Label: information for the user

Pregabalina Viatris 25mg hard EFG capsules

Pregabalina Viatris 50mg hard EFG capsules

Pregabalina Viatris 75mg hard EFG capsules

Pregabalina Viatris 100mg hard EFG capsules

Pregabalina Viatris 150mg hard EFG capsules

Pregabalina Viatris 200mg hard EFG capsules

Pregabalina Viatris 225mg hard EFG capsules

Pregabalina Viatris 300mg hard EFG capsules

pregabalina

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What is Pregabalina Viatris and for what it is used

2.What you need to know before starting to take Pregabalina Viatris

3.How to take Pregabalina Viatris

4.Possible adverse effects

5.Storage of Pregabalina Viatris

6.Contents of the package and additional information

Pregabalina Viatris contains the active ingredient pregabalin, which belongs to a group of medicines used for the treatment of epilepsy, peripheral and central neuropathic pain, and generalized anxiety disorder (GAD) in adults.

Peripheral and central neuropathic pain:Pregabalina Viatris is used for the treatment of chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles. Peripheral and central neuropathic pain could also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

Epilepsy:Pregabalina Viatris is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalina Viatris to treat epilepsy when your current treatment does not control the disease. You must take Pregabalina Viatris in addition to your current treatment. Pregabalina Viatris should not be administered alone, but always used in combination with other antiepileptic treatments.

Generalized anxiety disorder:Pregabalina Viatris is used in the treatment of generalized anxiety disorder (GAD). The symptoms of GAD are excessive and prolonged anxiety and worry that are difficult to control. GAD can also produce restlessness or feeling of excitement or nervousness, feeling easily fatigued (tired), difficulty concentrating or mind going blank, irritability, muscle tension, or sleep disturbances. This is different from everyday life stress and tensions.

Do not take Pregabalina Viatris

• If you are allergic to pregabalin or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pregabalina Viatris.

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.
• Some patients treated with Pregabalina Viatris 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 diffuse skin rash. If you experience any of these symptoms, you should seek medical attention immediately.
• Pregabalina Viatris 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 medication.
• Pregabalina Viatris may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.
• Patients with diabetes who gain weight while taking pregabalin may need to adjust 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 pain or spasticity with similar adverse effects, so the intensity of these effects may increase when taken together.
• There have been reports of heart failure in some patients treated with Pregabalina Viatris. Most of them were elderly patients with cardiovascular disease.Before using this medication, you should inform your doctor if you have a history of heart disease.
• There have been reports of renal insufficiency in some patients treated with Pregabalina Viatris. If during treatment with Pregabalina Viatris you notice a decrease in your ability to urinate, you should inform your doctor, as discontinuing treatment may improve this situation.
• Some patients taking antiepileptic medications, such as Pregabalina Viatris, have reported thoughts of self-harm or suicide or have shown suicidal behavior. If you experience any of these thoughts or behaviors, you should contact your doctor as soon as possible.
• When Pregabalina Viatris is taken with other medications that may cause constipation (such as certain types of pain medications), it may be possible to experience gastrointestinal problems (such as constipation and intestinal blockage or paralysis). Inform your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may indicate that you have a higher risk of becoming dependent on Pregabalina Viatris.
• There have been reports of seizures during treatment with Pregabalina Viatris or shortly after discontinuing treatment with Pregabalina Viatris. If you experience seizures, you should contact your doctor immediately.
• There have been reports of encephalopathy (brain dysfunction) in some patients taking Pregabalina Viatris and having other underlying diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of respiratory difficulty. If you have neurological disorders, respiratory disorders, kidney insufficiency, 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 Pregabalina Viatris (need to continue taking the medication). They may experience withdrawal effects when they stop using Pregabalina Viatris (see section3, “How to take Pregabalina Viatris” and “If you interrupt treatment with Pregabalina Viatris”). If you are concerned that you may become dependent on Pregabalina Viatris, you should consult your doctor.

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

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

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

Children and adolescents

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

Other medications and Pregabalina Viatris

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

Pregabalina Viatris and certain medications may exert a mutual influence on each other (interactions). When Pregabalina Viatris is used with certain medications that have a sedative effect (including opioids), these effects may be potentiated, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Pregabalina Viatris is taken with other medications that contain:

• Oxycodone– (used as an analgesic)
• Lorazepam– (used to treat anxiety)
• Alcohol

Pregabalina Viatris can be taken with oral contraceptives.

Taking Pregabalina Viatris with food, drinks, and alcohol

Pregabalina Viatris capsules can be taken with or without food.

It is recommended not to take alcohol during treatment with Pregabalina Viatris.

Pregnancy and breastfeeding

You should not take Pregabalina Viatris during pregnancy or lactation, unless your doctor has told you to.Pregabalin use during the first 3 months of pregnancy may cause congenital anomalies 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 out of 100 babies had such congenital anomalies. This contrasts with 4 out of 100 babies born to women not treated with pregabalin in the study. Congenital anomalies reported include facial clefts, eye abnormalities, neurological system abnormalities (including the brain), kidney abnormalities, and genital abnormalities.

