PREGABALIN SUN 25 mg HARD CAPSULES

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

Do not take Pregabalin SUN

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 SUN

• 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 diffuse 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 could 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.
• Some diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medicines.
• Certain adverse effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medicines for treatment, for example, for pain or spasticity (stiff or rigid muscles), with similar adverse effects to those of Pregabalin, so 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 them were elderly patients with cardiovascular diseases. Before using this medicine, you should tell your doctor if you have a history of heart disease.
• Cases of kidney problems (renal failure) have been reported in some patients treated with this medicine. If you notice a decrease in your ability to urinate during treatment with 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 committing suicide or have shown 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 medicines that can cause constipation (such as some types of painkillers), 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, tell your doctor if you have a history of alcoholism or drug abuse or dependence, as this may indicate that you have a higher risk of becoming dependent on pregabalin.
• Cases of seizures have been reported during treatment with pregabalin or shortly after stopping treatment with this medicine. If you have seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported 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.
• Cases of difficulty breathing have been reported. 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.

Some people may become dependent on pregabalin (need to keep taking this medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3 "How to take Pregabalin SUN" and "If you stop taking Pregabalin SUN").

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 symptoms while taking Pregabalin SUN, it could be a sign that you have become dependent:

• You need to take this medicine for a longer period than indicated by your doctor
• You feel that you need to take more than the recommended dose
• You use this medicine for reasons other than those prescribed
• You have made repeated attempts, without success, to stop using this medicine or control its use
• When you stop taking this medicine, 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, including when it is appropriate to stop taking this medicine and how to do it safely.

Children and adolescents

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

Taking Pregabalin SUN 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 interact with each other (interactions). When pregabalin is used with certain medicines that have a sedative effect (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 painkiller)

Lorazepam - (used to treat anxiety)

Alcohol

Pregabalin SUN can be taken with oral contraceptives.

Taking Pregabalin SUN with food, drinks, and alcohol

Pregabalin SUN capsules can be taken with or without food

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

Pregnancy, breastfeeding, and fertility

Do not take pregabalin during pregnancy or breastfeeding, unless your doctor has told 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 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 malformations. This compares with 4 babies out of 100 born to women not treated with pregabalin in the study. Congenital malformations of the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

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 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.

Pregabalin SUN contains sodium and mannitol

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

Mannitol may have a mild laxative effect.

3. How to take Pregabalin SUN

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the prescribed dose.

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 this medicine 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, unless 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 SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin SUN

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 SUN

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, discuss this with your doctor first. He will tell you how to do it. If treatment is stopped, 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, known as withdrawal symptoms. These effects 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 severely if you have been taking this medicine for a longer period. If you experience withdrawal symptoms, you should contact your doctor.

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.

Severe Adverse Effects:

If you experience any of the following adverse effects, discontinue treatment with Pregabalin SUN and contact your doctor or go to the nearest hospital, as you may need urgent medical attention.

• Hypersensitivity (uncommon, may affect up to 1 in 100 people) and allergic reactions (which can include swelling of the face, swelling of the tongue, difficulty breathing, itching) (rare, may affect up to 1 in 1,000 people).

• Severe skin reaction characterized by reddish patches, 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 reactions can 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 in the face or tongue, or if your skin turns red anddevelops blisters or peeling, you should seek medical attention immediately.

• 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 Adverse Effects:

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

• Dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people)

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability
• Attention disturbance, movement disturbance, memory impairment, memory loss, tremors, speech disturbance, 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
• Body swelling including limbs
• Feeling of drunkenness, gait disturbances
• Weight gain
• Sore throat
• Muscle cramp, muscle pain, back pain, limb pain, neck stiffness
• 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 impairment, 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 - abnormal and uncontrolled movements of the limbs, decreased reflexes, 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, watery eyes, eye irritation
• Heart rate changes, increased heart rate, low blood pressure, high blood pressure, heart failure
• Flushing, hot flashes
• Breathing difficulties, dry nose, nasal congestion
• Cough, facial swelling, hives, itching, nasal discharge, nasal bleeding, snoring
• Increased saliva production, heartburn, numbness around the mouth
• Sweating, rash, chills, fever
• Cold sensation in hands and feet
• Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Difficulty or pain when urinating, inability to hold urine
• Weakness, thirst, chest tightness
• Breast pain
• Painful menstrual periods
• Generalized swelling
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, decreased potassium in blood, increased creatinine in blood, neutropenia)

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

• Changes in heart rhythm
• Altered sense of smell, wavering vision, altered depth perception, visual glare, loss of vision
• Dilated pupils, strabismus
• Eye inflammation (keratitis)
• Cold sweat, throat tightness, tongue swelling
• Difficulty swallowing
• Slow or reduced body movement
• Difficulty writing correctly
• Fluid in the lungs
• Seizures
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances
• Increased fluid in the abdominal area
• Muscle damage
• Milk secretion, abnormal breast growth, increased breast size in men
• Menstrual period interruption
• Kidney problems, reduced urine output, urine retention
• Decreased white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Jaundice (yellowing of the 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).

Unknown: frequency cannot be estimated from available data

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

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

Certain adverse 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 (stiff or rigid muscles), with similar adverse effects 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: breathing difficulties, shallow breathing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pregabalin SUN

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

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Pregabalin SUN Composition

The active ingredient is pregabalin. Each hard capsule contains 25 mg of pregabalin.

The other ingredients are:

Capsule content:

Mannitol, talc

Capsule composition:

Gelatin, titanium dioxide (E171), purified water, sodium lauryl sulfate

Printing ink:

Shellac lacquer, propylene glycol, iron oxide black (E172), potassium hydroxide

Product Appearance and Package Contents

Pregabalin SUN 25 mg hard capsules:

Hard gelatin capsules of size "4" with an opaque white cap and an opaque white body, marked with "rbx" in black ink on the cap and with "PG25" on the body, containing white or off-white powder. The length of the capsule is approximately 14.0 - 14.8 mm.

OPA/Al/PVC/Al blister:

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

PVC/Aluminum blister:

Package sizes: 14, 21, 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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

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

France: PREGABALINE CRISTERS PHARMA 25 mg, gélule

Germany: PREGABALIN BASICS 25 mg Hartkapseln

Date of the last revision of this leaflet:January 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/