Pregabalin Viatris Pharma

Patient Information Leaflet

Pregabalin Viatris Pharma 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains

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

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

Pregabalin Viatris Pharma 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 Pharma 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 warmth, burning, pulsing, throbbing pain, shooting pain, acute 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 (tiredness), and can impact physical and social activities and overall quality of life.
Epilepsy: Pregabalin Viatris Pharma is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Viatris Pharma to help manage your epilepsy when your current treatment is not adequately controlling your condition. You must take Pregabalin Viatris Pharma in addition to your existing treatment. Pregabalin Viatris Pharma is not used as monotherapy but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin Viatris Pharma is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of being tense or on edge, easy fatigability (tiredness), difficulty concentrating or mental blanks, irritability, muscle tension, or sleep disturbances. These conditions are different from the stress and pressures of everyday life.

2. What you need to know before taking Pregabalin Viatris Pharma

Do not take Pregabalin Viatris Pharma
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 Pharma.

• In some patients treated with Pregabalin Viatris Pharma, 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, contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Discontinue pregabalin and contact your doctor immediately if you experience any symptoms related to these serious skin reactions, described in section 4.
• Pregabalin Viatris Pharma 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 are familiar with the effects this medicine may have on you.
• Pregabalin Viatris Pharma may cause blurred vision, loss of vision, or other visual disturbances, many of which are transient. If you experience any changes in vision, contact your doctor immediately.
• In some diabetic patients who gain weight during pregabalin treatment, adjustment of diabetes medications may be necessary.
• Some side effects, such as somnolence, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have side effects similar to those of pregabalin, and 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 Pharma; most of these patients were elderly with cardiovascular diseases. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
• Cases of renal failure have been reported in some patients treated with Pregabalin Viatris Pharma. If during treatment with Pregabalin Viatris Pharma you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• Some patients treated with antiepileptic medicines such as Pregabalin Viatris Pharma have experienced suicidal thoughts and self-harming thoughts (hurting oneself), or have shown suicidal behavior. If at any time you have such thoughts or behaviors, contact your doctor immediately.
• When Pregabalin Viatris Pharma is used together with other medicines that may 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 alcohol, prescription medicine, or illegal substance abuse or dependence, as this may indicate that you are at higher risk of becoming dependent on Pregabalin Viatris Pharma.
• Seizures have been reported when taking Pregabalin Viatris Pharma 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 Pharma 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 neurological disorders, respiratory conditions, impaired kidney 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 Pharma (i.e., feel the need to continue taking the medicine). They may experience withdrawal symptoms when they stop using Pregabalin Viatris Pharma (see section 3, “How to take Pregabalin Viatris Pharma” and “If you stop taking Pregabalin Viatris Pharma”). If you are concerned about the possibility of developing dependence on Pregabalin Viatris Pharma, talk to your doctor.
If you notice any of the following signs while taking Pregabalin Viatris Pharma, 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 the 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, consult your doctor to discuss the best treatment approach for you, including when and how to safely discontinue the medicine.

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 Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin Viatris Pharma and other medicines may interact with each other. When Pregabalin Viatris Pharma is taken together with other medicines that have sedative effects (including opioids), these effects may be enhanced and may lead to respiratory failure, coma, and death. The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin Viatris Pharma is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
Pregabalin Viatris Pharma may be taken together with oral contraceptives.

Pregabalin Viatris Pharma with food, drinks, and alcohol
Pregabalin Viatris Pharma capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin Viatris Pharma.

Pregnancy and breastfeeding
Pregabalin Viatris Pharma should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise.
The use of pregabalin during the first three months of pregnancy may cause congenital malformations in the newborn requiring medical treatment. In a study examining data from Nordic women who took pregabalin during the first three 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 the 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Pregabalin Viatris Pharma 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.

Pregabalin Viatris Pharma contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

Pregabalin Viatris Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e., it is essentially “sodium-free.”

3. How to take Pregabalin Viatris Pharma

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.
Pregabalin Viatris Pharma 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 appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day.
• Your doctor will instruct you to take Pregabalin Viatris Pharma two or three times a day. If you take the medicine twice daily, take Pregabalin Viatris Pharma 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 Pharma 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 Pharma 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 Pharma as directed, unless you have kidney problems.
Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin Viatris Pharma until your doctor tells you to stop treatment.

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

If you forget to take Pregabalin Viatris Pharma
It is important to take Pregabalin Viatris Pharma 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 that case, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin Viatris Pharma
Do not stop taking Pregabalin Viatris Pharma suddenly. If you wish to stop taking Pregabalin Viatris Pharma, speak to your doctor first. Your doctor will advise you on how to do this.
If treatment is to be stopped, it should be gradually tapered over a period of at least 1 week.

You should know that after stopping long-term or short-term treatment with Pregabalin Viatris Pharma, you may experience certain side effects, known as withdrawal effects. These effects include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, restlessness, 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 Pharma 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 sexual interest, irritability.
• Attention disorders, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling unwell.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea and abdominal distension.
• 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 self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased sexual interest, including inability to reach orgasm, delayed ejaculation.
• Visual disturbances, eye movement abnormalities, visual alterations including tubular vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement-related tremor, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling of malaise.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disturbances (flushing), hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensitivity 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, 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 visual field oscillation, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatic inflammation.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disorders.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Interrupted 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 breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated red patches on the trunk, target-shaped or circular rashes, often with central blisters, skin exfoliation, 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, 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 (liver inflammation).

Not known: frequency cannot be estimated from the available data

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

After stopping short-term or long-term treatment with Pregabalin Viatris Pharma, you should be aware that you may experience certain side effects, known as withdrawal effects (see “If you stop taking Pregabalin Viatris Pharma”).
If you experience swelling of the face or tongue, or if you develop skin redness with the onset of blisters and skin peeling, seek immediate medical attention.
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 side effects similar to those of 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:
respiratory difficulties, shallow breathing.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 Pharma

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 bottle. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Pregabalin Viatris Pharma 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: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E171),
sodium lauryl sulfate, anhydrous colloidal silica, black ink (containing shellac, black iron oxide (E172),
propylene glycol, potassium hydroxide) and purified water.
The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172).

Pregabalin Viatris Pharma is available in seven PVC packages with an aluminium-coated side:
one package containing 14 capsules in 1 blister, one package containing 21 capsules in 1 blister,
one package containing 56 capsules in 4 blisters, one package containing 84 capsules in 4 blisters,
one package containing 100 capsules in 10 blisters, one package containing 112 capsules in 8
blisters, and one package containing 100 capsules x 1 in the form of unit-dose divisible blisters.
Pregabalin Viatris Pharma is also available in HDPE bottles containing 200 capsules for the strengths
of 25 mg, 75 mg, 150 mg and 300 mg.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, The Netherlands
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg im Breisgau, Germany
or
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900 Hungary
For further information on this medicinal product, please contact the local representative of the
Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Viatris Viatris
Tél/Tel: +32 (0)2 658 61 00 UAB
Tel: +370 52051288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: +32 (0)2 658 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 Limited
Tlf: +45 28 11 69 32 Tel: (+356) 21 200 174
Deutschland Nederland
Viatris Healthcare GmbH Mylan Healthcare BV
Tel: +49 (0)800 0700 800 Tel: +31 (0)20 426 3300
Eesti Norge
Viatris 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 Viatris Healthcare, Lda.
Tél: +33 (0)4 37 25 75 00 Tel: +351 21 412 72 00
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Pharma S.r.l. Viatris Oy
Tel: +39 02 612 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 18711600
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.