Pregabalin Medreg

Leaflet accompanying the packaging: patient information

Pregabalin Medreg, 75 mg, hard capsules

Pregabalin Medreg, 150 mg, hard capsules

Pregabalin

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for 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 Pregabalin Medreg and what is it used for
• 2. Important information before taking Pregabalin Medreg
• 3. How to take Pregabalin Medreg
• 4. Possible side effects
• 5. How to store Pregabalin Medreg
• 6. Contents of the packaging and other information

1. What is Pregabalin Medreg and what is it used for

Pregabalin Medreg belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorders (GAD) in adults.
Neuropathic pain of peripheral and central origin:Pregabalin Medreg is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain. Painful sensations can be described as: a feeling of heat, burning, pulsating, shooting, stabbing, as sharp pain, cramps, aching, 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:Pregabalin Medreg is used to treat certain types of epilepsy (partial seizures, which are or are not secondarily generalized) in adults. The doctor may prescribe Pregabalin Medreg if the current treatment does not fully control the course of the disease. Pregabalin Medreg should always be used as an adjunctive therapy to the current treatment. Pregabalin Medreg should not be used as monotherapy (as the only medicine), but always in combination with other antiepileptic medicines.
Generalized anxiety disorders:Pregabalin Medreg is used to treat generalized anxiety disorders (GAD). GAD symptoms include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, nervousness, or a feeling of being on edge, easy fatigue, difficulty concentrating or a feeling of "emptiness in the head", irritability, increased muscle tension, or sleep disturbances. Symptoms are different from stress and tension associated with daily life.

2. Important information before taking Pregabalin Medreg

When not to take Pregabalin Medreg

• 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 Pregabalin Medreg, the doctor or pharmacist should be consulted.

• In some patients taking Pregabalin Medreg, symptoms suggesting 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 doctor should be contacted immediately.
• Taking Pregabalin Medreg has been associated with dizziness and drowsiness, which can cause more frequent accidental injuries (falls) in elderly patients. Therefore, caution should be exercised until the possible reaction to the medicine is known.
• Taking Pregabalin Medreg may cause blurred vision, loss of vision, or other vision disturbances, most of which are transient. If any changes in vision occur, the doctor should be informed immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust the antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injuries may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the severity 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 Medreg; these were mainly elderly patients with cardiovascular disorders. Before taking this medicine, the patient should inform the doctor if they have ever had heart disease.
• -There have been reports of kidney failure in some patients taking Pregabalin Medreg. If the patient notices a decrease in urine output while taking Pregabalin Medreg, they should inform the doctor, as stopping the medicine may cause the symptom to resolve.
• Some patients taking antiepileptic medicines, such as Pregabalin Medreg, have had thoughts of self-harm or suicide. If the patient has ever had such thoughts or behaviors, they should contact the doctor immediately.
• If Pregabalin Medreg is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (such as constipation, obstruction, or paralysis of the intestines) may occur. The doctor should be informed if the patient experiences constipation, especially if they are prone to it.
• Before starting to take this medicine, the doctor should be informed 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 Pregabalin Medreg.
• There have been reports of seizures during treatment with Pregabalin Medreg or shortly after stopping treatment with Pregabalin Medreg. If seizures occur, the doctor should be contacted immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other underlying diseases who took Pregabalin Medreg. The doctor should be informed about all serious diseases, including liver or kidney diseases.
• There have been reports of breathing difficulties. If the patient has nervous system disorders, respiratory disorders, kidney function disorders, or is over 65 years old, the doctor may recommend a different dosing schedule. If the patient experiences breathing difficulties or shallow breathing, they should contact the doctor.

Due to pregabalin, there have been reports of severe skin rash, 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.

• Dependence
  Some people may become dependent on Pregabalin Medreg (need to continue taking the medicine). After stopping treatment with Pregabalin Medreg, withdrawal symptoms may occur (see section 3 "How to take Pregabalin Medreg" and "Stopping Pregabalin Medreg").
  If the patient is concerned that they may become dependent on Pregabalin Medreg, they should discuss this with their doctor.
  If the patient experiences any of the following symptoms while taking Pregabalin Medreg, 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 recommended.
  • Taking the medicine for reasons other than prescribed.
  • Repeatedly trying to stop or control the use of the medicine but failing 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 discuss this 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 Pregabalin Medreg in children and adolescents (under 18 years of age) have not been established, so pregabalin should not be used in this age group.

  Pregabalin Medreg and other medicines

  The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
  Pregabalin Medreg and some other medicines may interact with each other (interactions).
  Taken with other medicines that have a sedating effect (e.g., opioids), Pregabalin Medreg may enhance these effects and cause respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Pregabalin Medreg is taken with medicines containing:

  • oxycodone (used as a painkiller)
  • lorazepam (used for anxiety)
  • alcohol

  Pregabalin Medreg can be taken with oral contraceptives.

  Taking Pregabalin Medreg with food, drink, and alcohol

  Pregabalin Medreg capsules can be taken with or without food.
  Alcohol should not be consumed while taking Pregabalin Medreg.

  Pregnancy, breastfeeding, and fertility

  If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
  Pregabalin Medreg 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 that require treatment. 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.

  Driving and using machines

  Pregabalin Medreg may cause dizziness, drowsiness, and decreased concentration.
  The patient should not drive a car, operate complex machines, or perform potentially hazardous activities until they know how the medicine affects their ability to perform these activities.

  Pregabalin Medreg contains lactose

  Patients with intolerance to some sugars should contact their doctor before taking this medicine.

  3. How to take Pregabalin Medreg

  This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the doctor or pharmacist should be consulted. 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.

