Pregabalin Qualigen 25 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pregabalin Qualigen 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, as you may need to read it again.
• If you have any questions, consult 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 these effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Pregabalin Qualigen is and what it is used for
2. What you need to know before taking Pregabalin Qualigen
3. How to take Pregabalin Qualigen
4. Possible side effects
5. How to store Pregabalin Qualigen
6. Package contents and other information

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

Pregabalin belongs to a group of medicines used for the treatment of 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 pain sensation may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, muscle spasms, 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 activities 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 to treat epilepsy when your current treatment does not adequately control the condition. You should take pregabalin as an add-on to your current treatment. Pregabalin must not be used as monotherapy, but should always be used 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 fatigue, difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbance. This is different from the everyday stress and strains of normal life.

2. What you need to know before taking Pregabaline Qualigen

Do not take Pregabaline Qualigen

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

Warnings and precautions

Talk to your doctor or pharmacist before starting pregabalin:

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance 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.
• Dizziness and drowsiness have been associated with pregabalin, 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.
• 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 drowsiness, 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 adverse 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 this medicine. 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 this medicine. 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 taking 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 have shown such behavior, 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 medicines), gastrointestinal problems (e.g., constipation, intestinal blockage, or intestinal paralysis) may occur. Inform your doctor if you experience 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 issues; 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 the medicine. 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 breathing difficulties 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 problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (a need to keep taking the medicine). They may experience withdrawal effects when they stop using pregabalin (see section 3, "How to take Pregabaline Qualigen" and "If you stop taking Pregabaline Qualigen"). 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 pregabalin, it could be a sign that you have become dependent:

• You feel the need to take the medicine for longer than recommended by your doctor.
• You feel you need to take a higher dose than recommended.
• 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, talk to 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), so pregabalin should not be used in this age group.

Other medicines and Pregabaline Qualigen

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

Pregabalin 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, drowsiness, 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

This medicine may be taken with oral contraceptives.

Taking Pregabaline Qualigen with food, drinks, and alcohol

Pregabalin capsules may be taken with or without food.

Alcohol consumption is not recommended during treatment with pregabalin.

Pregnancy, breastfeeding, and fertility

You should not take pregabalin during pregnancy or breastfeeding unless your doctor has instructed you to do so. 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 reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This contrasts 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 genitals.

Women of childbearing potential should use an effective method of contraception. 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, drowsiness, 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.

3. How to take Pregabaline Qualigen

Follow exactly the administration instructions for this medicine given 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.

Pregabalin 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, which has been adjusted for your condition, will generally range between 150 mg and 600 mg daily.
• Your doctor will instruct you to take pregabalin two or three times a day. If twice daily, take pregabalin once in the morning and once at night, approximately at the same time each day. If three times daily, take pregabalin in the morning, at midday, and at night, approximately at the same time every day.

If you feel that the effect of pregabalin 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 pregabalin as usual, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems.

Swallow the capsule whole with water.

Continue taking pregabalin until your doctor tells you to stop.

If you take more Pregabaline Qualigen than you should

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

As a result of taking more pregabalin 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 Pregabaline Qualigen

It is important that you take pregabalin 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 normal. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabaline Qualigen

Do not stop taking pregabalin suddenly. If you wish to discontinue pregabalin, speak with your doctor first. He or she will advise you on how to do so. Discontinuation should be done gradually over a period of at least one week.

After ending short- or long-term treatment with pregabalin, 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 pregabalin 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 can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people):

• Dizziness, somnolence, headache

Common adverse effects (may affect more than 1 in 100 people):

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, 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
• Dizziness, 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 adverse effects (may affect more than 1 in 1,000 people):

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Changes in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggressiveness, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, problems in sexual relationships including inability to reach climax, delayed ejaculation
• Changes in vision, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, tremor with 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
• Difficulty breathing, dry nose, nasal congestion
• Increased saliva production, burning sensations, 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 coldness in hands and feet

Rare adverse effects (may affect less than 1 in 1,000 people):

• Altered sense of smell, oscillating vision, depth perception disturbance, visual brightness, vision loss
• Dilated pupils, strabismus
• Cold sweat, throat tightness, tongue swelling
• Pancreatitis (inflammation of the pancreas)
• Difficulty swallowing
• Slow or reduced body mobility
• Difficulty writing properly
• 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, 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, throat, nose, genitals, and eyes. These serious 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 adverse effects (may affect up to 1 in 10,000 people):

• Liver failure
• Hepatitis (inflammation of the liver)

Adverse effects with unknown frequency (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 Qualigen”).

If you experience swelling of the face or tongue, or if your skin becomes red with blisters or peeling, 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es .

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pregabalin Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Pregabalina Qualigen

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

The other components (excipients) are: mannitol (E-421), pregelatinized corn starch, talc, titanium dioxide (E-171), yellow iron oxide (E-172), and gelatin.

The components of the printing ink are: shellac, black iron oxide (E-172), propylene glycol, strong ammonia solution, and potassium hydroxide.

Appearance of the product and contents of the pack

Pregabalina Qualigen 25 mg are opaque, hard gelatin capsules, ivory in colour, marked with "25". PVC/Aluminum blisters in cardboard boxes containing 56 hard capsules.

Precut single-dose PVC/Aluminum blisters in cardboard boxes containing 56 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona - Spain

Manufacturer
Pliva Croatia, Ltd.
Prilaz Baruna Filipovica 25
10000 Zagreb
Croatia

or

Merckle GmbH
Ludwig-Merckle Strasse 3
D-89143 Blaubeuren - Weiler
Germany

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

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/