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 that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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. Package contents 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 antiepileptic medicines.

Generalized anxiety disorder

Linefor is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that are 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.

• Some patients taking pregabalin have experienced symptoms indicating an allergic reaction. 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 symptoms of severe skin reactions listed in section 4, they should stop taking pregabalin and seek medical help immediately.
• Taking pregabalin has been associated with dizziness and somnolence, which may have resulted in more frequent accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the patient is aware of the possible 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 antidiabetic 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 at the same time.
• 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 inform their doctor about any history of heart disease.

• There have been reports of kidney failure in some patients taking pregabalin. If the patient notices a decrease in urine output while taking Linefor, they should inform their doctor, as stopping the medicine may cause the symptom to disappear.
• Some patients taking antiepileptic medicines such as Linefor have had thoughts of self-harm or suicide or have shown 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 paralysis of the intestines) 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 discuss it with 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 failing
• Feeling unwell after stopping the medicine and feeling better after taking it again
  If the patient experiences any of these symptoms, they should discuss it with their doctor to determine the best course of treatment, including when to stop taking the medicine and how to do it 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 3 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 3 months of pregnancy and found birth defects in 6 out of every 100 babies born, while 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 genital organs.
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 machines, or perform other potentially hazardous activities until they have determined the effect 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 consult their doctor before taking the medicine.

3. How to take Linefor

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient 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 intended for oral use only.

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

• The patient should take as many capsules as the doctor has prescribed.
• The selected dose, depending on the patient's condition, is usually in the range of 150 mg to 600 mg per day.
• The doctor will prescribe taking Linefor twice or three times a day. When taking it twice a day, Linefor should be taken in the morning and evening at the same time every day. When taking it 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 according to the presented scheme, unless they have kidney disease.
In patients with impaired renal function, the doctor may decide on a different dosing schedule and/or change the dose of the medicine.
The capsule should be swallowed whole and washed down with water.
Linefor should be taken for as long as the doctor has prescribed. 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 immediately go to the nearest hospital emergency department. The patient should take the packaging of Linefor with them. After taking a higher dose of Linefor than prescribed, the patient may feel sleepy, confused, excited, 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 the treatment according to the prescribed schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Linefor

The patient should not stop taking Linefor suddenly. If the patient wants to stop taking Linefor, they should first discuss it with their doctor. The doctor will inform them how to do it. 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 section "Stopping Linefor"). These symptoms include sleep disturbances, headache, nausea, feeling of 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.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of swelling of the face or tongue, or if a skin rash with blisters or peeling occurs, the patient should seek medical advice 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 at the same time.

Other side effects

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

• Dizziness, somnolence, headache

Common (occurring in less than 1 in 10 people):

• Increased appetite
• Mood swings, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, feeling of tingling, numbness, sedation, lethargy, insomnia, feeling of fatigue, strange feeling

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 of intoxication, ataxia
• Weight gain
• Muscle spasms, joint pain, back pain, limb pain
• Sore throat

Uncommon (occurring in less than 1 in 100 people):

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Changes in self-perception, restlessness, depression, excitement, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased sexual interest, sexual disturbances, 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, feeling of burning, tremor when moving, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
• Heart rhythm disturbances, accelerated heart rate, low blood pressure, high blood pressure, changes in heart rate, heart failure
• Sudden flushing of the face, sudden hot flashes
• Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
• Increased salivation, heartburn, feeling of 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 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, nosebleeds, coughing, snoring
• Painful menstruation
• Coldness of hands and feet

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

• Changed sense of smell, feeling of image oscillation, changed sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or limited movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG recordings corresponding to heart rhythm disturbances
• Muscle damage
• Breast discharge, breast hypertrophy, 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 the occurrence of red, flat, plate-like, or round patches on the torso, often with blisters in their center, peeling of the skin, ulcers in the mouth, throat, nose, genital organs, 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) Parkinson's syndrome, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness).

Very rare (occurring in 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 section "Stopping Linefor").
After the medicine was placed on the market, the following side effects were also 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Linefor

The medicine should be stored out of sight and reach of children.
The medicine should not be taken 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 indicates the expiry date, and after the abbreviation Lot/LOT, it indicates 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 that are no longer needed. This will help protect the environment.

6. Package contents 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, cornstarch, 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 what the package contains

25 mg capsules
White, hard gelatin capsules with the inscription "25" on the capsule body.
Capsule size 4.
50 mg capsules
White, hard gelatin capsules with the inscription "50" on the capsule body.
Capsule size 3.
75 mg capsules
Hard gelatin capsules with a white body and the inscription "75" and a red-brown cap. Capsule size 3.
100 mg capsules Red-brown, hard gelatin capsules with the inscription "100" on the capsule body.
Capsule size 1.
150 mg capsules White, hard gelatin capsules with the inscription "150" on the capsule body.
Capsule size 1.
200 mg capsules Light brown, hard gelatin capsules with the inscription "200" on the capsule body.
Capsule size 0.
Hard gelatin capsules with a white body and the inscription "225" and a light brown cap. Capsule size 0.
225 mg capsules
Hard gelatin capsules with a white body and the inscription "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 packages of 14, 21, 56, 60, or 84 hard capsules.
Linefor 75 mg and 150 mg are also available in packages 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