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-lasting pain caused by damage to the nerves. Many different diseases can cause peripheral neuropathic pain, such as diabetes or shingles. The pain can feel like burning, stabbing, throbbing, shooting, aching, tenderness, tingling, numbness, or a "pins and needles" sensation. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, which can have an impact on your physical and social functioning and overall quality of life.
Epilepsy:Pregabalin Aurovitas is used to treat a type of epilepsy where partial seizures (seizures that affect only one part of the brain) occur either alone or with generalized seizures (seizures that affect the whole brain). Your doctor will have prescribed Pregabalin Aurovitas for you to help treat your epilepsy when your current treatment is not controlling your seizures. Pregabalin Aurovitas should always be taken in addition to your current treatment and not instead of it. Pregabalin Aurovitas should not be used on its own to treat epilepsy.
Generalized anxiety disorder:Pregabalin Aurovitas is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include feeling anxious or worried, and these feelings are present for most of the time, being unable to control these feelings, and having at least three of the following: restlessness, feeling "on edge", being easily irritated, having difficulty concentrating, feeling afraid that something bad might happen, difficulty sleeping, and having physical symptoms such as muscle tension. These symptoms are persistent and have a significant impact on your daily 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, tell your doctor or pharmacist if you have any of the following conditions or if you experience any of the following:

• Some patients taking Pregabalin Aurovitas have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as rash. If you experience any of these symptoms, you should contact a doctor immediately.
• Pregabalin Aurovitas has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients. Therefore, you should be cautious until you are used to the effects of the medicine.
• Pregabalin Aurovitas may cause blurred vision, double vision, and other changes in vision. If you experience any changes in your vision, you should contact a doctor immediately.
• Some patients with diabetes who gain weight while taking pregabalin may need to adjust their blood sugar medicines.
• Some side effects, such as dizziness and sleepiness, have been reported more frequently in patients taking other medicines that can cause these side effects, such as opioids, and may be increased when Pregabalin Aurovitas is taken with these medicines.
• There have been reports of heart failure in some patients taking Pregabalin Aurovitas; these patients were mostly elderly and had pre-existing heart conditions. Before taking this medicine, make sure your doctor knows if you have ever had any heart problems.
• There have been reports of kidney failure in some patients taking Pregabalin Aurovitas. If you experience a decrease in urination or other signs of kidney problems while taking Pregabalin Aurovitas, you should contact a doctor immediately.
• Some patients taking antiepileptic drugs, such as Pregabalin Aurovitas, have had thoughts of harming themselves or others. If you have ever had such thoughts, you should contact a doctor immediately.
• If you are taking any medicines that may cause constipation (such as certain pain medicines), you may have an increased risk of gastrointestinal problems (such as constipation, obstruction, or paralytic ileus). You should tell 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 street drugs; this may indicate an increased risk of dependence on Pregabalin Aurovitas.
• There have been reports of seizures in patients taking Pregabalin Aurovitas or shortly after stopping Pregabalin Aurovitas. If you experience seizures, you should contact a doctor immediately.
• There have been reports of decreased brain function (encephalopathy) in some patients taking Pregabalin Aurovitas who have other underlying conditions. You should tell your doctor about any serious medical conditions you have had, including liver or kidney disease.

You should tell your doctor about all your serious medical conditions, including liver or kidney disease.

• There have been reports of difficulty breathing. If you have a condition that affects your breathing, such as chronic obstructive pulmonary disease, or if you have a condition that affects your nervous system, such as multiple sclerosis, or if you are over 65 years old, your doctor may need to adjust your dose. If you experience difficulty breathing or shallow breathing, you should contact a doctor immediately.
• There have been reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, with pregabalin. If you experience any symptoms of a severe skin reaction, such as blistering, peeling, or rashes, you should stop taking pregabalin and seek medical help immediately.

Dependence
Some people may become dependent on Pregabalin Aurovitas (need to continue taking the medicine). After stopping Pregabalin Aurovitas, you may experience withdrawal symptoms (see section 3 "How to take Pregabalin Aurovitas" and "Stopping Pregabalin Aurovitas"). If you are concerned about becoming dependent on Pregabalin Aurovitas, you should talk to your doctor.
If you experience any of the following symptoms while taking Pregabalin Aurovitas, it may indicate dependence:

• Needing to take the medicine for longer than prescribed by your doctor.
• Needing to take more of the medicine than prescribed by your doctor.
• Taking the medicine for reasons other than prescribed by your doctor.
• Repeatedly trying to stop or control the use of the medicine but being unable to do so.
• Feeling unwell when the medicine is stopped or when the dose is reduced, and feeling better when the medicine is taken again. If you experience any of these symptoms, you should 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 effectiveness 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 if you are taking, have recently taken, or might take any other medicines.
Pregabalin Aurovitas and some other medicines may affect each other. Pregabalin Aurovitas taken with other medicines that have a sedating effect (such as opioids) may increase the sedating effect and can cause respiratory failure, coma, and death.
The risk of dizziness, sleepiness, and confusion may be increased if Pregabalin Aurovitas is taken with other medicines that have similar effects, such as:

• Oxycodone (used to treat pain)
• Lorazepam (used to treat anxiety)
• Alcohol

Pregabalin Aurovitas can be taken with oral contraceptives.

