PREGABALIN TARBIS FARMA 25 mg HARD CAPSULES

2. What you need to know before you take Pregabalin Tarbis Farma

Do not take Pregabalin

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 Pregabalin.

• Some patients taking Pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin. 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 the medicine has.

• Pregabalin may cause blurred vision, loss of vision, or other changes in vision, many of which are temporary. 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 dose adjustment of their diabetic treatments.

• There have been reports of heart failure in some patients taking Pregabalin. Most of these patients were elderly with cardiovascular conditions. Before taking this medicine, you should tell your doctor if you have a history of heart disease.

• There have been reports of kidney failure in some patients taking Pregabalin. If you notice a decrease in your ability to urinate while taking Pregabalin, you should inform your doctor as stopping treatment may improve this condition.

• Some patients taking antiepileptics, such as Pregabalin, have had thoughts of harming themselves or suicidal behavior. If at any time you have these thoughts or show this behavior, contact your doctor as soon as possible.

• When Pregabalin is taken with other medicines that may cause constipation (such as some types of painkillers), 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, prescribed drugs, or illegal drugs; you may be at a higher risk of becoming dependent on Pregabalin.

• There have been reports of seizures during treatment with Pregabalin or shortly after stopping treatment with Pregabalin. If you have a seizure, contact your doctor immediately.

• There have been reports of reduced brain function (encephalopathy) in some patients taking Pregabalin who had other conditions. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

• There have been reports of difficulty breathing. 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 Tarbis Farma (need to keep taking the medicine). They may have withdrawal effects when they stop taking Pregabalin Tarbis Farma (see section 3, “How to take Pregabalin Tarbis Farma” and “If you stop taking Pregabalin Tarbis Farma”). If you are concerned about the possibility of becoming dependent on Pregabalin Tarbis Farma, you should talk to your doctor.

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

• You need to take the medicine for longer than your doctor recommended
• You feel you need to take more of the medicine than the recommended dose
• You are using the medicine for reasons other than those prescribed
• You have made repeated attempts to stop or control the use of the medicine but failed
• When you stop taking the medicine, you feel unwell and feel better once you start taking the medicine again

If you notice any of these symptoms, talk to your doctor to discuss the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely.

Children and adolescents

Pregabalin has not been studied in children and adolescents (under 18 years). Therefore, pregabalin should not be used in this age group.

Using Pregabalin Tarbis Farma with other medicines

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

Pregabalin Tarbis Farma and certain other medicines may affect each other (interact). When Pregabalin is used with certain medicines that have sedative effects (including opioids), these effects may be enhanced, leading 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 painkiller)

Lorazepam - (used to treat anxiety)

Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Pregabalin Tarbis Farma with food, drinks, and alcohol

Pregabalin capsules can be taken with or without food.

It is advised not to drink alcohol while taking Pregabalin.

Pregnancy and breastfeeding

Do not take Pregabalin during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause birth defects 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 birth defects. This compares with 4 babies out of 100 born to women who were not treated with pregabalin in the study. Abnormalities have been reported in the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals.

A reliable method of contraception should be used in women of childbearing potential. 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 Tarbis Farma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine the appropriate dose for you.

Pregabalin Tarbis Farma is for oral use only.

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

• Take the number of capsules 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 Tarbis Farma either twice or three times a day. For twice daily, take Pregabalin Tarbis Farma once in the morning and once in the evening, at approximately the same time every day. For three times a day, take Pregabalin Tarbis Farma in the morning, at noon, and in the evening, at approximately the same time every day.

If you think that the effect of Pregabalin Tarbis Farma 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 Tarbis Farma normally, except if 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 Pregabalin Tarbis Farma until your doctor tells you to stop.

If you take more Pregabalin Tarbis Farma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the emergency department of the nearest hospital, taking the pack with you, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

As a result of taking more Pregabalin Tarbis Farma than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

If you forget to take Pregabalin Tarbis Farma

It is important that you take your Pregabalin Tarbis Farma 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 time for your next dose. In this case, continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Tarbis Farma

Do not stop taking Pregabalin Tarbis Farma unless your doctor tells you to. If you are going to stop taking the treatment, this should be done gradually over a minimum of one week.

Once you have stopped taking Pregabalin Tarbis Farma, either after a short or long treatment period, you should know that you may experience certain side effects. These include sleep disturbances, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have been taking Pregabalin Tarbis Farma for a longer period.

If you have any further questions on 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, changes in sexual appetite, irritability
• Alteration of attention, clumsiness of movement, deterioration of memory, memory loss, tremors, difficulty speaking, sensation of tingling, 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
• Swelling of the body including limbs
• Feeling of drunkenness, alterations in gait
• Weight gain
• Muscle cramp, joint pain, back pain, pain in limbs
• Sore throat

Uncommon: may affect up to 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar levels, 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 deterioration, difficulty thinking, problems with sexual relationships 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, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation
• Alterations in heart rhythm, 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, heartburn, numbness around the mouth
• Sweating, rash, chills, fever
• Muscle spasms, swollen joints, 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, hives, 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, altered depth perception, visual glare, loss of vision
• 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 alterations in heart rhythm
• 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, not raised, 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 (yellow color 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 Pregabalina Tarbis Farma ('drug dependence').

After stopping short-term or long-term treatment with Pregabalina Tarbis Farma, you should know that you may experience certain side effects, called withdrawal effects (see "If you stop taking Pregabalina Tarbis Farma").

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.

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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pregabalina Tarbis Farma

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 or on the bottle after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, it must be used within 3 months.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in 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 Pregabalina Tarbis Farma

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

The other ingredients are: mannitol, cornstarch, talc, gelatin, titanium dioxide (E171), shellac, iron oxide black (E172), propylene glycol, and potassium hydroxide.

Appearance of Pregabalina Tarbis Farma and Package Contents

Hard gelatin capsules containing a white to off-white powder.

The hard capsules are white, approximately 14.4 mm x 5.3 mm, with "138" marked on the capsule cap and "J" on the body.

This medicine is available in blister packs of PCV Aluminum or Aluminum/Aluminum of 7, 14, 21, 28, 50, 56, 84, 98, 100, 100x1, 112, 168, 200, and 500 capsules.

It is also available in HDPE bottles of 60, 200, and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medicine is authorized in the Member States of the European Economic Area with the following names:

NL Pregabaline Amarox 25 mg hard capsule

DE Pregabalin Amarox 25 mg hard capsules

ES Pregabalina Tarbis Farma 25 mg hard capsules EFG

Date of the last revision of this leaflet:May 2024

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