Prospect: information for the user

Pregabalina Aurovitas 75 mg hard capsules EFG

Read this prospect carefully before starting to use this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Pregabalina Aurovitas

3.How to take Pregabalina Aurovitas

4.Possible adverse effects

5.Storage of Pregabalina Aurovitas

6.Contents of the package and additional information

PregabalinaAurovitasbelongs to a group of medications used for the treatment of epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalinais used for the treatment of chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, numbness, tingling, and pins and needles sensation. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

Epilepsy:Pregabalinais used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribepregabalinato treat epilepsy when your current treatment does not control the disease. You must takepregabalinain addition to your current treatment.Pregabalinashould not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalinais used in the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are excessive and prolonged anxiety and worry that are difficult to control. GAD can also produce restlessness or feeling of excitement or nervousness, feeling easily fatigued (tired), difficulty concentrating, feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from everyday stress and tension.

Do not takePregabalina Aurovitas

•If you are allergic topregabalinaor any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to takePregabalina Aurovitasif you have:

•Some patients treated with pregabalina have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If you experience any of these symptoms, you should see your doctor immediately.

•Pregabalinahas been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you become familiar with the effects of the medication.

•Pregabalinamay cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.

•Diabetic patients who gain weight while taking pregabalina may need to change their diabetes medications.

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

•Cases of heart failure have been reported in some patients treated with pregabalina. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you should inform your doctor if you have a history of heart disease.

•Cases of renal insufficiency have been reported in some patients treated with pregabalina. If during treatment withpregabalinayou note a decrease in your ability to urinate, you should inform your doctor as the interruption of treatment may improve this situation.

•Some patients treated with antiepileptic medications such aspregabalinahave had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or exhibit such behavior, contact your doctor as soon as possible.

•Whenpregabalinais taken with other medications that may cause constipation (such as certain 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 medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on Pregabalina Aurovitas.

•Cases of seizures have been reported during treatment with pregabalina or shortly after discontinuing treatment with pregabalina. If you experience seizures, contact your doctor immediately.

•Cases of encephalopathy (brain dysfunction) have been reported in some patients taking pregabalina and having other diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• Cases of breathing difficulties have been reported. If you have neurological disorders, respiratory disorders, renal insufficiency, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.
• Cases of severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with pregabalina treatment. Stop taking pregabalina and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

Dependence

Some people may become dependent on Pregabalina Aurovitas (need to continue taking the medication). They may experience withdrawal symptoms when they stop using Pregabalina Aurovitas (see section 3, “How to take Pregabalina Aurovitas” and “If you interrupt treatment withPregabalina Aurovitas”). If you are concerned that you may become dependent on Pregabalina Aurovitas, it is essential to 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 medication for a longer time than recommended by your doctor.
• You feel the need to take more of the recommended dose.
• You are using the medication for reasons other than those prescribed.
• You have made repeated and unsuccessful attempts to stop or control the use of the medication.
• When you stop taking the medication, you experience discomfort and feel better once you take the medication again.

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

Children and adolescents

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

Other medications and Pregabalina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregabalinaand certain medications may influence each other (interactions). When pregabalina is used with certain medicationsthat have a sedative effect (including opioids), these effects may be potentiated, and may cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase ifpregabalinais taken with other medications that contain:

Oxycodone (used as a pain medication)

Lorazepam (used to treat anxiety)

Alcohol

Pregabalinacan be taken with oral contraceptives.

Taking Pregabalina Aurovitas with food, drinks, and alcohol

Thepregabalinacapsules can be taken with or without food.

It is recommended not to take alcohol during treatment withpregabalina.

Pregnancy, breastfeeding, and fertility

You should not takepregabalinaduring pregnancy or lactation, unless your doctor has indicated otherwise. The use of pregabalina during the first 3 months of pregnancy may cause congenital anomalies in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalina during the first 3 months of pregnancy, 6 out of 100 babies had such congenital anomalies. This contrasts with 4 out of 100 babies born to women not treated with pregabalina in the study. The anomalies included facial clefts, eye, nervous system (including the brain), kidney, and genital abnormalities.