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

  • The patient should take the number of capsules prescribed by the doctor.
  • The dose, which is tailored to the patient and their condition, will usually be between 150 mg and 600 mg per day.
  • The doctor will inform the patient whether to take Pregabalin Medreg twice or three times a day. If taken twice a day, Pregabalin Medreg should be taken in the morning and evening, at the same time every day. If taken three times a day, Pregabalin Medreg should be taken in the morning, at noon, and in the evening, at the same time every day.

  If the patient feels that Pregabalin Medreg is too strong or too weak, they should inform their doctor or pharmacist.
  Elderly patients (over 65 years old) should take Pregabalin Medreg according to the presented schedule, unless they have kidney disease.
  In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or change the dose of the medicine.
  Pregabalin Medreg is intended for oral use only.
  The capsule should be swallowed whole, with water.
  The patient should continue taking Pregabalin Medreg until the doctor advises them to stop.

  Taking a higher dose of Pregabalin Medreg than recommended

  The doctor or pharmacist should be informed immediately, or the patient should go to the nearest hospital emergency department. The patient should take the packaging or bottle of Pregabalin Medreg with them. After taking a higher dose of Pregabalin Medreg than recommended, 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 Pregabalin Medreg

  It is important to take Pregabalin Medreg regularly at the same time every day. If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. In this case, the patient should continue treatment according to the prescribed schedule. A double dose should not be taken to make up for a missed dose.

  Stopping Pregabalin Medreg

  Pregabalin Medreg should not be stopped suddenly. If the patient wants to stop taking Pregabalin Medreg, they should first discuss this with their doctor. The doctor will inform them how to do this. If 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 Pregabalin Medreg, certain side effects may occur, known as withdrawal symptoms. 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 Pregabalin Medreg for a longer period. If withdrawal symptoms occur, the doctor should be contacted. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Pregabalin Medreg can cause side effects, although not everybody gets them.
  Very common(may affect more than 1 in 10 people):

  • dizziness, drowsiness, headaches

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

  • increased appetite
  • elevated mood, confusion, disorientation, decreased sexual interest, irritability
  • difficulty concentrating, clumsiness, memory impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation
  • blurred vision, double vision
  • dizziness, balance disturbances, falls
  • dry mouth, constipation, vomiting, bloating, diarrhea, nausea, abdominal distension
  • erectile dysfunction
  • body swelling, including limb swelling
  • feeling of intoxication, 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 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 problems, 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, tremors when moving, decreased 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 rhythm, heart failure
  • sudden flushing of the skin, 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 pain when urinating, 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, hives, rhinitis, nosebleeds, cough, snoring
  • painful menstruation
  • chilliness of hands and feet

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

  • altered sense of smell, sensation of swaying, altered sense of depth, bright vision, loss of vision
  • pupil dilation, strabismus
  • cold sweats, throat tightness, tongue swelling
  • pancreatitis
  • difficulty swallowing
  • slow or limited body movements
  • difficulty writing correctly
  • ascites
  • fluid in the lungs
  • seizures
  • changes in ECG tracing corresponding to heart rhythm disturbances
  • muscle damage
  • galactorrhea, breast enlargement, gynecomastia
  • amenorrhea
  • kidney failure, decreased urine output, urinary retention
  • decreased white blood cell count
  • inappropriate behavior, suicidal behavior, suicidal thoughts
  • allergic reactions, which may include 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 their center

  that peel, 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)
  • 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(may affect up to 1 in 10,000 people):

  • liver failure
  • hepatitis

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

  • dependence on Pregabalin Medreg ("drug dependence")

  The patient should be aware that after stopping short-term or long-term treatment with Pregabalin Medreg, certain side effects may occur, known as withdrawal symptoms (see section "Stopping Pregabalin Medreg").

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

  Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injuries may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin, and the severity of these effects may be greater when such medicines are taken at the same time.
  After the medicine was placed on the market, the following side effects were 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, 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
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects can help gather more information on the safety of the medicine.

  5. How to store Pregabalin Medreg

  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 and blister after: EXP.
  The expiry date refers to the last day of the month stated.
  The medicine should not be stored above 30°C.
  Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Pregabalin Medreg contains

  • The active substance of the medicine is pregabalin. Each hard capsule contains 75 mg or 150 mg of pregabalin.
  • The other ingredients are: lactose monohydrate, cornstarch, talc, gelatin, titanium dioxide (E 171), indigo carmine (E 132, only for 75 mg), and erythrosine (E 127, only for 75 mg).

  What Pregabalin Medreg looks like and contents of the pack

  Pregabalin Medreg, 75 mg:
  Hard gelatin capsules, size 4, with a white body and purple cap, containing a white or almost white powder.
  Pregabalin Medreg, 150 mg:
  Hard gelatin capsules, size 2, with a white cap and white body, containing a white or almost white powder.
  The capsules are provided in PVC/PVDC/Aluminum blisters, in a cardboard box.
  Package sizes: 14, 28, 30, 56, 60, 84, 90, 98, 100, or 112 hard capsules.
  Not all package sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder:

  Medreg s.r.o.
  Na Florenci 2116/15
  Nové Město
  110 00 Prague 1
  Czech Republic
  tel.: (+420) 516 770 199

  Manufacturer:

  Laboratorios Liconsa S.A.
  Avda. Miralcampo, 7, Pol. Ind. Miralcampo
  19200 Azuqueca de Henares, Guadalajara
  Spain

  This medicine is authorized in the Member States of the European Economic Area under the following names:

  Czech Republic:
  Pregabalin Medreg
  Poland:
  Pregabalin Medreg
  Slovakia:
  Pregabalin Medreg 75 mg
  Pregabalin Medreg 150 mg

  Date of last revision of the leaflet: