Pregabalin Viatris

Patient Information Leaflet: Information for the User

Pregabalin Viatris 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

pregabalin
Please read this leaflet carefully before 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 side 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 Generalised Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin Viatris is used to treat chronic pain caused by
damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes
or herpes zoster. Pain sensations may be described as heat, burning, throbbing, pulsating pain, shooting
pain, sharp pain, cramping pain, discomfort, tingling, numbness, or stabbing pain. Peripheral and
central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, and
can impact physical and social activities and overall quality of life.
Epilepsy: Pregabalin Viatris is used to treat certain types of epilepsy in adults (partial seizures with
or without secondary generalisation). Your doctor will prescribe Pregabalin Viatris to help manage your
epilepsy when your current treatment does not adequately control your condition. You will need to take
Pregabalin Viatris in addition to your existing treatment. Pregabalin Viatris is not used as monotherapy,
but must always be used in combination with other antiepileptic treatments.
Generalised Anxiety Disorder: Pregabalin Viatris is used to treat Generalised Anxiety Disorder (GAD).
Symptoms of Generalised Anxiety Disorder are characterised by excessive and prolonged anxiety and worry
that are difficult to control. Generalised Anxiety Disorder may also cause restlessness or a feeling of
tension or being on edge, easy fatigability, difficulty in concentrating or memory lapses, irritability,
muscle tension, or sleep disturbances. These conditions are different from the stress and strains of
everyday 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 taking Pregabalin Viatris.

• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Discontinue use of pregabalin and contact your doctor immediately if you experience any symptoms related to these severe skin reactions, as described in section 4.
• In some patients treated with Pregabalin Viatris, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these reactions occur, you must contact your doctor 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 or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbance, you should contact your doctor immediately.
• In diabetic patients who gain weight during treatment with pregabalin, adjustment of antidiabetic medications may be necessary.
• Some 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, which have similar adverse effects to pregabalin; the severity of these effects may increase when these medicines are taken together.
• Cases of heart failure have been reported in some patients treated with Pregabalin Viatris; most of these patients were elderly and had cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with this medicine, you must inform your doctor.
• 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 urination, inform your doctor, as discontinuing use of this medicine may improve this condition.
• Some patients taking antiepileptic medicines such as Pregabalin Viatris have experienced suicidal thoughts and self-harming thoughts (hurting oneself), or have shown suicidal behaviour. At any time if you have such thoughts or exhibit such behaviour, contact your doctor immediately.
• When used together with other medicines that can cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g. constipation, bowel obstruction or paralytic ileus) may occur. Inform your doctor if you experience constipation, especially if you are prone to this condition.
• Before taking this medicine, inform your doctor if you have a history of abuse or dependence on alcohol, prescription medicines, or illegal substances, as this may indicate that you are at higher risk of becoming dependent on Pregabalin Viatris.
• Seizures have been reported when taking Pregabalin Viatris or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking Pregabalin Viatris when they have other medical conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have occurred. If you have nervous system disorders, respiratory disorders, impaired renal function, or are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.

Dependence
Some people may become dependent on Pregabalin Viatris (i.e., feel the need to continue 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 the possibility of developing dependence on Pregabalin Viatris, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Viatris, you may have developed dependence on the medicine:

• You feel the need to take the medicine longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons different from those for which it was 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 when you start taking it again. If you notice any of these signs, talk to your doctor to discuss the best treatment approach for you, including when and how to safely discontinue use.

Children and adolescents
The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established, 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 take any other medicines.
Pregabalin Viatris and other medicines may interact with each other. When taken together with other medicines that have sedative effects (including opioids), Pregabalin Viatris may enhance these effects and may cause respiratory failure, coma, and death.
The intensity 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 for the treatment of anxiety)
• Alcohol

Pregabalin Viatris can be taken at the same time as oral contraceptives.
Pregabalin Viatris with food, drink, and alcohol
Pregabalin Viatris capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Viatris.
Pregnancy and breastfeeding
Pregabalin Viatris should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. Use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital malformations, compared with 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (oro-facial clefts), eye, nervous system (including brain), kidney, and genital abnormalities have been reported.
Women of childbearing potential must use an effective method of contraception. If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Pregabalin Viatris may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform these activities.
Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

3. How to take Pregabalin Viatris

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the dose suitable 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 suitable for you and your condition generally ranges between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregabalin Viatris two or three times a day. If you take the medicine twice daily, take Pregabalin Viatris once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times daily, take Pregabalin Viatris once in the morning, once in the afternoon, and once 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, talk to your doctor or pharmacist.
If you are elderly (aged over 65 years), you should normally take Pregabalin Viatris as directed, unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or a different dose if you have kidney problems. Swallow the capsule whole with water.
Continue taking Pregabalin Viatris until your doctor tells you to stop treatment.