A reliable contraceptive method should be used in women of childbearing age. If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Pregabalina Viatris may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Pregabalina Viatris is exclusively for oral use.

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

• Take the number of capsules indicated by your doctor.
• The dose, adjusted for you and your condition, will generally be between 150mg and 600mg per day.
• Your doctor will tell you to take Pregabalina Viatris two or three times a day. In the case of two times a day, take Pregabalina Viatris once in the morning and once at night, approximately at the same hour every day. In the case of three times a day, take Pregabalina Viatris in the morning, at noon, and at night, approximately at the same hour every day.

If you estimate that the action of Pregabalina Viatris is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65years old), take Pregabalina Viatris normally, except if you have kidney problems.

Your doctor may prescribe another dosing regimen or different doses if you have kidney problems.

Swallow the entire capsule with water.

Continue taking Pregabalina Viatris until your doctor tells you to stop.

If you take more Pregabalina Viatris than you should

Call your doctor or go to the nearest emergency service immediately. Bring the package or bottle of Pregabalina Viatris capsules with you. As a result of taking more Pregabalina Viatris than you should, you may feel drowsy, confused, agitated, or restless. Seizures have also been reported.

If you forget to take Pregabalina Viatris

It is essential to take Pregabalina Viatris capsules regularly at the same hour every day. If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose. In that case, continue with the next dose normally. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pregabalina Viatris

Do not stop taking Pregabalina Viatris suddenly. If you want to stop taking Pregabalina Viatris, talk to your doctor first. He will tell you how to do it. If you are going to stop treatment, this should be done gradually over a minimum of one week.

Once a short- or long-term treatment with Pregabalina Viatris is completed, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include sleep problems, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking Pregabalina Viatris for a longer period. If you experience withdrawal effects, see your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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.
• Euphoria, confusion, disorientation, decreased sexual desire, irritability.
• Alteration of attention, clumsiness of movement, deterioration of memory, memory loss, tremors, difficulty speaking, sensation of numbness, tingling, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.
• Difficulty with erection.
• Swelling of the body including extremities.
• Sensation of intoxication, alterations in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in extremities.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar, high blood sugar.
• 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, increased sexual desire, sexual dysfunction including inability to achieve orgasm, delayed ejaculation.
• Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, sensation of burning, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.
• Dry eyes, swollen eyes, eye pain, tired eyes, watery eyes, eye irritation.
• Changes 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, burning, 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 urinating, inability to hold urine.
• Weakness, thirst, chest oppression.
• Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood).
• Hypersensitivity, swollen face, itching, urticaria, runny nose, nasal bleeding, cough, snoring.
• Painful menstrual periods.
• Sensation of cold in hands and feet.

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

• Altered sense of smell, oscillating vision, alteration of depth perception, visual brightness, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat oppression, swollen tongue.
• Pancreatitis.
• Difficulty swallowing.
• Reduced mobility of the body.
• Difficulty writing correctly.
• Fluid accumulation in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to alterations in heart rhythm.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual interruption.
• Renal insufficiency, reduced urine output, urinary retention.
• Decreased white blood cell count.
• Inappropriate behavior, suicidal behavior, suicidal thoughts.
• Allergic reactions, which may include difficulty breathing, conjunctivitis, and severe skin reactions characterized byflat, red patches or circular patches 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).
• Icterus (yellow 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 insufficiency.
• Heptatitis (inflammation of the liver).

Frequency not known: cannot be estimated from available data

• Becoming dependent on Pregabalina Viatris (“drug dependence”).

Once a short- or long-term treatment with Pregabalina Viatris is completed, you should know that you may experience certain side effects, called withdrawal effects (see “If you stop taking Pregabalina Viatris”).

If you experience swelling in the face or tongue, or if your skin becomes red and blisters or peels, you should seek immediate medical attention.

Certain side 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, with similar side effects to pregabalin, so the intensity of these side effects may increase when taken together.

The following adverse reactions have been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Blister pack:Store in the original packaging to protect it from moisture.

Bottle:Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Pregabalin Viatris

The active ingredient is pregabalin. Each hard capsule contains 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg or 300mg of pregabalin.

The other components are: hydroxypropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate,purified water,Shellac lacquer, iron oxide black (E172),propylene glycol, potassium hydroxide, concentrated ammonia solution, iron oxide yellow (E172) and erythrosine (E127).

Appearance of Pregabalin Viatris and packaging contents

Hard capsule.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Manufacturer

Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary

McDermott Laboratories Limited under the commercial name of Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Logiters, Logistica, Portugal, S.A., Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Spain

Viatris Pharmaceuticals, S.L.

Phone:+ 34 900 102 712

Last review date of this leaflet: February 2024

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.