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 read again 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 disorder (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. The pain can be described as: a feeling of heat, burning, throbbing, shooting, stabbing, 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 may or may not be secondary generalized) in adults. The doctor may prescribe Pregabalin Medreg if the current treatment does not fully control 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 disorder:Pregabalin Medreg 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 fatigue, difficulty concentrating or feeling empty-headed, irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stress and tension of everyday 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 patient's 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 injury 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 disease.
• There have been reports of breathing difficulties. If the patient has nervous system disorders, breathing 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.

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 attempting to stop or control the use of the medicine without success.
• 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 they plan to take.
Pregabalin Medreg and some other medicines may interact with each other (interactions).
Taken with other medicines that have a sedating effect (such as opioids), Pregabalin Medreg may enhance these effects and cause respiratory failure, coma, and death. The severity of dizziness, drowsiness, and decreased concentration may increase if Pregabalin Medreg is taken with medicines containing:

• oxycodone (used as a painkiller)
• lorazepam (used as an anxiolytic)
• 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. In a Scandinavian study, analysis of data from women who took pregabalin during the first 3 months of pregnancy showed birth defects in 6 out of 100 born children, while in women who were not treated with pregabalin, birth defects occurred in 4 out of 100 born children. 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 consult their doctor before taking this medicine.

3. How to take Pregabalin Medreg

This medicine should always be taken as directed 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 disorder:

• 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 should be informed or the patient should go to the nearest hospital emergency department immediately. 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, known as withdrawal symptoms, may occur. 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, headache

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
• erectile dysfunction
• body swelling, including limb swelling
• feeling drunk, ataxia
• weight gain
• muscle spasms, joint pain, back pain, limb pain
• throat pain

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 changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric 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
• dry eyes, eye swelling, eye pain, decreased eye movements, tearing, eye irritation
• heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, 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 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
• coldness of hands and feet

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

• changed sense of smell, feeling of rocking, changed 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 with proper writing
• ascites
• fluid in the lungs
• seizures
• changes in ECG corresponding to heart rhythm disturbances
• muscle damage
• breast discharge, 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 can peel, causing 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)
• Parkinson's syndrome, i.e., symptoms similar to Parkinson's disease, such as: tremors, slowed movement (reduced 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, known as withdrawal symptoms, may occur (see section "Stopping Pregabalin Medreg").

If the patient experiences swelling of the face or tongue, 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 injury 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 introduced to 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 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
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 packaging 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.
Pack sizes: 14, 28, 30, 56, 60, 84, 90, 98, 100, or 112 hard capsules.
Not all pack 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: