PREGABALIN 25 mg Hard Capsules

Зміст інструкції

1. 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
   1. What is Pregabalin Viatris Pharma 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

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

Pregabalin Viatris Pharma 300 mg hard capsules
pregabalin

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Pregabalin Viatris Pharma is and what it is used for
• 2. What you need to know before you take 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 is Pregabalin Viatris Pharma 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 heat, burning, throbbing, pulsating, stabbing, sharp, cramp-like, suffering, tingling, numbness ,prickling. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances and fatigue (tiredness) and can impact physical and social activity and overall quality of life.

Epilepsy:Pregabalin Viatris Pharma is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin Viatris Pharma to help in the treatment of your epilepsy when the treatment you are already receiving does not control the condition. You will need to take Pregabalin Viatris Pharma in addition to the treatment you are already undergoing. Pregabalin Viatris Pharma is not used alone, but must always be combined with other antiepileptic treatments.

Generalized Anxiety Disorder:Pregabalin Viatris Pharma is used for the treatment of Generalized Anxiety Disorder (GAD). The symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder can also cause restlessness or a feeling of tension or being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension or sleep disturbances. These conditions are different from the stress and tensions 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 indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with pregabalin. Stop using pregabalin and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, as described in section 4.
• Pregabalin Viatris Pharma has been associated with dizziness and drowsiness, which may increase the risk of accidental injuries (falls) in the elderly. Therefore, you should be careful until you are familiar with the effects the medicine may have on you.
• Pregabalin Viatris Pharma can cause blurred or loss of vision or other changes in vision, many of which are transient. If you experience any changes in vision, contact your doctor immediately.
• In some patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust diabetes medications.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of pregabalin and the severity of these effects may increase when these medicines are taken together.
• There have been reports of heart failure in some patients treated with Pregabalin Viatris Pharma; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatmentwith this medicine you must inform your doctor.
• There have been reports of kidney failure in some patients treated with Pregabalin Viatris Pharma. If you notice a decrease in urination during treatment with Pregabalin Viatris Pharma, you should inform your doctor because stopping the use of this medicine may improve this condition.
• Some patients taking antiepileptic medicines such as Pregabalin Viatris Pharma have experienced suicidal thoughts and self-harm (hurting themselves), or have shown suicidal behavior. At any time if you have thoughts or show behavior of this type, contact your doctor immediately.
• When Pregabalin Viatris Pharma is used together with other medicines that can cause constipation (such as some types of pain medications), gastrointestinal problems (e.g., constipation, blocked or paralyzed bowel) may occur. Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine, tell your doctor if you have a history of alcohol, prescription drug, or illegal substance abuse, as this may indicate that you are at higher risk of becoming dependent on Pregabalin Viatris Pharma.
• Cases of seizures have been reported when taking Pregabalin Viatris Pharma or shortly after its discontinuation. If you experience seizures, contact your doctor immediately.
• Cases of decreased brain function (encephalopathy) have occurred in some patients taking Pregabalin Viatris Pharma when they have other conditions. Tell your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of difficulty breathing have occurred. If you suffer from nervous system diseases, respiratory diseases, kidney impairment, or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Tell your doctor if you have difficulty breathing or are breathing shallowly.

Dependence
Some people may become dependent on Pregabalin Viatris Pharma (i.e., feel the
need to continue taking the medicine). They may experience withdrawal effects 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 a 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 a dependence on the medicine:

• You feel the need to take the medicine for longer than recommended by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine, you do not feel well 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 plan for you, including when it is appropriate to stop taking it and how to do so safely.

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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Pregabalin Viatris Pharma and other medicines can influence each other (interaction). When
Pregabalin Viatris Pharma is taken together with other medicines that have sedative
effects (including opioids), it can enhance these effects and may cause respiratory failure,
coma and death. The intensity of dizziness, drowsiness and decreased concentration
may increase if Pregabalin Viatris Pharma is taken together with other medicines containing:
Oxycodone – (used as a pain reliever)
Lorazepam – (used to treat anxiety)
Alcohol
Pregabalin Viatris Pharma can be taken at the same time as oral contraceptives.

Pregabalin Viatris Pharma with food, beverages and alcohol
Pregabalin Viatris Pharma capsules can 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 breastfeeding, unless your
doctor has told you otherwise.
The use of pregabalin during the first 3 months of pregnancy may cause birth defects in
the newborn that require medical care. In a study that examined data from women in the
Nordic countries who had taken pregabalin during the first 3 months of pregnancy, 6 children out of 100 had
such birth defects, compared to 4 children out of 100 born to women not treated with
pregabalin in the study. Anomalies of the face (orofacial clefts), eyes, the
nervous system (including the brain), kidneys and genitals have been reported.
Women of childbearing potential should use an effective method of contraception. If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Pregabalin Viatris Pharma can cause dizziness, drowsiness and decreased concentration. Do
not drive, operate complex machinery or engage in potentially dangerous activities until
you have ascertained whether this medicine alters your ability to perform these activities.

Pregabalin Viatris Pharma contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact him 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. Do not take more medicine than prescribed.
The doctor will establish 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 varies between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregabalin Viatris Pharma two or three times a day. If you take the medicine twice a day, take Pregabalin Viatris Pharma once in the morning and once in the evening, always at approximately the same time. If you take the medicine three times a day, take Pregabalin Viatris Pharma once in the morning, once in the afternoon and once in the evening, always at approximately the same time.

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 (over 65 years of age), you should take Pregabalin Viatris Pharma as normal
unless you have kidney problems.
The doctor may prescribe you a different dosage and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue to take Pregabalin Viatris Pharma until your doctor tells you to stop the
treatment.

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

If you forget to take Pregabalin Viatris Pharma
It is important to take the 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 if you have not already taken it
unless it is time to take the next dose. In this case, take the next dose as
scheduled. Do not take a double dose to make up for the forgotten dose.

If you stop taking Pregabalin Viatris Pharma
Do not suddenly stop taking Pregabalin Viatris Pharma. If you want to stop
taking Pregabalin Viatris Pharma, talk to your doctor first. They will explain how to do it.
If the treatment is stopped, the discontinuation must be done gradually over
at least 1 week.
You should know that after discontinuation of long and short-term treatment with Pregabalin Viatris
Pharma, you may experience some undesirable effects, the so-called withdrawal effects. These effects
include, sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures,
nervousness, depression, suicidal or self-harm thoughts, pain, sweating and dizziness. These
effects may occur more frequently or severely if you have taken Pregabalin Viatris Pharma
for a longer period of time. If you experience withdrawal effects, you should 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 everyone gets 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 excitement, confusion, disorientation, decreased libido, irritability.
• Difficulty with concentration, clumsiness, impaired memory, 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, diarrhea, nausea and abdominal bloating.
• Difficulty with erection.
• Swelling of the body, including hands and feet.
• Feeling of intoxication, abnormalities in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in the limbs.
• Sore throat.

Uncommon: may affect 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 with ideation, increased sexual interest, including inability to reach orgasm, delayed ejaculation
• Changes in vision, abnormalities in eye movement, changes in vision including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell
• Dry eyes, swollen eyes, eye pain, eye weakness, watery eyes, eye irritation
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure,
• Vasomotor disorders (flushing), hot flashes
• Difficulty breathing, dry nose, nasal congestion,
• Increased saliva production, heartburn, loss of sensitivity around the mouth
• Sweating, rash, chills, fever
• Muscle contractions, swollen joints, muscle stiffness, pain including muscle pain, neck pain
• Breast pain
• Difficulty or pain when urinating, incontinence
• Weakness, thirst, feeling of tightness in the chest
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased creatinine, reduced potassium levels.
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, coughing, snoring,
• Painful menstrual cycles
• Cold hands and feet

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

• Alteration of smell, sensation of visual field oscillation, altered depth perception, visual brilliance, loss of vision
• Dilated pupils, strabismus,
• Cold sweats, feeling of constriction in the throat, swelling of the tongue
• Inflammation of the pancreas
• Difficulty swallowing
• Slowed or reduced body movement
• Difficulty writing properly
• Increased fluid in the abdomen
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disorders.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast growth in men
• Interrupted menstrual cycles
• Kidney failure, reduced urine volume, urinary retention,
• Reduced white blood cell count
• Inappropriate behavior, suicidal behavior, suicidal thoughts
• Allergic reactions, which may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by reddish, non-elevated patches on the trunk, shaped like targets or circles, often with central blisters, skin exfoliation, ulcers of the mouth, 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 similar to Parkinson's disease such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness).

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

• Liver failure.
• Hepatitis (inflammation of the liver).

Not known: frequency cannot be estimated based on available data

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

After stopping short- or long-term treatment with Pregabalin Viatris Pharma, you should
know that you may experience some side effects, so-called withdrawal effects (see
“If you stop taking Pregabalin Viatris Pharma”).

In case of swelling of the face or tongue, or in case of redness of the skin and the onset of
blisters and skin exfoliation, seek immediate medical attention.
Some side effects, such as drowsiness, may be more common because patients with
spinal cord injury may be treated with 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 in the post-marketing phase of the medicine:
difficulty breathing, shallow breaths.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed 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 which is stated on the pack or the 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 in waste water 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 Pharma contains
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 ingredients are: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E171),
sodium lauryl sulfate, colloidal anhydrous silica, black ink (contains 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 blister packs with one side covered in aluminium:
a pack of 14 capsules containing 1 blister, a pack of 21 capsules containing 1 blister,
a pack of 56 capsules containing 4 blisters, a pack of 84 capsules containing 4 blisters,
a pack of 100 capsules containing 10 blisters, a pack of 112 capsules containing 8
blisters and a pack of 100 capsules x 1 in the form of unit-dose divisible blisters.
Pregabalin Viatris Pharma is also available in an HDPE bottle containing 200 capsules for the dosages
of 25 mg, 75 mg, 150 mg and 300 mg.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, 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
Authorisation Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: +32 (0)2 658 61 00

Lietuva
Viatris
UAB
Tel: +370 52051288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Limited
Tel: (+356) 21 200 174

Nederland
Mylan Healthcare BV
Tel: +31 (0)20 426 3300

Deutschland
Viatris Healthcare GmbH
Tel: +49 (0)800 0700 800

Norge
Viatris AS
Tlf: +47 66 75 33 00

Eesti
Viatris OÜ
Tel: +372 6363 052

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

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

Polska
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00

Portugal
Viatris Healthcare, Lda.
Tel: +351 21 412 72 00

France
Viatris Santé
Tél: +33 (0)4 37 25 75 00

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

Slovenija
Viatris d.o.o.
Tel: +386 1 236 31 80

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Pharma S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
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 .