Pregabalin aurovitas

Patient Information Leaflet

Pregabalin Aurovitas, 75 mg, hard capsules
Pregabalin Aurovitas, 150 mg, hard capsules
Pregabalin Aurovitas, 300 mg, hard capsules
Pregabalinum
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Pregabalin Aurovitas is and what it is used for
2. What you need to know before taking 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 belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalised anxiety disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Aurovitas is used to treat long-term pain caused by nerve damage. Various conditions, such as diabetes or shingles, can cause peripheral neuropathic pain. Pain sensations may be described as burning, shooting, stabbing, aching, tingling, or numbness. Peripheral and central neuropathic pain may also be associated with changes in mood, sleep disturbances, and 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 with or without secondary generalisation) in adults. Your doctor may prescribe Pregabalin Aurovitas if your current treatment does not fully control your condition. Pregabalin Aurovitas should always be used as an add-on therapy to your current treatment. Pregabalin Aurovitas must not be used as monotherapy (as the only medicine), but always in combination with other antiepileptic medicines.
Generalised anxiety disorder (GAD): Pregabalin Aurovitas is used to treat generalised anxiety disorder (GAD). Symptoms of GAD include prolonged, excessive anxiety and worry that are difficult to control. GAD may also cause restlessness, feeling keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, increased muscle tension, or sleep disturbances. These symptoms are different from the stress and tension associated with everyday life.

2. Important information before using Pregabalin Aurovitas

When not to use Pregabalin Aurovitas
Do not use this medicine 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 treatment with Pregabalin Aurovitas, discuss this with your doctor or pharmacist.

• Some patients taking Pregabalin Aurovitas have experienced symptoms suggesting an allergic reaction. These symptoms include: swelling of the face, lips, tongue, or throat, as well as widespread skin rash. If any of these symptoms occur, contact your doctor immediately.
• Use of Pregabalin Aurovitas has been associated with dizziness and somnolence, which may lead to an increased risk of accidental injuries (falls) in elderly patients. Therefore, caution should be exercised until the patient's response to the medicine is known.
• Treatment with Pregabalin Aurovitas may cause blurred vision, loss of vision, or other visual disturbances, most of which are transient. If any changes in vision occur, inform your doctor immediately.
• In patients with diabetes, weight gain during pregabalin treatment may necessitate adjustment of antidiabetic therapy.
• Certain adverse effects, such as somnolence, may occur more frequently, as patients with spinal cord injury may be taking other medications, e.g., analgesics or muscle relaxants, which have similar adverse effects to pregabalin, and the severity of these effects may be greater when such medicines are taken concomitantly.
• Cases of heart failure have been reported in some patients taking Pregabalin Aurovitas; these were mostly elderly individuals with cardiovascular disorders. Before using this medicine, the patient should inform the doctor if they have ever had heart disease.
• Cases of renal failure have been reported in some patients taking Pregabalin Aurovitas. If the patient notices a decrease in frequency of urination while taking Pregabalin Aurovitas, they should inform their doctor, as discontinuation of the medicine may resolve this symptom.
• Some patients taking antiepileptic medicines, such as Pregabalin Aurovitas, have had thoughts of self-harm or suicide or exhibited suicidal behaviors. If the patient ever experiences such thoughts or behaviors, contact the doctor immediately.
• If Pregabalin Aurovitas is used concomitantly with other medicines that may cause constipation (such as certain analgesics), gastrointestinal problems (e.g., constipation, bowel obstruction, or intestinal paralysis) may occur. Inform the doctor if the patient experiences constipation, especially if they are prone to it.
• Before starting treatment with this medicine, inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Pregabalin Aurovitas.
• Seizures have been reported during treatment with Pregabalin Aurovitas or shortly after discontinuation of Pregabalin Aurovitas. If seizures occur, contact the doctor immediately.
• Cases of worsening brain function (encephalopathy) have been reported in some patients with concomitant other diseases who were taking Pregabalin Aurovitas. The patient should

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

• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction, or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient develops breathing difficulties or shallow breathing, contact the doctor.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of pregabalin. If the patient develops any of the symptoms of serious skin reactions listed in section 4, treatment with pregabalin should be discontinued and immediate medical help sought.

