Package Leaflet: Information for the User

Pregabalina Normon 200 mg Hard Capsules EFG

Read this leaflet carefully before you start taking 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Pregabalina Normon and what is it used for

2. What you need to know before taking Pregabalina Normon

3. How to take Pregabalina Normon

4. Possible side effects

5. Storage of Pregabalina Normon

6. Contents of the pack and additional information

Pregabalina Normon 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:Pregabalina Normon 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 Normon is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe this medication to treat epilepsy when your current treatment does not control the disease. You must take this medication in addition to your current treatment. This medication should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalina Normon is used in the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are 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 tensions.

Do not takePregabalinaNormon

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 this medication:

• 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 widespread skin rash. If you experience any of these symptoms, you should immediately see your doctor.
• 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.
• 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.
• 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.
• There have been reports of heart failure 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.
• There have been reports of renal insufficiency in some patients treated with pregabalin. If during pregabalin treatment you note a decrease in your ability to urinate, you should inform your doctor since 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 ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on pregabalin.
• There have been reports of seizures during pregabalin treatment or shortly after discontinuing pregabalin treatment. If you experience seizures, contact your doctor immediately.
• There have been reports of encephalopathy (brain dysfunction) in some patients taking pregabalin and who had other underlying diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of respiratory difficulty. If you have neurological disorders, respiratory disorders, renal 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 the medication). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabalin Normon" and "If you interrupt treatment with Pregabalin Normon"). If you are concerned that you may become dependent on pregabalin, it is essential to consult your doctor.

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

•You need to take the medication for a longer time 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 of pregabalin have not been established in children and adolescents (under 18 years) and therefore pregabalin should not be used in this age group.

Other medications and Pregabalin Normon

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

Pregabalin Normon and certain medications may exert a mutual influence on 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.

Pregabalin Normon can be taken with oral contraceptives.

Taking Pregabalin Normon with food, drinks, and alcohol

The capsules of Pregabalin Normon can be taken with and without food.

It is recommended not to take alcohol during treatment with this medication.

Pregnancy and breastfeeding

You should not take pregabalin 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 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 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

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.

Pregabalin Normon contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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.

Pregabalina Normon 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 this medication two or three times a day. In the case of twice a day, take this medication once in the morning and once at night, approximately at the same time every day. In the case of three times a day, take this medication in the morning, at noon, and at night, approximately at the same time every day.

If you estimate that the effect 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 this medication normally, except if you have kidney problems.

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

Swallow the entire capsule with water.

Continue taking this medication until your doctor tells you to stop.

If you take more Pregabalina Normon 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 Normon 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 Normon

It is essential to take Pregabalina Normon 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 Pregabalina Normon

Do not stop taking this medication suddenly. If you want to stop taking this medication, 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 this medication is completed, you should know that you may experience certain adverse effects, called withdrawal effects. 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 effects may appear more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, consult 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.

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.
• Attention disturbance, clumsiness, memory deterioration, memory loss, tremors, difficulty speaking, numbness, 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, gait disturbances.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Throat pain.

Rare: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• Change in self-perception, anxiety, 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 reach climax, 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, burning sensation, 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.
• 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, burning sensation, 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 urinating, inability to hold urine.
• Weakness, thirst, chest tightness.
• 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 disturbances.
• 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 (which may include difficulty breathing, conjunctivitis, and a severe skin reaction characterized by flat, non-elevated red 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 (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms, including tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

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

Frequency unknown: cannot be estimated from available data

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

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

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

Certain side effects, such as drowsiness, may be more frequent as 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, 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.

This medication does not require special storage conditions..

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofPregabalinaNormon 200 mg hard capsules EFG

The active ingredient is pregabalina. Each hard capsule contains 200 mg of pregabalina.

The other components are:

Capule content: lactose monohydrate, cornstarch and talc.

Capsule coating: gelatine, titanium dioxide (E171) and iron oxide red (E-172).

Pregabalina Normon 200 mg is presented in the form of hard capsules of pink color.Blister ofaluminum/PVC-PVDC(60) or aluminum/aluminum-polyamide-PVC.

Pregabalina Normon 200 mg is available in a pack of 21 or 84 capsules.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of review of this leaflet: December 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Deviceshttp://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79858/P_79858.html