Leaflet: information for the user

Pregabalina Aristo 100 mg hard capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Pregabalina Aristo

4. Possible side effects

5. Storage of Pregabalina Aristo

6. Contents of the pack and additional information

Pregabalina belongs 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:Pregabalina is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes.

The pain sensation can be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a sensation of pins and needles.

Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

Epilepsy:Pregabalina is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalina to treat epilepsy when your current treatment does not control the disease. You must take pregabalina in addition to your current treatment. Pregabalina should not be administered alone, but always used in combination with other antiepileptic medications.

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

Do not take Pregabalina Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina Aristo.

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

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

• Pregabalin has 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.

• Pregabalin may 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 immediately inform your doctor.

• Patients with diabetes who gain weight while taking pregabalin 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), and with adverse effects similar to those of pregabalin, so that the intensity of these effects may increase when taken together.

• Cases of heart failure have been reported in some patients treated with this medication. 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 this medication. If during treatment with pregabalin you notice a decrease in your ability to urinate, you should inform your doctor since stopping treatment may improve this situation.

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

• When pregabalin is taken with other medications that can 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 illicit drugs; you may have a higher risk of becoming dependent on pregabalin.

• Cases of seizures have been reported during treatment with pregabalin or shortly after stopping treatment with this medication. If you experience seizures, contact your doctor immediately.

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

• Cases of respiratory difficulty 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.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medication). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalina Aristo" and "If you interrupt treatment with Pregabalina Aristo"). If you are concerned that you may become dependent on pregabalin, it is essential to consult your doctor.

If you notice any of the following signs while taking pregabalin, 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 a higher dose than recommended.
• 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 pregabalin should not be used in this age group.

Taking Pregabalina Aristo with other medications

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

Pregabalin and certain medications may exert a mutual influence on each other (interactions). When pregabalin is used with certain medications that have a sedative effect (including opioids), these effects may be potentiated, 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 medications that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medication can be taken with oral contraceptives.

Taking Pregabalina Aristo with food, drinks, and alcohol

Pregabalin capsules can be taken with and without food.

It is recommended not to take alcohol during treatment with pregabalin.

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or lactation, unless your doctor has indicated otherwise. The use of pregabalin 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 pregabalin 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 pregabalin in the study. Facial abnormalities (cleft palate), eye abnormalities, neurological system abnormalities (including the brain), kidney abnormalities, and genital abnormalities have been reported.

A reliable contraceptive method should be used in women of childbearing age. 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

Pregabalina Aristo may 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.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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 as indicated by your doctor.

•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 pregabalina two or three times a day. In the case of twice a day, take pregabalina once in the morning and once at night, approximately at the same time every day. In the case of three times a day, take pregabalina in the morning, at noon, and at night, approximately at the same time every day.

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

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

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

Swallow the capsule whole with water.

Continue taking pregabalina until your doctor tells you to stop.

If you take more Pregabalina Aristo 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 ingested.

As a result of having taken more pregabalina than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forgot to take Pregabalina Aristo

It is essential to take the pregabalina capsules regularly at the same time 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 Aristo

Do not stop taking pregabalina unless your doctor tells you to. 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 with pregabalina is completed, whether it is long-term or short-term, you should know that you may experience certain adverse effects. These include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These symptoms may appear more frequently or severely if you have been taking pregabalina for a longer period.

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.
• Somnolence.
• Headache.

Common: may affect up to 1 in 10 people

• Increased appetite.
• Sensation of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Alteration of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, drowsiness, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.
• Difficulty achieving 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.

Rare: 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 sexual appetite, 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, reflexes decreased, hyperactivity, dizziness when standing, sensitive skin, loss of taste, sensation of burning, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.

Decreased tear production, swelling of eyes, eye pain, tired eyes, watery eyes, eye irritation.

Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.

Flushing, 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 tightness.

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.

Menstrual cramps.

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 constriction, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Reduced mobility of the body.
• Difficulty writing correctly.
• Fluid accumulation in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual interruption.
• Renal insufficiency, reduced urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions (which may include difficulty breathing, conjunctivitis, and a severe skin reaction characterized by flat, non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin desquamation, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Icterus (yellowing of the skin and eyes).
• Parkinsonism, Parkinson-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 (inflammation of the liver).

Frequency not known: cannot be estimated from available data

• Becoming dependent on pregabalin ("drug dependence").

After completing a short or long-term treatment with pregabalin, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalin Aristo").

If you experience swelling in the face or tongue, or if your skin becomes red and blistered or peels, seek immediate medical attention.

Certain side effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity (tense or rigid muscles), with similar side effects to 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 or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, 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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Pregabalina Aristo Composition

The active ingredient is pregabalin.

Each pregabalina Aristo hard capsule 100 mg contains 100 mg of pregabalin.

The other components (excipients) are:

Capsule content: pregelatinized cornstarch, mannitol, talc

Capsule coating: gelatin, titanium dioxide (E-171), iron oxide red (E-172).

Printing ink: contains shellac lacquer, iron oxide black (E-172), propylene glycol (E-1520) and ammonium hydroxide (E527).

Appearance of the product and contents of the package

Pregabalina Aristo 100 mg are hard orange-yellow capsules marked with "100" on the capsule body.

It is available in a box with PVC aluminum/aluminum blisters containing 21, 84 or 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible manufacturer

Pharmathen International S.A

Industrial Park Sapes, Rodopi Prefecture, Block

No 5, Rodopi 69300

Greece

or

Pharmathen S.A

6, Dervenakion str., 153 51 Pallini, Attiki

Greece

or

Aristo Pharma GmbH

Wallenroder Straße 8-10, 13435 Berlin, Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medication is authorized in the European Economic Area member states with the following names:

Danish: Pregabalin Aristo

Portuguese: Pregabalina Aristo

Italian: Pregabalin Aristo

Spanish: Pregabalina Aristo

Last review date of this leaflet: April 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/