Pregabalin Aurovitas

Package Leaflet: Information for the User

Pregabalin Aurovitas, 75 mg, hard capsules

Pregabalin Aurovitas, 150 mg, hard capsules

Pregabalin Aurovitas, 300 mg, hard capsules

Pregabalin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

Important information for patients.

• You should keep this leaflet, you may need to read it again.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Pregabalin Aurovitas is used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.
Neuropathic pain:Pregabalin Aurovitas is used to treat long-standing pain caused by nerve damage. Many different diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The pain can be described as hot, burning, throbbing, shooting, stabbing, sharp, crampy, aching, heavy, or tender. 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 a certain type of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Aurovitas if your current treatment does not fully control your condition. Pregabalin Aurovitas should always be used in addition to your current treatment, not as a replacement. Pregabalin Aurovitas should not be used as monotherapy (on its own), but always in combination with other anti-epileptic medicines.
Generalized anxiety disorder:Pregabalin Aurovitas 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, difficulty concentrating, or feeling "empty" in the head, irritability, increased muscle tension, or sleep disturbances. These symptoms are different from the stress and tension of everyday life.

2. Before you take Pregabalin Aurovitas

When not to take Pregabalin Aurovitas

If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Pregabalin Aurovitas, talk to your doctor or pharmacist.

• Some patients taking Pregabalin Aurovitas have reported symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, contact your doctor immediately.
• Taking Pregabalin Aurovitas has been associated with dizziness and somnolence, which may increase the occurrence of accidental injuries (falls) in elderly people. Therefore, be cautious until you know how the medicine affects you.
• Taking Pregabalin Aurovitas may cause blurred vision, double vision, or other vision disturbances, most of which are transient. If you experience any changes in your vision, inform your doctor immediately.
• In patients with diabetes, weight gain may occur during treatment with pregabalin, which may require a change in antidiabetic treatment.
• Certain side effects, such as dizziness and somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines (e.g., pain or muscle relaxant medicines) that have similar side effects to pregabalin, and the intensity of these effects may be increased when these medicines are taken together.
• Heart failure has been reported in some patients taking Pregabalin Aurovitas; these were mostly elderly patients with pre-existing heart conditions. Before taking this medicine, tell your doctor if you have ever had heart disease.
• Renal failure has been reported in some patients taking Pregabalin Aurovitas. If you experience a decrease in urination while taking Pregabalin Aurovitas, inform your doctor, as stopping the medicine may cause the symptom to resolve.
• Some patients taking antiepileptic medicines, such as Pregabalin Aurovitas, have had thoughts of harming themselves or others, or have experienced suicidal behaviors. If you have ever had such thoughts or behaviors, contact your doctor immediately.
• If Pregabalin Aurovitas is taken with other medicines that can cause constipation (such as certain pain medicines), gastrointestinal problems (e.g., constipation, obstruction, or paralytic ileus) may occur. Inform your doctor if you experience constipation, especially if you are prone to it.
• Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or any illegal drugs; this may indicate an increased risk of dependence on Pregabalin Aurovitas.
• Seizures have been reported in patients taking Pregabalin Aurovitas or shortly after stopping treatment with Pregabalin Aurovitas. If you experience seizures, contact your doctor immediately.
• Brain disorders (encephalopathy) have been reported in some patients with pre-existing conditions taking Pregabalin Aurovitas. Inform your doctor about all serious illnesses you have had, including liver or kidney disease.

Inform your doctor about all serious illnesses you have had, including liver or kidney disease.

• Breathing difficulties have been reported. If you have neurological disorders, respiratory disorders, kidney disorders, or are over 65 years old, your doctor may recommend a different dosing schedule. If you experience breathing difficulties or shallow breathing, contact your doctor.
• A severe skin reaction, including Stevens-Johnson syndrome and toxic epidermal necrolysis, has been reported with pregabalin use. If you experience any symptoms of severe skin reactions mentioned in section 4, 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 treatment with Pregabalin Aurovitas, withdrawal symptoms may occur (see section 3 "How to take Pregabalin Aurovitas" and "Stopping Pregabalin Aurovitas"). If you are concerned about becoming dependent on Pregabalin Aurovitas, talk to your doctor.
If you experience any of the following symptoms while taking Pregabalin Aurovitas, it may indicate dependence:

• Need to take the medicine for a longer period than prescribed by your doctor.
• Feeling the need to take a higher dose than prescribed.
• Taking the medicine for reasons other than prescribed.
• Repeatedly trying to stop or control the use of the medicine but being unable to do so.
• Feeling unwell after stopping the medicine and feeling better after taking it again. If you experience any of these symptoms, talk to your doctor to discuss the best course of treatment, including when to stop taking the medicine and how to do so safely.

Children and adolescents

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

Pregabalin Aurovitas and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Pregabalin Aurovitas and certain other medicines may affect each other (interact). Pregabalin Aurovitas taken with other medicines that have a sedating effect (e.g., opioids) may increase these effects and cause respiratory failure, coma, and death.
The intensity of dizziness, somnolence, and decreased concentration may increase if Pregabalin Aurovitas is taken with medicines containing:
oxycodone (used as a pain medicine)
lorazepam (used as an anxiolytic)
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.
Do not drink alcohol while taking Pregabalin Aurovitas.

