Pregabalin Pensa 25 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalina pensa 25 mg hard capsules EFG

Read all of this 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. Do 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What pregabalin pensa is and what it is used for

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

Epilepsy: Pregabalin is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe pregabalin when your current treatment does not adequately control your condition. You should take pregabalin in addition to your current treatment. Pregabalin should not be used as monotherapy, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalin 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 fatigability (tiredness), difficulty in concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the stress and pressures of everyday life.

2. What you need to know before taking Pregabalina pensa

Do not take Pregabalina pensa

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

Warnings and precautions

Consult your doctor or pharmacist before starting pregabaline.

• Some patients treated with pregabaline have reported symptoms indicating 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 immediate medical attention.
• Serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabaline treatment. Stop taking pregabaline and seek immediate medical help if you notice any of the symptoms related to these serious skin reactions described in section 4.
• Pregabaline 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 of the medicine.
• Pregabaline may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any visual disturbances, inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabaline 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 that have similar adverse effects to pregabaline, thereby increasing the intensity of these effects when used concomitantly.
• Cases of heart failure have been reported in some patients treated with this medicine. Most of these patients were elderly with cardiovascular diseases. 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 this medicine. If during treatment with pregabaline you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.
• Some patients taking antiepileptic medicines such as pregabaline have had thoughts of harming themselves or of suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or have displayed such behavior, contact your doctor as soon as possible.
• Gastrointestinal problems (e.g., constipation and intestinal obstruction or paralysis) may occur when pregabaline is taken together with other medicines that can cause constipation (such as certain types of pain medications). Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, you must inform your doctor if you have a history of alcoholism or drug abuse or dependence. Do not take a higher dose than the one prescribed for you.
• Seizures have been reported during treatment with pregabaline or shortly after discontinuation of the medicine. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabaline who had other underlying diseases. 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 disorders of the nervous system, respiratory disorders, renal failure, 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 people may become dependent on pregabaline (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop taking pregabaline (see section 3, “How to take Pregabalina pensa” and “If you stop taking Pregabalina pensa”). If you are concerned about becoming dependent on pregabaline, it is important to consult your doctor.

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

• You feel the need to take the medicine for longer than recommended by your doctor.
• You feel 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 your 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, talk to your doctor to discuss the best management 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 pregabaline have not been established in children and adolescents (under 18 years of age), and therefore pregabaline should not be used in this age group.

Other medicines and Pregabalina pensa

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

Pregabaline and certain medicines may interact with each other. When pregabaline 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 pregabaline is taken together with other medicines containing:

Oxycodone – (used as an analgesic)

Lorazepam – (used to treat anxiety)

Alcohol

This medicine can be taken with oral contraceptives.

Taking Pregabalina pensa with food, drinks, and alcohol

Pregabaline capsules can be taken with or without food.

It is advised not to consume alcohol during treatment with pregabaline.

Pregnancy, breastfeeding, and fertility

Do not take pregabaline during pregnancy or while breastfeeding, unless your doctor has specifically instructed you to do so.

The use of pregabaline 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 pregabaline during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations. This compares with 4 out of 100 babies born to women not treated with pregabaline in the study. Malformations reported include facial clefts, eyes, nervous system (including the brain), kidneys, and genitals.

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

Driving and using machines

Pregabaline may cause dizziness, somnolence, and reduced concentration. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.

Pregabalina pensa contains lactose monohydrate

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

3. How to take Pregabalina pensa

Follow exactly the dosing instructions for this medicine provided by your doctor.

If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina 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, is generally between 150 mg and 600 mg daily.
• Your doctor will instruct you to take pregabaline twice or three times a day. If twice daily, take pregabaline once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabaline in the morning, at midday, and at night, approximately at the same time each day.

If you feel that the effect of pregabaline 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 pregabaline as usual, unless 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 pregabaline until your doctor tells you to stop.

If you take more Pregabalina pensa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Go immediately to the nearest emergency department. Take the packaging or bottle of pregabaline capsules with you. As a result of taking more pregabaline than prescribed, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalina pensa

It is important to take pregabaline capsules regularly at the same time each day. If you miss 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 normal. Do not take a double dose to make up for a missed dose.

If you stop treatment with Pregabalina pensa

Do not stop taking pregabaline suddenly. If you wish to discontinue pregabaline, speak to your doctor first. They will advise you on how to do so. If stopping treatment, it should be done gradually over a minimum of one week.

After stopping pregabaline treatment, whether short-term or long-term, 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, diarrhea, 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 pregabaline for a longer period of time. If you experience withdrawal effects, you should 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 may cause adverse effects, although not everyone experiences 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 sex drive, irritability.
• Attention disturbance, clumsiness of movement, 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.
• Difficulty in erection.
• Swelling of the body including the 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, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sex drive, 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.
• Changes in heart rate, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushing, hot flushes.
• Difficulty breathing, dry nose, 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, low 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, oscillating vision, altered 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 the electrocardiogram (ECG) corresponding to disturbances in heart rhythm.
• 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 behavior, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterized by non-elevated red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, affecting 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, Parkinson's disease-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 (inflammation of the liver).

Frequency not known: cannot be estimated from available data

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

After stopping short-term 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 pensa”).

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

Certain adverse effects, such as drowsiness, may be more frequent because patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, which have adverse effects similar to those of Pregabalina, 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 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 pensa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the pack or on the bottle after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pregabalina pensa

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

The other components are: monohydrate lactose, corn starch and talc. The 25 mg capsule contains gelatin and titanium dioxide (E171).

Appearance of the product and contents of the pack

Pregabalina pensa 25 mg are hard gelatin capsules with a white body and white cap, type Coni-Snap. Capsule size: 4 (approximately 14.3 mm in length). The capsule is filled with a white or almost white powder.

Transparent PVC/PE/PVdC//Aluminum/PVdC blisters containing 14 and 56 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles, Barcelona

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra

Portugal

Date of the most recent revision of this leaflet: July 2024

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