Pregabalin Viatris 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pregabalin Viatris 25 mg hard capsules EFG

Pregabalin Viatris 50 mg hard capsules EFG

Pregabalin Viatris 75 mg hard capsules EFG

Pregabalin Viatris 100 mg hard capsules EFG

Pregabalin Viatris 150 mg hard capsules EFG

Pregabalin Viatris 200 mg hard capsules EFG

Pregabalin Viatris 225 mg hard capsules EFG

Pregabalin Viatris 300 mg hard capsules EFG

pregabalin

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pregabalin Viatris contains the active substance pregabalin, which 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 Viatris 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 warmth, burning, throbbing, shooting, stabbing, sharp pain, spasms, continuous pain, tingling, numbness, and pins-and-needles 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 Viatris is used in the treatment of certain types of epilepsy (partial seizures with or without secondary generalization) in adults. Your doctor will prescribe Pregabalin Viatris when your current treatment does not adequately control your condition. You should take Pregabalin Viatris as an add-on to your current therapy. Pregabalin Viatris must not be used alone, but always in combination with other antiepileptic treatments.

Generalized anxiety disorder: Pregabalin Viatris is used to treat 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 stresses and strains of life.

2. What you need to know before taking Pregabalin Viatris

Do not take Pregabalin Viatris

• 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 to take Pregabalin Viatris.

• 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.
• Some patients treated with Pregabalin Viatris have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of a widespread skin rash. If you experience any of these symptoms, you must seek medical help immediately.
• Pregabalin 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 this medicine may have on you.
• Pregabalin Viatris may cause blurred vision, vision loss, or other changes in eyesight, many of which are transient. If you experience any changes in your vision, 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 somnolence, may be more frequent because patients with spinal cord injury may be taking other medications for conditions such as pain or spasticity, which have similar adverse effects to Pregabalin, thereby increasing the intensity of these effects when taken together.
• Cases of heart failure have been reported in some patients treated with Pregabalin Viatris. 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 Pregabalin Viatris. If during treatment with Pregabalin Viatris you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.
• Some patients treated with antiepileptic medicines such as Pregabalin Viatris have had thoughts of harming themselves or of suicide, or have exhibited suicidal behaviour. If at any time you experience such thoughts or have exhibited such behaviour, contact your doctor as soon as possible.
• When Pregabalin Viatris 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 or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on Pregabalin Viatris.
• Cases of seizures during treatment with Pregabalin Viatris or shortly after stopping treatment have been reported. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking Pregabalin Viatris who also had other medical conditions. 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 impairment, 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 Pregabalin Viatris (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Pregabalin Viatris (see section 3, “How to take Pregabalin Viatris” and “If you stop taking Pregabalin Viatris”). If you are concerned about possibly becoming dependent on Pregabalin Viatris, it is important to 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 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, speak with 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), and therefore 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 might need to take any other medicines.

Pregabalin Viatris and certain medicines may interact with each other. When Pregabalin Viatris is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced, potentially leading to respiratory failure, coma, and death. The degree of dizziness, somnolence, and reduced concentration may increase if Pregabalin Viatris is taken together with other medicines containing:

• Oxycodone – (used as an analgesic)
• 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.

You are advised 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 specifically 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, compared with 4 out of every 100 babies born to women not treated with pregabalin in the study. Malformations reported include facial clefts, eye, nervous system (including the brain), kidney, and genital abnormalities.

An effective method of contraception should be used in women of childbearing potential. 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 reduced concentration. You should 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.

Sodium

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

3. How to take Pregabalin Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 Viatris is for oral use only.

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

• Take the number of capsules prescribed by your doctor.
• The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg daily.
• Your doctor will instruct you to take Pregabalin Viatris two or three times a day. If twice daily, take Pregabalin Viatris once in the morning and once in the evening, approximately at the same time each day. If three times daily, take Pregabalin Viatris in the morning, at midday, and in the evening, approximately at the same time each day.

If you feel that the effect of Pregabalin Viatris 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 Viatris as normal, 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 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 department immediately. Take the pack 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 Pregabalin Viatris 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 nearly time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Pregabalin Viatris

Do not stop taking Pregabalin Viatris suddenly. If you wish to stop taking Pregabalin Viatris, speak to your doctor first. Your doctor will advise you on how to do this. If you are going to stop treatment, it should be done gradually over a minimum of one week.

After stopping short-term or long-term treatment with Pregabalin Viatris, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, feeling anxious, diarrhoea, 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 Viatris 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 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 sexual drive, irritability.
• Attention disturbances, 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 limbs.
• Feeling of drunkenness, disturbances in gait.
• Weight gain.
• Muscle cramp, 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.
• Change 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 relations 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 during movement, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, swollen eyes, 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, 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 cold in hands and feet.

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

• Altered sense of smell, flickering vision, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis (inflammation of the pancreas).
• Difficulty swallowing.
• Slowed 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 behaviors, suicidal thoughts.
• Allergic reactions, which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by flat, non-elevated red patches or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and ulcers in the 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 Pregabalina Viatris ("drug dependence").

After stopping short-term or long-term treatment with Pregabalina Viatris, you should be aware that you may experience certain adverse effects known as withdrawal effects (see "If you stop taking Pregabalina Viatris").

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

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

Reporting of adverse effects:

If you experience any adverse effects, 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 Viatris

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Vial: Keep the vial tightly closed to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Pregabaline Viatris

The active substance 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: hydroxypropyl cellulose, corn starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, shellac lacquer, black iron oxide (E172), propylene glycol, potassium hydroxide, concentrated ammonia solution, yellow iron oxide (E172) and erythrosine (E127).

Appearance of Pregabaline Viatris and contents of the pack

Hard capsule.

Some pack sizes may not 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 trading as 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Spain

Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

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

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