PREGABALIN VIATRIS 50 mg HARD CAPSULES

2. What you need to know before taking Pregabalin Viatris

Do not take Pregabalin Viatris

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

Warnings and precautions

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

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
• Some patients treated with Pregabalin 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 rash. If you experience any of these symptoms, you should immediately consult your doctor.
• Pregabalin Viatris has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you are familiar with the effects that the medicine may have.
• Pregabalin Viatris may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should immediately inform your doctor.
• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medications.
• Certain side effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medications for treatment, for example, for pain or spasticity, with similar side effects to those of Pregabalin, so the intensity of these effects may increase when taken together.
• Cases of heart failure have been reported in some patients treated with Pregabalin Viatris. Most of them were elderly patients with cardiovascular diseases. Before using this medicine, you should inform your doctor if you have a history of heart disease.
• Cases of renal failure have been reported in some patients treated with Pregabalin Viatris. If you notice a decrease in your ability to urinate during treatment with Pregabalin Viatris, you should inform your doctor, as discontinuation of treatment may improve this situation.
• Some patients treated with antiepileptics, such as Pregabalin Viatris, have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you present these thoughts or have shown such behavior, contact your doctor as soon as possible.
• When Pregabalin Viatris is taken with other medications that can cause constipation (such as some types of pain medications), gastrointestinal problems (such as 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, prescription medications, or illegal drugs; you may be at a higher risk of becoming dependent on Pregabalin Viatris.
• Cases of seizures have been reported during treatment with Pregabalin Viatris or shortly after discontinuation of treatment with Pregabalin Viatris. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients who were taking Pregabalin Viatris and had other diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, renal 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 Viatris (need to continue taking the medicine). They may experience withdrawal effects when they stop taking Pregabalin Viatris (see section 3, "How to take Pregabalin Viatris" and "If you stop taking Pregabalin Viatris"). If you are concerned that you may become dependent on Pregabalin Viatris, it is important that you consult your doctor.

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

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

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 it safely.

Children and adolescents

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

Other medicines and Pregabalin Viatris

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

Pregabalin Viatris and certain medicines may interact with each other (interactions). When Pregabalin Viatris is used with certain sedative medicines (including opioids), these effects may be enhanced, and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if Pregabalin Viatris is taken with other medicines that contain:

• Oxycodone - (used as a pain reliever)
• Lorazepam - (used to treat anxiety)
• Alcohol

Pregabalin Viatris can be taken with oral contraceptives.

Taking Pregabalin Viatris with food, drinks, and alcohol

Pregabalin Viatris capsules can be taken with or without food.

It is recommended not to drink alcohol during treatment with Pregabalin Viatris.

Pregnancy and breastfeeding

You should not take Pregabalin Viatris 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 congenital malformations in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares to 4 babies out of 100 born to women not treated with pregabalin in the study. Congenital malformations of the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals have been reported.

An effective contraceptive method should be used in women of childbearing age. 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 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 medicine affects your ability to perform these activities.

Sodium

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

3. How to take Pregabalin Viatris

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

Your doctor will determine the dose that is right for you.

Pregabalin Viatris is for oral use only.

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

• Take the number of capsules that your doctor has indicated.
• 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 indicate that you take Pregabalin Viatris twice or three times a day. In the case of twice a day, take Pregabalin Viatris once in the morning and once in the evening, approximately at the same time every day. In the case of three times a day, take Pregabalin Viatris in the morning, at noon, and in the evening, approximately at the same time every day.

If you think the effect of Pregabalin Viatris is too strong or too weak, tell your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Pregabalin Viatris 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 Viatris until your doctor tells you to stop.

If you take more Pregabalin Viatris than you should

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

If you forget to take Pregabalin Viatris

It is important that you take the Pregabalin Viatris capsules regularly at the same time 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 as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Pregabalin Viatris

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

Once you have finished a short or long-term treatment with Pregabalin Viatris, you should be aware that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling of anxiety, diarrhea, flu-like symptoms, seizures, nervousness, 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 Viatris for a longer period. If you experience withdrawal effects, you should consult your doctor.

If you have any other 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 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, decreased sexual appetite, irritability.
• Attention alteration, movement clumsiness, 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 with erection.
• Body swelling including extremities.
• Feeling of intoxication, gait disturbances.
• Weight gain.
• Muscle cramp, 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 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, increased sexual appetite, sexual relationship problems 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, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, eye swelling, eye pain, tired eyes, teary eyes, eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.
• Flushing, hot flashes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, 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 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, depth perception alteration, 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 heart rhythm disturbances.
• 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, which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by reddish patches or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. 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, 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 Viatris ("drug dependence").

Once you have finished a short or long-term treatment with Pregabalina Viatris, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Pregabalina Viatris").

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

Certain adverse 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 adverse effects to those of pregabalin, so the intensity of these effects may increase when taken together.

The following adverse effects have been reported in post-marketing experience: breathing difficulties, 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 that does not appear in this prospectus. 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 Viatris

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

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

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

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

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pregabalina Viatris

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

The other components are: hydroxypropylcellulose, cornstarch, 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 Pregabalina Viatris and Package Contents

Hard capsule.

Some package sizes may only 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 trade name 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Spain

Viatris Pharmaceuticals, S.L.

Tel: + 34 900 102 712

Date of the last revision of this prospectus: February 2024

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