PREGABALIN OPKO 75 mg HARD CAPSULES

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

Do not take Pregabalin OPKO

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.

• Some patients taking pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin. Discontinue 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 may increase the risk of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are used to any effect the medicine may have.

• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are temporary. If you experience any changes in your vision, you should inform your doctor immediately.

• Patients with diabetes who gain weight while taking pregabalin may need a change in their diabetes treatment.

• Certain side effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medicines for treatment, for example, pain or spasticity, with similar side effects to pregabalin, so the intensity of these effects may increase when taken together.

• There have been reports of heart failure in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular conditions. Before taking this medicine, you should inform your doctor if you have a history of heart disease.

• There have been reports of kidney failure in some patients treated with pregabalin. If you notice a decrease in your ability to urinate while taking pregabalin, you should inform your doctor, as stopping the medicine may improve this situation.

• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or suicidal behavior. If at any time you have these thoughts or have shown such behavior, you should contact your doctor immediately.

• When Pregabalin is taken with other medicines that can cause constipation (such as some types of painkillers), it is possible that gastrointestinal problems (such as constipation, blocked or paralyzed colon) may occur. Tell 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; you may be at a higher risk of becoming dependent on pregabalin.

• There have been reports of seizures when taking pregabalin or shortly after stopping treatment with pregabalin. If you experience seizures, contact your doctor immediately.

• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other illnesses. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• There have been reports of breathing difficulties. 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.

Dependence

Some people may become dependent on pregabalin (need to keep taking the medicine). They may have withdrawal effects when they stop taking pregabalin (see section 3, "How to take Pregabalin OPKO" and "If you stop taking Pregabalin OPKO"). 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 signs while taking pregabalin, 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 that you need to take more than the recommended dose
• You are using the medicine for reasons other than those prescribed
• You have made repeated 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 start taking the medicine again

If you notice any of these, talk to your doctor to discuss the best course of treatment for you, including when it is appropriate to stop and how to do so 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.

Other medicines and Pregabalin OPKO

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregabalin and some other medicines may affect each other (interact). When used with certain medicines that have sedating effects (including opioids), pregabalin may increase these effects and cause respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with medicines that contain:

Oxycodone - (used as a painkiller)

Lorazepam - (used to treat anxiety)

Alcohol

Pregabalin can be taken with oral contraceptives.

Pregabalin OPKO with food and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking pregabalin.

Pregnancy, breastfeeding, and fertility

Pregabalin should not be taken 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 out of 100 babies had congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals.

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. You should 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 OPKO contains sodium

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

3. How to take Pregabalin OPKO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin OPKO is for oral use only.

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, is generally 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 a day, take pregabalin in the morning, at midday, and in the evening, approximately at the same time every day.

If you think that the effect of pregabalin 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, except if you have kidney problems.

Your doctor may prescribe a different dosing regimen or dose 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 OPKO than you should

Contact your doctor or go to the nearest hospital emergency department immediately. Take your capsule box or bottle with you. You may feel drowsy, confused, agitated, or restless as a result of taking more pregabalin than you should. There have also been reports of seizures and loss of consciousness (coma).

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pregabalin OPKO

It is important that you take your pregabalin capsules regularly at the same time every 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, just continue with the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin OPKO

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, talk to 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 short- or long-term treatment with pregabalin, you should be aware that you may experience certain side effects, known as withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, suicidal thoughts, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, 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.

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 interest, irritability.
• Attention alteration, movement clumsiness, memory impairment, memory loss, tremor, speech difficulty, 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.
• Erectile dysfunction.
• Body swelling, including limbs.
• Feeling of drunkenness, altered gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.

• Throat pain.

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, panic attack, apathy, aggression, elevated mood, mental deterioration, 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, reduced 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, eye swelling, eye pain, tired eyes, watery eyes, eye irritation.
• Alterations in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heartbeats, heart failure.
• Flushing, hot flashes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, stomach acidity, 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, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (increased creatine phosphokinase in blood, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, hives, nasal discharge, nasal bleeding, cough, snoring.
• Painful menstrual periods.
• Cold sensation in hands and feet.

Rare: may affect up to 1 in 1,000 people

• Altered sense of smell, oscillating vision, altered depth perception, visual glare, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing correctly.
• Increased fluid in the abdomen.
• Fluid in the lungs.

• Convulsions.

• Changes in the electrocardiogram (ECG) corresponding to alterations in heart rhythm.
• Muscle damage.
• Breast secretion, abnormal breast growth, increased breast size in men.
• Interrupted menstrual periods.
• Kidney failure, decreased urine volume, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions that may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by reddish, non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, i.e., symptoms similar to Parkinson's disease, such as tremor, bradykinesia (decreased movement ability), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known: frequency cannot be estimated from available data

• Developing dependence on pregabalin ('drug dependence').

After interrupting short- or long-term treatment with pregabalin, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Pregabalin OPKO").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

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, which have similar adverse effects to those of pregabalin, so the intensity of these effects may increase when taken together.

The following adverse reactions have been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of Adverse Effects

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

5. Storage of Pregabalin OPKO

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date indicated on the outer packaging (CAD). The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer use. This way, you will help protect the environment.

6. Package Contents and Other Information

Composition of Pregabalin OPKO:

Capsule content:

The active ingredient is pregabalin. Each capsule contains 75 mg of pregabalin.

Excipients: Cornstarch (Starcap1500) Talc

Capsule shell:

Purified water

Titanium dioxide (E 171)

Sodium lauryl sulfate

Red iron oxide (E172)

Gelatin.

Black ink (lacquer (E904), black iron oxide (E172), potassium hydroxide)

Appearance of Pregabalin OPKO and Package Contents

Pregabalin OPKO 75 mg; Size '4', hard gelatin capsule with orange opaque cap and white opaque body, marked with '1360' on the cap and with '75' on the body with black ink containing white to off-white powder.

Pregabalin OPKO is available in packages of 56 hard capsules, approximately 14.4 mm long; in PVC/PVDC/Al blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OPKO Health Spain, S.L.U.

Pl. Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona,

Spain

Date of Last Revision of this Prospectus: August 2024

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