LYRICA 25 mg HARD CAPSULES

2. What you need to know before you take Lyrica

Do not take Lyrica

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Lyrica.

• Some patients taking Lyrica 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 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.

• Lyrica has been associated with dizziness and somnolence, which may increase the occurrence of accidental injury (falls) in older patients. Therefore, you should be cautious until you are used to the effects of the medicine.

• Lyrica 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.

• Diabetic patients who gain weight while taking pregabalin may need a dose adjustment of their diabetic treatments.

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

• Heart failure has been reported in some patients taking Lyrica. Most were elderly patients with cardiovascular conditions. Before using this medicine, you should tell your doctor if you have a history of heart disease.

• Kidney failure has been reported in some patients taking Lyrica. If you notice a decrease in your ability to urinate while taking Lyrica, you should inform your doctor, as stopping treatment may improve this condition.

• Some patients taking antiepileptics, such as Lyrica, 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 Lyrica is taken with other medications that can cause constipation (such as some types of pain medications), 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, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; you may be at a higher risk of becoming dependent on Lyrica.

• Seizures have been reported during treatment with Lyrica or shortly after stopping treatment with Lyrica. If you experience seizures, contact your doctor immediately.

• Reduced brain function (encephalopathy) has been reported in some patients taking Lyrica who had other conditions. Tell your doctor if you have a history of any serious disease, including liver or kidney disease.

• Breathing difficulties 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.

Dependence

Some people may become dependent on Lyrica (need to keep taking the medicine). They may have withdrawal effects when they stop using Lyrica (see section 3, "How to take Lyrica" and "If you stop taking Lyrica"). If you are concerned that you may become dependent on Lyrica, it is important that you consult your doctor.

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

• You need to take the medicine for longer than your doctor recommended.
• 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 take the medicine again.

If you notice any of these signs, talk to your doctor to discuss the best care plan for you, including when it is appropriate to stop treatment 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.

Using Lyrica with other medicines

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

Lyrica and certain medicines may influence each other (interactions). When Lyrica is used with certain sedating medications (including opioids), these effects may be enhanced, leading to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Lyrica is taken with other medications that contain:

Oxycodone - (used as a pain reliever)

Lorazepam - (used to treat anxiety)

Alcohol

Lyrica can be taken with oral contraceptives.

Taking Lyrica with food, drinks, and alcohol

Lyrica capsules can be taken with or without food.

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

Pregnancy and breastfeeding

Do not take Lyrica 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 reviewing 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 to 4 babies out of 100 born to women not treated with pregabalin in the study. Congenital malformations reported include those of the face (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

Lyrica 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.

Lyrica contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Lyrica contains sodium

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

3. How to take Lyrica

Always take this medicine exactly as your doctor 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.

Lyrica 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 Lyrica either twice or three times a day. For twice-daily dosing, take Lyrica once in the morning and once in the evening, approximately at the same time every day. For three-times-daily dosing, take Lyrica in the morning, at noon, and in the evening, approximately at the same time every day.

If you think that the effect of Lyrica is too strong or too weak, talk to your doctor or pharmacist.

If you are an older patient (over 65 years of age), you should take Lyrica as normal, except if you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking Lyrica until your doctor tells you to stop.

If you take more Lyrica than you should

Call your doctor or go to the nearest emergency room immediately. Take the pack or container of Lyrica capsules with you. As a result of taking more Lyrica 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 Lyrica

It is important that you take your Lyrica 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 a forgotten dose.

If you stop taking Lyrica

Do not stop taking Lyrica suddenly. If you want to stop taking Lyrica, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, it should be done gradually over a minimum of one week.

Once you have finished a short or long-term treatment course with Lyrica, you should be aware that you may experience certain side effects, called withdrawal effects. 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 effects may occur more frequently or be more severe if you have been taking Lyrica for a longer period. If you experience withdrawal effects, you should contact your doctor.

If you have any other 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 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 appetite, irritability.
• Attention alteration, movement clumsiness, 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 with erection.
• Body swelling including limbs.
• Feeling of drunkenness, gait disturbances.
• Weight gain.
• Muscle cramp, 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 levels.
• 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, 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, teary 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, heartburn, 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 hold urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, 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 abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual period interruption.
• Kidney failure, reduced urine output, urine 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 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 may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellow skin and eyes).
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known: cannot be estimated from the available data

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

Once you have finished a short or long-term treatment with Lyrica, you should be aware that you may experience certain adverse effects, called withdrawal effects (see "If you stop taking Lyrica").

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 (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: 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 is not listed 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 Lyrica

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

Do not use this medicine after the expiration date that appears on the packaging or bottle.

The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lyrica

The active ingredient is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, or 300 mg of pregabalin.

The other ingredients are: lactose monohydrate, cornstarch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, colloidal anhydrous silica, black ink (which contains Shellac lacquer, black iron oxide (E172), propylene glycol, potassium hydroxide), and water.

The 75 mg, 100 mg, 200 mg, 225 mg, and 300 mg capsules also contain red iron oxide (E172).

Lyrica is available in eight package sizes formed by PVC with an aluminum foil on the back: a package of 14 capsules containing a blister strip, a package of 21 capsules containing a blister strip, a package of 56 capsules containing 4 blister strips, a package of 70 capsules containing 5 blister strips, a package of 84 capsules containing 4 blister strips, a package of 100 capsules containing 10 blister strips, a package of 112 capsules containing 8 blister strips, and a package of 100 x 1 capsules with the blister precut in unit doses.

Additionally, Lyrica is available in high-density polyethylene bottles containing 200 capsules in the case of the 25 mg, 75 mg, 150 mg, and 300 mg concentrations.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands.

Manufacturer:

Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany.

or

Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary.

or

MEDIS INTERNATIONAL a.s., výrobní závod Bolatice, Prumyslová 961/16, 747 23 Bolatice, Czech Republic.

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Date of the Last Revision of this Prospectus:04/2024

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.