Pregabalin Stada

Leaflet accompanying the packaging: information for the user

Pregabalin Stada, 25 mg, hard capsules

Pregabalin Stada, 50 mg, hard capsules

Pregabalin Stada, 75 mg, hard capsules

Pregabalin Stada, 150 mg, hard capsules

Pregabalin Stada, 225 mg, hard capsules

Pregabalin Stada, 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 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pregabalin Stada and what is it used for
• 2. Important information before taking Pregabalin Stada
• 3. How to take Pregabalin Stada
• 4. Possible side effects
• 5. How to store Pregabalin Stada
• 6. Contents of the pack and other information

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

Pregabalin Stada belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.

Neuropathic pain of peripheral and central origin

Pregabalin Stada is used to treat long-lasting pain caused by damage to the nerves. 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 pain, as sharp pain, stabbing, cramping, 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 Stada 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 Stada if the patient's current treatment does not fully control the disease. Pregabalin Stada should always be used as an add-on therapy to the patient's current treatment. Pregabalin Stada should not be used as monotherapy, but always in combination with other antiepileptic medicines.

Generalized anxiety disorder

Pregabalin Stada 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 or irritability, easy fatigue, difficulty concentrating or feeling of "emptiness in the head", 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 Stada

When NOT to take Pregabalin Stada

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

Warnings and precautions

Before taking Pregabalin Stada, the patient should discuss it with their doctor or pharmacist.

• Some patients taking Pregabalin Stada have reported symptoms indicating an allergic reaction. These include swelling of the face, lips, tongue, and throat, and widespread skin rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Taking Pregabalin Stada has been associated with dizziness and drowsiness. This may cause 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.
• Pregabalin Stada may cause blurred vision or loss of vision, or other vision disturbances, most of which are transient. If any vision disturbances occur, the patient should inform their doctor immediately.
• In patients with diabetes, who gain weight during treatment with pregabalin, 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. 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 Stada; these were mostly elderly people with cardiovascular diseases. 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 Stada. If the patient notices a decrease in the amount and frequency of urine while taking Pregabalin Stada, they should inform their doctor, as stopping the medicine may cause the symptom to disappear.
• A small number of patients taking antiepileptic medicines, such as Pregabalin Stada, have had thoughts of self-harm or suicide. If the patient has ever had such thoughts, they should contact their doctor immediately.
• If Pregabalin Stada 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 patient should inform their doctor if they experience constipation, especially if they are prone to it.
• If the patient has a history of drug or alcohol abuse, they should inform their doctor before taking Pregabalin Stada. The patient should not take more of the medicine than prescribed by their doctor.
• There have been reports of seizures during treatment with Pregabalin Stada or shortly after stopping treatment with this medicine. If seizures occur, the patient should contact their doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases who took Pregabalin Stada. The patient should inform their doctor about all serious diseases they have had, including liver or kidney diseases.
• There have been reports of breathing difficulties. If the patient experiences nervous system disorders, breathing difficulties, 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 their doctor.

Children and adolescents

The safety and efficacy of Pregabalin Stada in children and adolescents (under 18 years of age) have not been established, so pregabalin should not be used in this age group.

Pregabalin Stada and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Pregabalin Stada and certain other medicines may affect each other (interactions). Pregabalin Stada taken with certain other medicines that have a sedating effect (including opioids) may increase these effects and lead to respiratory failure, coma, and death.

The degree of dizziness, drowsiness, and decreased concentration may increase if Pregabalin Stada is taken with medicines containing:

oxycodone - (a painkiller)

lorazepam - (a medicine used for anxiety)

alcohol.

Pregabalin Stada may be taken with oral contraceptives.

Taking Pregabalin Stada with food, drink, and alcohol

Pregabalin Stada capsules can be taken with or without food.

The patient should not drink alcohol while taking Pregabalin Stada.

Pregnancy and breastfeeding

Pregabalin Stada should not be taken by women who are pregnant or breastfeeding, unless their doctor advises them to do so. 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 ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin Stada may cause dizziness, drowsiness, and decreased concentration. The patient should not drive, operate complex machines, or perform potentially hazardous activities until they have an understanding of how this medicine affects them.

Pregabalin Stada contains lactose

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Pregabalin Stada

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose

The doctor will determine the dose of Pregabalin Stada that is right for the patient.

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

• The patient should take the number of capsules as prescribed by their doctor.
• The dose will generally be between 150 mg and 600 mg per day.
• The doctor will tell the patient if they should take Pregabalin Stada twice or three times a day. If taken twice a day, Pregabalin Stada should be taken in the morning and evening, at approximately the same time every day. If taken three times a day, Pregabalin Stada should be taken in the morning, afternoon, and evening, at approximately the same time every day.

If the patient thinks that Pregabalin Stada is too strong or too weak, they should talk to their doctor or pharmacist.

Elderly patients

Patients over 65 years of age should take Pregabalin Stada as prescribed, unless they have kidney problems.

Patients with kidney disease

In patients with impaired kidney function, the doctor may decide on a different dosing schedule and/or adjust the dose of Pregabalin Stada.

Method of administration

Pregabalin Stada is for oral use only.

The capsule should be swallowed whole with water.

Duration of treatment

Pregabalin Stada should be taken for as long as the doctor has prescribed.

Taking more Pregabalin Stada than prescribed

The patient should inform their doctor or go to the nearest hospital emergency department immediately. The patient should take the packaging of Pregabalin Stada with them. After taking more Pregabalin Stada than prescribed, the patient may feel drowsy, confused, agitated, or restless. There have also been reports of seizures.

