PREGABALIN NORMON 200 mg TABLETS

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

Do not takePregabalinNormon

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 this medicine:

• 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 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.

• 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 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.

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

• Certain adverse effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medications for treatment, 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.

• Heart failure has been reported in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases. Before using this medicine, you should inform your doctor if you have a history of heart disease.

• Kidney failure has been reported in some patients treated with pregabalin. 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 treated with antiepileptics, 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), 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; this may mean that you have a higher risk of becoming dependent on pregabalin.
• Seizures have been reported during treatment with pregabalin or shortly after stopping treatment with pregabalin. If you experience seizures, contact your doctor immediately.
• Reduced brain function (encephalopathy) has been reported in some patients taking pregabalin who had other illnesses. Inform your doctor if you have a history of any serious illness, 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 pregabalin (need to continue taking the medicine). They may experience withdrawal effects when they stop taking pregabalin (see section 3, "How to take Pregabalin Normon" and "If you stop taking Pregabalin Normon"). 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 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.

Other medicines andPregabalinNormon

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

Pregabalin and certain medicines may have an influence on each other (interactions). When pregabalin is used with certain sedating medicines (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 pain reliever)
• Lorazepam - (used to treat anxiety)
• Alcohol

Pregabalin can be taken with oral contraceptives.

TakingPregabalinNormon with food, drinks, and alcohol

The tablets of this medicine can be taken with or without food.

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

Pregnancy and breastfeeding

Do not take pregabalin during pregnancy or breastfeeding, unless your doctor has told you to. 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 to 4 babies out of 100 born to women not treated with pregabalin in the study. Malformations of the face (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.

3. How to take Pregabalin Normon

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

Your doctor will determine the dose that is right for you.

This medicine is for oral use only.

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

• Take the number of tablets 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. If twice a day, take pregabalin once in the morning and once in the evening, approximately at the same time every day. If three times a day, 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 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 different doses if you have kidney problems.

Swallow the tablet whole with water .

The tablet can be divided into equal doses.

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

If you take more Pregabalin Normon than you should

Call your doctor or go to the nearest emergency room immediately. Take the pack of pregabalin tablets with you. 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.

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

If you forget to take Pregabalin Normon

It is important that you take the tablets of this medicine 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 the next dose as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin Normon

Do not stop taking pregabalin suddenly. If you want to stop taking this medicine, talk to your doctor first, they 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 with this medicine, you should know 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 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 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, tremors 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.
• Breathing difficulties, 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, urticaria, 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, depth perception alteration, visual glare, vision loss.
• 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 torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the 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 pregabalin ("drug dependence").

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

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 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 Normon

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 after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalin Normon

The active ingredient is pregabalin.

Pregabalin Normon 25 mg EFG tablets: each tablet contains 25 mg of pregabalin.

Pregabalin Normon 50 mg EFG tablets: each tablet contains 50 mg of pregabalin.

Pregabalin Normon 75 mg EFG tablets: each tablet contains 75 mg of pregabalin.

Pregabalin Normon 100 mg EFG tablets: each tablet contains 100 mg of pregabalin.

Pregabalin Normon 150 mg EFG tablets: each tablet contains 150 mg of pregabalin.

Pregabalin Normon 200 mg EFG tablets: each tablet contains 200 mg of pregabalin.

Pregabalin Normon 300 mg EFG tablets: each tablet contains 300 mg of pregabalin.

The other components are: anhydrous colloidal silica, crospovidone, magnesium stearate, hydroxypropylcellulose, and microcrystalline cellulose.

Product Appearance and Package Contents

Pregabalin Normon 25 mg EFG tablets: round, biconvex, white or almost white tablets with engraving "P1" on one side and a score line on the other, with a diameter of 5.2 mm. The tablet can be divided into equal doses.

Pregabalin Normon 50 mg EFG tablets: round, biconvex, beveled, white or almost white tablets with engraving "P2" on one side and a score line on the other, with a diameter of 7.2 mm. The tablet can be divided into equal doses.

Pregabalin Normon 75 mg EFG tablets: round, biconvex, beveled, white or almost white tablets with engraving "P3" on one side and a score line on the other, with a diameter of 8.2 mm. The tablet can be divided into equal doses.

Pregabalin Normon 100 mg EFG tablets: round, biconvex, beveled, white or almost white tablets with engraving "P4" on one side and a score line on the other, with a diameter of 9.2 mm. The tablet can be divided into equal doses.

Pregabalin Normon 150 mg EFG tablets: round, biconvex, beveled, white or almost white tablets with engraving "P5" on one side and a score line on the other, with a diameter of 10.4 mm. The tablet can be divided into equal doses.

Pregabalin Normon 200 mg EFG tablets: round, biconvex, beveled, white or almost white tablets with engraving "P6" on one side and a score line on the other, with a diameter of 12.1 mm. The tablet can be divided into equal doses.

Pregabalin Normon 300 mg EFG tablets: elongated, biconvex, white or almost white tablets with engraving "P7" on one side and a score line on the other, with a diameter of 17.7 mm x 8.2 mm. The tablet can be divided into equal doses.

Pregabalin Normon 25 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in a package of 56 tablets.

Pregabalin Normon 50 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in a package of 56 tablets.

Pregabalin Normon 75 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in a package of 56 tablets.

Pregabalin Normon 100 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in packages of 56 tablets and 84 tablets.

Pregabalin Normon 150 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in a package of 56 tablets.

Pregabalin Normon 200 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in packages of 56 tablets and 84 tablets.

Pregabalin Normon 300 mg EFG tablets are available in aluminum/aluminum-polyamide-PVC pre-cut unit dose blisters in a package of 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus: December 2024

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