PREGABALIN AUROVITAS 25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pregabalin Aurovitas 25 mg Hard Capsules EFG

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

• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Pregabalin Aurovitas is and what it is used for
2. What you need to know before you take Pregabalin Aurovitas
3. How to take Pregabalin Aurovitas
4. Possible side effects
5. Storage of 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 generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalin is used to treat long-standing pain caused by damage to the nerves. There are many diseases that can cause peripheral neuropathic pain, such as diabetes or shingles. The feeling of pain may be described as hot, burning, throbbing, shooting, stabbing, sharp, crampy, aching, heavy, or tender. Peripheral neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can have an impact on physical and social activity and overall quality of life.

Epilepsy:Pregabalin is used in the treatment of a certain form of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin for you to help treat your epilepsy when your current treatment is not controlling your condition. You should take pregabalin in addition to your current treatment. Pregabalin should not be taken alone but should always be used in combination with other anti-epileptic treatments.

Generalized anxiety disorder:Pregabalin is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include excessive and persistent worry, and being "on edge". GAD can also cause restlessness, feeling tired, difficulty concentrating, irritability, and sleep disturbances. This is different from the worries and concerns of everyday life.

2. What you need to know before you take Pregabalin Aurovitas

Do not takePregabalin Aurovitas

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

Warnings and precautions

Consult your doctor before taking Pregabalin Aurovitas if you have:

• Some patients taking pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.
• Pregabalin has been associated with dizziness and somnolence, which may increase the occurrence of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are used to the effects of the medicine.
• Pregabalin may cause blurred vision, loss of vision or other changes in your vision, many of which are temporary. If you experience any changes in your vision, you should immediately inform your doctor.
• Diabetic patients who gain weight while taking pregabalin may need an adjustment in their blood sugar controlling medications.
• Certain side effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (muscle stiffness or rigidity), with side effects similar to those of pregabalin, so the intensity of these effects may be increased when taken together.
• There have been reports of heart failure in some patients taking pregabalin. Most of these patients had pre-existing heart conditions. Before taking this medicine, you should tell your doctor if you have any history of heart disease.
• There have been reports of kidney failure in some patients taking pregabalin. If you notice a decrease in your ability to urinate while taking pregabalin, you should inform your doctor as stopping treatment may improve this condition.
• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicidal thoughts or behavior. If at any time you have these thoughts or show this behavior, contact your doctor as soon as possible.
• When pregabalin is taken with other medications that may cause constipation (such as some types of pain medications), it is possible that gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean you have a higher risk of becoming dependent on Pregabalin Aurovitas.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with pregabalin. If you experience seizures, contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other conditions. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of difficulty breathing. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.
• There have been reports of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Dependence

Some people may become dependent on Pregabalin Aurovitas (need to keep taking the medicine). They may have withdrawal symptoms when they stop using Pregabalin Aurovitas (see section 3, "How to take Pregabalin Aurovitas" and "If you stop taking Pregabalin Aurovitas"). If you are concerned that you may become dependent on Pregabalin Aurovitas, it is important that you consult your doctor.

If you notice any of the following signs while taking Lyrica, it could be a sign that you have become dependent:

• You need to take the medicine for longer than recommended by your doctor.
• You feel that you need to take more than the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

If you notice any of these signs, talk to your doctor to discuss the best care plan for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

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

Other medicines and Pregabalin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregabalin and certain other medicines may influence each other (interactions). When pregabalin is used with certain medicines that have a sedating effect (including opioids), these effects may be increased, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medicines that contain:

Oxicodona (used as a pain reliever)

Lorazepam (used to treat anxiety)

Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Pregabalin Aurovitas with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy, breastfeeding, and fertility

Do not take pregabalin during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genitals.

An effective contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Pregabalin Aurovitas contains sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Pregabalin Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Do not take more than the recommended dose.

Your doctor will determine the appropriate dose for you.

Pregabalin is for oral use only.

Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

• Take the number of capsules that your doctor has told you to take.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.
• Your doctor will tell you to take pregabalin either twice or three times a day. For twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. For three times a day, take pregabalin in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of pregabalin is too strong or too weak, talk to your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take pregabalin as normal, except if you have kidney problems.

Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabalin Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

If you forget to take Pregabalin Aurovitas

It is important that you take your pregabalin capsules regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. In that case, continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Aurovitas

Do not stop taking pregabalin suddenly. If you want to stop taking Pregabalin Aurovitas, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, it should be done gradually over a minimum of one week.

After stopping treatment with pregabalin, short-term or long-term, you should know that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Attention alteration, movement clumsiness, memory impairment, memory loss, tremors, speech difficulty, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen.
• Difficulty with erection.
• Body swelling including extremities.
• Feeling of drunkenness, gait disturbances.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in the extremities.
• Sore throat.

Uncommon(may affect up to 1 in 100 people):

• Loss of appetite, weight loss, low blood sugar, high blood sugar levels.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems, including inability to reach climax, delayed ejaculation.
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, eye swelling, eye pain, tired eyes, teary eyes, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushing, hot flashes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, inability to hold urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Cold sensation in hands and feet.

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

• Altered sense of smell, oscillating vision, altered depth perception, visual glare, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing correctly.
• Increased fluid in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual period interruption.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions (which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by reddish patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Jaundice (yellowing of the skin and eyes).
  • Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known(cannot be estimated from the available data):

• Becoming dependent on Pregabalina Aurovitas ("drug dependence").

Once you have finished a short or long-term treatment with Pregabalina Aurovitas, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Pregabalina Aurovitas").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

Certain adverse effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (stiff or rigid muscles), with adverse effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pregabalina Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofPregabalina Aurovitas

• The active ingredient is pregabalin. Each hard capsule contains 25 mg of pregabalin.
• The other components are:

Capsule content:cornstarch, talc.

Capsule shell:titanium dioxide (E171), gelatin, sodium lauryl sulfate.

Printing ink:Shellac lacquer, propylene glycol, black iron oxide (E172), potassium hydroxide.

Product Appearance and Package Contents

Hard gelatin capsule, size "5", with white cap and body, with "Z" printed on the cap and "10" on the body with black ink, containing a white or off-white granular powder.

Pregabalina Aurovitas is available in PVC transparent/Aluminum blister packs.

Package sizes: 14, 21, 56, 84, and 100 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

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

Date of the last revision of this prospectus: February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).