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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 packaging 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 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 pain, or as sharp, 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 current treatment does not fully control the disease. Pregabalin Stada should always be used as an add-on therapy to the currently used treatment. Pregabalin Stada should not be used as monotherapy, but always in combination with other antiepileptic drugs.

Generalized anxiety disorder

Pregabalin Stada 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, feeling on edge or irritability, easily becoming fatigued, 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 starting to take 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, as well as 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 pregabalin treatment, it may be necessary to adjust their 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 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 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 renal 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 drugs, 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 the treatment. 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 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 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 plan to take.
Pregabalin Stada and certain other medicines may affect each other (interact). 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 - (painkiller)
lorazepam - (medicine used in anxiety states)
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 pregnant or breastfeeding women, unless their doctor advises otherwise. 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

Pregabalin Stada may cause dizziness, drowsiness, and decreased concentration. The patient should not drive, operate complex machines, or perform potentially hazardous activities until they know how the 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. In case of doubt, the patient should consult 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 prescribed by their doctor.
• The dose adjusted 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 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 feels that Pregabalin Stada is too strong or too weak, they should consult their doctor or pharmacist.

Elderly patients

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

Patients with kidney disease

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

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 recommends.

Taking a higher dose of Pregabalin Stada than recommended

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 a higher dose of Pregabalin Stada than recommended, 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 Pregabalin Stada capsules regularly at the same times every day.
If a dose is missed, the patient 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 the 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, certain 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 long time.
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 Stada 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.

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, tingling, numbness, excessive 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
• 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, nystagmus, decreased reflexes, increased activity, dizziness when standing, skin hypersensitivity, loss of taste, burning sensation, tremors when moving, consciousness disturbances, 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, 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 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
• renal 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, peeling, and pain)
• 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, and stiffness

Very rare (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 intensity 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 those not listed in the 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:
Jerozolimskie Avenue 181C,
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the 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 the month stated.
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 use. This will help protect the environment.

6. Contents of the packaging and other information

What Pregabalin Stada contains

• The active substance of the medicine 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 ring.
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 ring.
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