Label: Information for the Patient

Pregabalina SUN 300 mg Hard Capsules EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, 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 should not give it to others who 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 label. See section 4.

Pregabalina SUN 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 SUN is used for the treatment of chronic pain caused by nerve damage. Various diseases 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 pins and needles sensation. 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 SUN 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 SUN in addition to your current treatment. Pregabalina SUN should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalina SUN 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 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 SUN

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 SUN

• 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 the appearance of a widespread skin rash. If you experience any of these symptoms, you should immediately seek medical attention.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention 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.
• Some diabetic patients 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 should inform your doctor if you have a history of heart disease.
• Severe cases of kidney problems (insufficiency) have been reported in some patients treated with this medication. If during pregabalin treatment you notice a decrease in your ability to urinate, you should inform your doctor, as discontinuing treatment may improve this situation.
• Some patients taking 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 a history of alcoholism or abuse or of illegal drugs, as this may indicate a higher risk of becoming dependent on pregabalin.
• Severe cases of seizures have been reported during pregabalin treatment or shortly after discontinuing treatment with this medication. If you experience seizures, contact your doctor immediately.
• Severe cases of encephalopathy (brain dysfunction) 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 respiratory difficulty 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 pregabalin (need to continue taking this medication). They may experience withdrawal effects when they stop taking pregabalin (see section 3 "How to take Pregabalina SUN" and "If you interrupt treatment with Pregabalina SUN").

If you are concerned that you may become dependent on pregabalin, it is essential to consult with your doctor.

If you notice any of the following symptoms while taking Pregabalina SUN, it could be a sign that you have become dependent:

• You need to take this medication for a longer period than indicated by your doctor
• You feel the need to take a higher dose than recommended
• You use this medication for reasons other than those prescribed
• You have made repeated attempts, without success, to stop using this medication or control its use
• When you stop taking this medication, you do not feel well, and you feel better when you take it again

If you notice any of these symptoms, talk to your doctor to analyze the best treatment for you, even to see when it is appropriate to stop taking this medication 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), so pregabalin should not be used in this age group.

Taking Pregabalina SUN 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 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

Pregabalina SUN can be taken with oral contraceptives.

Taking Pregabalina SUN with food, drinks, and alcohol

Pregabalina SUN capsules can be taken with or without food

It is recommended not to consume alcohol during pregabalin treatment.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy or breastfeeding, 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. 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 fertile women. 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.

Pregabalina SUN contains sodium and mannitol

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule; it is essentially "sodium-free".

Mannitol may have a mild laxative effect.

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 doses than prescribed.

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, adjusted for you and your condition, will generally be between 150 mg and 600 mg per day.
• Your doctor will instruct 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 hour every day. In the case of three times a day, take pregabalina 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), you should take pregabalina normally, 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 pregabalina until your doctor tells you to stop.

If you take more Pregabalina SUN 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 taking 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 SUN

It is essential to take the pregabalina 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 with Pregabalina SUN

Do not stop taking pregabalina abruptly. If you want to stop taking pregabalina, discuss it with your doctor first. He will instruct you on how to do it. If you interrupt the treatment, you should do it gradually over a minimum of one week.

Once the treatment with pregabalina is completed, whether short-term or long-term, you should know that you may experience certain adverse effects, known as withdrawal symptoms. 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 symptoms may appear more frequently or severely if you have been taking this medication for a longer period. If you experience withdrawal symptoms, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following severe side effects, discontinue treatment with Pregabalina SUN and contact your doctor or visit the nearest hospital, as you may need urgent medical attention.

• Severe hypersensitivity (rare, may affect up to 1 in 1,000 people) and allergic reactions (which may include facial swelling, tongue swelling, difficulty breathing, itching)

• Severe skin reaction characterized by flat, red patches, often with central blisters, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). (rare, may affect up to 1 in 1,000 people)

If you experience swelling of the face or tongue, or if your skin becomes red and presents blisters or peeling, you must seek immediate medical assistance.

