Leaflet: information for the user

Premax 20 mg/ml oral solution EFG

Pregabalin

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.

This medication 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:This medication 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 pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a sensation of pinpricks. 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:This medication is used for the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe this medication to treat epilepsy when your current treatment does not control the disease. You must take this medication in addition to your current treatment. This medicationshould not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:This medication is used for 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 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 take Premax:

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 starting to take this medicine.

• Some patients treated with this medicine 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 must see your doctor immediately.

• 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.

• This medicine has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you must be cautious until you become familiar with the effects the medicine can have.

• This medicine 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 must inform your doctor immediately.

• Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.

• Certain side 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 side effects to pregabalin, so the intensity of these side effects may increase when taken together.

• Severe cases of heart failure have been reported in some patients treated with this medicine. Most of them were elderly patients with cardiovascular diseases.Before using this medicine, you must inform your doctor if you have a history of heart disease.

• Severe cases of kidney failure have been reported in some patients treated with this medicine. If during treatment with this medicine you notice a decrease in your ability to urinate, you must inform your doctor since stopping treatment may improve this situation.

• Some patients treated with antiepileptic medications, such as this medicine, 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 this medicine is taken with other medications that can 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; it may mean that you have a higher risk of becoming dependent on Premax.

• Severe cases of seizures have been reported during treatment with this medicine or shortly after stopping treatment with this medicine. If you experience seizures, contact your doctor immediately.

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

• Severe cases of respiratory difficulty have been reported. If you have neurological 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 Premax (need to continue taking the medicine). They may experience withdrawal effects when they stop using Premax (see section 3, “How to take Premax” and “If you stop taking Premax”). If you are concerned that you may become dependent on Premax, 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 medicine for a longer time than recommended by your doctor.
• You feel the need to take more of the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated and 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 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.

Use of Premax with other medicines

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

Pregabalin and certain medicines may exert a mutual influence on each other (interactions). When this medicine is used with certain medicines 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 this medicine is taken with other medicines that contain:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Premax with food, drinks, and alcohol

This medicine can be taken with and without food.

It is recommended not to take alcohol during treatment with this medicine.

Pregnancy and breastfeeding

You must not take this medicine during pregnancy or lactation, unless your doctor has told you to. 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 babies out of 100 had such congenital anomalies. This contrasts with 4 babies out of 100 born to women not treated with pregabalin in the study. Congenital anomalies of the face (cleft palate), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains parahydroxybenzoic acid methyl ester (E218), parahydroxybenzoic acid propyl ester (E216), and sodium

This medicine may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216).

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Dolor neuropático periférico y central, epilepsia o trastorno de ansiedad generalizada:

• Take the solution as directed by your doctor.
• The dose, adjusted for you and your condition, will generally be between 150 mg (7.5 ml) and 600 mg (30 ml) per day.
• Your doctor will tell you to take this medication two or three times a day. If two times a day, take this medication once in the morning and once at night, approximately at the same hour every day. If three times a day, take this medication in the morning, at noon, and at night, approximately at the same hour every day.

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

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

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

Continue taking this medication until your doctor tells you to stop.

Administration:

Instructions for use

This medication is exclusively for oral use.

1. Open the bottle: press down the cap and turn it clockwise (Figure 1).

1. Only the first time you use it:A adapter for the bottle is provided with the oral syringe. This adapter should be placed on the neck of the bottle, making it easier to extract the solution with the syringe. If the adapter is not on the bottle, remove the adapter and the 5 ml syringe from the transparent bag. Place the bottle on a firm surface, and proceed to place the adapter on the neck of the bottle with the flat side facing you and pressing it down (Figure 2).

1. Press the plunger of the syringe to the end of the syringe barrel (towards the tip) to remove excess air. Insert the syringe into the adapter of the bottle with a slight rotational movement (Figure 3).

1. Invert the bottle (with the syringe in place) and load the syringe with the liquid by pulling the plunger of the syringe downwards until just past the graduation mark corresponding to the prescribed amount in milliliters (ml) (Figure 4). Remove air bubbles from the syringe by pulling the plunger up to the correct graduation mark.

1. Put the bottle back in its normal position, without removing the syringe from the adapter of the bottle (Figure 5).

1. Remove the syringe from the adapter of the bottle (Figure 6).

1. Empty the contents of the syringe directly into the mouth by pressing the plunger to the end of the syringe barrel (Figure 7).

Nota:Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).

[For example, a dose of 150 mg (7.5 ml) will require removing two volumes from the bottle to reach the complete dose. Using the syringe, remove first 5 ml, empty the contents directly into the mouth, and then take the syringe again for 2.5 ml, emptying the remaining contents into the mouth.]

1. Wash the syringe by taking water with the help of the plunger and expelling it from the syringe by pressing the plunger towards the tip, at least three times (Figure 8).

1. Put the cap back on the bottle (leaving the adapter on the neck of the bottle) (Figure 9).

Tabla 1. Volume to extract with the syringe to obtain the prescribed dose of this medication

If you take more Premax than you should

Call your doctor or go to the nearest emergency service immediately. Bring the bottle or vial of the oral solution of this medication with you. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported. 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.

If you forgot to take Premax

It is essential to take the oral solution of this medication 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 as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Premax

Do not stop taking this medication unless your doctor tells you to. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once the treatment with this medication is completed, both short and long-term, you should know that you may experience certain adverse effects. These include sleep problems, 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 this medication 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

Common: may affect up to 1 in 10 people

• Euphoria, confusion, disorientation, decreased sexual desire, irritability.
• Attention disturbances, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, 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, gait disturbances.
• Weight gain.
• Muscle cramps, 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.
• 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 desire, 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 noise, general discomfort.
• Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation.
• Heart rhythm disturbances, 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 rigidity, 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 menstrual periods.
• 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, tongue swelling.
• Pancreatitis inflammation.
• Difficulty swallowing.
• Reduced mobility or movement 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 disturbances.
• 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.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by flat, red patches, often with central blisters, skin peeling, 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 (yellow skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle rigidity.

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

• Liver insufficiency.
• Heptatitis (liver inflammation).

Frequency not known: cannot be estimated from available data

•Dependence on Premax (“drug dependence”).

Once a short or long-term treatment with Premax has been completed, 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, you should 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

Reporting of adverse effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 or in the bottle. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

This medication should be used within 60 days after the first opening of the bottle.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Premax

The active ingredient is pregabalina. Each ml contains 20 mg of pregabalina.

The other components are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), anhydrous sodium dihydrogen phosphate, monohydrogen phosphate disodium, sucralose, strawberry flavor 10131/P, purified water.

Appearance of Premax and contents of the packaging

Premax 20 mg/ml oral solution EFG is a transparent and colorless solution that is presented in a white HDPE bottle containing 473 ml of oral solution in a cardboard container. The packaging also contains an oral syringe with graduations of 1.25 ml and a total capacity of 5 ml and a bottle adapter.

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

One Pharma S.A.

60th km National Road Atenas-Lamia,

32 009 Schimatari, Viotia

Greece

VIANEX PLANT-A

12 Km National Road Athens-Lamia,

144 51 Metamorfossi

Greece

Date of the last review of this leaflet: May 2024

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