PREGABALIN ARISTO 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Pregabalin Aristo 100 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Pregabalin Aristo is and what it is used for
2. What you need to know before you take Pregabalin Aristo
3. How to take Pregabalin Aristo
4. Possible side effects
5. Storage of Pregabalin Aristo
6. Contents of the pack and other information

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

Pregabalin 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-lasting pain caused by damage to the nerves. There are several diseases that can cause peripheral neuropathic pain, such as diabetes or shingles.

The feeling of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles.

Peripheral and central 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 to treat certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin for you to treat 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 are prolonged and excessive worry and anxiety that are difficult to control. GAD can also cause restlessness or feeling on edge or nervous or irritable, being easily fatigued (tired), having difficulty concentrating or an empty mind, irritability, muscle tension, or sleep disturbances. This is different from the stress and tension of everyday life.

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

Do not take Pregabalin Aristo

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 or pharmacist before taking Pregabalin 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 rash. If you experience any of these symptoms, you should see your doctor immediately.

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

• Pregabalin has been associated with dizziness and somnolence, which may increase the risk 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 vision, many of which are transient. If you experience any changes in your vision, you should inform your doctor immediately.

• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medication.

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

• There have been reports of heart failure in some patients treated with this medicine. Most of them were elderly patients with cardiovascular disease. Before using this medicine, you should tell your doctor if you have a history of heart disease.

• There have been reports of renal failure in some patients treated with this medicine. If you notice a decrease in your ability to urinate while taking pregabalin, you should inform your doctor, as stopping treatment may improve this situation.

• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicidal behavior. If at any time you have 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 some types of pain medications), gastrointestinal problems (e.g., constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you suffer from 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.

• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment with this medicine. 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 illnesses. Tell your doctor if you have a history of any serious illness, 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.

Dependence

Some people may become dependent on pregabalin (need to keep taking the medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3, "How to take Pregabalin Aristo" and "If you stop taking Pregabalin Aristo"). If you are concerned that you may become dependent on pregabalin, it is important that you 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 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 of pregabalin in children and adolescents (under 18 years) have not been established, so pregabalin should not be used in this age group.

Taking Pregabalin Aristo with other medicines

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

Pregabalin and certain medicines may influence each other (interactions). When pregabalin is used with certain sedating medications (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:

Oxycodone - (used as a pain reliever)

Lorazepam - (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Pregabalin Aristo with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol during treatment with pregabalin.

Pregnancy and breastfeeding

Do not take pregabalin during pregnancy or breastfeeding, unless your doctor has told you to. 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 in the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares with 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (orofacial clefts), 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 Aristo may cause dizziness, somnolence, and decreased concentration. Do 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.

3. How to take Pregabalin Aristo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will determine the dose that is right 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-daily dosing, take pregabalin once in the morning and once in the evening, approximately at the same time every day. For three-times-daily dosing, 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 and/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 Aristo 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.

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 Aristo

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 forgotten doses.

If you stop taking Pregabalin Aristo

Do not stop taking pregabalin unless your doctor tells you to. Your doctor 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.

Once you have finished taking pregabalin, either after short-term or long-term treatment, you should know that you may experience certain side effects. These 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 symptoms may occur more frequently or be more severe if you have been taking pregabalin for a longer period.

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 Frequent:may affect more than 1 in 10 people

• Dizziness.
• Somnolence.
• Headache.

Frequent: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Alteration of attention, clumsiness, memory impairment, memory loss, tremors, difficulty speaking, 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.
• Swelling of the body including limbs.
• Feeling of drunkenness, gait disturbances.
• Weight gain.
• Muscle cramp, 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 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, reflexes diminished, 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, swollen eyes, eye pain, tired eyes, tearful eyes, eye irritation.
• Heart rhythm disorders, 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, 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 disorders.
• 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, not raised, 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 erythemas may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)).
• Jaundice (yellow color 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 pregabalin ("drug dependence").

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

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 somnolence, 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 side 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 or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pregabalina Aristo

Keep this medicine out of the 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 the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalina Aristo

The active ingredient is pregabalin.

Each hard capsule of Pregabalina Aristo 100 mg contains 100 mg of pregabalin

The other components (excipients) are:

Capsule content: pregelatinized cornstarch, mannitol, talc

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

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

Product Appearance and Package Contents

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

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 Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

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

Denmark: Pregabalin Aristo

Portugal: Pregabalina Aristo

Italy: Pregabalin Aristo

Spain: Pregabalina Aristo

Date of the last revision of this prospectus: April 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/