Dependence
Some individuals may become dependent on Pregabalin Aurovitas (a need to continue taking the medicine). Withdrawal symptoms may occur after stopping Pregabalin Aurovitas (see section 3 "How to take Pregabalin Aurovitas" and "Stopping treatment with Pregabalin Aurovitas"). If the patient is concerned about becoming dependent on Pregabalin Aurovitas, they should speak to their doctor.
If the patient notices any of the following symptoms while taking Pregabalin Aurovitas, this may indicate dependence:

• Needing to take the medicine for a longer period than prescribed by the doctor.
• Feeling the need to take a higher dose than recommended.
• Using the medicine for reasons other than those for which it was prescribed.
• Repeated unsuccessful attempts to stop or control taking this medicine.
• Feeling unwell after stopping the medicine and feeling better after restarting it. If the patient notices any of these symptoms, they should speak to their doctor to discuss the best treatment approach, including when and how to stop taking this medicine safely.

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

Pregabalin Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Pregabalin Aurovitas and certain other medicines may interact with each other. Pregabalin Aurovitas, when taken concomitantly with other centrally acting sedative medicines (including opioids), may enhance these effects and lead to respiratory depression, coma, and death.
The degree of dizziness, somnolence, and reduced concentration may increase if Pregabalin Aurovitas is taken together with medicines containing:
oxycodone – (used as a painkiller)
lorazepam – (used for anxiety)
alcohol
Pregabalin Aurovitas may be used concomitantly with oral contraceptives.

Taking Pregabalin Aurovitas with food, drink, and alcohol
Pregabalin Aurovitas capsules may be taken with or without food.
Alcohol should not be consumed while taking Pregabalin Aurovitas.

Pregnancy, breastfeeding, and fertility
Pregabalin Aurovitas should not be used during pregnancy or while breastfeeding unless otherwise decided by the doctor. Use of pregabalin by women during the first three months of pregnancy may cause congenital malformations in the unborn child requiring treatment. In a Scandinavian countries study, analysis of data from women who took pregabalin during the first three months of pregnancy showed congenital malformations in 6 out of every 100 live births, whereas congenital malformations occurred in 4 out of every 100 live births in women not treated with pregabalin. Reported congenital malformations involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
Women of childbearing potential should use an effective method of contraception. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
Pregabalin Aurovitas may cause dizziness, somnolence, and reduced concentration. Do not drive a car, operate complex machinery, or perform potentially hazardous activities until the effect of this medicine on the ability to perform these activities has been determined.

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

3. How to use Pregabalin Aurovitas

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist. Do not take a higher dose than prescribed.
The doctor will determine the dose most appropriate for the individual patient.
Pregabalin Aurovitas is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy or generalized anxiety disorder:

• Take the number of capsules recommended by the doctor.
• The dose adjusted to the patient and their condition will usually range from 150 mg to 600 mg per day.
• The doctor will inform the patient whether Pregabalin Aurovitas should be taken twice or three times daily. If taken twice daily, Pregabalin Aurovitas should be administered in the morning and evening, at the same time each day. If taken three times daily, Pregabalin Aurovitas should be taken in the morning, at midday, and in the evening, at the same time each day.

If the patient feels that the effect of Pregabalin Aurovitas is too strong or too weak,
they should inform their doctor or pharmacist.
Patients of advanced age (over 65 years) should take Pregabalin Aurovitas according to the outlined regimen unless they have kidney disease.
In patients with impaired renal function, the doctor may decide on a different dosing regimen and/or adjust the dose.
The capsule should be swallowed whole with water.
Continue taking Pregabalin Aurovitas as long as the doctor has not advised stopping the treatment.
Taking more Pregabalin Aurovitas than prescribed
Contact a doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging or container with you. After taking more than the prescribed dose of Pregabalin Aurovitas, the patient may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.
If a dose of Pregabalin Aurovitas is missed
It is important to take Pregabalin Aurovitas regularly at the same time each day. If a dose is missed, take it as soon as possible, unless it is almost time for the next dose. In that case, continue treatment according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
Stopping Pregabalin Aurovitas
Do not stop taking Pregabalin Aurovitas suddenly. If the patient wishes to discontinue Pregabalin Aurovitas, they should first discuss this with their doctor. The doctor will advise on how to do so. If treatment needs to be stopped, it should be done gradually over at least one week.
Be aware that after short- or long-term use of Pregabalin Aurovitas, certain unwanted effects may occur, known as withdrawal symptoms. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, 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 prolonged period. If withdrawal symptoms occur, contact the doctor.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common (may occur in more than 1 in 10 people):

• Dizziness, somnolence, headache.