A reliable contraceptive method should be used in fertile women. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Pregabalina Aurovitas contains sodium:

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take a dose greater than the one prescribed to you.

Your doctor will determine the appropriate dose for you.

Pregabalina is exclusively for oral use.

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

•Take the number of capsules indicated by your doctor.

•The dose, adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.

•Your doctor will instruct you to takepregabalinatwo or three times a day. In the case of twice a day, takepregabalinaonce in the morning and once at night, approximately at the same hour every day. In the case of three times a day, takepregabalinain the morning, at noon, and at night, approximately at the same hour every day.

If you estimate that the action ofpregabalinais too strong or too weak, inform your doctor or pharmacist.

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

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

Swallow the capsule whole with water.

Continue takingpregabalinauntil your doctor tells you to stop.

If you use more Pregabalina Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional. As a result of having taken morepregabalinathan you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forgot to use Pregabalina Aurovitas

It is essential to take thepregabalinacapsules regularly at the same hour every day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In that case, continue with the next dose normally. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Pregabalina Aurovitas

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

Once the treatment withpregabalinais completed, whether short-term or long-term, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include: sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been takingpregabalinafor a longer period. If you experience withdrawal effects, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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.

•Euphoria, confusion, disorientation, decreased libido, irritability.

•Alteration of attention, clumsiness, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation.

•Blurred vision, double vision.

•Dizziness, balance problems, falls.

•Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.

•Difficulty with erection.

•Swelling of the body including extremities.

•Sensation of intoxication, alterations in gait.

•Weight gain.

•Muscle cramps, joint pain, back pain, pain in extremities.

•Throat pain.

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

•Loss of appetite, weight loss, low blood sugar, high blood sugar.

•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 libido, sexual dysfunction, including inability to achieve orgasm, delayed ejaculation.

•Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness on standing, sensitive skin, loss of taste, burning sensation, tremors on movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.

•Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation.

•Alterations in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart beat, heart failure.

•Flushes, hot flashes.

•Difficulty breathing, dry nose, nasal congestion.

•Increased saliva production, burning sensation, 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 urinating, inability to hold urine.

•Weakness, thirst, chest oppression.

•Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood).

•Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring.

•Painful menstruation.

•Sensation of cold in hands and feet.

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

•Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision.

•Dilated pupils, strabismus.

•Cold sweat, throat oppression, swollen tongue.

•Pancreatitis.

•Difficulty swallowing.

•Slowed or reduced body movement.

•Difficulty writing correctly.

•Fluid accumulation in the abdominal area.

•Pulmonary edema.

•Seizures.

•Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations.

•Muscle damage.

•Milk secretion, abnormal breast growth, increased breast size in men.

•Menstrual cycle interruption.

•Renal insufficiency, reduced urine output, urinary retention.

•Decreased white blood cell count.

• Improper behavior, suicidal behavior, suicidal thoughts.

•Severe skin reactions that may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterizedby flat, red patches, often with central blisters, peeling skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

•Liver insufficiency.

•Hepatitis (liver inflammation).

Unknown frequency(cannot be estimated from available data):

•Becoming dependent on Pregabalina Aurovitas (“drug dependence”).

Once a short or long-term treatment with Pregabalina Aurovitas is completed, you should know that you may experience certain side 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 becomes red and blistered or peels, you should seek medical attention immediately.

Certain side 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 (tense or rigid muscles), with side effects similar to those of pregabalin, so the intensity of these side effects may increase when taken together.

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

Reporting of adverse reactions

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

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofPregabalina Aurovitas

-The active ingredient is pregabalina. Each hard capsule contains 75 mg of pregabalina.

-The other components are:

Hard capsule content:maize starch, talc.

Capsule coating:titanium dioxide (E171), gelatin, sodium lauryl sulfate, iron oxide red (E172).

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

Appearance of the product and contents of the package

Hard gelatin capsule size “4”, with orange cap and white body, with “Z” printed on the cap and “12” on the body with black ink, containing a white or off-white granular powder.

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

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

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,Venda Nova

2700-487 Amadora

Portugal

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).