Pregnancy, breastfeeding, and fertility

Pregabalin Aurovitas should not be taken during pregnancy or breastfeeding unless your doctor decides otherwise. Taking pregabalin during the first three months of pregnancy may cause birth defects in the unborn baby. A Scandinavian study analyzed data from women who took pregabalin during the first three months of pregnancy and found birth defects in 6 out of 100 babies born, while in women not treated with pregabalin, birth defects occurred in 4 out of 100 babies born. The reported birth defects included facial defects, eye defects, central nervous system defects (including brain defects), kidney defects, and genital defects.
Women of childbearing age should use effective contraception. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin Aurovitas may cause dizziness, somnolence, and decreased concentration. Do not drive, operate complex machinery, or perform potentially hazardous activities until you know how the medicine affects you.

What Pregabalin Aurovitas contains

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

3. How to take Pregabalin Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the dose that is right for you.
Pregabalin Aurovitas is for oral use only.

Neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules as instructed by your doctor.
• The dose will generally be between 150 mg and 600 mg per day.
• Your doctor will tell you how many times a day to take Pregabalin Aurovitas. If you take it twice a day, take it once in the morning and once in the evening, at the same time each day. If you take it three times a day, take it in the morning, afternoon, and evening, at the same time each day.

If you think that the effect of Pregabalin Aurovitas is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients (over 65 years old) should take Pregabalin Aurovitas as prescribed, unless they have kidney problems.
For patients with kidney problems, your doctor may prescribe a different dose and/or dose schedule.
Swallow the capsule whole with water.
Continue taking Pregabalin Aurovitas until your doctor tells you to stop.

If you take more Pregabalin Aurovitas than you should

Contact your doctor or go to the nearest hospital emergency department immediately. Take the medicine pack or bottle with you.
After taking too much Pregabalin Aurovitas, you may feel drowsy, confused, agitated, or have seizures and loss of consciousness (coma).

If you forget to take Pregabalin Aurovitas

It is important to take Pregabalin Aurovitas regularly at the same time each day. If you miss a dose, take it as soon as you remember, unless it is time for your next dose. In this case, continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

Stopping Pregabalin Aurovitas

Do not stop taking Pregabalin Aurovitas unless your doctor tells you to. If you want to stop taking Pregabalin Aurovitas, talk to your doctor first. Your doctor will advise you how to do this. If treatment is to be stopped, it should be done gradually over a minimum of one week.
Be aware that after stopping short-term or long-term treatment with Pregabalin Aurovitas, you may experience certain side effects, known as withdrawal symptoms. These symptoms include insomnia, headache, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, excessive sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have taken Pregabalin Aurovitas for a longer period. If you experience withdrawal symptoms, contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Dizziness, somnolence, headache.

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

• Increased appetite
• Mood swings, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory impairment, loss of memory, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
• Blurred vision, double vision
• Dizziness, balance disturbances, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• Difficulty achieving an erection
• Edema, including peripheral edema
• 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 perception, restlessness, depression, agitation, mood changes, difficulty finding the right words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased libido, 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 sensitivity, loss of taste, feeling of burning, tremors, decreased consciousness, loss of consciousness, syncope, increased sensitivity to noise, feeling unwell
• Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
• Cardiac arrhythmias, tachycardia, hypotension, hypertension, changes in heart rhythm, heart failure
• Flushing, hot flushes
• 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, back pain
• Chest pain
• Urination difficulties or pain while urinating, urinary incontinence
• Weakness, thirst, tightness in the chest
• Changes in blood test results and liver function (increased creatine phosphokinase, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels, decreased potassium levels)
• Hypersensitivity, facial swelling, itching, hives, rhinitis, nosebleeds, coughing, snoring
• Painful menstruation
• Cold hands and feet.

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

• Changes in smell, feeling of swaying, changes in depth perception, bright vision, loss of vision
• Dilated pupils, strabismus
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or limited body movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG corresponding to arrhythmias
• Muscle damage
• Galactorrhea, gynecomastia, breast enlargement in men
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions, which may be characterized by difficulty breathing, eye inflammation (keratitis), and severe skin reactions with red, flat, target-like, or circular patches on the torso, often with blisters in the center, peeling of the 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)
• Parkinsonian syndrome, characterized by symptoms similar to Parkinson's disease, such as tremors, slowed movements (reduced mobility), 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").

Be aware that after stopping short-term or long-term treatment with Pregabalin Aurovitas, you may experience certain side effects, known as withdrawal symptoms (see section "Stopping Pregabalin Aurovitas").

If you experience facial swelling or tongue swelling, or if you experience skin redness with blisters or peeling, seek medical attention immediately.

Certain side effects, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines (e.g., pain or muscle relaxant medicines) that have similar side effects to pregabalin, and the intensity of these effects may be increased when these medicines are taken together.
After the medicine was marketed, the following side effects were reported: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the national reporting system via the Medicines Agency website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

Side effects can also be reported to the marketing authorization holder.

5. How to store Pregabalin Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Pregabalin Aurovitas contains

The active substance is pregabalin.
Each hard capsule contains 75 mg, 150 mg, or 300 mg of pregabalin.
The other ingredients are:
Caplet core:corn starch, talc
Caplet shell: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 black ink printing: "Z" on the cap and "12" on the body, containing a white or off-white granular powder.
Pregabalin Aurovitas, 150 mg, hard capsules
White hard gelatin capsules, size 2, with black ink printing: "Z" on the cap and "14" on the body, containing a white or off-white granular powder.
Pregabalin Aurovitas, 300 mg, hard capsules
Orange and white hard gelatin capsules, size 0, with black ink printing: "Z" on the cap and "17" on the body, containing a white or off-white granular powder.
Pregabalin Aurovitas hard capsules are available in transparent PVC/Aluminum blisters, in a cardboard box.
Pack sizes:28 and 56 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

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 medicinal product 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