Pregabalin Normon 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalin Normon 25 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pregabalin Normon is and what it is used for
2. What you need to know before taking Pregabalin Normon
3. How to take Pregabalin Normon
4. Possible adverse effects
5. How to store Pregabalin Normon
6. Contents of the pack and other information

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

Pregabalin Normon belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain: Pregabalin Normon is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and prickling sensations. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, and may affect physical and social activity and overall quality of life.

Epilepsy: Pregabalin 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 medicine when your current treatment does not adequately control your condition. You should take this medicine as an add-on to your current therapy. This medicine must not be used as monotherapy, but should always be used in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalin Normon 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 may also cause restlessness or a feeling of being keyed up or on edge, easy fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stresses and strains of life.

2. What you need to know before taking Pregabalin Normon

Do not take Pregabalin Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• Some patients treated with pregabalin have reported symptoms suggesting an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek medical attention immediately.
• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention if you notice any symptoms related to these serious 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 this medicine may have on you.
• Pregabalin may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, you must inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.
• Certain adverse effects, such as somnolence, may be more frequent in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity (stiff or rigid muscles), which have similar side effects to pregabalin; thus, the intensity of these effects may increase when taken concomitantly.
• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with cardiovascular disease. Before using this medicine, you must inform your doctor if you have a history of heart disease.
• Cases of renal failure have been reported in some patients treated with pregabalin. If during treatment with pregabalin you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.
• Some patients receiving antiepileptic medicines such as pregabalin have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or behaviors, contact your doctor as soon as possible.
• When pregabalin is taken together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal 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 alcohol, prescription medicines, or illegal drugs, or have had dependence on them; this may mean you are at higher risk of becoming dependent on pregabalin.
• Seizures have been reported during treatment with pregabalin or shortly after discontinuation of pregabalin treatment. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.
• Cases of difficulty breathing have been reported. If you have neurological disorders, respiratory disorders, renal impairment, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

Dependence

Some individuals may become dependent on pregabalin (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop using pregabalin (see section 3, "How to take Pregabalin Normon" and "If you stop taking Pregabalin Normon"). If you are concerned about possibly becoming dependent on pregabalin, it is important to consult your doctor.

If you notice any of the following signs while taking this medicine, it could be a sign of dependence:

• You need to take the medicine for longer than recommended by your doctor.
• You feel you need to take a higher dose than prescribed.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better again once you take it.

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

Children and adolescents

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

Other medicines and Pregabalin Normon

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

Pregabalin Normon and certain medicines may interact with each other. When pregabalin is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and reduced concentration may increase if pregabalin is taken together with other medicines containing:

Oxycodone (used as an analgesic).

Lorazepam (used to treat anxiety).

Alcohol.

Pregabalin can be taken with oral contraceptives.

Taking Pregabalin Normon with food, drinks, and alcohol

Pregabalin Normon capsules can be taken with or without food.

It is advised not to consume alcohol during treatment with this medicine.

Pregnancy and breastfeeding

You should not take pregabalin during pregnancy or breastfeeding unless your doctor has specifically instructed you to do so. The use of pregabalin during the first three 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 three months of pregnancy, 6 out of every 100 babies had such congenital malformations. This compares with 4 out of every 100 babies born to women not treated with pregabalin in the study. Malformations reported include facial clefts, eyes, nervous system (including the brain), kidneys, and genital organs.

An effective method of contraception should be used in women of childbearing potential. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Pregabalin may cause dizziness, somnolence, and reduced 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 Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pregabalin Normon

Follow exactly the instructions for use of this medicine as given by your doctor.

If you have any doubts, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalin Normon is for oral use only.

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

Take the number of capsules indicated by your doctor.

The dose, adjusted according to your condition, will generally range between 150 mg and 600 mg daily.

Your doctor will instruct you to take this medicine twice or three times a day. If twice daily, take it once in the morning and once at night, approximately at the same time each day. If three times daily, take it in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take this medicine as usual, unless 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 this medicine until your doctor tells you to stop.

If you take more Pregabalin Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

As a result of taking more Pregabalin Normon than recommended, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Normon

It is important to take Pregabalin Normon 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 almost 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 missed dose.

If you stop taking Pregabalin Normon

Do not stop taking this medicine suddenly. If you wish to discontinue treatment, speak to your doctor first. He or she will advise you on how to do so. If you are stopping treatment, this should be done gradually over a minimum of one week.

After ending short-term or long-term treatment with this medicine, you should be aware that you may experience certain adverse effects known as withdrawal effects. These effects include sleep disturbances, headache, nausea, feelings of anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, 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 of time. If you experience withdrawal effects, contact your doctor.

If you have any further 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 everyone experiences them.

Very common: may affect more than 1 in 10 people

• Dizziness, somnolence, headache

Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Attention disturbance, movement clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Vertigo, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen.
• Erectile dysfunction.
• Swelling of the body including limbs.
• Feeling of drunkenness, disturbances in gait.
• Weight gain.
• Muscle cramps, 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 levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, light flashes, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, 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 flushes.
• Breathing difficulty, nasal dryness, nasal congestion.
• Increased saliva production, burning, 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 control urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Feeling of cold in hands and feet.

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

• Altered sense of smell, flickering vision, disturbance in depth perception, visual glare, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body movement.
• Difficulty writing properly.
• Increased fluid 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, breast enlargement in men.
• Interruption of menstrual periods.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behaviors, suicidal thoughts.
• Allergic reactions (which may include breathing difficulty, eye swelling (keratitis), 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, mouth ulcers, throat, nose, genital, and eye sores. 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, Parkinson-like symptoms such as tremor, bradykinesia (reduced ability to move), and muscle rigidity.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency not known: cannot be estimated from available data

• Becoming dependent on pregabalin (“drug dependence”).

After ending short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects known as withdrawal effects (see “If you stop taking Pregabalina Normon”).

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

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

The following adverse reaction has been reported during post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin NORMON

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pregabalina Normon 25 mg hard capsules EFG

The active substance is pregabalin. Each hard capsule contains 25 mg of pregabalin.

The other components are:

Capsule contents: monohydrate lactose, corn starch and talc.

Capsule shell: gelatin and titanium dioxide (E-171).

Pregabalina Normon 25 mg is presented as white hard capsules. Packaged in aluminum/PVC-PVDC (60) or aluminum/aluminum-polyamide-PVC blisters.

Available in packs of 56 capsules and 100 capsules (clinical pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: December 2023

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79854/P_79854.html