Linefor

Leaflet attached to the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Linefor and what is it 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 packaging and other information

1. What is Linefor and what is it used for

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

Neuropathic pain of peripheral and central origin

Linefor is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. The pain can be described as a feeling of heat, burning, pulsating, shooting, stabbing, as sharp pain, cramps, soreness, tingling, or numbness. 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, which are or are not secondarily generalized) in adults. The doctor may prescribe Linefor if the current treatment is not fully effective. Linefor is given as an add-on therapy to the current treatment. Linefor should not be used alone, but always 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, nervousness, or feeling on edge, easy fatigability, difficulty concentrating or feeling of emptiness in the head, irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stresses and tensions of everyday life.

2. Important information before taking Linefor

When not to take 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 to take Linefor, the patient should discuss it with their doctor or pharmacist.

• In some patients taking pregabalin, symptoms indicating an allergic reaction have occurred. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any of the serious skin reactions listed in section 4, they should stop taking pregabalin and seek medical attention immediately.
• Taking pregabalin has been associated with dizziness and somnolence, which may lead to an increased risk of accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the patient is familiar with the effects of the medicine.
• Taking pregabalin may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. If any changes in vision occur, the patient should inform their doctor immediately.
• In patients with diabetes who gain weight while taking pregabalin, it may be necessary to adjust their anti-diabetic treatment.
• Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may also take other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the intensity of these effects may be greater when such medicines are taken concomitantly.
• There have been reports of heart failure in some patients taking pregabalin; these were mainly elderly patients with cardiovascular disorders.

Before taking this medicine, the patient should tell their doctor if they have a history of heart disease.

• There have been reports of renal failure in some patients taking pregabalin. If the patient experiences a decrease in urine output while taking Linefor, they should inform their doctor, as stopping the medicine may cause the symptom to resolve.
• Some patients taking anti-epileptic medicines such as Linefor have had thoughts of self-harm or suicide or have exhibited suicidal behavior. If the patient has ever had such thoughts or behavior, they should contact their doctor immediately.
• If pregabalin is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal disturbances (such as constipation, obstruction, or paralytic ileus) may occur. The patient should inform their doctor if they experience constipation, especially if they are prone to it.

Dependence
Some people may become dependent on Linefor (need to continue taking the medicine). After stopping Linefor, withdrawal symptoms may occur (see section 3 "How to take Linefor" and "Stopping Linefor"). If the patient is concerned that they may become dependent on Linefor, they should talk to their doctor.
If the patient experiences any of the following symptoms while taking Linefor, it may indicate dependence:

• Need 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 prescribed
• Repeatedly trying to stop or control the use of the medicine but being unable to do so
• Feeling unwell after stopping the medicine and feeling better after taking it again
  If the patient experiences any of these symptoms, they should talk to their 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 Linefor in children and adolescents (under 18 years of age) have not been established, so pregabalin should not be used in this age group.

Linefor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Linefor and some medicines may interact with each other (interactions). When taken with other medicines with a sedating effect (e.g., opioids), Linefor may enhance these effects and cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Linefor is taken with medicines containing:

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

Linefor can be taken with oral contraceptives.

Linefor with food, drink, and alcohol

Linefor capsules can be taken with or without food.
The patient should not drink alcohol while taking Linefor.

Pregnancy and breastfeeding

Linefor should not be taken during pregnancy or breastfeeding, unless the doctor decides otherwise. Taking pregabalin during the first three months of pregnancy may cause birth defects in the unborn child. A Scandinavian study analyzing data from women who took pregabalin during the first three months of pregnancy found birth defects in 6 out of every 100 babies born, whereas in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genitals.
Women of childbearing age should use effective contraception. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Linefor may cause dizziness, somnolence, and decreased concentration. The patient should not drive, operate complex machinery, or perform other potentially hazardous activities until they have determined the effects of the medicine on their ability to perform these activities.

Linefor contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Linefor

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist. The patient should not take more of the medicine than prescribed.
The doctor will determine the dose of the medicine that is most suitable for the patient.
Linefor is for oral use only.

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

• The patient should take the number of capsules prescribed by the doctor.
• The dose will generally be between 150 mg and 600 mg per day.
• The doctor will advise the patient to take Linefor either twice or three times a day. When taken twice a day, Linefor should be taken in the morning and evening at the same time every day. When taken three times a day, Linefor should be taken in the morning, at noon, and in the evening at the same time every day.