• Pancreatitis (which includes symptoms such as severe stomach pain, often with nausea and vomiting) (rare, may affect up to 1 in 1,000 people)

Other side effects:

Very common (may affect more than 1 in 10 people)

• Dizziness, somnolence, headache

Common (may affect up to 1 in 10 people)

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Attention alteration, movement clumsiness, memory deterioration, memory loss, tremors, speech difficulty, paresthesia, sedation, lethargy, insomnia, fatigue, abnormal sensation
• Blurred vision, double vision
• Dizziness, balance problems, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, abdominal distension
• Erectile dysfunction
• Swelling of the body, including extremities
• Feeling of intoxication, gait disturbances
• Weight gain
• Throat irritation
• Muscle cramps, joint pain, back pain, limb pain, neck contracture
• Throat irritation

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 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 - abnormal and uncontrolled movements of the extremities, 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
• Dry eyes, eye swelling, eye pain, tired eyes, watery eyes, eye irritation
• Heart rhythm alterations, increased heart rate, low blood pressure, high blood pressure, heart failure
• Flushes, hot flashes
• Difficulty breathing, dry nose, nasal congestion
• Cough, facial swelling, urticaria, itching, nasal discharge, nasal bleeding, snoring
• Increased saliva production, mouth burning, numbness around the mouth
• Sweating, rash, chills, fever
• Cold sensation in hands and feet
• Muscle spasms, joint swelling, muscle rigidity, pain including muscle pain, neck pain
• Difficulty or pain urinating, inability to hold urine
• Weakness, thirst, chest oppression
• Breast pain
• Painful menstrual periods
• Generalized swelling
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, decreased potassium in blood, elevated creatinine in blood, neutropenia)

Rare (may affect up to 1 in 1,000 people)

• Changes in heart rhythm
• Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision
• Dilated pupils, strabismus
• Eye inflammation (keratitis)
• Cold sweat, throat constriction, tongue swelling
• Difficulty swallowing
• Reduced mobility or movement
• Difficulty writing correctly
• Pulmonary edema
• Seizures
• Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations
• Increased fluid in the abdominal area
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual cycle interruption
• Renal problems, decreased urine output, urinary retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Icterus (yellow skin and eyes)
• Parkinsonism, Parkinson's disease-like symptoms, such as tremors, bradykinesia (decreased ability to move), and muscle rigidity.

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

• Liver failure.
• Hepatitis (liver inflammation).

Not known: their frequency cannot be estimated from available data

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

After discontinuing short-term or long-term treatment with Pregabalina Sun, you should know that you may experience certain side effects, known as withdrawal symptoms (see "If you discontinue treatment with Pregabalina SUN").

Certain side effects, such as dizziness, 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 Pregabalin, so the intensity of these side effects may increase when taken together.

There have been reports of the following adverse reaction in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse reactions, 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 after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Bottle: once opened, capsules must be used within the next 30 days

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and unused medications if you are unsure. By doing so, you will help protect the environment.

Pregabalina SUN Composition

The active ingredient is pregabalina. Each hard capsule contains 300 mg of pregabalina.

The other components are:

Capsule content:

Manitol, talco

Capsule composition:

Gelatina, dióxido de titanio (E171), laurilsulfato sódico, agua purificada, óxido de hierro rojo (E172)

Printing ink:

Laca Shellac, propilenglicol, óxido de hierro negro (E172), hidróxido de potasio

Appearance of the product and contents of the package

Pregabalina SUN 300 mg hard capsules:

Hard gelatin capsules of size “0” with opaque red cap and opaque white body marked with “rbx” in black ink on the cap and with “PG300” in the body containing white or off-white powder. The length of the capsule is approximately 21.0 – 21.8 mm.

OPA/Al/PVC/Al blister:

Package sizes: 14, 21, 56, 84, 98, 100 or 112 hard capsules

PVC/Aluminium blister:

Package sizes: 14, 21, 28, 56, 84, 98, 100 or 112 hard capsules.

HDPE bottle with child-resistant closure:

Package sizes: 14, 21, 30, 56, 84, 98, 100 or 112 hard capsules.

HDPE bottle with screw cap:

Package size: 500 hard capsules

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible manufacturer:

Terapia, S.A.

124, Fabricii Street

400 632 – Cluj Napoca

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 - Barcelona

Spain

+34 93 342 78 90

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France:PREGABALINE CRISTERS PHARMA 300 mg, gélule

Germany:PREGABALIN BASICS 300 mg Hartkapseln

Netherlands:Pregabaline SUN 300 mg, harde capsules

Poland:Tabagine

Romania:Pregabalina Terapia 300 mg capsule

United Kingdom (Northern Ireland):Pregabalin Sun 300 mg Capsules, Hard

Last review date of this leaflet:January2024

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