Taking Pregabalin Aurovitas with food, drink, and alcohol

Pregabalin Aurovitas hard 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 has decided that it is necessary. Taking pregabalin during the first three months of pregnancy has been associated with an increased risk of birth defects. In a study of pregnancies in patients taking pregabalin, birth defects were seen in about 6 out of every 100 pregnancies, compared to about 4 out of every 100 pregnancies in patients who were not taking pregabalin. The birth defects seen with pregabalin included heart problems, cleft palate, and other defects of the central nervous system, kidneys, and genitals. Women of childbearing age should use effective contraception.

Driving and using machines

Pregabalin Aurovitas may cause dizziness, sleepiness, and confusion, and can affect your ability to drive or operate machinery. Do not drive, operate complex machinery, or engage in other potentially hazardous activities until you know how this medicine affects you.

What Pregabalin Aurovitas contains

Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which 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 best dose for you.
Pregabalin Aurovitas is for oral use only.

Neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules prescribed 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 the capsules. If you take two capsules a day, take one in the morning and one in the evening. If you take three capsules a day, take one in the morning, one at lunchtime, and one in the evening.

If you feel that the effect of Pregabalin Aurovitas is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients (over 65 years old) may need to take a lower dose of Pregabalin Aurovitas. Patients with kidney problems may need to take a lower dose of Pregabalin Aurovitas. Swallow the capsule whole with water. Continue taking Pregabalin Aurovitas until your doctor tells you to stop.

Overdose

If you take more Pregabalin Aurovitas than you should, contact a doctor or go to the nearest hospital emergency unit immediately. Take the medicine pack with you. You may feel drowsy, confused, agitated, or restless, or you may experience fits or loss of consciousness (coma).

Missed dose

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. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Pregabalin Aurovitas

Do not stop taking Pregabalin Aurovitas unless your doctor tells you to. If you want to stop taking Pregabalin Aurovitas, discuss this with your doctor. Your doctor will advise you on how to stop taking the medicine gradually over a minimum of one week. You may experience side effects when you stop taking Pregabalin Aurovitas, such as trouble sleeping, headache, nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain, sweating, and dizziness. These symptoms may be more common or severe if you have been taking Pregabalin Aurovitas for a long time. If you experience any of these symptoms, you should contact a doctor.

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, headache.

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

• Increased appetite
• Mood changes, confusion, difficulty concentrating, decreased sexual interest, irritability
• Difficulty with speech, memory problems, loss of memory, tremors, difficulty walking, numbness, tingling, sedation, lethargy, insomnia, fatigue, feeling abnormal
• Blurred vision, double vision
• Dizziness, balance disorder, falls
• Dry mouth, constipation, vomiting, bloating, diarrhea, nausea
• Difficulty achieving an erection
• Edema (swelling)
• Feeling drunk, unsteady gait
• 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 swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elation, psychotic reactions, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, changes in vision, including tunnel vision, flashes of light, jerky movements, decreased reflexes, increased muscle tone, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
• Dry eyes, eye swelling, eye pain, decreased eye movements, tearing, eye irritation
• Abnormal heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Flushing, hot flushes
• Breathing difficulties, dry nose, stuffy nose
• Increased salivation, heartburn, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, back pain
• Chest pain.
• Difficulty urinating or pain while urinating, 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, decreased potassium)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, coughing, snoring
• Painful menstruation
• Cold hands and feet.

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

• Changes in smell, altered sense of depth, bright vision, loss of vision
• Dilated pupils, squint
• Cold sweats, tightness in the throat, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced movements
• Difficulty writing
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG readings indicating heart rhythm disorders
• Muscle damage
• Galactorrhea, breast hypertrophy, gynecomastia
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal ideation, suicidal attempts
• Allergic reactions, which may be characterized by difficulty breathing, eye inflammation (keratitis), and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
• Jaundice (yellowing of the skin and whites of the eyes)
• Parkinsonian syndrome, characterized by symptoms such as tremor, slowed movement (reduced mobility), and stiffness (muscle rigidity)

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

• Liver failure
• Hepatitis.

Frequency not known: cannot be estimated from the available data

• Dependence on Pregabalin Aurovitas ("addiction").

You may experience side effects when you stop taking Pregabalin Aurovitas (see section "Stopping Pregabalin Aurovitas").

If you experience swelling of the face or tongue, or if you experience redness of the skin with blisters or peeling, you should seek medical help immediately.

Some side effects, such as dizziness and sleepiness, have been reported more frequently in patients taking other medicines that can cause these side effects, such as opioids, and may be increased when Pregabalin Aurovitas is taken with these medicines.
After the medicine was marketed, the following side effects were reported: difficulty breathing, shallow breathing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for the reporting of side effects" section below.
Contact details for the reporting of side effects:

Department of Drug Safety and Pharmacovigilance, 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, you can help provide more information on the safety of this medicine.

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 and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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:

Contents of the capsule:corn starch, 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 capsules)

• (for 75 mg and 300 mg capsules)

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, containing a white or almost white granular powder.
Pregabalin Aurovitas 150 mg hard capsules
White hard gelatin capsules, size 2, with "Z" printed on the cap and "14" printed on the body, containing a white or almost 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, containing a white or almost 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 Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

PL:

Pregabalin Aurovitas

PT:

Pregabalina Aurobindo

Date of last revision of the leaflet: 02/2024