If the patient feels that Linefor is too strong or too weak, they should inform their doctor or pharmacist.
Patient over 65 years of age should take Linefor as prescribed, unless they have kidney problems.
In patients with impaired renal function, the doctor may decide to adjust the dose or dosing schedule.
The capsule should be swallowed whole with water.
Linefor should be taken for as long as the doctor prescribes. The treatment can only be stopped on the doctor's advice.

Taking a higher dose of Linefor than prescribed

The patient should inform their doctor or go to the nearest hospital emergency department immediately. The patient should take the packaging of Linefor with them. After taking a higher dose of Linefor than prescribed, the patient may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

Missing a dose of Linefor

It is important to take Linefor regularly at the same times every day. If a dose is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should continue with the prescribed schedule. The patient should not take a double dose to make up for a missed dose.

Stopping Linefor

The patient should not stop taking Linefor suddenly. If the patient wants to stop taking Linefor, they should first talk to their doctor. The doctor will advise how to do this. If the treatment needs to be stopped, it should be done gradually over at least one week.
The patient should be aware that after stopping short-term or long-term treatment with Linefor, certain side effects may occur, 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 severe if the patient has taken Linefor for a longer period. If withdrawal symptoms occur, the patient should contact their doctor.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences swelling of the face or tongue or a skin rash with blisters or peeling, they should seek medical attention immediately.

Some side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may also take other medicines, such as painkillers or muscle relaxants, which have similar side effects to Linefor, and the intensity of these effects may be greater when such medicines are taken concomitantly.

Other side effects

Very common (affecting more than 1 in 10 people):

• Dizziness, somnolence, headache

Common (affecting up to 1 in 10 people):

• Increased appetite
• Mood swings, confusion, disorientation, decreased sexual interest, 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 disturbances, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• Difficulty achieving an erection
• Body swelling, including limb swelling
• Feeling drunk, ataxia
• Weight gain
• Muscle spasms, joint pain, back pain, limb pain
• Sore throat

Uncommon (affecting up to 1 in 100 people):

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in self-perception, restlessness, depression, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased sexual interest, 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 when standing up, skin hypersensitivity, loss of taste, burning sensation, tremor when moving, impaired consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
• Cardiac arrhythmias, tachycardia, hypotension, hypertension, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Breathing difficulties, dry 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 activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
• Hypersensitivity, facial swelling, itching, urticaria, rhinitis, nasal bleeding, coughing, snoring
• Painful menstruation
• Cold hands and feet

Rare (affecting up to 1 in 1,000 people):

• Altered sense of smell, sensation of rocking, altered sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or restricted movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG tracing corresponding to heart rhythm disturbances
• 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, characterized by red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe 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) Parkinsonian syndrome, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness).

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

• Liver failure
• Hepatitis

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

• Dependence on Linefor ("drug dependence")

The patient should be aware that after stopping short-term or long-term treatment with Linefor, certain side effects may occur, known as withdrawal symptoms (see "Stopping Linefor").
After the medicine was placed on the market, the following side effects have also been reported: breathing difficulties, shallow breathing.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Linefor

The medicine should be stored 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 month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging 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 the imprint "25" on the body of the capsule. Capsule size 4.
50 mg capsules
White, hard gelatin capsule with the imprint "50" on the body of the capsule. Capsule size 3.
75 mg capsules
Hard gelatin capsule with a white body and the imprint "75" and a red-brown cap. Capsule size 3.
100 mg capsules Red-brown, hard gelatin capsule with the imprint "100" on the body of the capsule.
Capsule size 1.
150 mg capsules White, hard gelatin capsule with the imprint "150" on the body of the capsule.
Capsule size 1.
200 mg capsules Light brown, hard gelatin capsule with the imprint "200" on the body of the capsule.
Capsule size 0.
Hard gelatin capsule with a white body and the imprint "225" and a light brown cap. Capsule size 0.
225 mg capsules
Hard gelatin capsule with a white body and the imprint "300" and a red-brown cap. Capsule size 0.
300 mg capsules
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

Pharmaceutical Works 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