Common (may occur in no more than 1 in 10 people):

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory impairment, amnesia, tremor, speech difficulties, tingling sensation, numbness, sedation, lethargy, insomnia, feeling of fatigue, unusual feeling
• Blurred vision, double vision
• Dizziness, balance disorders, fall
• Dry mouth, constipation, vomiting, bloating, diarrhoea, nausea, feeling of abdominal distension
• Difficulty achieving erection
• Swelling of the body, including limbs
• Feeling of alcohol intoxication, unsteady gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat.

Uncommon (may occur in no more than 1 in 100 people):

• Loss of appetite, weight loss, low blood sugar, high blood sugar
• Disturbances in self-perception, psychomotor agitation, depression, restlessness, mood changes, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased libido, sexual problems including inability to achieve orgasm, delayed ejaculation
• Visual disturbances, abnormal eye movements, visual impairment including tunnel vision, perception of flashes, jerky movements, diminished reflexes, increased activity, dizziness upon standing, skin hypersensitivity, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, impaired eye movement, tearing, eye irritation
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
• Sudden reddening of facial skin, sudden hot flushes
• Breathing difficulties, dryness in the nose, nasal congestion
• Increased salivation, heartburn, 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 during urination, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function tests (increased creatine kinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine concentration, decreased blood potassium concentration)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet.

Rare (may occur in no more than 1 in 1,000 people):

• Altered sense of smell, sensation of swaying vision, altered depth perception, vivid vision, vision loss
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowed or restricted body movements
• Difficulty writing properly
• Ascites
• Fluid in the lungs
• Seizures
• ECG changes indicative of heart rhythm disturbances
• Muscle damage
• Nipple discharge, gynecomastia, breast enlargement in males
• Absence of menstruation
• Kidney failure, reduced urine volume, urinary retention
• Decreased white blood cell count
• Abnormal behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions, which may include breathing difficulties, eye inflammation (keratitis), and severe skin reaction characterised by red, flat, circular or oval patches on the trunk, often with blisters in the centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. Such serious 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)
• Parkinsonism, i.e. symptoms resembling Parkinson's disease such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

Very rare (may occur in no more than 1 in 10,000 people):

• Liver failure
• Hepatitis.

Frequency not known: frequency cannot be estimated from available data

• Dependence on Pregabalin Aurovitas (medicinal product dependence).

It should be noted that certain adverse reactions, known as withdrawal symptoms, may occur after discontinuation of short- or long-term treatment with Pregabalin Aurovitas (see section "Discontinuing treatment with Pregabalin Aurovitas").

If swelling of the face or tongue occurs, or if reddening of the skin with accompanying blisters or skin peeling develops, seek immediate medical advice.

Some adverse reactions, such as somnolence, may occur more frequently because patients with spinal cord injury may be taking other medicines for conditions such as pain or spasticity, which have similar adverse effects to pregabalin, and the severity of these effects may be increased when such medicines are taken concomitantly.

After the medicine was placed on the market, the following adverse reactions have been reported: breathing difficulties, shallow breathing.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting adverse reactions helps provide more information on the safety of the medicine.

Adverse reactions can also be reported to the marketing authorisation 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 stated on the blister pack or carton after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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.
Other ingredients are:
Capsule contents: maize starch, talc
Capsule shell: titanium dioxide (E 171), gelatin, sodium lauryl sulfate, iron oxide red (E 172) (for 75 mg and 300 mg strengths)
Printing 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
Hard gelatin capsules, size 4, with an orange cap and a white body, printed in black ink with "Z" on the cap and "12" on the body, containing white or almost white granular powder.
Pregabalin Aurovitas 150 mg, hard capsules
Hard gelatin capsules, size 2, with a white cap and a white body, printed in black ink with "Z" on the cap and "14" on the body, containing white or almost white granular powder.
Pregabalin Aurovitas 300 mg, hard capsules
Hard gelatin capsules, size 0, with an orange cap and a white body, printed in black ink with "Z" on the cap and "17" on the body, containing white or almost white granular powder.
Pregabalin Aurovitas hard capsules are available in transparent PVC/Aluminium blisters, packed in a cardboard carton.
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 Warszawa
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 European Economic Area countries under the following names:
Poland: Pregabalin Aurovitas
Portugal: Pregabalina Aurobindo