If you take more Pregabalin Viatris than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the pack of Pregabalin Viatris capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more Pregabalin Viatris than you should have. Seizures and loss of consciousness (coma) have also been reported.

If you forget to take Pregabalin Viatris
It is important to take Pregabalin Viatris capsules regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Viatris
Do not stop taking Pregabalin Viatris suddenly. If you wish to stop taking Pregabalin Viatris, talk to your doctor first. Your doctor will advise you on how to do this. If treatment is to be stopped, it should be gradually discontinued over a period of at least 1 week.
You should know that after stopping long-term or short-term treatment with Pregabalin Viatris, you may experience some unwanted effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, suicidal or self-harming thoughts, pain, sweating, and dizziness. These effects may occur more frequently or be more severe if you have taken Pregabalin Viatris for a longer period of time. If you experience withdrawal effects, contact your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may occur in more than 1 in 10 people

• Dizziness, drowsiness, headache

Common: may occur in up to 1 in 10 people

• Increased appetite
• Feeling of excitement, confusion, disorientation, decreased interest in sex, irritability
• Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange
• Blurred vision, double vision
• Vertigo, balance disorders, falls
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, and abdominal swelling
• Difficulty in erection
• Swelling of the body, including hands and feet
• Feeling of drunkenness, abnormalities in gait
• Weight gain
• Muscle cramps, joint pain, back pain, limb pain
• Sore throat

Uncommon: may occur in up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Altered perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased interest in sex, sexual problems including inability to reach orgasm, delayed ejaculation
• Visual disturbances, abnormal eye movements, visual alterations including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell
• Dry eyes, eye swelling, eye pain, eye weakness, watery eyes, eye irritation
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heart rate, heart failure
• Vasomotor disturbances (flushing), hot flushes
• Breathing difficulties, dry nose, nasal congestion
• Increased saliva production, heartburn, loss of sensation around the mouth
• Sweating, rash, chills, fever
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or painful urination, incontinence
• Weakness, thirst, chest tightness
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels, decreased potassium levels)
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
• Painful menstrual cycles
• Cold hands and feet

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

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss
• Dilated pupils, strabismus
• Cold sweats, throat tightness, tongue swelling
• Inflammation of the pancreas
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing properly
• Fluid accumulation in the abdomen
• Fluid in the lungs
• Seizures
• Electrocardiogram (ECG) changes corresponding to heart rhythm disorders
• Muscle damage
• Breast discharge, abnormal breast growth, breast enlargement in men
• Disrupted menstrual cycles
• Kidney failure, reduced urine volume, urinary retention
• Reduced white blood cell count
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterised by flat, non-elevated red spots on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth ulcers, 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, i.e. symptoms resembling Parkinson’s disease such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness)

Very rare: may occur in up to 1 in 10,000 people

• Liver failure
• Hepatitis (inflammation of the liver)

Not known: frequency cannot be estimated from the available data

• Becoming dependent on Pregabalin Viatris (“drug dependence”)

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

If you experience swelling of the face or tongue, or if you develop skin redness, blistering, and skin peeling, seek immediate medical advice.

Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to pregabalin, and the severity of these effects may increase when these medicines are taken together.

The following adverse reaction has been reported during the post-marketing phase of the medicine: breathing difficulties, shallow breathing.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 or blister after the wording: EXP. The expiry date refers to the last day of the month.
Blister: Store in the original packaging to protect the medicine from moisture.
Bottle: Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information
What Pregabalin Viatris contains
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 ingredients are: hydroxypropylcellulose, maize starch, talc, gelatin, titanium dioxide (E171), sodium lauryl sulfate, purified water, shellac, black iron oxide (E172), propylene glycol, potassium hydroxide and concentrated ammonia solution, yellow iron oxide (E172) and erythrosine (E127).

Description of the appearance of Pregabalin Viatris and contents of the pack
Hard capsule.

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary

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

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 02 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Tel.: +359 2 44 55 400 Tél/Tel: +32 02 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd.
Tlf: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatros OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Viatris Limited Slovenija
Tel: +353 1 8711600 Viatris d.o.o.
Tel: +386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 (0)2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 1 8711600

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