PreMax 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Premax 50 mg tablets EFG Pregabalin

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Premax and what is it 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: Premax is used to treat chronic pain caused by nerve damage. Various conditions can cause peripheral neuropathic pain, such as diabetes or herpes. The pain may be described as warmth, burning, throbbing, shooting, stabbing, sharp pain, spasms, continuous pain, tingling, numbness, or a pins-and-needles sensation. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

Epilepsy: Pregabalin is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin if your current treatment does not adequately control your seizures. You should take pregabalin as an add-on to your current treatment. Pregabalin must not be used as monotherapy; it should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalin is used to treat generalized anxiety disorder (GAD). Symptoms of GAD include excessive and prolonged anxiety and worry that are difficult to control. GAD may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and worries of normal life.

2. What you need to know before taking Premax

Do not take Premax

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Premax

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek medical attention immediately.
• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek immediate medical help if you notice any symptoms related to these serious skin reactions described in section 4.
• Dizziness and drowsiness have been associated with pregabalin, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of this medicine.
• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.
• Certain adverse effects, such as drowsiness, may be more frequent in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity (tight or rigid muscles), which have similar side effects to pregabalin; thus, the intensity of these effects may increase when taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular diseases.

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

• Cases of kidney problems (renal failure) have been reported in some patients treated with pregabalin. If you notice a decrease in your ability to urinate during treatment with pregabalin, inform your doctor, as discontinuation of treatment may improve this condition.
• Some patients taking antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or behaviors, contact your doctor as soon as possible.
• When pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal 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 medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on pregabalin.
• Seizures have been reported during pregabalin treatment or shortly after discontinuation of pregabalin. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have disorders of the nervous system, respiratory disorders, renal failure, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience difficulty breathing or shallow breathing.

Dependence

Some people may become dependent on Premax (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Premax (see section 3, “How to take Premax” and “If you stop taking Premax”). If you are concerned about possibly becoming dependent on pregabalin, it is important 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 longer than recommended by your doctor.
• You feel you need to take a higher dose than prescribed.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it.

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

Children and adolescents

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

Other medicines and Premax

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

Pregabalin and certain medicines may interact with each other. When pregabalin is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if pregabalin is taken with other medicines containing:

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

Pregabalin tablets can be taken with or without food.

Alcohol consumption is not recommended during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy or breastfeeding unless your doctor has specifically instructed you to do so. 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 reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations. This compares with 4 out of 100 babies born to women not treated with pregabalin in the study. Malformations reported include those of the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genitals.

Women of childbearing potential should use an effective method of contraception. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.

3. How to take Premax

Follow exactly the instructions for using this medicine given by your doctor.

If you are unsure, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin is for oral use only.

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

• Take the number of tablets your doctor has prescribed.
• The dose, which has been adjusted for your condition, is generally between 150 mg and 600 mg daily.
• Your doctor will instruct you to take pregabalin two or three times a day. If twice daily, take pregabalin once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabalin in the morning, at midday, and at night, approximately at the same time each day.

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

If you are an elderly patient (over 65 years of age), you should take pregabalin as usual, unless you have kidney problems.

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

Swallow the tablet with water, without crushing or dissolving it.

The tablet may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount ingested.
As a result of taking more pregabalin than recommended, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Premax

It is important that you take pregabalin tablets regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, continue with your next dose as normal. Do not take a double dose to make up for a missed dose.

If you stop taking Premax

Do not stop taking Premax suddenly. If you wish to discontinue Premax, speak to your doctor first. He or she will advise you on how to do so. If you are going to stop treatment, it should be done gradually over a minimum of one week.

After completing short- or long-term treatment with Premax, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, feelings of anxiety, diarrhea, flu-like symptoms, seizures, restlessness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking Premax for a longer period of time. If you experience withdrawal effects, you should consult your doctor.

If you have any further questions about 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 everyone experiences them.

Very common adverse effects, which may affect more than 1 in 10 people, are:

• Dizziness, drowsiness, headache

Common adverse effects, which may affect up to 1 in 10 people, are:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sex drive, irritability
• Attention disturbance, clumsiness of movement, 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 in erection
• Swelling of the body including limbs
• Feeling of drunkenness, disturbances in gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon adverse effects, which may affect up to 1 in 100 people, are:

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Altered perception of self, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sex drive, sexual relationship problems including inability to reach climax, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise
• Dry eyes, eye swelling, 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 flushes
• Breathing difficulty, nasal dryness, nasal congestion
• Increased saliva production, burning, 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 control urine
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, low blood potassium)
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring
• Painful menstrual periods
• Cold sensation in hands and feet

Rare adverse effects, which may affect up to 1 in 1,000 people, are:

• Altered sense of smell, oscillating vision, depth perception disturbance, visual brightness, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing properly
• Increased fluid 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, breast enlargement in men
• Interruption of menstrual periods
• Kidney failure, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behaviors, suicidal thoughts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by flat red patches or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Jaundice (yellowing of the skin and eyes)
• Parkinsonism, Parkinson-like symptoms such as tremor, bradykinesia (reduced ability to move), and muscle rigidity

Very rare adverse effects, which may affect up to 1 in 10,000 people, are:

• Liver failure (liver problems)
• Hepatitis (liver inflammation)

Frequency not known: cannot be estimated from available data

• Becoming dependent on Premax ("drug dependence")

After stopping short- or long-term treatment with Premax, you should be aware that you may experience certain adverse effects known as withdrawal effects (see "If you stop taking Premax").

If you experience swelling of the face or tongue, or if your skin becomes red with blisters or peeling, seek immediate medical attention.

Certain adverse 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 (tight or stiff muscles), which have adverse effects similar to those of Pregabalin, so that the intensity of these effects may increase when taken together.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es .

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Premax

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

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date corresponds to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Premax

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

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

Appearance of the product and contents of the pack

Round, biconvex, white, scored tablet marked with “M1” on one side.

Premax is available in blisters made of polyamide/aluminum/polyvinyl chloride (PVC), packed in cardboard boxes containing 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/