PREGABALIN 75 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Pregabalin Aurovitas, 75 mg, hard capsules
3. Pregabalin Aurovitas, 150 mg, hard capsules
4. Pregabalin Aurovitas, 300 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet:
5. What is Pregabalin Aurovitas and what is it used for
6. Important information before taking Pregabalin Aurovitas
   1. When not to take Pregabalin Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Pregabalin Aurovitas and other medicines
   5. Taking Pregabalin Aurovitas with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. What Pregabalin Aurovitas contains
7. How to take Pregabalin Aurovitas
   1. Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:
   2. Taking more Pregabalin Aurovitas than prescribed
   3. Missing a dose of Pregabalin Aurovitas
   4. Stopping Pregabalin Aurovitas treatment
8. Possible side effects
   1. Frequency not known: frequency cannot be estimated from the available data
   2. 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.
   3. Reporting side effects
9. How to store Pregabalin Aurovitas
10. Package contents and other information
    1. What Pregabalin Aurovitas contains
    2. What Pregabalin Aurovitas looks like and contents of the pack
    3. Marketing authorization holder:
    4. Manufacturer/Importer:
    5. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: 02/2024

Leaflet attached to the packaging: information for the user

Pregabalin Aurovitas, 75 mg, hard capsules

Pregabalin Aurovitas, 150 mg, hard capsules

Pregabalin Aurovitas, 300 mg, hard capsules

Pregabalin

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

important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• 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 Aurovitas and what is it used for
• 2. Important information before taking Pregabalin Aurovitas
• 3. How to take Pregabalin Aurovitas
• 4. Possible side effects
• 5. How to store Pregabalin Aurovitas
• 6. Package contents and other information

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

Pregabalin Aurovitas 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 Aurovitas 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, pulsation, shooting, stabbing, sharp pain, cramps, aching, tingling, numbness, or tingling.
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 Aurovitas is used to treat certain types of epilepsy (partial seizures, which are or are not secondarily generalized) in adults. The doctor may prescribe Pregabalin Aurovitas if the current treatment does not fully control the course of the disease. Pregabalin Aurovitas should always be used as an adjunctive therapy to the current treatment. Pregabalin Aurovitas should not be used as monotherapy (as the only medicine), but always in combination with other antiepileptic drugs.
Generalized anxiety disorder:Pregabalin Aurovitas is used to treat generalized anxiety disorder (GAD). GAD symptoms include prolonged, excessive anxiety and worry that are difficult to control. GAD can also cause restlessness, nervousness, or a feeling of being "on edge", easy fatigability, difficulty concentrating, or a 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 Aurovitas

When not to take Pregabalin Aurovitas

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 Aurovitas, the doctor or pharmacist should be consulted.

• In some patients taking Pregabalin Aurovitas, 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 Aurovitas has been associated with dizziness and drowsiness, which can cause more frequent accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the possible reaction to the medicine is known.
• Taking Pregabalin Aurovitas 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 change the antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injuries may be taking other medicines, e.g., 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.
• Cases of heart failure have been reported in some patients taking Pregabalin Aurovitas; these were mostly elderly people with cardiovascular disorders. Before taking this medicine, the patient should inform the doctor if they have ever had heart disease.
• Cases of kidney failure have been reported in some patients taking Pregabalin Aurovitas. If, during Pregabalin Aurovitas treatment, the patient notices a decrease in urine output, they should inform the doctor, as stopping the medicine may cause the symptom to disappear.
• Some patients taking antiepileptic drugs, such as Pregabalin Aurovitas, 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 the doctor immediately.
• If Pregabalin Aurovitas is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (e.g., 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 drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Pregabalin Aurovitas.
• Cases of seizures have been reported during Pregabalin Aurovitas treatment or shortly after stopping Pregabalin Aurovitas treatment. If seizures occur, the doctor should be contacted immediately.
• Cases of brain function impairment (encephalopathy) have been reported in some patients with other underlying diseases who took Pregabalin Aurovitas. The doctor should be informed about all serious diseases, including liver or kidney diseases.

should inform the doctor about all serious diseases, including liver or kidney diseases.

• Cases of breathing difficulties have been reported. 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.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin use. If the patient experiences any of the serious skin reaction symptoms listed in section 4, they should stop taking pregabalin and seek medical attention immediately.

Dependence
Some people may become dependent on Pregabalin Aurovitas (need to continue taking the medicine). After stopping Pregabalin Aurovitas treatment, withdrawal symptoms may occur (see section 3 "How to take Pregabalin Aurovitas" and "Stopping Pregabalin Aurovitas treatment"). If the patient is concerned about becoming dependent on Pregabalin Aurovitas, they should discuss this with their doctor.
If, while taking Pregabalin Aurovitas, the patient notices any of the following symptoms, 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 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 notices 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 Aurovitas in children and adolescents (under 18 years of age) have not been established, so pregabalin should not be used in this age group.

