Product Information for the User

Lyrica 25 mg hard capsules,

Lyrica 50 mg hard capsules,

Lyrica 75 mg hard capsules,

Lyrica 100 mg hard capsules,

Lyrica 150 mg hard capsules,

Lyrica 200 mg hard capsules,

Lyrica 225 mg hard capsules,

Lyrica 300 mg hard capsules

pregabalina

Read this leaflet carefully before you start to take 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; do not give it to others even if they 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 leaflet. See section 4.

Lyrica belongs to a group of medications used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Lyrica is used for the treatment of chronic pain caused by nerve damage. There are various diseases that 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 a sensation of pinpricks. 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:Lyrica is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Lyrica to treat epilepsy when your current treatment does not control the disease. You must take Lyrica in addition to your current treatment. Lyrica should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Lyrica 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 a feeling of excitement or nervousness, feeling easily fatigued (tired), having difficulty concentrating or feeling mentally blank, irritability, muscle tension, or sleep disturbances. This is different from the stress and tensions of everyday life.

Do not take Lyrica

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lyrica.

• Some patients treated with Lyrica 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 widespread skin rash. If you experience any of these symptoms, you should seek immediate 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 medical attention immediately if you observe 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 risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects the medication may have.

• Lyrica 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 inform your doctor immediately.

• Patients with diabetes 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 adverse effects similar to those of pregabalin, so that the intensity of these effects may increase when taken together.

• Severe cases of heart failure have been reported in some patients treated with Lyrica. 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 failure have been reported in some patients treated with Lyrica. If during treatment with Lyrica you notice a decrease in your ability to urinate, you should inform your doctor since stopping treatment may improve this situation.

• Some patients taking antiepileptic medications, such as Lyrica, have had thoughts of self-harm or suicide or have shown suicidal behavior.or have shown such behavior. If at any time you experience these thoughtsor have shown such behavior, contact your doctor as soon as possible.

• When Lyrica is taken with other medications that may 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 ever abused or had dependence on alcohol, prescription medications, or illegal drugs; it may mean that you have a higher risk of becoming dependent on Lyrica.

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

• Severe cases of brain dysfunction (encephalopathy) have been reported in some patients taking Lyrica and who had other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• Severe cases of breathing difficulty 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 continue taking the medication). They may experience 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 essential to 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 medication for a longer period than recommended by your doctor.
• You feel the need to take a higher dose than recommended.
• You are using the medication for reasons other than those prescribed.
• You have made repeated and unsuccessful attempts to stop or control the use of the medication.
• When you stop taking the medication, you experience discomfort and feel better once you take the medication again.

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

Children and adolescents

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

Use of Lyrica with other medications

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

Lyrica and certain medications may exert a mutual influence on each other (interactions). When Lyrica 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 Lyrica is taken with other medications that contain:

Oxycodone – (used as an analgesic)

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 recommended not to take alcohol during treatment with Lyrica.

Pregnancy and breastfeeding

You should not take Lyrica during pregnancy or lactation, 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 babies out of every 100 had such congenital anomalies. This contrasts with 4 babies out of every 100 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 women of childbearing age. 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

Lyrica 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.

Lyrica contains lactose monohydrate

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Lyrica contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Lyrical is exclusively for oral use.

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

• Take the number of capsules 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 tell you to take Lyrical two or three times a day. In the case of two times a day, take Lyrical once in the morning and once at night, approximately at the same time every day. In the case of three times a day, take Lyrical in the morning, at noon, and at night, approximately at the same time every day.

If you estimate that the action of Lyrical is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take Lyrical normally, except if you have kidney problems.

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

Swallow the capsule whole with water.

Continue taking Lyrical until your doctor tells you to stop.

If you take more Lyrical than you should

Call your doctor or go to the nearest emergency service immediately. Bring the box or bottle of Lyrical capsules with you. As a result of taking more Lyrical 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 Lyrical

It is essential to take Lyrical 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 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 treatment with Lyrical

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

Once a short- or long-term treatment with Lyrical is completed, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression,thoughts of self-harm or suicide,pain, sweating, and dizziness.

These effects may appear more frequently or severely if you have been taking Lyrical for a longer period of time.If you experience withdrawal effects, see your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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.
• Euphoria, confusion, disorientation, decreased libido, irritability.
• Disturbances in attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.
• Difficulty with erection.
• Swelling of the body including extremities.
• Sensation of intoxication, alterations in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in extremities.
• 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, 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, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, sensation of burning, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.
• Eye dryness, eye swelling, eye pain, tired eyes, watery eyes, eye irritation.
• Changes in heart rhythm, 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, burning, numbness around the mouth.
• Sweating, rash, chills, fever.
• Muscle spasms, joint swelling, muscle rigidity, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain urinating, inability to hold urine.
• Weakness, thirst, chest oppression.
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring.
• Menstrual cramps.
• Sensation of cold in hands and feet.

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

• Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat constriction, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Reduced mobility of the body.
• Difficulty writing correctly.
• Fluid accumulation in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual interruption.
• Renal insufficiency, reduced urine output, urinary 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 byflat red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin desquamation, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Icterus (yellow skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle rigidity.

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

• Liver insufficiency.
• Hepatitis (inflammation of the liver).

Frequency not known: cannot be estimated from available data

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

Once a short- or long-term treatment with Lyrica is completed, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Lyrica").

If you experience swelling in the face or tongue, or if your skin becomes red and blisters or peels, you should seek immediate medical attention.

Certain side 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 (tense or rigid muscles), with side effects similar to those of Pregabalin, so the intensity of these side 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 side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughtheSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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 or in the bottle.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 components are: lactose monohydrate, cornstarch, talc, gelatin, titanium dioxide (E171), sodium laurilsulfate, anhydrous colloidal silica, black ink containing Shellac, iron oxide black (E172), propylene glycol, potassium hydroxide, and water.

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

Lyrica is available in eight pack sizes formed by PVC with an aluminium foil on the back: a pack of 14 capsules containing a blister strip, a pack of 21 capsules containing a blister strip, a pack of 56 capsules containing 4 blister strips, a pack of 70 capsules containing 5 blister strips, a pack of 84 capsules containing 4 blister strips, a pack of 100 capsules containing 10 blister strips, a pack of 112 capsules containing 8 blister strips and a pack of 100 x 1 capsules with the pre-cut blister in single-dose.

In addition, 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 pack sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder:

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

Responsible for Manufacturing:

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:

Last review date of this leaflet:04/2024

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