsule with a white body and a red-brown cap. Capsule size 3.
100 mg capsules Red-brown, hard gelatin capsule with "100" printed on the body of the capsule.
Capsule size 1.
150 mg capsules White, hard gelatin capsule with "150" printed on the body of the capsule.
Capsule size 1.
200 mg capsules Light brown, hard gelatin capsule with "200" printed on the body of the capsule.
Capsule size 0.
225 mg capsules
Hard gelatin capsule with a white body and a light brown cap. Capsule size 0.
300 mg capsules
Hard gelatin capsule with a white body and a red-brown cap. Capsule size 0.
Linefor 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg hard capsules are packaged in aluminum/PVC/PVDC blisters in a cardboard box.
Linefor is available in packs of 14, 21, 56, 60, or 84 hard capsules.
Linefor 75 mg and 150 mg are also available in packs of 28 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

This medicine is authorized in the Member States of the European Economic Area 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
Date of last revision of the leaflet:April 2024