Pregabalin Aurovitas 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 Aurovitas and some other medicines may interact with each other (interactions). Pregabalin Aurovitas taken with other medicines with a sedating effect (e.g., opioids) may enhance these effects and cause respiratory failure, coma, and death.
The degree of dizziness, drowsiness, and decreased concentration may increase if Pregabalin Aurovitas is taken with medicines containing:
oxycodone - (used as a painkiller)
lorazepam - (used for anxiety)
alcohol
Pregabalin Aurovitas may be taken with oral contraceptives.

Taking Pregabalin Aurovitas with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregabalin Aurovitas 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 baby. A Scandinavian study analyzing 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 genitals.
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 child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Pregabalin Aurovitas 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.

What Pregabalin Aurovitas contains

Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Pregabalin Aurovitas

This medicine should always be taken as directed by the doctor or pharmacist. 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 right for the patient.
Pregabalin Aurovitas is for oral use only.

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 Aurovitas twice or three times a day. If taken twice a day, Pregabalin Aurovitas should be taken in the morning and evening, at the same time every day. If taken three times a day, Pregabalin Aurovitas should be taken in the morning, at noon, and in the evening, at the same time every day.

If the patient feels that the effect of Pregabalin Aurovitas is too strong or too weak, they should inform their doctor or pharmacist.
Elderly patients (over 65 years old) should take Pregabalin Aurovitas according to the presented schedule, 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.
The patient should continue taking Pregabalin Aurovitas until the doctor advises them to stop.

Taking more Pregabalin Aurovitas than prescribed

The doctor or the nearest hospital emergency department should be contacted immediately. The patient should take the packaging or bottle of Pregabalin Aurovitas with them.
After taking more Pregabalin Aurovitas than prescribed, the patient may feel drowsy, confused, excited, or restless. Cases of seizures and loss of consciousness (coma) have also been reported.

Missing a dose of Pregabalin Aurovitas

It is important to take Pregabalin Aurovitas 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 Aurovitas treatment

Pregabalin Aurovitas treatment should not be stopped suddenly. If the patient wants to stop taking Pregabalin Aurovitas, 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 Pregabalin Aurovitas treatment, 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 Aurovitas 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 Aurovitas 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
• Mood swings, confusion, disorientation, decreased sexual interest, irritability
• Difficulty concentrating, clumsiness, memory impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, malaise
• 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(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, increased 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 twitching, 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
• Cold hands and feet.

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

• Changed sense of smell, feeling of swaying, changed sense of depth, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, throat constriction, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or restricted body movements
• Difficulty with proper writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG recordings corresponding to heart rhythm disturbances
• Muscle damage
• Nipple 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 manifest as difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by the appearance of red, flat, plate-like, or round patches on the torso, often with blisters in their center, skin peeling, 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)
• Parkinsonian 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 Aurovitas ("drug dependence").

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

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, e.g., 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, pharmacist, or nurse. 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
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Pregabalin Aurovitas

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 blister or carton after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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. Package contents and other information

What Pregabalin Aurovitas contains

The active substance of the medicine is pregabalin.
Each hard capsule contains 75 mg, 150 mg, or 300 mg of pregabalin.
The other ingredients of the medicine are:
Capsule content:cornstarch, talc
Cap and body of the capsule:titanium dioxide (E 171), gelatin, sodium lauryl sulfate, iron oxide red (E 172) (for 75 mg and 300 mg doses)

• (for 75 mg and 300 mg doses)

Ink:shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.

What Pregabalin Aurovitas looks like and contents of the pack

Hard capsules.
Pregabalin Aurovitas, 75 mg, hard capsules
Orange and white hard gelatin capsules, size 4, with "Z" printed on the cap and "12" printed on the body with black ink, containing a white or off-white granular powder.
Pregabalin Aurovitas, 150 mg, hard capsules
White and white hard gelatin capsules, size 2, with "Z" printed on the cap and "14" printed on the body with black ink, containing a white or off-white granular powder.
Pregabalin Aurovitas, 300 mg, hard capsules
Orange and white hard gelatin capsules, size 0, with "Z" printed on the cap and "17" printed on the body with black ink, containing a white or off-white granular powder.
Pregabalin Aurovitas hard capsules are available in transparent PVC/Aluminum blisters, in a cardboard box.
Package sizes:28 and 56 hard capsules.
Not all package sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

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

Poland:
Pregabalin Aurovitas
Portugal:
Pregabalina Aurobindo

Date of last revision of the leaflet: 02/2024