Missing a dose of Pregabalin Stada

It is important to take the capsules regularly at the same times each day.

If the patient misses a dose, they should take it as soon as possible, unless it is time for the next dose. In this case, the patient should continue treatment as prescribed. The patient should not take a double dose to make up for a missed dose.

Stopping Pregabalin Stada treatment

The patient should not stop taking Pregabalin Stada unless their doctor advises them to do so. If treatment is to be stopped, it should be done gradually over a minimum of 1 week.

The patient should be aware that after stopping short-term or long-term treatment with Pregabalin Stada, some side effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if the patient has taken Pregabalin Stada for a longer period.

If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences swelling of the face or tongue, or if they have redness of the skin with blisters or peeling, they should seek medical advice immediately.

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

• dizziness, drowsiness, headache

Common side effects (may affect up to 1 in 10 people)

• increased appetite
• elevated mood, confusion, disorientation, decreased libido, irritability
• difficulty concentrating, clumsiness, memory impairment, loss of memory, tremors, speech disturbances, feeling of tingling, numbness, excessive sedation, lethargy, insomnia, feeling of fatigue, abnormal sensation
• blurred vision, double vision
• dizziness, balance disturbances, falls
• dry mouth, constipation, vomiting, bloating, diarrhea, nausea, abdominal distension
• erectile dysfunction
• edema of the body, including limbs
• feeling of intoxication, ataxia
• weight gain
• muscle spasms, joint pain, back pain, limb pain
• sore throat

Uncommon side effects (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, mental disorders, difficulty thinking, increased libido, sexual problems, including inability to achieve orgasm, delayed ejaculation
• vision disturbances, unusual eye movements, vision disturbances, including tunnel vision, flashes of light, jerky movements, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, feeling of burning, tremors 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
• 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, 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, cough, snoring
• painful menstruation
• coldness of hands and feet

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

• changed sense of smell, feeling of rocking, changed sense of depth, vivid vision, loss of vision
• pupil dilation, strabismus
• cold sweats, tightness in the throat, tongue swelling
• pancreatitis
• difficulty swallowing
• slow or limited movements
• difficulty writing
• ascites
• fluid in the lungs
• seizures
• changes in ECG 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
• allergic reactions (which may include difficulty breathing, eye inflammation, and severe skin reactions characterized by rash, blisters, and peeling)
• 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 movements, and stiffness

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

• liver failure
• hepatitis

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. 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 not listed in this leaflet, they should inform 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 22 492 13 01

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 this medicine.

5. How to store Pregabalin Stada

The medicine should be stored out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage instructions for this 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 need. This will help protect the environment.

6. Contents of the pack and other information

What Pregabalin Stada contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 150 mg, 225 mg, or 300 mg of pregabalin.
• The other ingredients are: lactose monohydrate, cornstarch, talc, gelatin, titanium dioxide (E 171). The 75 mg, 225 mg, and 300 mg capsules also contain iron oxide red (E172). Only the 50 mg and 225 mg capsules contain: shellac, iron oxide black (E172), propylene glycol.

What Pregabalin Stada looks like and contents of the pack

25 mg capsules

White hard capsules (approximately 14 mm).

50 mg capsules

White hard capsules (approximately 16 mm). The body is marked with a black circular line.

75 mg capsules

White-orange hard capsules (approximately 14 mm).

150 mg capsules

White hard capsules (approximately 18 mm).

225 mg capsules

White-light orange hard capsules (approximately 19 mm). The body is marked with a black circular line.

300 mg capsules

White-orange hard capsules (approximately 22 mm).

Pregabalin Stada 25 mg is available in PVC/Aluminum foil packs of 14, 21, 28, 30, 56, 60, 70, 84, 100, 200, and 210 capsules.

Pregabalin Stada 50 mg is available in PVC/Aluminum foil packs of 14, 21, 28, 30, 56, 60, 84, 100, 200, and 210 capsules.

Pregabalin Stada 75 mg is available in PVC/Aluminum foil packs of 14, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Pregabalin Stada 150 mg is available in PVC/Aluminum foil packs of 14, 21, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Pregabalin Stada 225 mg is available in PVC/Aluminum foil packs of 14, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Pregabalin Stada 300 mg is available in PVC/Aluminum foil packs of 14, 21, 28, 30, 56, 60, 70, 100, 200, and 210 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Lamp San Prospero S.p.a.

Via Della Pace, 25/A

41030 San Prospero (MO)

Italy

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

Belgium: Pregabaline EG 25 (50, 75, 100, 150, 200, 225, 300) mg hard capsules

Luxembourg: Pregabaline EG 25 (50, 75, 100, 150, 200, 225, 300) mg capsules

Czech Republic: Pregabalin STADA Arzneimittel AG

Denmark: Pregabalin AL 25 (50, 75, 100, 150, 200, 225, 300) mg hard capsules

Spain: Pregabalina Stada 25 (50, 75, 100, 150, 200, 300) mg hard capsules EFG

France: Pregabaline EG LABO 25 (50, 75, 100, 150, 200, 300) mg capsules

Hungary: Pregabalin STADA Arzneimittel 75 (150) mg hard capsules

Ireland: Pregabalin Clonmel 25 (50, 75, 100, 150, 200, 225, 300) mg hard capsules

Italy: PREGABALIN EG STADA Italia

Malta: Pregabalin Clonmel 50 (75, 150) mg hard capsules

Portugal: Pregabalina Ciclum

Slovenia: Pregabalin STADA Arzneimittel 25 (75, 150, 300) mg hard capsules

Slovakia: Pregabalin Stada Arzneimittel

Date of last revision of the leaflet: 05/2022