Package Insert: Information for the User

Premax 100 mg Tablets EFG
Pregabalin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

3. How to Take Premax
4. Possible Adverse Effects
5. Storage of Premax

6. Contents of the Package 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:Premax is used for the treatment of chronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a sensation of pinching. 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: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 rather always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalina is used in the treatment of generalized anxiety disorder (GAD). Symptoms of GAD 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), having difficulty concentrating or feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from the stress and tensions of everyday life.

Do not takePremax

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 Premax

• 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 exercise caution 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), with similar adverse effects to pregabalin, so the intensity of these effects may increase when taken together.
• Severe cases of heart failure have been reported in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases.

Before using this medication, you must inform your doctor if you have a history of heart disease.

• Severe cases of kidney problems (renal insufficiency) have been reported in some patients treated with pregabalin. If during pregabalin treatment you notice 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 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; this may indicate that you have a higher risk of becoming dependent on pregabalin.
• Severe cases of seizures have been reported during pregabalin treatment or shortly after discontinuing pregabalin treatment. If you experience seizures, contact your doctor immediately.
• Severe cases of brain dysfunction (encephalopathy) have been reported in some patients taking pregabalin and having other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• Severe cases of breathing difficulties have been reported. If you have neurological disorders, respiratory disorders, kidney 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 Premax (need to continue taking the medication). They may experience withdrawal effects when they stop using Premax (see section 3, "How to take Premax" and "If you interrupt Premax treatment"). 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 Premax, it could be a sign that you have become dependent:

• You need to take the medication for a longer period 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 of pregabalin have not been established in children and adolescents (under 18 years) and therefore pregabalin should not be used in this age group.

Other medications and Premax

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 influence 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 Premax with food, drinks, and alcohol

Pregabalin tablets can be taken with or without food.

It is recommended not to take alcohol during pregabalin treatment.

Pregnancy, breastfeeding, and fertility

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

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 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. Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin 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 pregabalin two or three times a day. In the case of two times a day, take pregabalin once in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take pregabalin in the morning, at noon, and at night, approximately at the same hour every day.

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

If you are an elderly patient (over 65 years old), you should take pregabalin 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 with water, without crushing or dissolving it.

The capsule can be divided into equal doses.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Premax 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 pregabalin 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 takePremax

It is essential to take the pregabalin capsules 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 withPremax

Do not stop taking Premax suddenly. If you want to stop taking Premax, 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 a long-term or short-term treatment with Premax has been completed, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include insomnia, 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 taking Premax for 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.

The very common side effects, which may affect more than 1 in 10 people, are:

• Dizziness, drowsiness, headache

The common side effects, which may affect up to 1 in 10 people, are:

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Disturbances in attention, clumsiness of movement, deterioration of memory, memory loss, tremors, difficulty speaking, 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
• Sore throat

The uncommon side effects, which may affect up to 1 in 100 people are:

• 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 when standing, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.
• Eye dryness, eye swelling, 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 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.
• Dysmenorrhea (painful menstruation).
• Sensation of cold in hands and feet.

The rare side effects, which may affect up to 1 in 1,000 people, are:

• 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 (inflammation of the pancreas)
• Difficulty swallowing
• Reduced mobility of the body
• Difficulty writing correctly
• Fluid accumulation in the abdominal area
• Pulmonary edema
• Seizures
• Changes in electrocardiogram (ECG) corresponding to alterations in heart rhythm
• 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 that may include difficulty breathing, conjunctivitis (inflammation of the eyes), and a severe skin reaction characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat, nasal, genital, and eye ulcers. 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's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle stiffness.

The very rare side effects, which may affect up to 1 in 10,000 people, are:

• Liver insufficiency (liver problems).
• Hepatitis (inflammation of the liver).

Unknown frequency: cannot be estimated from available data

• Becoming dependent on Premax (“drug dependence”).

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

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

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 Pregabalina, 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.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting of adverse reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 the abbreviation CAD.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofPremax

The active ingredient is pregabalin. Each tablet contains 50 mg of pregabalin.

The other components (excipients) are: microcrystalline cellulose and magnesium stearate.

Appearance of the product and content of the container

Round, biconvex, scored tablet, white in color, marked with “M1” on one face.

Premax is available in blistersofpoliamide/Aluminum/polyvinylchloride (PVC)incartonsofpaperthat contain56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda.Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: December 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/